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Der GKV-Spitzenverband hat am 27. April 2026 Beschlüsse nach § 35 Abs. 5a SGB V zur Wiederanwendung von Festbeträgen für Fertigarzneimittel der Festbetragsgruppe Protonenpumpenhemmer (Gruppe 1) gefasst. Die Beschlüsse des GKV-Spitzenverbandes treten am 15. Juni 2026 in Kraft. Gegen diese Beschlüsse kann innerhalb eines Monats nach Bekanntgabe beim Landessozialgericht Berlin-Brandenburg Försterweg 2-6 14482 Potsdam schriftlich, in elektronischer Form oder zur Niederschrift des Urkundsbeamten der Geschäftsstelle Klage erhoben werden. Die Erläuterungen und Servicedateien stehen auf der Website des GKV-Spitzenverbandes zum Download bereit.

Im Dezember 2025 verabschiedeten Europäisches Parlament und Rat eine Überarbeitung der EUDR. Die Verordnung gilt ab dem 30. Dezember 2026 für große und mittlere Unternehmen sowie Kleinst- und Kleinunternehmen der Holzbranche und ab dem 30. Juni 2027 für andere Kleinst- und Kleinunternehmen (KMU). Um die Umsetzung zu vereinfachen, wurde gestern ein aktualisierter Leitfaden sowie ein neues FAQ-Dokument veröffentlicht, die von den Interessenträgern am häufigsten angesprochenen Themen und präzisieren und die Verpflichtungen für die nachgelagerte Lieferkette als auch die vereinfachten Regelungen für KMU erläutern. Ergänzend veranschaulichen aktualisierte EUDR-Infografiken anhand praktischer Beispiele unterschiedliche Lieferkettenszenarien. Die Dokumente wurden mit den Mitgliedstaaten im Hinblick auf eine harmonisierte Durchsetzung innerhalb der EU abgestimmt. Zudem wird ein neuer delegierten Rechtsakt vorgeschlagen, der gezielte Änderungen des Anwendungsbereichs der EUDR vorsieht. Vorgeschlagen werden u.a. Ergänzungen zu bestimmten nachgelagerten Produkten wie Palmölderivate sowie verschiedene Ausnahmen zu denen u.a. Produktmuster, bestimmte Papier-Verpackungsmaterialien und Marketingmaterialien zählen. Der Entwurf steht bis zum 1. Juni 2026 zur öffentlichen Stellungnahme offen. Mitgliedsfirmen, die eine Kommentierung über Pharma Deutschland einreichen möchten, werden bis spätestens Dienstag, den 26. Mai 2026 um eine Rückmeldung gebeten. Der Rechtsakt wird den Mitgliedstaaten zur Zustimmung vorgelegt. Parallel wird ebenfalls das Informationssystem aktualisiert, um die Überarbeitung abzubilden und Benutzerfreundlichkeit zu verbessern.

1 Stakeholders’ targeted consultation about EU4Health work programme 2027 Fields marked with * are mandatory. Name email Stakeholders’ targeted consultation EU4Health work programme 2027 The EU4Health Programme, adopted in March 2021, is the response to the COVID-19 pandemic and aims to build a strong European Health Union by supporting legislative and non-legislative Union health priorities. Health is a vital investment and the EU4Health programme represents an unprecedented level of EU financial support in the health area, with an initial budget of EUR 5.3 billion for the 2021-27 period, subsequently adjusted to EUR 4.6 billion following the revision of the 2021-2027 Multiannual Financial Framework. The European Commission is building a strong European Health Union, in which all EU countries prepare and respond together to health crises, medical supplies are available, affordable and innovative, and countries work together to improve prevention, treatment and aftercare for diseases such as cancer or cardiovascular diseases. This targeted consultation is intended to seek the opinion of stakeholders about current and future Union health priorities and strategic orientations on key health needs to be addressed through the EU4Health work programme 2027. The results will be compiled in a summary stakeholders’ consultation report (see the report on stakeholders' consultation conducted in 2025 – ).link For further information please read the consultation strategy ( ).link This targeted consultation will be available from 4 May to 12 June 2026. Please read carefully the privacy statement ( ) before proceeding.link   * * https://health.ec.europa.eu/document/download/b11138ee-903e-4b15-8b35-9672b3df842e_en?filename=funding_eu4health_2025-consultation_report_en.pdf https://ec.europa.eu/eusurvey/files/925d9e59-1df4-455f-a060-bccd03fe6f0d/7c599adc-1b82-428c-be0e-5e388dd90ef9 https://ec.europa.eu/eusurvey/files/925d9e59-1df4-455f-a060-bccd03fe6f0d/d5c35bb7-a368-4060-96cf-3e109617b526 2 About your organisation 1. Please indicate the Member State or associated country you are located in, if applicable. If not applicable, please select "Other non-EU country" Select the country Austria Belgium Bulgaria Croatia Cyprus Czechia Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovak Republic Slovenia Spain Sweden Norway Iceland Ukraine Moldova Montenegro Bosnia and Herzegovina Serbia Other non-EU country * 3 If you are located in a non-EU country, please specify the country. 2. These comments represent the views of: Please choose only one from the list below. Academia or education establishments Civil society organisations (associations, foundations, NGOs, professional organisations and similar entities) Established networks in the field of health (e.g., one of the European Reference Networks) Healthcare professional Hospitals Individual Member States’ authorities (national, regional, local) Patient organisations Primary care delivery organisation Private entities (profit or non-profit) Research institutes Other If you have chosen 'Other', please specify. Please indicate the full name of the organisation. 3. Has your organisation been a beneficiary of the EU4Health Programme so far? Yes No Do not know/Not relevant Did you previously apply for funding from the EU4Health Programme? Yes, but was not selected No EU4Health work programme 2027 – strategic orientations and priorities * * * * 4 The EU4Health Programme (Regulation (EU) 2021/522) was adopted in March 2021. So far, five work programmes were adopted between 2021 and 2025. The adoption process of the work programme 2026 is ongoing. These work programmes have covered relevant areas of interventions for achieving the general and specific objectives of the EU4Health Regulation. 4. For simplification and to provide a high-level framing, the actions in the EU4Health work programmes were clustered in 'strands of actions'. In your view, how effectively does each strand allocate resources to  Please address both current and future health needs while maintaining balance across priorities? see the consultation strategy ( ) for the description of the strands.link Please score from one to five : 1 = Least effective to  5 = Most effective. Each score can only be used once 1 2 3 4 5 Strand of action 01: Crisis preparedness Strand of action 02: Health promotion and disease prevention Strand of action 03: Health systems and healthcare workforce Strand of action 04: Digital Transformation Strand of action 05: Cancer, cardiovascular and other NCDs 5. In your opinion, in which area of prevention, preparedness and response to cross-border threats to health there is a need for action through EU4Health? Respiratory or contact-based viruses with pandemic potential Vector-borne or animal-reservoir viruses with epidemic potential Antimicrobial resistance * * * * * * https://health.ec.europa.eu/document/download/cd36b495-db10-4e16-9210-205939b2d3a0_en?filename=funding_eu4health-awp-2024survey_cs_en.pdf 5 Armed conflict related threats and chemical, biological, radiological and nuclear (CBRN) threats Other Please specify if "Other" 100 character(s) maximum 6. In which area there is a need for action by EU4Health for improving health promotion and disease prevention? Mental health initiatives Prevention and reduction of tobacco use Vaccination Reducing harmful use of alcohol Other Please specify if "Other" 100 character(s) maximum 7. How can EU4Health strengthen healthcare systems and healthcare workforce to better respond to patients' needs? Enhancing healthcare workforce training Increasing cross-border collaborations (e.g. patients accessing healthcare in another EU Member State) Ensuring available and affordable medicinal products, medical devices and crisis-relevant products Improving accessibility of healthcare Other Please specify if "Other" 100 character(s) maximum 8. In your opinion, in which area of digital health there is a need for action through EU4Health? Rights of patients under the European Health Data Space Application/ Use of Artificial Intelligence in healthcare Uptake of the European Health Record exchange Format Use of health data by researchers and innovators Other Please specify if "Other" 100 character(s) maximum * * * 6 9. In your opinion, in which area of cancer, cardiovascular and other non-communicable diseases there is a need for action through EU4Health? Support the uptake of cancer screening activities Support cancer treatment activities Support cardiovascular disease prevention Support cardiovascular disease treatment Other Please specify if "Other" 100 character(s) maximum 10. In your opinion, which areas covered by the EU4Health Programme support best Europe's competitiveness? Between 2 and 3 selections Actions on disease prevention, health promotion and for addressing health determinants (including cancer) Supporting global commitments and health initiatives Strengthening the capability for prevention, preparedness, and response to cross-border threats to health Complementing national stockpiling on essential crisis relevant products Training a reserve of medical, healthcare and support staff Improving the availability, accessibility and affordability of medicinal products, medical devices and crisis- relevant products Improving health data and promoting the uptake of digital tools and services and the digital transformation of healthcare systems (including through Artificial Intelligence) Improving access to quality, patient-centred, outcome-based healthcare and related care services Other Please specify if "Other" 100 character(s) maximum 11. In your view, which areas of innovation require priority action under EU4Health to foster health advancements? Between 2 and 3 selections Biotechnology applications Digital health technologies Personalised medicine Health system integration Advanced therapeutics * * * 7 Digital health & AI Other Please specify if "Other" 100 character(s) maximum 12. In your opinion, where does the EU4Health Programme bring the most added value for the European citizens? Promoting collaboration between Member States (e.g., via Joint Actions) Enabling the preparedness and response to serious-cross border health threats Tackling current and future health priorities (e.g. mental health, cancer, aging, etc.) Implementing actions on health legislation (e.g. European Health Data Space, health technology assessment) Support to the European Reference Networks Other Please specify if "Other" 100 character(s) maximum 13. What do you consider the most pressing health needs that the EU4Health Programme unmet should address? Between 2 and 3 selections Chronic disease management Access to healthcare services Health inequalities New and emerging diseases Rare diseases Mental health Cardiovascular diseases Antimicrobial resistance Access to medical countermeasures Pandemic preparedness Chemical, biological, radiological and nuclear (CBRN) threats Other Please specify if "Other" 100 character(s) maximum * * 8 14. What (would have) happened to your action/ project, without European-level funding through the EU4Health Programme? Likely funded by a public source at national or regional level, without any major changes in scope, duration or level of ambition Likely funded by a private source at national or regional level, without any major changes in scope, duration or level of ambition Likely funded (by either a public or private source), but with a substantial reduction in scope, duration or level of ambition No funding secured (by either a public or private source), but would have taken place later No funding secured, and would not have taken place at all Likely funded by another EU programme, without any major changes in scope, duration or level of ambition Other Please specify if "Other" 100 character(s) maximum 15. What should be the primary focus of the EU4Health Programme in 2027? 2000 character(s) maximum 16. From your point of view, what are the major priorities not yet addressed by EU4Health work programmes? 2000 character(s) maximum * * * 9

Die Europäische Kommission hat eine Konsultation zu den künftigen Prioritäten der EU-Gesundheitspolitik gestartet. Ziel ist es, fundierte Beiträge für die Ausarbeitung des EU4Health-Arbeitsprogramms 2027 zu sammeln. Interessierte Akteure aus dem Gesundheitsbereich sind eingeladen, ihre Perspektiven und Empfehlungen einzubringen. Im Mittelpunkt der Konsultation stehen fünf zentrale Themenfelder: Krisenvorsorge und der Umgang mit grenzüberschreitenden Gesundheitsbedrohungen, Gesundheitsförderung und Prävention, die Stärkung von Gesundheitssystemen und Fachkräften, die digitale Transformation sowie die Bekämpfung von Krebs, Herz-Kreislauf-Erkrankungen und anderen nichtübertragbaren Krankheiten. Die Konsultation läuft noch bis zum 12. Juni 2026. Unterhalb dieses Artikels stellen wir Ihnen den Fragebogen, der online ausgefüllt werden muss, zur Ansicht zur Verfügung. Die eingegangenen Beiträge werden in einem zusammenfassenden Bericht ausgewertet und auf der EU4Health-Website veröffentlicht. Gerne können Sie Ihre Antworten auch an Anna Wehage ( wehage@pharmadeutschland.de ) senden. Bei ausreichender Rückmeldung werden wir uns an der Konsultation beteiligen. Hintergrund: Das EU4Health-Programm wurde im März 2021 verabschiedet und verfolgt das Ziel, eine starke Europäische Gesundheitsunion aufzubauen. Dazu gehört insbesondere, dass die EU-Mitgliedstaaten gemeinsam auf Gesundheitskrisen reagieren, die Versorgung mit medizinischen Produkten sichern und die Zusammenarbeit bei Prävention, Behandlung und Versorgung von Patientinnen und Patienten stärken. Für das Finanzierungsinstrument wurde den Zeitraum 2021–2027 ursprünglich ein Budget von 5,3 Milliarden Euro vorgesehen, das im Zuge der Überarbeitung des Mehrjährigen Finanzrahmens auf 4,6 Milliarden Euro angepasst wurde.

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged. 04 May 2026 EMA/PRAC/89531/2026 Human Medicines Division Pharmacovigilance Risk Assessment Committee (PRAC) Draft agenda for the meeting on 04-07 May 2026 Chair: Ulla Wändel Liminga – Vice-Chair: Liana Martirosyan 04 May 2026, 13:00 – 19:30, room 2C 05 May 2026, 08:30 – 19:30, room 2C 06 May 2026, 08:30 – 19:30, room 2C 07 May 2026, 08:30 – 16:00, room 2C Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, this agenda is a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006 Rev.1). http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000508.jsp&mid=WC0b01ac0580028d2a https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/output-european-medicines-agency-policy-access-documents-related-medicinal-products-human-veterinary_en.pdf Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 2/58 Table of contents 1. Introduction 10 1.1. Welcome and declarations of interest of members, alternates and experts .......... 10 1.2. Agenda of the meeting on 04-07 May 2026 .......................................................... 10 1.3. Minutes of the previous meeting on 07-10 April 2026 .......................................... 10 2. EU referral procedures for safety reasons: urgent EU procedures 10 2.1. Newly triggered procedures ................................................................................. 10 2.2. Ongoing procedures ............................................................................................. 10 2.3. Procedures for finalisation.................................................................................... 10 3. EU referral procedures for safety reasons: other EU referral procedures 10 3.1. Newly triggered procedure ................................................................................... 10 3.2. Ongoing procedures ............................................................................................. 10 3.3. Procedures for finalisation.................................................................................... 11 3.4. Re-examination procedures .................................................................................. 11 3.5. Others .................................................................................................................. 11 4. Signals assessment and prioritisation 11 4.1. New signals detected from EU spontaneous reporting systems and/or other sources ............................................................................................................................. 11 4.1.1. Alprazolam (NAP); amitriptyline hydrochloride / medazepam (NAP); amitriptyline / chlordiazepoxide (NAP); bromazepam (NAP); bromazepam / propantheline bromide (NAP); brotizolam (NAP); chlordiazepoxide (NAP); chlordiazepoxide / clidinium bromide (NAP); cinolazepam (NAP); clidinium bromide / diazepam (NAP); clobazam (NAP); cyclobarbital calcium / diazepam (NAP);clonazepam (NAP); clotiazepam (NAP); cloxazolam (NAP); delorazepam (NAP); diazepam (NAP); diazepam / gamma-amino-beta-hydroxybutyric acid (NAP); diazepam / isopropamide iodide (NAP); diazepam / octatropine methylbromide (NAP); diazepam / otilonium bromide (NAP); diazepam / sulpiride (NAP); diazepam / sulpiride / pyridoxine hydrochloride (NAP); estazolam (NAP); ethyl loflazepate (NAP); etizolam (NAP); flunitrazepam (NAP); flurazepam (NAP); ketazolam (NAP); loprazolam (NAP); lorazepam (NAP); lormetazepam (NAP); medazepam (NAP); mexazolam (NAP); midazolam - BUCCOLAM (CAP), NAP; nitrazepam (NAP); nordazepam (NAP); oxazepam (NAP); pinazepam (NAP); prazepam (NAP); remimazolam – BYFAVO (CAP), NAP; temazepam (NAP); tofisopam (NAP); trimebutine maleate / medazepam (NAP) ................................................................... 11 4.1.2. Amoxicillin (NAP); amoxicillin/clavulanic acid (NAP) ..................................................... 12 4.1.3. Dapagliflozin – EDISTRIDE (CAP); DAPAGLIFLOZIN VIATRIS (CAP); FORXIGA (CAP), NAP; dapagliflozin / metformin – EBYMECT (CAP), XIGDUO (CAP), NAP; dapagliflozin / saxagliptin – QTERN (CAP); dapagliflozin/sitagliptin (NAP) ............................................................... 12 4.1.4. Exenatide – BYDUREON (CAP), BYETTA (CAP); insulin icodec / semaglutide - KYINSU (CAP); semaglutide – KAYSHILD (CAP), OZEMPIC (CAP), RYBELSUS (CAP), WEGOVY (CAP), WEGOVY FLEXTOUCH (CAP) ................................................................................................... 12 4.1.5. Ixekizumab - TALTZ (CAP) ........................................................................................ 12 4.1.6. Semaglutide – OZEMPIC (CAP), RYBELSUS (CAP), WEGOVY (CAP), WEGOVY FLEX TOUCH (CAP), KAYSHILD (CAP); insulin icodec / semaglutide - KYINSU (CAP) ........................... 13 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 3/58 4.1.7. Tocilizumab – AVTOZMA (CAP); RoACTEMRA (CAP); TOCILIZUMAB STADA (CAP); TUYORY(CAP); TYENNE (CAP) ................................................................................... 13 4.2. Signals follow-up and prioritisation ...................................................................... 13 4.2.1. Pancreatin (NAP) ..................................................................................................... 13 4.3. Variation procedure(s) resulting from signal evaluation ...................................... 13 5. Risk management plans (RMPs) 14 5.1. Medicines in the pre-authorisation phase ............................................................. 14 5.1.1. Arimoclomol (CAP MAA) - EMEA/H/C/006736, Orphan .................................................. 14 5.1.2. Azacitidine (CAP MAA) - EMEA/H/C/006695 ................................................................ 14 5.1.3. Cefepime / Zidebactam (CAP MAA) - EMEA/H/C/006799 ............................................... 14 5.1.4. Icotrokinra hydrochloride (CAP MAA) - EMEA/H/C/006730 ............................................ 14 5.1.5. Obicetrapib (CAP MAA) - EMEA/H/C/006516 ............................................................... 14 5.1.6. Obicetrapib / Ezetimibe (CAP MAA) - EMEA/H/C/006517 ............................................... 14 5.1.7. Ranibizumab (CAP MAA) - EMEA/H/C/006527.............................................................. 14 5.1.8. Ranibizumab (CAP MAA) - EMEA/H/C/006926.............................................................. 15 5.1.9. Ruxolitinib hemifumarate (CAP MAA) - EMEA/H/C/006618 ............................................ 15 5.1.10. Senaparib (CAP MAA) - EMEA/H/C/006708 ................................................................. 15 5.1.11. Sufentanil / Ketamine (CAP MAA) - EMEA/H/C/006395, PUMA ....................................... 15 5.1.12. Tafamidis (CAP MAA) - EMEA/H/C/006711 .................................................................. 15 5.1.13. Trilaciclib (CAP MAA) - EMEA/H/C/006709 .................................................................. 15 5.2. Medicines in the post-authorisation phase – PRAC-led procedures ....................... 16 5.2.1. Atazanavir – REYATAZ (CAP); Atazanavir / Cobicistat – EVOTAZ (CAP) – EMA/VR/0000288444 ............................................................................................................................. 16 5.2.2. Lecanemab – LEQEMBI (CAP) – EMA/VR/0000302769 .................................................. 16 5.2.3. Pegcetacoplan – ASPAVELI (CAP) – EMA/VR/0000333829 ............................................. 16 5.3. Medicines in the post-authorisation phase – CHMP-led procedures ...................... 16 5.3.1. Abiraterone acetate – ABIRATERONE MYLAN (CAP); NAP – EMA/VR/0000291298 ............ 16 5.3.2. Adalimumab – IMRALDI (CAP) – EMA/X/0000321285 ................................................... 17 5.3.3. Alemtuzumab – LEMTRADA (CAP) – EMA/VR/0000335041 ............................................ 17 5.3.4. Apixaban – ELIQUIS (CAP) – EMA/VR/0000327005 ...................................................... 17 5.3.5. Atidarsagene autotemcel – LIBMELDY (CAP) – EMA/VR/0000334917 .............................. 18 5.3.6. Belimumab – BENLYSTA (CAP) – EMA/VR/0000306408 ................................................ 18 5.3.7. Belzutifan – WELIREG (CAP); Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000313634 19 5.3.8. Belzutifan – WELIREG (CAP) – EMA/VR/0000326853 .................................................... 19 5.3.9. Cabotegravir – VOCABRIA (CAP) – EMA/VR/0000332087 .............................................. 19 5.3.10. Cabotegravir – APRETUDE (CAP) – EMA/VR/0000331993 .............................................. 20 5.3.11. Cetuximab – ERBITUX (CAP) – EMA/VR/0000326978 ................................................... 20 5.3.12. Cetuximab – ERBITUX (CAP) – EMA/VR/0000327014 ................................................... 20 5.3.13. COVID-19 mRNA vaccine – SPIKEVAX (CAP) – EMA/VR/0000335829 ............................. 20 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 4/58 5.3.14. Damoctocog alfa pegol – JIVI (CAP) – EMA/VR/0000326847 ......................................... 21 5.3.15. Deferasirox – EXJADE (CAP) – EMA/VR/0000333352 .................................................... 21 5.3.16. Difelikefalin – KAPRUVIA (CAP) – EMA/VR/0000316094 ................................................ 22 5.3.17. Dimethyl fumarate – TECFIDERA (CAP) – EMA/VR/0000320745 .................................... 22 5.3.18. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000312495........................................ 22 5.3.19. Epcoritamab – TEPKINLY (CAP) – EMA/VR/0000311043 ............................................... 23 5.3.20. Filgotinib – JYSELECA (CAP) – EMA/VR/0000325892 .................................................... 23 5.3.21. Florbetapir (18F) – AMYVID (CAP) – EMA/VR/0000333287 ............................................ 23 5.3.22. Formoterol / Glycopyrronium bromide / Budesonide – RILTRAVA AEROSPHERE (CAP) – EMA/X/0000287672 ................................................................................................. 24 5.3.23. Formoterol / Glycopyrronium bromide / Budesonide – TRIXEO AEROSPHERE (CAP) – EMA/X/0000287664 ................................................................................................. 24 5.3.24. Glecaprevir / Pibrentasvir – MAVIRET (CAP) – EMA/VR/0000316551 .............................. 24 5.3.25. Glofitamab – COLUMVI (CAP) – EMA/VR/0000327100 .................................................. 25 5.3.26. Glycopyrronium – SIALANAR (CAP) – EMA/X/0000287532 ............................................ 25 5.3.27. Inclisiran – LEQVIO (CAP) – EMA/VR/0000293324 ....................................................... 25 5.3.28. Ipilimumab – YERVOY (CAP); Nivolumab – OPDIVO (CAP) – EMA/VR/0000319172........... 26 5.3.29. Lacosamide – LACOSAMIDE UCB (CAP); VIMPAT (CAP) – EMA/VR/0000321459 ............... 26 5.3.30. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000327013........................................... 26 5.3.31. Octreotide – OCZYESA (CAP) – EMA/VR/0000333073 ................................................... 27 5.3.32. Pegvaliase – PALYNZIQ (CAP) – EMA/VR/0000302032 .................................................. 27 5.3.33. Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000316576 .......................................... 27 5.3.34. Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000312515 .......................................... 28 5.3.35. Ponatinib – ICLUSIG (CAP) – EMA/X/0000296489 ........................................................ 28 5.3.36. Rucaparib – RUBRACA (CAP) – EMA/VR/0000332297 ................................................... 29 5.3.37. Sacituzumab govitecan – TRODELVY (CAP) – EMA/VR/0000312649 ............................... 29 5.3.38. Secukinumab – COSENTYX (CAP) – EMA/VR/0000326984 ............................................ 29 5.3.39. Serplulimab – HETRONIFLY (CAP) – EMA/VR/0000290021 ............................................ 30 5.3.40. Somapacitan – SOGROYA (CAP) – EMA/VR/0000264734 .............................................. 30 5.3.41. Sotatercept – WINREVAIR (CAP) – EMA/VR/0000315667 .............................................. 31 5.3.42. Tirzepatide – MOUNJARO (CAP) – EMA/VR/0000310637 ............................................... 31 5.3.43. Trastuzumab – ZERCEPAC (CAP) – EMA/X/0000321364 ............................................... 31 5.3.44. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/VR/0000326482 .............................. 31 5.3.45. Upadacitinib – RINVOQ (CAP) – EMA/VR/0000312506 .................................................. 32 5.3.46. Upadacitinib – RINVOQ (CAP) – EMA/VR/0000325958 .................................................. 32 5.3.47. Ustekinumab – USRENTY (CAP) – EMA/VR/0000325350 ............................................... 32 5.3.48. Ustekinumab – STELARA (CAP) – EMA/VR/0000316205 ................................................ 33 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 5/58 6. Periodic safety update reports (PSURs) 33 6.1. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) only .......................................................................................................... 33 6.1.1. Alemtuzumab – LEMTRADA (CAP) – EMA/PSUR/0000321520 ........................................ 33 6.1.2. Amikacin – ARIKAYCE LIPOSOMAL (CAP) – EMA/PSUR/0000321506 .............................. 33 6.1.3. Atogepant – AQUIPTA (CAP) – EMA/PSUR/0000321517 ................................................ 34 6.1.4. Brolucizumab – BEOVU (CAP) – EMA/PSUR/0000321518 .............................................. 34 6.1.5. Chenodeoxycholic acid – CHENODEOXYCHOLIC ACID LEADIANT (CAP) – EMA/PSUR/0000321503 ........................................................................................... 34 6.1.6. Chikungunya vaccine (live) – IXCHIQ (CAP) – EMA/PSUR/0000327923 .......................... 34 6.1.7. Concizumab – ALHEMO (CAP) – EMA/PSUR/0000321510 .............................................. 34 6.1.8. Dibotermin alfa – INDUCTOS (CAP) – EMA/PSUR/0000321514 ...................................... 35 6.1.9. Etrasimod – VELSIPITY (CAP) – EMA/PSUR/0000321519 .............................................. 35 6.1.10. Futibatinib – LYTGOBI (CAP) – EMA/PSUR/0000321515 ................................................ 35 6.1.11. Herpes zoster vaccine (recombinant, adjuvanted) – SHINGRIX (CAP) – EMA/PSUR/0000321507 ........................................................................................... 35 6.1.12. Histamine dihydrochloride – CEPLENE (CAP) – EMA/PSUR/0000321522 .......................... 35 6.1.13. Inavolisib – ITOVEBI (CAP) – EMA/PSUR/0000321509 .................................................. 35 6.1.14. Lasmiditan – RAYVOW (CAP) – EMA/PSUR/0000321508 ............................................... 36 6.1.15. Macitentan / Tadalafil – YUVANCI (CAP) – EMA/PSUR/0000321504 ................................ 36 6.1.16. Maralixibat – LIVMARLI (CAP) – EMA/PSUR/0000321513 .............................................. 36 6.1.17. Marstacimab – HYMPAVZI (CAP) – EMA/PSUR/0000321516 .......................................... 36 6.1.18. Mirikizumab – OMVOH (CAP) – EMA/PSUR/0000321511 ............................................... 36 6.1.19. Nemolizumab – NEMLUVIO (CAP) – EMA/PSUR/0000321530 ......................................... 37 6.1.20. Olipudase alfa – XENPOZYME (CAP) – EMA/PSUR/0000321501 ...................................... 37 6.1.21. Selumetinib – KOSELUGO (CAP) – EMA/PSUR/0000321505 ........................................... 37 6.1.22. Tobramycin – VANTOBRA (CAP) – EMA/PSUR/0000321512 ........................................... 37 6.1.23. Trabectedin – YONDELIS (CAP) – EMA/PSUR/0000321523 ............................................ 37 6.1.24. Vilobelimab – GOHIBIC (CAP) – EMA/PSUR/0000321533 .............................................. 37 6.2. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) and nationally authorised products (NAPs) .............................................. 38 6.2.1. Choriogonadotropin alfa – OVITRELLE (CAP), NAP; Chorionic gonadotrophin (NAP); Human chorionic gonadotropin (NAP) – EMA/PSUR/0000321521 .............................................. 38 6.2.2. Midazolam – BUCCOLAM (CAP); NAP – EMA/PSUR/0000321529 .................................... 38 6.2.3. Sodium oxybate – XYREM (CAP); NAP – EMA/PSUR/0000321502 ................................... 38 6.3. PSUR single assessment (PSUSA) procedures including nationally authorised products (NAPs) only ........................................................................................... 38 6.3.1. Allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) – EMA/PSUR/0000321532 ........................................................................................... 38 6.3.2. Bivalirudin – EMA/PSUR/0000321527 ......................................................................... 39 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 6/58 6.3.3. Lactitol – EMA/PSUR/0000321534 ............................................................................. 39 6.3.4. Lisinopril, lisinopril / hydrochlorothiazide – EMA/PSUR/0000321531 ............................... 39 6.3.5. Progesterone – EMA/PSUR/0000321526 ..................................................................... 39 6.3.6. Silver sulfadiazine – EMA/PSUR/0000321525 .............................................................. 39 6.3.7. Terizidone – EMA/PSUR/0000321528 ......................................................................... 39 6.4. Follow-up to PSUR/PSUSA procedures ................................................................. 40 6.5. Variation procedure(s) resulting from PSUSA evaluation ..................................... 40 6.5.1. Sapropterin – KUVAN (CAP) – EMA/VR/0000301983 .................................................... 40 6.6. Expedited summary safety reviews ...................................................................... 40 7. Post-authorisation safety studies (PASS) 40 7.1. Protocols of PASS imposed in the marketing authorisation(s) .............................. 40 7.1.1. Lecanemab – LEQEMBI (CAP) – EMA/PASS/0000267311 .............................................. 40 7.1.2. Obecabtagene autoleucel – AUCATZYL (CAP) – EMA/PASS/0000300590 ......................... 40 7.1.3. Volanesorsen – WAYLIVRA (CAP) – EMA/PASS/0000334506 .......................................... 41 7.2. Protocols of PASS non-imposed in the marketing authorisation(s) ...................... 41 7.2.1. Abaloparatide – ELADYNOS (CAP) – EMA/PAM/0000281538 .......................................... 41 7.2.2. Garadacimab – ANDEMBRY (CAP) – EMA/PAM/0000267718 .......................................... 41 7.2.3. Tofacitinib – XELJANZ (CAP) – EMA/PAM/0000294280 .................................................. 41 7.3. Results of PASS imposed in the marketing authorisation(s) ................................. 42 7.4. Results of PASS imposed and non-imposed in the marketing authorisation(s) ..... 42 7.4.1. Conestat alfa – RUCONEST (CAP) – EMA/VR/0000326016............................................. 42 7.4.2. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000332196 .......................... 42 7.4.3. Emicizumab – HEMLIBRA (CAP) – EMA/VR/0000302494 ............................................... 42 7.4.4. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000333033........................................ 43 7.4.5. Eslicarbazepine acetate – ZEBINIX (CAP) – EMA/VR/0000332409 .................................. 43 7.4.6. Linaclotide – CONSTELLA (CAP) – EMA/VR/0000281586 ............................................... 43 7.4.7. Ofatumumab – KESIMPTA (CAP) – EMA/VR/0000315689 .............................................. 43 7.4.8. Ropeginterferon alfa-2b – BESREMI (CAP) – EMA/VR/0000332690 ................................ 44 7.4.9. Tacrolimus – ADVAGRAF (CAP); MODIGRAF (CAP); NAP – EMA/VR/0000315125 ............. 44 7.5. Interim results and other post-authorisation measures for imposed and non-imposed studies .................................................................................................................. 44 7.5.1. Abatacept – ORENCIA (CAP) – EMA/PAM/0000334018 ................................................. 44 7.5.2. Abrocitinib – CIBINQO (CAP) – EMA/PAM/0000333269 ................................................. 45 7.5.3. Atogepant – AQUIPTA (CAP) – EMA/PAM/0000334196 ................................................. 45 7.5.4. Atogepant – AQUIPTA (CAP) – EMA/PAM/0000334182 ................................................. 45 7.5.5. Diroximel fumarate – VUMERITY (CAP) – EMA/PAM/0000334226 ................................... 45 7.5.6. Etuvetidigene autotemcel – WASKYRA (CAP) – EMA/PAM/0000334844 ........................... 45 7.5.7. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000323622 ............................................. 46 7.5.8. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000326084 ............................................. 46 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 7/58 7.5.9. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000327550 ............................................. 46 7.5.10. Inotersen – TEGSEDI (CAP) – EMA/PAM/0000326086 .................................................. 46 7.5.11. Iptacopan – FABHALTA (CAP) – EMA/PAM/0000331969 ................................................ 47 7.5.12. Iptacopan – FABHALTA (CAP) – EMA/PAM/0000331978 ................................................ 47 7.5.13. Lasmiditan – RAYVOW (CAP) – EMA/PAM/0000332938 ................................................. 47 7.5.14. Naldemedine – RIZMOIC (CAP) – EMA/PAM/0000320323 .............................................. 47 7.5.15. Niraparib / Abiraterone acetate – AKEEGA (CAP) – EMA/PAM/0000302057 ..................... 47 7.5.16. Risdiplam – EVRYSDI (CAP) – EMA/PAM/0000310307 .................................................. 48 7.5.17. Rurioctocog alfa pegol – ADYNOVI (CAP) – EMA/PAM/0000326983 ................................ 48 7.5.18. Ustekinumab – STELARA (CAP) – EMA/PAM/0000310166 ............................................. 48 8. Renewals of the marketing authorisation, conditional renewal and annual reassessments 48 8.1. Annual reassessments of the marketing authorisation ......................................... 48 8.1.1. Glucarpidase – VORAXAZE (CAP) – EMA/S/0000322329 ............................................... 48 8.1.2. Pegzilarginase – LOARGYS (CAP) – EMA/S/0000326830 ............................................... 49 8.1.3. Susoctocog alfa – OBIZUR (CAP) – EMA/S/0000324538 ............................................... 49 8.1.4. Tabelecleucel – EBVALLO (CAP) – EMA/S/0000326533 ................................................. 49 8.2. Conditional renewals of the marketing authorisation ........................................... 49 8.2.1. Avapritinib – AYVAKYT (CAP) – EMA/R/0000335342 ..................................................... 49 8.2.2. Dorocubicel / Allogeneic umbilical cord-derived CD34- cells, non-expanded – ZEMCELPRO (CAP) – EMA/R/0000333327 ..................................................................................... 49 8.2.3. Elafibranor – IQIRVO (CAP) – EMA/R/0000335590 ....................................................... 50 8.2.4. Epcoritamab – TEPKINLY (CAP) – EMA/R/0000334812 ................................................. 50 8.2.5. Larotrectinib – VITRAKVI (CAP) – EMA/R/0000335017 ................................................. 50 8.2.6. Odronextamab – ORDSPONO (CAP) – EMA/R/0000333139 ........................................... 50 8.2.7. Tafasitamab – MINJUVI (CAP) – EMA/R/0000334308 ................................................... 50 8.3. Renewals of the marketing authorisation ............................................................. 50 8.3.1. Adalimumab – LIBMYRIS (CAP) – EMA/R/0000326540 ................................................. 50 8.3.2. Adalimumab – HUKYNDRA (CAP) – EMA/R/0000326487 ............................................... 51 8.3.3. Diroximel fumarate – VUMERITY (CAP) – EMA/R/0000327345 ....................................... 51 8.3.4. Pegcetacoplan – ASPAVELI (CAP) – EMA/R/0000326756 ............................................... 51 8.3.5. Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) – VAXNEUVANCE (CAP) – EMA/R/0000326976 .............................................................................................. 51 8.3.6. Ripretinib – QINLOCK (CAP) – EMA/R/0000326982 ...................................................... 51 8.3.7. Rivaroxaban – RIVAROXABAN VIATRIS (CAP) – EMA/R/0000327079 .............................. 52 8.3.8. Sacituzumab govitecan – TRODELVY (CAP) – EMA/R/0000326788 ................................. 52 8.3.9. Sugammadex – SUGAMMADEX MYLAN (CAP) – EMA/R/0000327067 .............................. 52 8.3.10. Zanubrutinib – BRUKINSA (CAP) – EMA/R/0000326587 ................................................ 52 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 8/58 9. Product related pharmacovigilance inspections 52 9.1. List of planned pharmacovigilance inspections ..................................................... 52 9.2. Ongoing or concluded pharmacovigilance inspections .......................................... 52 9.3. Others .................................................................................................................. 53 10. Other safety issues for discussion requested by the Member States, CHMP or the EMA 53 11. Scientific advice procedures 53 12. Organisational, regulatory and methodological matters 53 12.1. Mandate and organisation of the PRAC ................................................................. 53 12.1.1. PRAC membership ................................................................................................... 53 12.1.2. Nominated proxy ..................................................................................................... 53 12.2. Coordination with EMA Scientific Committees or CMDh-v ..................................... 53 12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups ......... 53 12.4. Cooperation within the EU regulatory network ..................................................... 53 12.4.1. PRAC strategic review and learning meeting (SRLM) under the Cyprus presidency of the European Union (EU) Council – Pafos, Cyprus, 12 – 13 May 2026 - update ..................... 53 12.5. Cooperation with International Regulators........................................................... 54 12.5.1. International Conference on Harmonisation (ICH) E23 guideline - update ....................... 54 12.6. Contacts of the PRAC with external parties and interaction with the Interested Parties to the Committee ...................................................................................... 54 12.7. PRAC work plan .................................................................................................... 54 12.8. Planning and reporting ......................................................................................... 54 12.8.1. Marketing authorisation applications (MAA) and technology forecast: April 2026 – December 2028 ...................................................................................................................... 54 12.9. Pharmacovigilance audits and inspections ........................................................... 54 12.9.1. Pharmacovigilance systems and their quality systems .................................................. 54 12.9.2. Pharmacovigilance inspections .................................................................................. 54 12.9.3. Pharmacovigilance audits.......................................................................................... 54 12.10. Periodic safety update reports (PSURs) & Union reference date (EURD) list ........ 54 12.10.1. Periodic safety update reports ................................................................................... 54 12.10.2. Granularity and Periodicity Advisory Group (GPAG) ...................................................... 55 12.10.3. PSURs repository ..................................................................................................... 55 12.10.4. Union reference date list – consultation on the draft list ............................................... 55 12.11. Signal management .............................................................................................. 55 12.11.1. Signal management – feedback from Signal Management Review Technical (SMART) Working Group .................................................................................................................... 55 12.12. Adverse drug reactions reporting and additional reporting .................................. 55 12.12.1. Management and reporting of adverse reactions to medicinal products ........................... 55 12.12.2. Additional monitoring ............................................................................................... 55 12.12.3. List of products under additional monitoring – consultation on the draft list .................... 55 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 9/58 12.13. EudraVigilance database ...................................................................................... 55 12.13.1. Activities related to the confirmation of full functionality ............................................... 55 12.14. Risk management plans and effectiveness of risk minimisations ......................... 56 12.14.1. Risk management systems ....................................................................................... 56 12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations .......... 56 12.15. Post-authorisation safety studies (PASS) ............................................................. 56 12.15.1. Post-authorisation Safety Studies – imposed PASS ...................................................... 56 12.15.2. Post-authorisation Safety Studies – non-imposed PASS ................................................ 56 12.16. Community procedures ......................................................................................... 56 12.16.1. Referral procedures for safety reasons ....................................................................... 56 12.17. Renewals, conditional renewals, annual reassessments ....................................... 56 12.18. Risk communication and transparency ................................................................. 56 12.18.1. Public participation in pharmacovigilance .................................................................... 56 12.18.2. Safety communication .............................................................................................. 56 12.19. Continuous pharmacovigilance ............................................................................. 57 12.19.1. Incident management .............................................................................................. 57 12.20. Impact of pharmacovigilance activities ................................................................ 57 12.20.1. Study on the implementation of controlled access to and distribution of medicinal products in EU Member States (SC02/EMA/2020/46/TDA/L4.02) - regulatory follow-up .................... 57 12.21. Others .................................................................................................................. 57 13. Any other business 57 14. Explanatory notes 57 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 10/58 1. Introduction 1.1. Welcome and declarations of interest of members, alternates and experts Pre-meeting list of participants and restrictions in relation to declarations of interests applicable to the items of the agenda for the PRAC plenary session to be held 04-07 May 2026. See April month 2026 PRAC minutes (to be published post June 2026 PRAC meeting). 1.2. Agenda of the meeting on 04-07 May 2026 Action: For adoption 1.3. Minutes of the previous meeting on 07-10 April 2026 Action: For adoption 2. EU referral procedures for safety reasons: urgent EU procedures 2.1. Newly triggered procedures None 2.2. Ongoing procedures None 2.3. Procedures for finalisation None 3. EU referral procedures for safety reasons: other EU referral procedures 3.1. Newly triggered procedure None 3.2. Ongoing procedures None Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 11/58 3.3. Procedures for finalisation None 3.4. Re-examination procedures1 None 3.5. Others None 4. Signals assessment and prioritisation2 4.1. New signals detected from EU spontaneous reporting systems and/or other sources 4.1.1. Alprazolam (NAP); amitriptyline hydrochloride / medazepam (NAP); amitriptyline / chlordiazepoxide (NAP); bromazepam (NAP); bromazepam / propantheline bromide (NAP); brotizolam (NAP); chlordiazepoxide (NAP); chlordiazepoxide / clidinium bromide (NAP); cinolazepam (NAP); clidinium bromide / diazepam (NAP); clobazam (NAP); cyclobarbital calcium / diazepam (NAP);clonazepam (NAP); clotiazepam (NAP); cloxazolam (NAP); delorazepam (NAP); diazepam (NAP); diazepam / gamma-amino-beta-hydroxybutyric acid (NAP); diazepam / isopropamide iodide (NAP); diazepam / octatropine methylbromide (NAP); diazepam / otilonium bromide (NAP); diazepam / sulpiride (NAP); diazepam / sulpiride / pyridoxine hydrochloride (NAP); estazolam (NAP); ethyl loflazepate (NAP); etizolam (NAP); flunitrazepam (NAP); flurazepam (NAP); ketazolam (NAP); loprazolam (NAP); lorazepam (NAP); lormetazepam (NAP); medazepam (NAP); mexazolam (NAP); midazolam - BUCCOLAM (CAP), NAP; nitrazepam (NAP); nordazepam (NAP); oxazepam (NAP); pinazepam (NAP); prazepam (NAP); remimazolam – BYFAVO (CAP), NAP; temazepam (NAP); tofisopam (NAP); trimebutine maleate / medazepam (NAP) Applicants: Neuraxpharm Pharmaceuticals S.L. (Buccolam), Paion Pharma GmbH (Byfavo), various PRAC Rapporteur: To be appointed Scope: Signal on miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations) Action: For adoption of PRAC recommendation EPITT 20272 – New signal Lead Member State(s): DK, PL, SI, NL, FR, FI, ES, BE, IT, HU, MT, AT, DE, PT, SK, IE, EE 1 Re-examination of PRAC recommendation under Article 32 of Directive 2001/83/EC 2 Each signal refers to a substance or therapeutic class. The route of marketing authorisation is indicated in brackets (CAP for Centrally Authorised Products; NAP for Nationally Authorised Products including products authorised via Mutual Recognition Procedures and Decentralised Procedure). Product names are listed for reference Centrally Authorised Products (CAP) only. PRAC recommendations will specify the products concerned in case of any regulatory action required Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 12/58 4.1.2. Amoxicillin (NAP); amoxicillin/clavulanic acid (NAP) Applicants: various PRAC Rapporteur: To be appointed Scope: Signal of encephalopathy Action: For adoption of PRAC recommendation EPITT 20264 – New signal Lead Member States: AT, DE 4.1.3. Dapagliflozin – EDISTRIDE (CAP); DAPAGLIFLOZIN VIATRIS (CAP); FORXIGA (CAP), NAP; dapagliflozin / metformin – EBYMECT (CAP), XIGDUO (CAP), NAP; dapagliflozin / saxagliptin – QTERN (CAP); dapagliflozin/sitagliptin (NAP) Applicants: AstraZeneca AB (Ebymect, Edistride, Forxiga, Qtern, Xigduo), Viatris Limited (Dapagliflozin Viatris), various PRAC Rapporteur: To be appointed Scope: Signal of lichen sclerosus Action: For adoption of PRAC recommendation EPITT 20259 – New signal Lead Member State(s): SE 4.1.4. Exenatide – BYDUREON (CAP), BYETTA (CAP); insulin icodec / semaglutide - KYINSU (CAP); semaglutide – KAYSHILD (CAP), OZEMPIC (CAP), RYBELSUS (CAP), WEGOVY (CAP), WEGOVY FLEXTOUCH (CAP) Applicants: AstraZeneca AB (Bydureon, Byetta), Novo Nordisk A/S (Ozempic, Kayshild, Kyinsu, Rybelsus, Wegovy, Wegovy flextouch) PRAC Rapporteur: To be appointed Scope: Signal of peripheral neuropathies Action: For adoption of PRAC recommendation EPITT 20270 – New signal Lead Member State(s): SE 4.1.5. Ixekizumab - TALTZ (CAP) Applicant: Eli Lilly and Co (Ireland) Limited PRAC Rapporteur: Dirk Mentzer Scope: Signal of Behcet’s syndrome Action: For adoption of PRAC recommendation EPITT 20269 – New signal Lead Member State(s): DE Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 13/58 4.1.6. Semaglutide – OZEMPIC (CAP), RYBELSUS (CAP), WEGOVY (CAP), WEGOVY FLEX TOUCH (CAP), KAYSHILD (CAP); insulin icodec / semaglutide - KYINSU (CAP) Applicant: Novo Nordisk A/S PRAC Rapporteur: To be appointed Scope: Signal of gastrointestinal volvulus Action: For adoption of PRAC recommendation EPITT 20260 – New signal Lead Member State(s): SE 4.1.7. Tocilizumab – AVTOZMA (CAP); RoACTEMRA (CAP); TOCILIZUMAB STADA (CAP); TUYORY(CAP); TYENNE (CAP) Applicants: Celltrion Healthcare Hungary Kft. (Avtozma), Fresenius Kabi Deutschland GmbH (Tyenne), Gedeon Richter (Tuyory), Roche Registration GmbH (RoActemra), STADA Arzneimittel AG (Tocilizumab STADA) PRAC Rapporteur: Dirk Mentzer Scope: Signal of cutaneous vasculitis Action: For adoption of PRAC recommendation EPITT 20261 – New signal Lead Member State(s): DE 4.2. Signals follow-up and prioritisation 4.2.1. Pancreatin (NAP) Applicant(s): various PRAC Rapporteur: Dennis Lex Scope: Signal of infection due to viral transmission Action: For adoption of PRAC recommendation EPITT 20205 – Follow-up to October 2025 4.3. Variation procedure(s) resulting from signal evaluation None Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 14/58 5. Risk management plans (RMPs) 5.1. Medicines in the pre-authorisation phase 5.1.1. Arimoclomol (CAP MAA) - EMEA/H/C/006736, Orphan Scope (pre D-180 phase): Treatment of Niemann-Pick disease type C (NPC) in patients aged 6 months and older in combination with miglustat Action: For adoption 5.1.2. Azacitidine (CAP MAA) - EMEA/H/C/006695 Scope (pre D-180 phase): Treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) Action: For adoption 5.1.3. Cefepime / Zidebactam (CAP MAA) - EMEA/H/C/006799 Scope (pre D-90 phase, accelerated assessment): Treatment of a number of infections in adults Action: For adoption 5.1.4. Icotrokinra hydrochloride (CAP MAA) - EMEA/H/C/006730 Scope (pre D-180 phase): Treatment of plaque psoriasis in adults and adolescents 12 years or older Action: For adoption 5.1.5. Obicetrapib (CAP MAA) - EMEA/H/C/006516 Scope (pre D-180 phase): Treatment of primary hypercholesterolaemia or mixed dyslipidaemia Action: For adoption 5.1.6. Obicetrapib / Ezetimibe (CAP MAA) - EMEA/H/C/006517 Scope (pre D-180 phase): Treatment of primary hypercholesterolaemia or mixed dyslipidaemia Action: For adoption 5.1.7. Ranibizumab (CAP MAA) - EMEA/H/C/006527 Scope (pre D-180 phase): Treatment of neovascular (wet) age-related macular Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 15/58 degeneration (AMD) Action: For adoption 5.1.8. Ranibizumab (CAP MAA) - EMEA/H/C/006926 Scope (pre D-60 phase): Treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to choroidal neovascularisation (CNV) Action: For adoption 5.1.9. Ruxolitinib hemifumarate (CAP MAA) - EMEA/H/C/006618 Scope (pre D-180 phase): Treatment of myelofibrosis (MF), polycythaemia vera (PV) and Graft versus host disease (GvHD) Action: For adoption 5.1.10. Senaparib (CAP MAA) - EMEA/H/C/006708 Scope (pre D-180 phase): Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer Action: For adoption 5.1.11. Sufentanil / Ketamine (CAP MAA) - EMEA/H/C/006395, PUMA Scope (pre D-180 phase): Treatment of acute pain in children aged 1 to less than 18 years. Action: For adoption 5.1.12. Tafamidis (CAP MAA) - EMEA/H/C/006711 Scope (pre D-180 phase): Treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Action: For adoption 5.1.13. Trilaciclib (CAP MAA) - EMEA/H/C/006709 Scope (pre D-180 phase): Prevention of chemotherapy-induced myelosuppression when administered prior to platinum/etoposide- or topotecan-containing regimens for extensive- stage small cell lung cancer (ES-SCLC) Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 16/58 5.2. Medicines in the post-authorisation phase – PRAC-led procedures 5.2.1. Atazanavir – REYATAZ (CAP); Atazanavir / Cobicistat – EVOTAZ (CAP) – EMA/VR/0000288444 Applicant: Bristol-Myers Squibb Pharma EEIG PRAC Rapporteur: Tiphaine Vaillant Scope: Submission of an updated RMP version 16 in order to propose the removal of the continued prospective monitoring via the Antiretroviral Pregnancy Registry (APR) as an additional pharmacovigilance activity. Action: For adoption 5.2.2. Lecanemab – LEQEMBI (CAP) – EMA/VR/0000302769 Applicant: Eisai GmbH PRAC Rapporteur: Eva Jirsová Scope: Submission of an updated RMP version 1.1 in order to propose an update to PASS study deadlines. In addition, the MAH has taken the opportunity to update Annex II accordingly. Action: For adoption 5.2.3. Pegcetacoplan – ASPAVELI (CAP) – EMA/VR/0000333829 Applicant: Swedish Orphan Biovitrum AB (publ) PRAC Rapporteur: Kimmo Jaakkola Scope: Submission of an updated RMP (version 5.1) in order to revise the patient number in the category 3 post-authorization safety study (PASS) Sobi.PEGCET-301 and the milestone date for the clinical study report for the Category 3 study APL2-307. Action: For adoption 5.3. Medicines in the post-authorisation phase – CHMP-led procedures 5.3.1. Abiraterone acetate – ABIRATERONE MYLAN (CAP); NAP – EMA/VR/0000291298 Applicants: Mylan Pharmaceuticals Limited, various PRAC Rapporteur: Maria del Pilar Rayon Scope: Grouped application comprising of 3 Extension of indication variations for ABIRATERONE MYLAN, as follows: C.I.6: to update the currently approved indication for metastatic hormone sensitive prostate cancer (mHSPC) patients to also include non-high risk mHSPC Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 17/58 C.I.6: to include the treatment of newly diagnosed mHSPC in adult men in combination with androgen deprivation therapy (ADT) and docetaxel in patients who are fit for chemotherapy C.I.6: to include the treatment of newly diagnosed high risk non-metastatic hormone sensitive prostate cancer (HSPC) in adult men in combination with ADT and radiotherapy The variations are based on literature data. As a consequence, sections 4.1, 4.2 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 1.2 of the RMP has also been submitted. Action: For adoption 5.3.2. Adalimumab – IMRALDI (CAP) – EMA/X/0000321285 Applicant: Samsung Bioepis NL B.V. PRAC Rapporteur: Karin Bolin Scope: Extension application to add a new strength of 80 mg solution for injection in a single dose 0.8 ml pre-filled pen (PFP). This is a grouped line extension application including four quality variations Action: For adoption 5.3.3. Alemtuzumab – LEMTRADA (CAP) – EMA/VR/0000335041 Applicant: Sanofi Belgium PRAC Rapporteur: Karin Erneholm Scope: A grouped application consisting of: C.4: Update of section 4.4 of the SmPC in order to add a new warning on vasculitis following request from Saudi Arabia and based on data from clinical studies and post-authorisation data sources. The RMP version 14.0 has also been submitted. In addition, the MAH took the opportunity to introduce editorial changes to the PI. C.4: Update of section 5.1 in order to update information on paediatrics based on final results from study EFC13429 (LemKids) listed as a category 3 study in the RMP; this is a phase 3 multi-center, open-label, single-arm, before and after switch study to evaluate the efficacy, safety and tolerability of alemtuzumab in paediatric patients with relapsing remitting multiple sclerosis (RRMS) with disease activity on prior disease modifying therapy. The RMP version 14.0 has also been submitted. Action: For adoption 5.3.4. Apixaban – ELIQUIS (CAP) – EMA/VR/0000327005 Applicant: Bristol-Myers Squibb Pfizer EEIG PRAC Rapporteur: Bianca Mulder Scope: Extension of indication to include neonates in the currently approved indication treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age for ELIQUIS, based on final results from Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 18/58 pivotal study CV185325. This is an open-label, multi-centre, randomized, active controlled trial to provide PK data and data on anti-Xa activity to support the extrapolation of efficacy to children, to evaluate safety and efficacy of apixaban in children (full term neonates to less than 18 years of age) who require anticoagulation for venous thromboembolism, and Study 2, modelling and simulation study to derive dosing of apixaban for use in neonates for treatment of venous thromboembolism; As a consequence, section 4.1, 4.2, 4.8, and 5.1 of the SmPC are updated. The Package Leaflet and Labelling are updated in accordance. Version 24.0 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to update the The Patient Card to mention Eliquis only once on the title page and refer to apixaban throughout the rest of the card. Action: For adoption 5.3.5. Atidarsagene autotemcel – LIBMELDY (CAP) – EMA/VR/0000334917 Applicant: Orchard Therapeutics (Netherlands) B.V. PRAC Rapporteur: Dirk Mentzer Scope: A grouped application consisting of: C.12: Submission of the final report from study 201222 listed as a category 3 study in the RMP. This is a Phase I/II clinical trial of haematopoietic stem cell gene therapy for the treatment of metachromatic leukodystrophy (MLD). C.12: Submission of the final report from study CUP 207394 listed as a category 3 study in the RMP. This is a gene therapy protocol using autologous haematopoietic stem cells for a patient with metachromatic leukodystrophy (MLD). C.12: Submission of the final report from studies CUP 206258 and HE 205029 listed as category 3 studies in the RMP. These are Expanded Access Programs (EAP) for hematopoietic stem cell gene therapy OTL-200 in subjects with early-onset metachromatic leukodystrophy (MLD). The RMP version 4.1 has also been submitted. Action: For adoption 5.3.6. Belimumab – BENLYSTA (CAP) – EMA/VR/0000306408 Applicant: Glaxosmithkline (Ireland) Limited PRAC Rapporteur: Karin Bolin Scope: Submission of the final report from study analysis BEL116559 listed as a category 3 study in the RMP. This is a pooled analyses of elderly (aged ≥65 years) subpopulation treated in select belimumab clinical trials to evaluate the safety of belimumab treatment in elderly patients with systemic lupus erythematosus (SLE). The RMP version 47.0 has also been submitted. Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 19/58 5.3.7. Belzutifan – WELIREG (CAP); Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000313634 Applicant: Merck Sharp & Dohme B.V. PRAC Rapporteur: Dennis Lex Scope: Worksharing variation to extend the indication for KEYTRUDA, in combination with belzutifan, and for WELIREG, in combination with pembrolizumab, for the adjuvant treatment of adult patients with clear cell renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, based on results from study MK-6482-022 (LITESPARK-022). This is a multicenter, double-blind, randomized phase 3 study to compare the efficacy and safety of belzutifan plus pembrolizumab versus placebo plus pembrolizumab, in the adjuvant treatment of clear cell renal cell carcinoma (ccRCC) post nephrectomy. As a consequence, sections 4.1, 4.8 and 5.1 of the SmPC for KEYTRUDA and sections 4.1, 4.2, 4.8 and 5.1 of the SmPC for WELIREG are updated. The Package Leaflet for WELIREG is updated in accordance. The RMP version 53.1 for KEYTRUDA and version 2.1 for WELIREG have also been submitted. In addition, the MAH took the opportunity to introduce minor formatting changes to the PI for KEYTRUDA and WELIREG. Action: For adoption 5.3.8. Belzutifan – WELIREG (CAP) – EMA/VR/0000326853 Applicant: Merck Sharp & Dohme B.V. PRAC Rapporteur: Dennis Lex Scope: Extension of indication to include in combination with lenvatinib, treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following a PD-1 or PD- L1 inhibitor for WELIREG, based on interim results from study P011V01MK6482 (LITESPARK- 011); this is an open-label, randomized, Phase 3 study of belzutifan in combination with lenvatinib vs cabozantinib for treatment in participants with advanced renal cell carcinoma (RCC) who have progressed after prior anti-PD-1/L1 Therapy. As a consequence, sections 4.1, 4.2, 4.8, and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 1.1 of the RMP has also been submitted. Action: For adoption 5.3.9. Cabotegravir – VOCABRIA (CAP) – EMA/VR/0000332087 Applicant: ViiV Healthcare B.V. PRAC Rapporteur: Dennis Lex Scope: Update of sections 4.4, 4.6 and 5.2 of the SmPC in order to update information on pregnancy based on interim results from study HPTN 084/084-01; this is phase 3 double blind safety and efficacy study of long-acting injectable cabotegravir compared to daily oral TDF/FTC for pre-exposure prophylaxis in HIV-uninfected women – Pregnancy Safety and PK Interim Analysis; the Package Leaflet is updated accordingly. The RMP version 6.0 has also been submitted. In addition, the MAH took the opportunity to bring the PI in line with the latest QRD template and to make typographical edits. Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 20/58 5.3.10. Cabotegravir – APRETUDE (CAP) – EMA/VR/0000331993 Applicant: ViiV Healthcare B.V. PRAC Rapporteur: Dennis Lex Scope: Update of sections 4.6 and 5.2 of the SmPC in order to update information and recommendations on pregnancy, based on interim results from the open label extension (OLE) phase of the Phase 3 study HPTN 084 (study 201739) on the use of cabotegravir (CAB) for HIV-1 pre-exposure prophylaxis (PrEP) during pregnancy. The Package Leaflet is updated accordingly. The RMP version 2.0 has also been submitted. In addition, the MAH took the opportunity to introduce updates to the information on excipients in alignment with the excipient guideline and to introduce minor editorial and formatting changes to the PI. Action: For adoption 5.3.11. Cetuximab – ERBITUX (CAP) – EMA/VR/0000326978 Applicant: Merck Europe B.V. PRAC Rapporteur: Mari Thorn Scope: Extension of indication to include in combination with encorafenib treatment of with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, who have received prior systemic therapy for ERBITUX, based on final results from study ARRAY-818-302 (BEACON- CRC); this is a randomized, open label, 3-arm Phase 3 design that investigated the BRAF inhibitor, encorafenib in combination with cetuximab with or without the mitogen-activated protein kinase (MEK) inhibitor, binimetinib, in patients with BRAF V600E-mutated mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1, and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 21.1 of the RMP has also been submitted. Action: For adoption 5.3.12. Cetuximab – ERBITUX (CAP) – EMA/VR/0000327014 Applicant: Merck Europe B.V. PRAC Rapporteur: Mari Thorn Scope: Extension of indication to include in combination with encorafenib and mFOLFOX6 treatment of metastatic colorectal cancer with a BRAF V600E mutation for ERBITUX, based on interim results from study C4221015 (BREAKWATER); this is an open-label, multicenter, 3-arm, randomized phase 3 study of EC alone or in combination with mFOLFOX6 versus standard-of-care chemotherapy in first-line participants with BRAF V600E-mutant mCR . As a consequence, sections 4.1, 4.2, 4.4, 4.8, and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 21.1 of the RMP has also been submitted. Action: For adoption 5.3.13. COVID-19 mRNA vaccine – SPIKEVAX (CAP) – EMA/VR/0000335829 Applicant: Moderna Biotech Spain S.L. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 21/58 PRAC Rapporteur: Marie Louise Schougaard Christiansen Scope: Update of sections 4.2, 4.8 and 5.1 of the SmPC to update the posology recommendation for the 2 years through 4 years age group, based on final results from the study mRNA-1273-P306 listed as a category 3 study in the RMP; this is an Open-Label, Phase 3 Study to Evaluate the Safety and Immunogenicity of the mRNA Vaccines for SARS-CoV-2 Variants in Participants Aged 6 Months to <6 Years; the Package Leaflet is updated accordingly. The RMP version 14.0 has also been submitted. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet. Action: For adoption 5.3.14. Damoctocog alfa pegol – JIVI (CAP) – EMA/VR/0000326847 Applicant: Bayer AG PRAC Rapporteur: Bianca Mulder Scope: Grouped application comprised of two Type II variations, as follows: C.6.a: Extension of indication to include treatment and prophylaxis of bleeding in previously untreated patients ≥7 years of age with haemophilia A for JIVI, following the guideline for clinical investigation of recombinant and human plasma-derived factor VIII products (EMA/CHMP/BPWP/144552/2009 rev 2). As a consequence, sections 4.1, 4.2, 4.4 and 4.8 of the SmPC are updated. The Package Leaflet is updated accordingly. C.4: Update of section 4.2 of the SmPC in order to update posology recommendations for patients 7 to <12 years of age, based on integrated analysis results from Part B of the Alfa- PROTECT study (21824) and PROTECT Kids extension study (15912). Alfa-PROTECT is a Phase 3, single-group treatment, open-label study to evaluate the safety of BAY 94-9027 infusions for prophylaxis and treatment of bleeding in previously treated children aged 7 to <12 years with severe hemophilia A. The PROTECT Kids study was a Phase 3, open-label, uncontrolled, multicenter study in previously treated children <12 years of age with severe hemophilia A (>50 prior EDs). Version 4.1 of the RMP has also been submitted. Action: For adoption 5.3.15. Deferasirox – EXJADE (CAP) – EMA/VR/0000333352 Applicant: Novartis Europharm Limited PRAC Rapporteur: Tiphaine Vaillant Scope: Update of sections 4.3 and 4.5 of the SmPC in order to remove the existing contraindication for the combination of deferasirox with other iron chelator therapies, based on a cumulative review of the available data. The Package Leaflet is updated accordingly. The RMP version 24.0 has also been submitted. Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 22/58 5.3.16. Difelikefalin – KAPRUVIA (CAP) – EMA/VR/0000316094 Applicant: Vifor Fresenius Medical Care Renal Pharma France PRAC Rapporteur: Mari Thorn Scope: A grouped application consisting of safety data from three studies of the oral difelikefalin formulation to support the safety of the intravenous difelikefalin formulation: C.I.13: Submission of the final report from study CR845-310301 listed as a category 3 study in the RMP. This is a multicenter, randomized, double-blind, placebo-controlled 12-week study to evaluate the safety and efficacy of oral difelikefalin in advanced chronic kidney disease subjects with moderate-to-severe pruritus with an up to 52-week long-term extension. The RMP version 3.0 has also been submitted. C.I.13: Submission of the final report from study CR845-310302 listed as a category 3 study in the RMP. This is a multicenter, randomized, double-blind, placebo-controlled 12-week study to evaluate the safety and efficacy of oral difelikefalin in advanced chronic kidney disease subjects with moderate-to-severe pruritus with an up to 52-week long-term extension C.I.13: Submission of the final report from study CR845-310501 listed as a category 3 study in the RMP. This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid for moderate-to-severe pruritus in adult subjects with atopic dermatitis. Action: For adoption 5.3.17. Dimethyl fumarate – TECFIDERA (CAP) – EMA/VR/0000320745 Applicant: Biogen Netherlands B.V. PRAC Rapporteur: Dennis Lex Scope: Submission of the final study results from 109MS306 (CONNECT) Part 2 listed as a category 3 study in the RMP; this is a phase 3 efficacy and safety study of BG00012 in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term multiple sclerosis outcomes of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The RMP version 17.1 has also been submitted. Action: For adoption 5.3.18. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000312495 Applicant: Astellas Pharma Europe B.V. PRAC Rapporteur: Eva Jirsová Scope: Extension of indication to include PADCEV, in combination with pembrolizumab, for use as neoadjuvant treatment and continued as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy, based on interim Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 23/58 results from study EV-303/KN-905; this is a randomized phase 3 study evaluating cystectomy with perioperative pembrolizumab and cystectomy with perioperative enfortumab, vedotin and pembrolizumab versus cystectomy alone in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer. As a consequence, sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 5.0 of the RMP has also been submitted. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet, and to bring the PI in line with the latest QRD template version 10.4. Action: For adoption 5.3.19. Epcoritamab – TEPKINLY (CAP) – EMA/VR/0000311043 Applicant: Abbvie Deutschland GmbH & Co. KG PRAC Rapporteur: Maria Martinez Gonzalez Scope: Extension of indication to include in combination with rituximab and lenalidomide treatment of patients with relapsed/refractory follicular lymphoma (FL) for Tepkinly, based on interim results from study M20-638; this is a Phase 3, open-label study to evaluate safety and efficacy of epcoritamab in combination with rituximab and lenalidomide (R2) compared to R2 in subjects with relapsed or refractory follicular lymphoma (EPCORE FL-1). As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 3.2.0 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to introduce minor changes to the PI. As part of the application, the MAH is requesting a 1-year extension of the market protection. Action: For adoption 5.3.20. Filgotinib – JYSELECA (CAP) – EMA/VR/0000325892 Applicant: Alfasigma S.p.A. PRAC Rapporteur: Petar Mas Scope: Extension of indication to include treatment of axial spondyloarthritis in adult patients with active radiographic axial spondyloarthritis (r-axSpA) and with active non-radiographic axial spondyloarthritis (nr-axSpA) for JYSELECA, based on interim results from study LPG0634-CL-336 (OLINGUITO); this is a Phase 3 randomized, placebo-controlled, double- blind, parallel-group program to evaluate efficacy and safety of filgotinib in adult subjects with active axial spondyloarthritis which provide evidence of the efficacy and safety of filgotinib up to Week 52. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 7.1 of the RMP has also been submitted. Action: For adoption 5.3.21. Florbetapir (18F) – AMYVID (CAP) – EMA/VR/0000333287 Applicant: Eli Lilly Nederland B.V. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 24/58 PRAC Rapporteur: Dennis Lex Scope: Update of section 4.8 of the SmPC in order to revise the frequency category of ADRs and include additional adverse reaction terms related to injection site reactions based on a pooled safety analysis incorporating cumulative florbetapir (18F) exposure data from 26 979 subjects from 48 clinical trials; the Package Leaflet is updated accordingly. The RMP version 6.1 has also been submitted. In addition, the MAH took the opportunity update Annex II.D of the SmPC to align with proposed RMP changes. Action: For adoption 5.3.22. Formoterol / Glycopyrronium bromide / Budesonide – RILTRAVA AEROSPHERE (CAP) – EMA/X/0000287672 Applicant: AstraZeneca AB PRAC Rapporteur: Jan Neuhauser Scope: Extension application to introduce a new strength (5 μg / 14.4 μg / 160 μg Pressurised inhalation, suspension) associated with a new indication for the “maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium or high dose inhaled corticosteroid and a long-acting beta2- agonist”. The RMP (version 3.1) is updated in accordance. Action: For adoption 5.3.23. Formoterol / Glycopyrronium bromide / Budesonide – TRIXEO AEROSPHERE (CAP) – EMA/X/0000287664 Applicant: AstraZeneca AB PRAC Rapporteur: Jan Neuhauser Scope: Extension application to introduce a new strength (5 μg / 14.4 μg / 160 μg Pressurised inhalation, suspension) associated with a new indication for the “maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium or high dose inhaled corticosteroid and a long-acting beta2- agonist”. The RMP (version 3.1) is updated in accordance. Action: For adoption 5.3.24. Glecaprevir / Pibrentasvir – MAVIRET (CAP) – EMA/VR/0000316551 Applicant: Abbvie Deutschland GmbH & Co. KG PRAC Rapporteur: Ana Sofia Diniz Martins Scope: Extension of indication to include treatment of Acute HCV for MAVIRET, based on final results from study M20-350; this is a multicenter, single-arm prospective study to evaluate safety and efficacy of GLE/PIB 8-week treatment in adults and adolescents with acute hepatitis C virus (HCV) infection. As a consequence, sections 4.1, 4.2, 4.8, 5.1, and 5.2, of the SmPC are updated. The Package Leaflet is updated in accordance. Version 10.0 of the RMP has also been submitted. In addition, the Marketing authorisation holder took the opportunity to update the list of local representatives in the Package Leaflet. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 25/58 Action: For adoption 5.3.25. Glofitamab – COLUMVI (CAP) – EMA/VR/0000327100 Applicant: Roche Registration GmbH PRAC Rapporteur: Veronika Macurova Scope: Update of sections 4.2, 4.4 and 4.8 of the SmPC in order to add a new warning on ‘haemophagocytic lymphohistiocytosis’ and to add it to the list of adverse drug reactions (ADRs) with frequency not known, based on a drug safety report. The Package Leaflet is updated accordingly. The RMP version 6.0 has also been submitted. In addition, the MAH took the opportunity to introduce minor editorial and administrative changes to the PI. Action: For adoption 5.3.26. Glycopyrronium – SIALANAR (CAP) – EMA/X/0000287532 Applicant: Proveca Pharma Limited PRAC Rapporteur: Zane Neikena Scope: Extension application to introduce a new pharmaceutical form associated with two new strengths (0.68 mg and 1.36 mg orodispersible tablets). Action: For adoption 5.3.27. Inclisiran – LEQVIO (CAP) – EMA/VR/0000293324 Applicant: Novartis Europharm Limited PRAC Rapporteur: Kimmo Jaakkola Scope: Grouping of two Type II C.I.6 variations to support the extension of the LEQVIO indication to paediatric patients aged 12 to less than 18 years with heterozygous and homozygous familial hypercholesterolaemia, as follows: C.I.6: Extension of indication to include the treatment of paediatric patients aged 12 to less than 18 years with heterozygous familial hypercholesterolaemia (HeFH) for LEQVIO based on the final results from study CKJX839C12301 (ORION-16). ORION-16 is a two part (double- blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in paediatric patients (12 to less than 18 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol. C.I.6: Extension of indication to include the treatment of paediatric patients aged 12 to less than 18 years with homozygous familial hypercholesterolaemia (HoFH) for LEQVIO based on the final results from study CKJX839C12302 (ORION-13). ORION-13 is a two part (double- blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in paediatric patients (12 to less than 18 years) with homozygous familial hypercholesterolemia and elevated LDL-cholesterol. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 26/58 As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 4.0 of the RMP has also been submitted. Action: For adoption 5.3.28. Ipilimumab – YERVOY (CAP); Nivolumab – OPDIVO (CAP) – EMA/VR/0000319172 Applicant: Bristol-Myers Squibb Pharma EEIG PRAC Rapporteur: Bianca Mulder Scope: Update of sections 4.4 and 4.8 of the SmPC in order to add 'Myocarditis-Myositis- Myasthenia Gravis Overlap Syndrome' to the list of adverse drug reactions (ADRs) with frequency 'Uncommon' based on postmarketing data and literature. The Package Leaflet is updated accordingly. The RMP version 46 and 52 respectively, had also been submitted. In addition, the MAH took the opportunity to implement editorial changes to the PI. Action: For adoption 5.3.29. Lacosamide – LACOSAMIDE UCB (CAP); VIMPAT (CAP) – EMA/VR/0000321459 Applicant: UCB Pharma PRAC Rapporteur: Karin Bolin Scope: Update of sections 4.2, 4.8, 5.1 and 5.2 of the SmPC in order to update clinical information based on final results from study SP0968 and study EP0223. SP0968 was a phase 2/3, multicenter, open-label, randomized, active comparator study that evaluated the PK, efficacy, safety, and tolerability of lacosamide in neonatal study participants with repeated electroencephalographic neonatal seizures compared with an Active Comparator chosen based on standard of care per the local practice and treatment guidelines. EP0223 is a comparative study on long-term neurodevelopmental outcomes in neonates treated with lacosamide versus other antiseizure medications for neonatal seizures. The RMP version 18.0 has also been submitted. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet and to implement corrections in some local languages in both Vimpat and Lacosamide UCB Product Information. Action: For adoption 5.3.30. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000327013 Applicant: Roche Registration GmbH PRAC Rapporteur: Mari Thorn Scope: A grouped application comprised of two Type II Variations, as follows: C.6.a: Extension of indication to include treatment of adult patients with active systemic lupus erythematosus (SLE) who are receiving standard therapy, for GAZYVARO, based on the results from study CA42750 (ALLEGORY); this is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of obinutuzumab in patients with SLE treated with standard-of-care therapy. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 6.6 of the SmPC are updated. The Package Leaflet is updated in Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 27/58 accordance. In addition, the Marketing authorisation holder (MAH) took the opportunity to update the SmPC with minor edits. Version 12 of the RMP has also been submitted. C.4: Update of section 4.2 of the SmPC to introduce short duration infusion (SDI) as method of administration for SLE patients, supported by previously submitted data in patients with Follicular Lymphoma and by simulations conducted using an integrated population PK model to estimate exposures following administration as an SDI to SLE patients. Action: For adoption 5.3.31. Octreotide – OCZYESA (CAP) – EMA/VR/0000333073 Applicant: Camurus AB PRAC Rapporteur: Eamon O Murchu Scope: Submission of the final report from study HS-19-647, listed as a category 3 study in the RMP. This is a Phase 3, open-label, single-arm, multi-center trial to assess the long-term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly. The RMP version 1.1 has also been submitted. Action: For adoption 5.3.32. Pegvaliase – PALYNZIQ (CAP) – EMA/VR/0000302032 Applicant: Biomarin International Limited PRAC Rapporteur: Rhea Fitzgerald Scope: A grouped application comprised of two Type II variations, as follows: C.I.6: Extension of indication to include treatment of adolescent patients aged 12 to <16 years with phenylketonuria (PKU) for PALYNZIQ, based on interim results from study 165- 306; this is a Phase 3 open label, randomized, controlled, 2-arm, multicenter study designed to evaluate the safety and efficacy of pegvaliase in adolescent participants 12 to <18 years old with PKU. As a consequence, sections 4.1, 4.2, 4.4, 4.8, and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. In addition, the Marketing authorisation holder (MAH) took the opportunity to update the PI to include editorial changes and remove references to the route of administration of adrenaline (injection) to allow physicians to prescribe any approved adrenaline device. C.I.4: Update of section 4.6 of the SmPC in order to update information on pregnancy based on a comprehensive assessment of all pregnancy and breastfeeding reports received from all sources. The RMP version 5.0 has also been submitted. Action: For adoption 5.3.33. Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000316576 Applicant: Merck Sharp & Dohme B.V. PRAC Rapporteur: Bianca Mulder Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 28/58 Scope: A grouped application consisting of: C.I.6. Extension of indication for KEYTRUDA for subcutaneous use to include treatment of melanoma for adolescents aged 12 years and older based on an extrapolation approach from adults to adolescents using pharmacokinetics modelling and simulation. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 52.1 of the RMP has also been submitted. In addition, the Marketing authorisation holder took the opportunity to implement some minor editorial and formatting changes in the PI. C.I.6. Extension of indication for KEYTRUDA for subcutaneous use to include treatment of classical Hodgkin lymphoma for adolescents aged 12 years and older based on an extrapolation approach from adults to adolescents using pharmacokinetics modelling and simulation. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Action: For adoption 5.3.34. Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000312515 Applicant: Merck Sharp & Dohme B.V. PRAC Rapporteur: Bianca Mulder Scope: Extension of indication to include in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment of adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin containing chemotherapy for KEYTRUDA, based on interim results from study KEYNOTE-905, an open label, randomised, interventional phase 3 study. As consequence, sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 51.1 of the RMP has also been submitted. Action: For adoption 5.3.35. Ponatinib – ICLUSIG (CAP) – EMA/X/0000296489 Applicant: Incyte Biosciences Distribution B.V. PRAC Rapporteur: Mari Thorn Scope: Extension application to introduce a new pharmaceutical form associated with a new strength (5 mg hard capsule) grouped with an Extension of Indication to include treatment of paediatric patients aged 6 years and older with chronic phase chronic myeloid leukaemia (CP- CML) who are resistant or intolerant to at least one tyrosine kinase inhibitor for ICLUSIG, based on interim results from study INCB 84344-102 and a final results from early- terminated study Ponatinib-1501; the first is an ongoing open-label, single-arm, Phase 1/2 study evaluating the safety and efficacy of ponatinib MONOTHERAPY for the treatment of R/R leukemias, lymphomas, or solid tumors in pediatric participants. The second is a Phase 1/2, single-arm, open-label, multicenter study designed to evaluate the safety, tolerability, PK, and efficacy of ponatinib when administered IN COMBINATION WITH multiagent CHEMOTHERAPY in pediatric patients with Ph+ ALL, Ph+ MPAL, or Ph-like ALL who had a relapse, were resistant or intolerant to at least 1 prior BCR-ABL1 TKI therapy, or had the T315I mutation. As a consequence, sections 1, 2, 3, 4.1, 4.2, 4.8, 5.1, 5.2, 6.1 and 6.5 of Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 29/58 the SmPC are updated. Package Leaflet is updated accordingly. The RMP version 23.4 has also been submitted. Action: For adoption 5.3.36. Rucaparib – RUBRACA (CAP) – EMA/VR/0000332297 Applicant: pharmaand GmbH PRAC Rapporteur: Mari Thorn Scope: Submission of the updated RMP version 9.0 in order to revise the originally anticipated overall survival (OS) maturity threshold for the ATHENA MONO study. Action: For adoption 5.3.37. Sacituzumab govitecan – TRODELVY (CAP) – EMA/VR/0000312649 Applicant: Gilead Sciences Ireland Unlimited Company PRAC Rapporteur: Bianca Mulder Scope: Extension of indication for treatment of adult patients with PD-L1-negative metastatic triple- negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer previously treated with an anti-PD-(L)1 agent in the curative setting for Trodelvy, based on results from study GS-US-592-6238 (ASCENT-03), which is a phase 3 study of sacituzumab govitecan (IMMU-132) versus treatment of physician's choice (TPC) in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD- (L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1. As a consequence, sections 4.1, 4.4, 4.5, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 4.1 of the RMP has also been submitted Action: For adoption 5.3.38. Secukinumab – COSENTYX (CAP) – EMA/VR/0000326984 Applicant: Novartis Europharm Limited PRAC Rapporteur: Maria Martinez Gonzalez Scope: Extension of indication to include treatment of polymyalgia rheumatica in adults who have had an inadequate response to glucocorticoids or who experience a relapse during glucocorticoid taper for COSENTYX, based on the week 52 primary analysis results from study CAIN457C22301 as well as supportive safety data from the Phase 3 study CAIN457R12301 (GCAptAIN) in giant cell arteritis (GCA) patients. Study CAIN457C22301 is a randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase 3 trial to evaluate efficacy and safety of secukinumab administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with polymyalgia rheumatica (PMR). As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 13.0 of the RMP has also been submitted. In addition, the MAH is taking this opportunity to implement updates regarding polysorbate Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 30/58 80 in the PI following the guidance on excipients, and to introduce minor editorial changes to the PI. Action: For adoption 5.3.39. Serplulimab – HETRONIFLY (CAP) – EMA/VR/0000290021 Applicant: Accord Healthcare S.L.U. PRAC Rapporteur: Jan Neuhauser Scope: Extension of indication to include HETRONIFLY in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma based on final results from study HLX10-004-NSCLC303; this is a randomized, double-blind, multi-center, phase III pivotal study, was conducted to compare the clinical efficacy and safety of serplulimab combined with chemotherapy (carboplatin and nab-paclitaxel) versus placebo combined with chemotherapy (carboplatin and nab-paclitaxel). As a consequence, sections 4.1, 4.2, 4.8, 5.1, 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. The RMP Version 1.3 has been submitted. Action: For adoption 5.3.40. Somapacitan – SOGROYA (CAP) – EMA/VR/0000264734 Applicant: Novo Nordisk A/S PRAC Rapporteur: Dennis Lex Scope: Grouped extension of indication application to include treatment of children born small for gestational age (SGA), Noonan syndrome (NS) and idiopathic short stature (ISS) for SOGROYA, based on interim results from the pivotal, confirmatory phase 3 study NN8640-4467 supported by the phase 3 study NN8640-4469 and the phase 2 study NN8640- 4245. Study 4467 is a study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin as well as evaluating long-term safety of somapacitan in a basket study design in children with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short stature. Study 4469 is a study evaluating the safety and efficacy of once-weekly dosing of somapacitan in a basket study design in paediatric participants with short stature either born small for gestational age or with turner syndrome, Noonan syndrome or idiopathic short stature. Study 4245 is a dose- finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 4.0 of the RMP has also been submitted. Furthermore, the PI is brought in line with the latest QRD template version 10.4. As part of the application, the MAH is requesting a 1-year extension of the market protection. Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 31/58 5.3.41. Sotatercept – WINREVAIR (CAP) – EMA/VR/0000315667 Applicant: Merck Sharp & Dohme B.V. PRAC Rapporteur: Zoubida Amimour Scope: Update of sections 4.4, 4.8, and 5.1 of the SmPC in order to update efficacy and safety information based on the final results from the study MK-7962-005 (HYPERION). MK- 7962-005 (HYPERION) is a Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the effect of sotatercept in participants who had received the diagnosis less than 1 year earlier, had an intermediate or high risk of death, and were receiving double or triple background therapy. The RMP version 2.1 has also been submitted. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet. Action: For adoption 5.3.42. Tirzepatide – MOUNJARO (CAP) – EMA/VR/0000310637 Applicant: Eli Lilly Nederland B.V. PRAC Rapporteur: Bianca Mulder Scope: Extension of indication to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, or stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease for MOUNJARO, based on final results from study I8F-MC-GPGN (SURPASS-CVOT). SURPASS-CVOT was a Phase 3, event-driven, multicentre, international, randomized, double-blind, active-comparator, parallel-group study to assess the effect of tirzepatide versus dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes. As a consequence, sections 4.1, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 8.1 of the RMP has also been submitted. In addition, the MAH took the opportunity to introduce minor editorial and formatting changes to the PI. Action: For adoption 5.3.43. Trastuzumab – ZERCEPAC (CAP) – EMA/X/0000321364 Applicant: Accord Healthcare S.L.U. PRAC Rapporteur: Dirk Mentzer Scope: Extension application to introduce a new pharmaceutical form (solution for injection), a new strength (600 mg) and a new route of administration (subcutaneous use). Action: For adoption 5.3.44. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/VR/0000326482 Applicant: Daiichi Sankyo Europe GmbH PRAC Rapporteur: Carla Torre Scope: Extension of indication to include treatment of adult patients with HER2-positive breast cancer (IHC3+ or ISH+) who have residual invasive disease after neoadjuvant HER2 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 32/58 targeted treatment for ENHERTU, based on interim results from study DS8201-A-U305 (DESTINY-Breast05); this is a phase 3, multicenter, randomized, open-label, active- controlled study of trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in subjects with high-risk HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy. As a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 10.2 of the RMP has also been submitted. Action: For adoption 5.3.45. Upadacitinib – RINVOQ (CAP) – EMA/VR/0000312506 Applicant: Abbvie Deutschland GmbH & Co. KG PRAC Rapporteur: Petar Mas Scope: Extension of indication to include the treatment of severe alopecia areata (AA) in adult and adolescents 12 years and older for RINVOQ, based on interim results from 2 pivotal, Phase 3 studies (M23-716 Study 1 and Study 2); those are randomized, double blind, placebo-controlled, multi-center studies of Upadacitinib evaluating the efficacy and safety of Upadacitinib 15 mg QD and 30 mg QD versus placebo for the treatment of severe AA in subjects who are at least 12 years of age. As a consequence, sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet and Annex II are updated in accordance. Version 18.0 of the RMP has also been submitted. As part of the application, the MAH is requesting a 1-year extension of the market protection. Action: For adoption 5.3.46. Upadacitinib – RINVOQ (CAP) – EMA/VR/0000325958 Applicant: Abbvie Deutschland GmbH & Co. KG PRAC Rapporteur: Petar Mas Scope: Extension of indication to include the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy, for RINVOQ, based on results from the two replicate Phase 3 studies M19-044: study 1 (R&D/25/1342) and study 2 (R&D/25/1343), as well as from integrated long-term safety data. Study 1 and study 2 are Phase 3, global, randomized, double-blind, placebo-controlled multi-center studies that evaluate the safety and efficacy of upadacitinib in adult and adolescent patients with non-segmental vitiligo. As a consequence, sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1 and 5.2 of the SmPC have been updated. The Package Leaflet has been updated in accordance. Version 19.0 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to introduce minor editorial changes to the PI. As part of the application, the MAH is requesting a 1-year extension of the market protection. Action: For adoption 5.3.47. Ustekinumab – USRENTY (CAP) – EMA/VR/0000325350 Applicant: Biosimilar Collaborations Ireland Limited Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 33/58 PRAC Rapporteur: Rhea Fitzgerald Scope: C.2.a (Type IB): To update sections 4.1, 4.5, 4.8 and 5.2 of the SmPC to reflect the removal of the wording “or have medical contraindications to such therapies” from the therapeutic indication for Crohn's disease, the brief update of interaction data, the update of safety data, and the addition of CYP450 interaction information, following assessment of the same changes for the reference product Stelara; Q.IV.2.a (Type II): To add 45 mg solution for injection in pre-filled pen (EU/1/25/1973/00x) and 90 mg solution for injection in pre-filled pen (EU/1/25/1973/00x); Version 1.1 of RMP (dated 21-Jan-2026) for which data lock point is 31-Oct-2025 has been included. Action: For adoption 5.3.48. Ustekinumab – STELARA (CAP) – EMA/VR/0000316205 Applicant: Janssen Cilag International PRAC Rapporteur: Rhea Fitzgerald Scope: Extension of indication to include treatment of ulcerative colitis in paediatric patients from the age of 2 years and older for STELARA, based on results from study CNTO1275PUC3001; this is a Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants (2 to <18 Years of Age) with Moderately to Severely Active Ulcerative Colitis. As a consequence, sections 4.1, 4.2, 4.8, 5.1, 5.2 and 6.6 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 32.2 of the RMP has also been submitted. Action: For adoption 6. Periodic safety update reports (PSURs) 6.1. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) only 6.1.1. Alemtuzumab – LEMTRADA (CAP) – EMA/PSUR/0000321520 Applicant: Sanofi Belgium PRAC Rapporteur: Karin Erneholm Scope: Evaluation of a PSUSA procedure (PSUSA/00010055/202509) Action: For adoption 6.1.2. Amikacin – ARIKAYCE LIPOSOMAL (CAP) – EMA/PSUR/0000321506 Applicant: Insmed Netherlands B.V. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 34/58 PRAC Rapporteur: Jean-Michel Dogné Scope: Evaluation of a PSUSA procedure (PSUSA/00010882/202509) Action: For adoption 6.1.3. Atogepant – AQUIPTA (CAP) – EMA/PSUR/0000321517 Applicant: Abbvie Deutschland GmbH & Co. KG PRAC Rapporteur: Rugile Pilviniene Scope: Evaluation of a PSUSA procedure (PSUSA/00000100/202509) Action: For adoption 6.1.4. Brolucizumab – BEOVU (CAP) – EMA/PSUR/0000321518 Applicant: Novartis Europharm Limited PRAC Rapporteur: Dirk Mentzer Scope: Evaluation of a PSUSA procedure (PSUSA/00010829/202510) Action: For adoption 6.1.5. Chenodeoxycholic acid – CHENODEOXYCHOLIC ACID LEADIANT (CAP) – EMA/PSUR/0000321503 Applicant: Leadiant GmbH PRAC Rapporteur: Adam Przybylkowski Scope: Evaluation of a PSUSA procedure (PSUSA/00010590/202510) Action: For adoption 6.1.6. Chikungunya vaccine (live) – IXCHIQ (CAP) – EMA/PSUR/0000327923 Applicant: Valneva Austria GmbH PRAC Rapporteur: Dirk Mentzer Scope: Evaluation of a PSUSA procedure (PSUSA/00011058/202511) Action: For discussion 6.1.7. Concizumab – ALHEMO (CAP) – EMA/PSUR/0000321510 Applicant: Novo Nordisk A/S PRAC Rapporteur: Marie Louise Schougaard Christiansen Scope: Evaluation of a PSUSA procedure (PSUSA/00011105/202509) Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 35/58 6.1.8. Dibotermin alfa – INDUCTOS (CAP) – EMA/PSUR/0000321514 Applicant: Medtronic Biopharma B.V. PRAC Rapporteur: Bianca Mulder Scope: Evaluation of a PSUSA procedure (PSUSA/00001034/202509) Action: For adoption 6.1.9. Etrasimod – VELSIPITY (CAP) – EMA/PSUR/0000321519 Applicant: Pfizer Europe MA EEIG PRAC Rapporteur: Karin Bolin Scope: Evaluation of a PSUSA procedure (PSUSA/00000273/202510) Action: For adoption 6.1.10. Futibatinib – LYTGOBI (CAP) – EMA/PSUR/0000321515 Applicant: Taiho Pharma Netherlands B.V. PRAC Rapporteur: Mari Thorn Scope: Evaluation of a PSUSA procedure (PSUSA/00000068/202509) Action: For adoption 6.1.11. Herpes zoster vaccine (recombinant, adjuvanted) – SHINGRIX (CAP) – EMA/PSUR/0000321507 Applicant: GlaxoSmithKline Biologicals PRAC Rapporteur: Sonja Radowan Scope: Evaluation of a PSUSA procedure (PSUSA/00010678/202510) Action: For adoption 6.1.12. Histamine dihydrochloride – CEPLENE (CAP) – EMA/PSUR/0000321522 Applicant: Laboratoires Delbert PRAC Rapporteur: Eamon O Murchu Scope: Evaluation of a PSUSA procedure (PSUSA/00001610/202510) Action: For adoption 6.1.13. Inavolisib – ITOVEBI (CAP) – EMA/PSUR/0000321509 Applicant: Roche Registration GmbH PRAC Rapporteur: Bianca Mulder Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 36/58 Scope: Evaluation of a PSUSA procedure (PSUSA/00011164/202510) Action: For adoption 6.1.14. Lasmiditan – RAYVOW (CAP) – EMA/PSUR/0000321508 Applicant: Eli Lilly Nederland B.V. PRAC Rapporteur: Jana Pecherova Scope: Evaluation of a PSUSA procedure (PSUSA/00011011/202510) Action: For adoption 6.1.15. Macitentan / Tadalafil – YUVANCI (CAP) – EMA/PSUR/0000321504 Applicant: Janssen Cilag International PRAC Rapporteur: Maria del Pilar Rayon Scope: Evaluation of a PSUSA procedure (PSUSA/00011090/202510) Action: For adoption 6.1.16. Maralixibat – LIVMARLI (CAP) – EMA/PSUR/0000321513 Applicant: Mirum Pharmaceuticals International B.V. PRAC Rapporteur: Adam Przybylkowski Scope: Evaluation of a PSUSA procedure (PSUSA/00011032/202509) Action: For adoption 6.1.17. Marstacimab – HYMPAVZI (CAP) – EMA/PSUR/0000321516 Applicant: Pfizer Europe MA EEIG PRAC Rapporteur: Marie Louise Schougaard Christiansen Scope: Evaluation of a PSUSA procedure (PSUSA/00011101/202510) Action: For adoption 6.1.18. Mirikizumab – OMVOH (CAP) – EMA/PSUR/0000321511 Applicant: Eli Lilly Nederland B.V. PRAC Rapporteur: Sonja Radowan Scope: Evaluation of a PSUSA procedure (PSUSA/00000049/202509) Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 37/58 6.1.19. Nemolizumab – NEMLUVIO (CAP) – EMA/PSUR/0000321530 Applicant: Galderma International PRAC Rapporteur: Liana Martirosyan Scope: Evaluation of a PSUSA procedure (PSUSA/00011111/202509) Action: For adoption 6.1.20. Olipudase alfa – XENPOZYME (CAP) – EMA/PSUR/0000321501 Applicant: Sanofi B.V. PRAC Rapporteur: Dennis Lex Scope: Evaluation of a PSUSA procedure (PSUSA/00011003/202509) Action: For adoption 6.1.21. Selumetinib – KOSELUGO (CAP) – EMA/PSUR/0000321505 Applicant: AstraZeneca AB PRAC Rapporteur: Mari Thorn Scope: Evaluation of a PSUSA procedure (PSUSA/00010936/202510) Action: For adoption 6.1.22. Tobramycin – VANTOBRA (CAP) – EMA/PSUR/0000321512 Applicant: Pari Pharma GmbH PRAC Rapporteur: Karin Bolin Scope: Evaluation of a PSUSA procedure (PSUSA/00010370/202509) Action: For adoption 6.1.23. Trabectedin – YONDELIS (CAP) – EMA/PSUR/0000321523 Applicant: Pharma Mar S.A. PRAC Rapporteur: Marie Louise Schougaard Christiansen Scope: Evaluation of a PSUSA procedure (PSUSA/00003001/202509) Action: For adoption 6.1.24. Vilobelimab – GOHIBIC (CAP) – EMA/PSUR/0000321533 Applicant: InflaRx GmbH PRAC Rapporteur: Liana Martirosyan Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 38/58 Scope: Evaluation of a PSUSA procedure (PSUSA/00011103/202510) Action: For adoption 6.2. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) and nationally authorised products (NAPs) 6.2.1. Choriogonadotropin alfa – OVITRELLE (CAP), NAP; Chorionic gonadotrophin (NAP); Human chorionic gonadotropin (NAP) – EMA/PSUR/0000321521 Applicants: Merck Europe B.V., various PRAC Rapporteur: Bianca Mulder Scope: Evaluation of a PSUSA procedure (PSUSA/00000736/202509) Action: For adoption 6.2.2. Midazolam – BUCCOLAM (CAP); NAP – EMA/PSUR/0000321529 Applicants: Neuraxpharm Pharmaceuticals S.L., various PRAC Rapporteur: Liana Martirosyan Scope: Evaluation of a PSUSA procedure (PSUSA/00010118/202509) Action: For adoption 6.2.3. Sodium oxybate – XYREM (CAP); NAP – EMA/PSUR/0000321502 Applicants: UCB Pharma, various PRAC Rapporteur: Ana Sofia Diniz Martins Scope: Evaluation of a PSUSA procedure (PSUSA/00010612/202510) Action: For adoption 6.3. PSUR single assessment (PSUSA) procedures including nationally authorised products (NAPs) only 6.3.1. Allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) – EMA/PSUR/0000321532 Applicants: various PRAC Lead: Dirk Mentzer Scope: Evaluation of a PSUSA procedure (PSUSA/00010582/202509) Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 39/58 6.3.2. Bivalirudin – EMA/PSUR/0000321527 Applicants: various PRAC Lead: Veronika Macurova Scope: Evaluation of a PSUSA procedure (PSUSA/00000421/202509) Action: For adoption 6.3.3. Lactitol – EMA/PSUR/0000321534 Applicants: various PRAC Lead: Jan Neuhauser Scope: Evaluation of a PSUSA procedure (PSUSA/00001819/202509) Action: For adoption 6.3.4. Lisinopril, lisinopril / hydrochlorothiazide – EMA/PSUR/0000321531 Applicants: various PRAC Lead: Carla Torre Scope: Evaluation of a PSUSA procedure (PSUSA/00010532/202509) Action: For adoption 6.3.5. Progesterone – EMA/PSUR/0000321526 Applicants: various PRAC Lead: Karin Bolin Scope: Evaluation of a PSUSA procedure (PSUSA/00002540/202509) Action: For adoption 6.3.6. Silver sulfadiazine – EMA/PSUR/0000321525 Applicants: various PRAC Lead: Maia Uusküla Scope: Evaluation of a PSUSA procedure (PSUSA/00002702/202509) Action: For adoption 6.3.7. Terizidone – EMA/PSUR/0000321528 Applicants: various PRAC Lead: Rugile Pilviniene Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 40/58 Scope: Evaluation of a PSUSA procedure (PSUSA/00002904/202509) Action: For adoption 6.4. Follow-up to PSUR/PSUSA procedures None 6.5. Variation procedure(s) resulting from PSUSA evaluation 6.5.1. Sapropterin – KUVAN (CAP) – EMA/VR/0000301983 Applicant: Biomarin International Limited PRAC Rapporteur: Eamon O Murchu Scope: Update of section 4.6 of the SmPC in order to update pregnancy information based on a cumulative pregnancy data analysis, following the PRAC request in the PSUR assessment for PSUR/0000257835. In addition, the MAH took the opportunity to introduce a minor editorial change to the PI. Action: For adoption 6.6. Expedited summary safety reviews3 None 7. Post-authorisation safety studies (PASS) 7.1. Protocols of PASS imposed in the marketing authorisation(s)4 7.1.1. Lecanemab – LEQEMBI (CAP) – EMA/PASS/0000267311 Applicant: Eisai GmbH PRAC Rapporteur: Eva Jirsová Scope: PASS protocol [107n]: Study BAN2401-G000-505; A prospective observational registry study to evaluate the use and safety of LEQEMBI in routine clinical practice (EEA) Action: For adoption 7.1.2. Obecabtagene autoleucel – AUCATZYL (CAP) – EMA/PASS/0000300590 Applicant: Autolus GmbH 3 Submission of expedited summary safety reports for review in addition to the requirements for submission of PSUR(s) falling within the pandemic period and requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 4 In accordance with Article 107n of Directive 2001/83/EC Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 41/58 PRAC Rapporteur: Karin Erneholm Scope: PASS protocol [107n]: Prospective, international, non-interventional study to assess the short- and long-term safety and effectiveness of adult patients with relapsed or refractory B cell acute lymphoblastic leukemia receiving Aucatzyl treatment. Action: For adoption 7.1.3. Volanesorsen – WAYLIVRA (CAP) – EMA/PASS/0000334506 Applicant: Akcea Therapeutics Ireland Limited PRAC Rapporteur: Dennis Lex Scope: PASS amendment (PASS 107o): PASS and Product Registry to further characterise the safety and effectiveness of WAYLIVRA in patients with Familial Chylomicronaemia Syndrome (FCS) under real-world conditions Action: For adoption 7.2. Protocols of PASS non-imposed in the marketing authorisation(s)5 7.2.1. Abaloparatide – ELADYNOS (CAP) – EMA/PAM/0000281538 Applicant: Theramex Ireland Limited PRAC Rapporteur: Karin Erneholm Scope: Protocol amendment for Study EUPAS1000000613 (MEA 001: European non- interventional post-authorization safety study (PASS) to evaluate cardiovascular (CV) events in patients newly exposed to abaloparatide or teriparatide) Action: For adoption 7.2.2. Garadacimab – ANDEMBRY (CAP) – EMA/PAM/0000267718 Applicant: CSL Behring GmbH PRAC Rapporteur: Marie Louise Schougaard Christiansen Scope: Feasibility and protocol assessment of the Non-Interventional Post Authorisation Safety Study CSL312_5006 to assess the long-term safety in adults and adolescents. Action: For adoption 7.2.3. Tofacitinib – XELJANZ (CAP) – EMA/PAM/0000294280 Applicant: Pfizer Europe MA EEIG PRAC Rapporteur: Liana Martirosyan 5 In accordance with Article 107m of Directive 2001/83/EC, supervised by PRAC in accordance with Article 61a (6) of Regulation (EC) No 726/2004 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 42/58 Scope: Xeljanz Submission of A3921321 study interim report (RMP category 3 study; MEA) and protocol amendment (version 8.0) "A Post-Authorisation Safety Study of the Utilisation and Prescribing Patterns of Xeljanz (tofacitinib) in the European Union Using Secondary Data Sources" Action: For adoption 7.3. Results of PASS imposed in the marketing authorisation(s)6 None 7.4. Results of PASS imposed and non-imposed in the marketing authorisation(s)7 7.4.1. Conestat alfa – RUCONEST (CAP) – EMA/VR/0000326016 Applicant: Pharming Group N.V. PRAC Rapporteur: Jan Neuhauser Scope: Submission of the final report from study PHARM/EU/aRMM/01 listed as a category 3 study in the RMP. This is a non-imposed non-interventional PASS concerning additional risk minimization measures for Ruconest – European survey of educational materials. The RMP version 22.0 has also been submitted. Action: For adoption 7.4.2. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000332196 Applicant: BioNTech Manufacturing GmbH PRAC Rapporteur: Liana Martirosyan Scope: Submission of the final report from study C4591009 listed as a category 3 study in the RMP. This is an observational PASS designed to assess safety events of interest (including myocarditis and pericarditis) among recipients of original monovalent Pfizer- BioNTech COVID-19 Vaccine, using data from administrative claims and electronic health records from data research partners participating in the Sentinel System. Action: For adoption 7.4.3. Emicizumab – HEMLIBRA (CAP) – EMA/VR/0000302494 Applicant: Roche Registration GmbH PRAC Rapporteur: Amelia Cupelli Scope: Submission of the final report from study MO40685 (PedNet) listed as a category 3 study in the RMP. This is a non-interventional, secondary data use post-authorization safety 6 In accordance with Article 107p-q of Directive 2001/83/EC 7 In accordance with Article 61a (6) of Regulation (EC) No 726/2004, in line with the revised variations regulation for any submission as of 4 August 2013 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 43/58 study (PASS) relying on data collected as part of the PedNet Registry. The RMP version 6.0 has also been submitted. Action: For adoption 7.4.4. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000333033 Applicant: Astellas Pharma Europe B.V. PRAC Rapporteur: Eva Jirsová Scope: Submission of the final report from study ISN: 7465-PV-0002 listed as a category 3 study in the RMP. This is a non-interventional PASS to assess patients', or their caregivers’, awareness and understanding of the content of the Padcev Patient Card (PC) related to the risk of skin reactions and reported behaviours to minimise the risk. The RMP version 5.2 has also been submitted. Action: For adoption 7.4.5. Eslicarbazepine acetate – ZEBINIX (CAP) – EMA/VR/0000332409 Applicant: Bial Portela & Ca S.A. PRAC Rapporteur: Dennis Lex Scope: Submission of the final report from the post authorisations safety study EURAP (BIA- 2093-402) listed as a category 3 study in the RMP. This is an international, prospective observational registry designed to assess the risks associated with antiepileptic drug exposure during pregnancy. The updated RMP version 23.0 has also been submitted. Risk information has been updated based on clinical evidence, including clinical trials and post- marketing data, together with a comprehensive review of the published literature. Action: For adoption 7.4.6. Linaclotide – CONSTELLA (CAP) – EMA/VR/0000281586 Applicant: Abbvie Deutschland GmbH & Co. KG PRAC Rapporteur: Dennis Lex Scope: Submission of the final report from study EVM-18888 (P21-481) listed as a category 3 study in the RMP. The study, titled "Linaclotide Safety Study for the Assessment of Diarrhoea Complications and Associated Risk Factors in Selected European Populations with IBS-C," is an observational safety study. It assesses the risk of severe complications of diarrhoea (SCD) during treatment with linaclotide, as well as other risk factors among patients with IBS-C in the UK, Sweden, and Spain. The RMP version 11.2 has also been submitted. Action: For adoption 7.4.7. Ofatumumab – KESIMPTA (CAP) – EMA/VR/0000315689 Applicant: Novartis Europharm Limited Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 44/58 PRAC Rapporteur: Amelia Cupelli Scope: Update of section 4.6 ‘pregnancy’ of the SmPC based on the final reports from Kesimpta Pregnancy Registry and the PRegnancy outcomes Intensive Monitoring (PRIM) study. Action: For adoption 7.4.8. Ropeginterferon alfa-2b – BESREMI (CAP) – EMA/VR/0000332690 Applicant: Aop Orphan Pharmaceuticals GmbH PRAC Rapporteur: Carla Torre Scope: Submission of the final report from the post-authorisation safety study (PASS) EUPAS29462, listed as a category 3 study in the RMP. This is a multicenter, non- interventional, observational and non-imposed post-authorisation safety study of ropeginterferon alfa-2b in polycythaemia vera patients. The RMP version 4.0 has also been submitted. Action: For adoption 7.4.9. Tacrolimus – ADVAGRAF (CAP); MODIGRAF (CAP); NAP – EMA/VR/0000315125 Applicants: Astellas Pharma Europe B.V., various PRAC Rapporteur: Eamon O Murchu Scope: Submission of the final report from noninterventional post-authorization safety study (NIPASS) listed as a category 3 study in the RMP. This is a feasibility assessment of conducting a NIPASS of outcomes associated with the use of tacrolimus around conception, or during pregnancy or lactation using data from available secondary use data sources to replicate the Transplant Pregnancy Registry International (TPRI) study. The RMP version 6.0 has also been submitted. Action: For adoption 7.5. Interim results and other post-authorisation measures for imposed and non-imposed studies 7.5.1. Abatacept – ORENCIA (CAP) – EMA/PAM/0000334018 Applicant: Bristol-Myers Squibb Pharma EEIG PRAC Rapporteur: Kimmo Jaakkola Scope: Interim study results for Study IM101240: Observational Registry of Abatacept in Patients with Juvenile Idiopathic Arthritis. Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 45/58 7.5.2. Abrocitinib – CIBINQO (CAP) – EMA/PAM/0000333269 Applicant: Pfizer Europe MA EEIG PRAC Rapporteur: Petar Mas Scope: Submission of the first progress report for the PASS B7451120, a prospective active surveillance study to monitor growth, development, and maturation among adolescents with atopic dermatitis exposed to abrocitinib. Action: For adoption 7.5.3. Atogepant – AQUIPTA (CAP) – EMA/PAM/0000334196 Applicant: Abbvie Deutschland GmbH & Co. KG PRAC Rapporteur: Rugile Pilviniene Scope: Submission of the third interim report for Study P22-392: Atogepant pregnancy exposure registry Action: For adoption 7.5.4. Atogepant – AQUIPTA (CAP) – EMA/PAM/0000334182 Applicant: Abbvie Deutschland GmbH & Co. KG PRAC Rapporteur: Rugile Pilviniene Scope: Third Interim report and Updated Protocol Submission - Study P22-419 Category 3 PASS: Observational study to assess pregnancy outcomes following exposure to atogepant Action: For adoption 7.5.5. Diroximel fumarate – VUMERITY (CAP) – EMA/PAM/0000334226 Applicant: Biogen Netherlands B.V. PRAC Rapporteur: Dennis Lex Scope: Third annual interim report for cat. 3 PASS 272MS401 (A prospective observational pregnancy exposure registry to characterise how DRF may affect pregnancy and infant outcomes). Action: For adoption 7.5.6. Etuvetidigene autotemcel – WASKYRA (CAP) – EMA/PAM/0000334844 Applicant: Fondazione Telethon Ets, ATMP PRAC Rapporteur: Jo Robays Scope: Submission of an updated PASS protocol (version 3.0) for the imposed interventional Post-Approval Safety Study (PASS) WAS-TLT003-01, a Category 1- Required additional Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 46/58 pharmacovigilance activity. The protocol is submitted within three months of the EC Decision as defined in the approved RMP (version 0.6) Action: For adoption 7.5.7. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000323622 Applicant: UCB Pharma PRAC Rapporteur: Dennis Lex Scope: P46 EP0241 Final Clinical Study Report for non-interventional retrospective cohort study using national pharmacy database to evaluate the real-world use of fenfluramine (Fintepla) for Dravet syndrome, Lennox-Gastaut syndrome, and other epilepsies in the United States. Action: For adoption 7.5.8. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000326084 Applicant: UCB Pharma PRAC Rapporteur: Dennis Lex Scope: P46 RWE1609 Final Clinical Study Report of non-interventional retrospective cohort study using US claims and fact-of-death to evaluate mortality rates and associated risk factors among patients diagnosed with Dravet Syndrome and Lennox-Gastaut Syndrome. Action: For adoption 7.5.9. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000327550 Applicant: UCB Pharma PRAC Rapporteur: Dennis Lex Scope: P46 Study RWE1608: non-interventional retrospective cohort analysis using US Komodo claims data to evaluate the impact of Fintepla initiation among LGS patients. Action: For adoption 7.5.10. Inotersen – TEGSEDI (CAP) – EMA/PAM/0000326086 Applicant: Akcea Therapeutics Ireland Limited PRAC Rapporteur: Rhea Fitzgerald Scope: Fourth annual report on A Prospective, Non-Interventional, Long-Term, Multinational Cohort Safety Study of Patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN). Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 47/58 7.5.11. Iptacopan – FABHALTA (CAP) – EMA/PAM/0000331969 Applicant: Novartis Europharm Limited PRAC Rapporteur: Lina Seibokiene Scope: PAM [MEA] - First Interim report of Post-authorization safety study of iptacopan in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) using data from the non- interventional IPIG PNH Registry Action: For adoption 7.5.12. Iptacopan – FABHALTA (CAP) – EMA/PAM/0000331978 Applicant: Novartis Europharm Limited PRAC Rapporteur: Lina Seibokiene Scope: PAM [MEA] -2nd Interim report of safety and eGFR data from all patients with recurrent complement 3 glomerulopathy (C3G) enrolled in the C3G EAP/MAP Action: For adoption 7.5.13. Lasmiditan – RAYVOW (CAP) – EMA/PAM/0000332938 Applicant: Eli Lilly Nederland B.V. PRAC Rapporteur: Jana Pecherova Scope: Interim study results for Observational Cohort Study of Lasmiditan Exposure and Motor Vehicle Accidents in the United States Action: For adoption 7.5.14. Naldemedine – RIZMOIC (CAP) – EMA/PAM/0000320323 Applicant: Shionogi B.V. PRAC Rapporteur: Eamon O Murchu Scope: 4th Annual Progress Report with interim report with study results for Naldemedine: An Observational Post-Authorisation Safety Study (PASS) of Patients with Chronic Opioid Use for Non-Cancer Pain and Cancer Pain who have Opioid-Induced Constipation (OIC) Action: For adoption 7.5.15. Niraparib / Abiraterone acetate – AKEEGA (CAP) – EMA/PAM/0000302057 Applicant: Janssen Cilag International PRAC Rapporteur: Jan Neuhauser Scope: Interim Study report for PCSONCA0485: Post authorization safety study to characterize the risk of second primary malignancies (SPM) including MDS/AML among metastatic prostate cancer patients exposed to AKEEGA. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 48/58 Action: For adoption 7.5.16. Risdiplam – EVRYSDI (CAP) – EMA/PAM/0000310307 Applicant: Roche Registration GmbH PRAC Rapporteur: Jan Neuhauser Scope: 4th annual progress report for Evrysdi non-interventional pregnancy surveillance Study BN42833 Action: For adoption 7.5.17. Rurioctocog alfa pegol – ADYNOVI (CAP) – EMA/PAM/0000326983 Applicant: BAXALTA INNOVATIONS GmbH PRAC Rapporteur: Bianca Mulder Scope: 5th Interim report of study PASS TAK-660-403: Evaluation of long-term safety of Adynovi/Adynovate (Antihaemophilic Factor [Recombinant] PEGylated, rurioctocog alfa pegol) in patients with haemophilia A Action: For adoption 7.5.18. Ustekinumab – STELARA (CAP) – EMA/PAM/0000310166 Applicant: Janssen Cilag International PRAC Rapporteur: Rhea Fitzgerald Scope: Second interim report for an Observational Postauthorization Safety Study To Describe The Safety Of Ustekinumab and Other Biologic Treatments in a Cohort of Patients With Ulcerative Colitis or Crohn’s Disease Using Compulsory Swedish Nationwide Healthcare Registers and the Independent Swedish National Quality Register for Inflammatory Bowel Disease (SWIBREG; PCSIMM002807); former MEA 047. Action: For adoption 8. Renewals of the marketing authorisation, conditional renewal and annual reassessments 8.1. Annual reassessments of the marketing authorisation 8.1.1. Glucarpidase – VORAXAZE (CAP) – EMA/S/0000322329 Applicant: Serb PRAC Rapporteur: Dennis Lex Scope: Annual reassessment of the marketing authorisation Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 49/58 Action: For adoption 8.1.2. Pegzilarginase – LOARGYS (CAP) – EMA/S/0000326830 Applicant: Immedica Pharma AB PRAC Rapporteur: Dennis Lex Scope: Annual reassessment of the marketing authorisation Action: For adoption 8.1.3. Susoctocog alfa – OBIZUR (CAP) – EMA/S/0000324538 Applicant: BAXALTA INNOVATIONS GmbH PRAC Rapporteur: Dirk Mentzer Scope: Annual reassessment of the marketing authorisation Action: For adoption 8.1.4. Tabelecleucel – EBVALLO (CAP) – EMA/S/0000326533 Applicant: Pierre Fabre Medicament PRAC Rapporteur: Amelia Cupelli Scope: Annual reassessment of the marketing authorisation Action: For adoption 8.2. Conditional renewals of the marketing authorisation 8.2.1. Avapritinib – AYVAKYT (CAP) – EMA/R/0000335342 Applicant: Blueprint Medicines (Netherlands) B.V. PRAC Rapporteur: Bianca Mulder Scope: Conditional renewal of the marketing authorisation Action: For adoption 8.2.2. Dorocubicel / Allogeneic umbilical cord-derived CD34- cells, non-expanded – ZEMCELPRO (CAP) – EMA/R/0000333327 Applicant: Cordex Biologics International Limited PRAC Rapporteur: Mari Thorn Scope: Conditional renewal of the marketing authorisation Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 50/58 8.2.3. Elafibranor – IQIRVO (CAP) – EMA/R/0000335590 Applicant: Ipsen Pharma PRAC Rapporteur: Rugile Pilviniene Scope: Conditional renewal of the marketing authorisation Action: For adoption 8.2.4. Epcoritamab – TEPKINLY (CAP) – EMA/R/0000334812 Applicant: Abbvie Deutschland GmbH & Co. KG PRAC Rapporteur: Maria Martinez Gonzalez Scope: Conditional renewal of the marketing authorisation Action: For adoption 8.2.5. Larotrectinib – VITRAKVI (CAP) – EMA/R/0000335017 Applicant: Bayer AG PRAC Rapporteur: Rugile Pilviniene Scope: Conditional renewal of the marketing authorisation Action: For adoption 8.2.6. Odronextamab – ORDSPONO (CAP) – EMA/R/0000333139 Applicant: Regeneron Ireland Designated Activity Company PRAC Rapporteur: Veronika Macurova Scope: Conditional renewal of the marketing authorisation Action: For adoption 8.2.7. Tafasitamab – MINJUVI (CAP) – EMA/R/0000334308 Applicant: Incyte Biosciences Distribution B.V. PRAC Rapporteur: Mari Thorn Scope: Conditional renewal of the marketing authorisation Action: For adoption 8.3. Renewals of the marketing authorisation 8.3.1. Adalimumab – LIBMYRIS (CAP) – EMA/R/0000326540 Applicant: STADA Arzneimittel AG Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 51/58 PRAC Rapporteur: Karin Bolin Scope: 5-year renewal of the marketing authorisation Action: For adoption 8.3.2. Adalimumab – HUKYNDRA (CAP) – EMA/R/0000326487 Applicant: STADA Arzneimittel AG PRAC Rapporteur: Karin Bolin Scope: 5-year renewal of the marketing authorisation Action: For adoption 8.3.3. Diroximel fumarate – VUMERITY (CAP) – EMA/R/0000327345 Applicant: Biogen Netherlands B.V. PRAC Rapporteur: Dennis Lex Scope: 5-year renewal of the marketing authorisation Action: For adoption 8.3.4. Pegcetacoplan – ASPAVELI (CAP) – EMA/R/0000326756 Applicant: Swedish Orphan Biovitrum AB (publ) PRAC Rapporteur: Kimmo Jaakkola Scope: 5-year renewal of the marketing authorisation Action: For adoption 8.3.5. Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) – VAXNEUVANCE (CAP) – EMA/R/0000326976 Applicant: Merck Sharp & Dohme B.V. PRAC Rapporteur: Dirk Mentzer Scope: 5-year renewal of the marketing authorisation Action: For adoption 8.3.6. Ripretinib – QINLOCK (CAP) – EMA/R/0000326982 Applicant: Deciphera Pharmaceuticals (Netherlands) B.V. PRAC Rapporteur: Barbara Kovacic Bytyqi Scope: 5-year renewal of the marketing authorisation Action: For adoption Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 52/58 8.3.7. Rivaroxaban – RIVAROXABAN VIATRIS (CAP) – EMA/R/0000327079 Applicant: Viatris Limited PRAC Rapporteur: Mari Thorn Scope: 5-year renewal of the marketing authorisation Action: For adoption 8.3.8. Sacituzumab govitecan – TRODELVY (CAP) – EMA/R/0000326788 Applicant: Gilead Sciences Ireland Unlimited Company PRAC Rapporteur: Bianca Mulder Scope: 5-year renewal of the marketing authorisation Action: For adoption 8.3.9. Sugammadex – SUGAMMADEX MYLAN (CAP) – EMA/R/0000327067 Applicant: Mylan Pharmaceuticals Limited PRAC Rapporteur: Terhi Lehtinen Scope: 5-year renewal of the marketing authorisation Action: For adoption 8.3.10. Zanubrutinib – BRUKINSA (CAP) – EMA/R/0000326587 Applicant: Beone Medicines Ireland Limited PRAC Rapporteur: Bianca Mulder Scope: 5-year renewal of the marketing authorisation Action: For adoption 9. Product related pharmacovigilance inspections 9.1. List of planned pharmacovigilance inspections None 9.2. Ongoing or concluded pharmacovigilance inspections Disclosure of information on results of pharmacovigilance inspections could undermine the protection of the purpose of these inspections, investigations and audits. Therefore such information is not reported in the agenda. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 53/58 9.3. Others None 10. Other safety issues for discussion requested by the Member States, CHMP or the EMA None 11. Scientific advice procedures Information related to this section cannot be released at the present time as it is deemed to contain commercially confidential information. 12. Organisational, regulatory and methodological matters 12.1. Mandate and organisation of the PRAC 12.1.1. PRAC membership Action: For information 12.1.2. Nominated proxy Action: For information 12.2. Coordination with EMA Scientific Committees or CMDh-v None 12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups None 12.4. Cooperation within the EU regulatory network 12.4.1. PRAC strategic review and learning meeting (SRLM) under the Cyprus presidency of the European Union (EU) Council – Pafos, Cyprus, 12 – 13 May 2026 - update PRAC lead: Panagiotis Psaras Action: For discussion Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 54/58 12.5. Cooperation with International Regulators 12.5.1. International Conference on Harmonisation (ICH) E23 guideline - update PRAC lead: Carla Torre Action: For information 12.6. Contacts of the PRAC with external parties and interaction with the Interested Parties to the Committee None 12.7. PRAC work plan None 12.8. Planning and reporting 12.8.1. Marketing authorisation applications (MAA) and technology forecast: April 2026 – December 2028 Action: For information 12.9. Pharmacovigilance audits and inspections 12.9.1. Pharmacovigilance systems and their quality systems None 12.9.2. Pharmacovigilance inspections None 12.9.3. Pharmacovigilance audits None 12.10. Periodic safety update reports (PSURs) & Union reference date (EURD) list 12.10.1. Periodic safety update reports None Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 55/58 12.10.2. Granularity and Periodicity Advisory Group (GPAG) PRAC lead: Petar Mas Action: For discussion 12.10.3. PSURs repository None 12.10.4. Union reference date list – consultation on the draft list Action: For adoption 12.11. Signal management 12.11.1. Signal management – feedback from Signal Management Review Technical (SMART) Working Group PRAC lead: Dennis Lex Action: For discussion 12.12. Adverse drug reactions reporting and additional reporting 12.12.1. Management and reporting of adverse reactions to medicinal products None 12.12.2. Additional monitoring None 12.12.3. List of products under additional monitoring – consultation on the draft list Action: For adoption 12.13. EudraVigilance database 12.13.1. Activities related to the confirmation of full functionality None Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 56/58 12.14. Risk management plans and effectiveness of risk minimisations 12.14.1. Risk management systems None 12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations None 12.15. Post-authorisation safety studies (PASS) 12.15.1. Post-authorisation Safety Studies – imposed PASS None 12.15.2. Post-authorisation Safety Studies – non-imposed PASS None 12.16. Community procedures 12.16.1. Referral procedures for safety reasons None 12.17. Renewals, conditional renewals, annual reassessments None 12.18. Risk communication and transparency 12.18.1. Public participation in pharmacovigilance None 12.18.2. Safety communication None Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 57/58 12.19. Continuous pharmacovigilance 12.19.1. Incident management None 12.20. Impact of pharmacovigilance activities 12.20.1. Study on the implementation of controlled access to and distribution of medicinal products in EU Member States (SC02/EMA/2020/46/TDA/L4.02) - regulatory follow- up PRAC lead: Liana Martirosyan Action: For discussion 12.21. Others None 13. Any other business None 14. Explanatory notes The Notes give a brief explanation of relevant agenda items and should be read in conjunction with the agenda. List of acronyms and abbreviations For a list of acronyms and abbreviations used in the PRAC agenda, see: List of abbreviations used in EMA human medicines scientific committees and CMDh documents, and in relation to EMA’s regulatory activities EU Referral procedures for safety reasons: Urgent EU procedures and Other EU referral procedures (Items 2 and 3 of the PRAC agenda) A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU). For further detailed information on safety related referrals please see: Referral procedures: human medicines | European Medicines Agency (europa.eu) Signals assessment and prioritisation (Item 4 of the PRAC agenda) A safety signal is information on a new or incompletely documented adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks. The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The adverse event could be a symptom of another illness or caused by another medicine taken by the patient. https://www.ema.europa.eu/en/documents/other/abbreviations-used-ema-scientific-committees-and-cmd-documents-and-relation-emas-regulatory-activities_en.pdf https://www.ema.europa.eu/en/documents/other/abbreviations-used-ema-scientific-committees-and-cmd-documents-and-relation-emas-regulatory-activities_en.pdf https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/89531/2026 Page 58/58 The evaluation of safety signals is required to establish whether or not there is a causal relationship between the medicine and the reported adverse event. The evaluation of safety signals may not necessarily conclude that the medicine caused the adverse event in question. In cases where a causal relationship is confirmed or considered likely, regulatory action may be necessary and this usually takes the form of an update of the summary of product characteristics and the package leaflet. Risk Management Plans (RMPs) (Item 5 of the PRAC agenda) The RMP describes what is known and not known about the side effects of a medicine and states how these risks will be prevented or minimised in patients. It also includes plans for studies and other activities to gain more knowledge about the safety of the medicine and risk factors for developing side effects. RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available. Assessment of Periodic Safety Update Reports (PSURs) (Item 6 of the PRAC agenda) A PSUR is a report providing an evaluation of the benefit-risk balance of a medicine, which is submitted by marketing authorisation holders at defined time points following a medicine’s authorisation. PSURs summarises data on the benefits and risks of a medicine and includes the results of all studies carried out with this medicine (in the authorised and unauthorised indications). Post-authorisation Safety Studies (PASS) (Item 7 of the PRAC agenda) A PASS is a study of an authorised medicinal product carried out to obtain further information on its safety, or to measure the effectiveness of risk management measures. The results of a PASS help regulatory agencies to evaluate the safety and benefit-risk profile of a medicine. Product related pharmacovigilance inspections (Item 9 of the PRAC agenda) Inspections carried out by regulatory agencies to ensure that marketing authorisation holders comply with their pharmacovigilance obligations. More detailed information on the above terms can be found on the EMA website: www.ema.europa.eu/ Article 58 procedures (Art 58) Article 58 of Regulation (EC) No 726/2004 allows the Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with the World Health Organisation (WHO) on medicinal products for human use that are intended exclusively for markets outside of the European Union (EU) http://www.ema.europa.eu/ 1. Introduction 1.1. Welcome and declarations of interest of members, alternates and experts 1.2. Agenda of the meeting on 04-07 May 2026 1.3. Minutes of the previous meeting on 07-10 April 2026 2. EU referral procedures for safety reasons: urgent EU procedures 2.1. Newly triggered procedures 2.2. Ongoing procedures 2.3. Procedures for finalisation 3. EU referral procedures for safety reasons: other EU referral procedures 3.1. Newly triggered procedure 3.2. Ongoing procedures 3.3. Procedures for finalisation 3.4. Re-examination procedures 3.5. Others 4. Signals assessment and prioritisation 4.1. New signals detected from EU spontaneous reporting systems and/or other sources 4.1.1. Alprazolam (NAP); amitriptyline hydrochloride / medazepam (NAP); amitriptyline / chlordiazepoxide (NAP); bromazepam (NAP); bromazepam / propantheline bromide (NAP); brotizolam (NAP); chlordiazepoxide (NAP); chlordiazepoxide / clidinium bromide... 4.1.2. Amoxicillin (NAP); amoxicillin/clavulanic acid (NAP) 4.1.3. Dapagliflozin – EDISTRIDE (CAP); DAPAGLIFLOZIN VIATRIS (CAP); FORXIGA (CAP), NAP; dapagliflozin / metformin – EBYMECT (CAP), XIGDUO (CAP), NAP; dapagliflozin / saxagliptin – QTERN (CAP); dapagliflozin/sitagliptin (NAP) 4.1.4. Exenatide – BYDUREON (CAP), BYETTA (CAP); insulin icodec / semaglutide - KYINSU (CAP); semaglutide – KAYSHILD (CAP), OZEMPIC (CAP), RYBELSUS (CAP), WEGOVY (CAP), WEGOVY FLEXTOUCH (CAP) 4.1.5. Ixekizumab - TALTZ (CAP) 4.1.6. Semaglutide – OZEMPIC (CAP), RYBELSUS (CAP), WEGOVY (CAP), WEGOVY FLEX TOUCH (CAP), KAYSHILD (CAP); insulin icodec / semaglutide - KYINSU (CAP) 4.1.7. Tocilizumab – AVTOZMA (CAP); RoACTEMRA (CAP); TOCILIZUMAB STADA (CAP); TUYORY(CAP); TYENNE (CAP) 4.2. Signals follow-up and prioritisation 4.2.1. Pancreatin (NAP) 4.3. Variation procedure(s) resulting from signal evaluation 5. Risk management plans (RMPs) 5.1. Medicines in the pre-authorisation phase 5.1.1. Arimoclomol (CAP MAA) - EMEA/H/C/006736, Orphan 5.1.2. Azacitidine (CAP MAA) - EMEA/H/C/006695 5.1.3. Cefepime / Zidebactam (CAP MAA) - EMEA/H/C/006799 5.1.4. Icotrokinra hydrochloride (CAP MAA) - EMEA/H/C/006730 5.1.5. Obicetrapib (CAP MAA) - EMEA/H/C/006516 5.1.6. Obicetrapib / Ezetimibe (CAP MAA) - EMEA/H/C/006517 5.1.7. Ranibizumab (CAP MAA) - EMEA/H/C/006527 5.1.8. Ranibizumab (CAP MAA) - EMEA/H/C/006926 5.1.9. Ruxolitinib hemifumarate (CAP MAA) - EMEA/H/C/006618 5.1.10. Senaparib (CAP MAA) - EMEA/H/C/006708 5.1.11. Sufentanil / Ketamine (CAP MAA) - EMEA/H/C/006395, PUMA 5.1.12. Tafamidis (CAP MAA) - EMEA/H/C/006711 5.1.13. Trilaciclib (CAP MAA) - EMEA/H/C/006709 5.2. Medicines in the post-authorisation phase – PRAC-led procedures 5.2.1. Atazanavir – REYATAZ (CAP); Atazanavir / Cobicistat – EVOTAZ (CAP) – EMA/VR/0000288444 5.2.2. Lecanemab – LEQEMBI (CAP) – EMA/VR/0000302769 5.2.3. Pegcetacoplan – ASPAVELI (CAP) – EMA/VR/0000333829 5.3. Medicines in the post-authorisation phase – CHMP-led procedures 5.3.1. Abiraterone acetate – ABIRATERONE MYLAN (CAP); NAP – EMA/VR/0000291298 5.3.2. Adalimumab – IMRALDI (CAP) – EMA/X/0000321285 5.3.3. Alemtuzumab – LEMTRADA (CAP) – EMA/VR/0000335041 5.3.4. Apixaban – ELIQUIS (CAP) – EMA/VR/0000327005 5.3.5. Atidarsagene autotemcel – LIBMELDY (CAP) – EMA/VR/0000334917 5.3.6. Belimumab – BENLYSTA (CAP) – EMA/VR/0000306408 5.3.7. Belzutifan – WELIREG (CAP); Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000313634 5.3.8. Belzutifan – WELIREG (CAP) – EMA/VR/0000326853 5.3.9. Cabotegravir – VOCABRIA (CAP) – EMA/VR/0000332087 5.3.10. Cabotegravir – APRETUDE (CAP) – EMA/VR/0000331993 5.3.11. Cetuximab – ERBITUX (CAP) – EMA/VR/0000326978 5.3.12. Cetuximab – ERBITUX (CAP) – EMA/VR/0000327014 5.3.13. COVID-19 mRNA vaccine – SPIKEVAX (CAP) – EMA/VR/0000335829 5.3.14. Damoctocog alfa pegol – JIVI (CAP) – EMA/VR/0000326847 5.3.15. Deferasirox – EXJADE (CAP) – EMA/VR/0000333352 5.3.16. Difelikefalin – KAPRUVIA (CAP) – EMA/VR/0000316094 5.3.17. Dimethyl fumarate – TECFIDERA (CAP) – EMA/VR/0000320745 5.3.18. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000312495 5.3.19. Epcoritamab – TEPKINLY (CAP) – EMA/VR/0000311043 5.3.20. Filgotinib – JYSELECA (CAP) – EMA/VR/0000325892 5.3.21. Florbetapir (18F) – AMYVID (CAP) – EMA/VR/0000333287 5.3.22. Formoterol / Glycopyrronium bromide / Budesonide – RILTRAVA AEROSPHERE (CAP) – EMA/X/0000287672 5.3.23. Formoterol / Glycopyrronium bromide / Budesonide – TRIXEO AEROSPHERE (CAP) – EMA/X/0000287664 5.3.24. Glecaprevir / Pibrentasvir – MAVIRET (CAP) – EMA/VR/0000316551 5.3.25. Glofitamab – COLUMVI (CAP) – EMA/VR/0000327100 5.3.26. Glycopyrronium – SIALANAR (CAP) – EMA/X/0000287532 5.3.27. Inclisiran – LEQVIO (CAP) – EMA/VR/0000293324 5.3.28. Ipilimumab – YERVOY (CAP); Nivolumab – OPDIVO (CAP) – EMA/VR/0000319172 5.3.29. Lacosamide – LACOSAMIDE UCB (CAP); VIMPAT (CAP) – EMA/VR/0000321459 5.3.30. Obinutuzumab – GAZYVARO (CAP) – EMA/VR/0000327013 5.3.31. Octreotide – OCZYESA (CAP) – EMA/VR/0000333073 5.3.32. Pegvaliase – PALYNZIQ (CAP) – EMA/VR/0000302032 5.3.33. Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000316576 5.3.34. Pembrolizumab – KEYTRUDA (CAP) – EMA/VR/0000312515 5.3.35. Ponatinib – ICLUSIG (CAP) – EMA/X/0000296489 5.3.36. Rucaparib – RUBRACA (CAP) – EMA/VR/0000332297 5.3.37. Sacituzumab govitecan – TRODELVY (CAP) – EMA/VR/0000312649 5.3.38. Secukinumab – COSENTYX (CAP) – EMA/VR/0000326984 5.3.39. Serplulimab – HETRONIFLY (CAP) – EMA/VR/0000290021 5.3.40. Somapacitan – SOGROYA (CAP) – EMA/VR/0000264734 5.3.41. Sotatercept – WINREVAIR (CAP) – EMA/VR/0000315667 5.3.42. Tirzepatide – MOUNJARO (CAP) – EMA/VR/0000310637 5.3.43. Trastuzumab – ZERCEPAC (CAP) – EMA/X/0000321364 5.3.44. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/VR/0000326482 5.3.45. Upadacitinib – RINVOQ (CAP) – EMA/VR/0000312506 5.3.46. Upadacitinib – RINVOQ (CAP) – EMA/VR/0000325958 5.3.47. Ustekinumab – USRENTY (CAP) – EMA/VR/0000325350 5.3.48. Ustekinumab – STELARA (CAP) – EMA/VR/0000316205 6. Periodic safety update reports (PSURs) 6.1. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) only 6.1.1. Alemtuzumab – LEMTRADA (CAP) – EMA/PSUR/0000321520 6.1.2. Amikacin – ARIKAYCE LIPOSOMAL (CAP) – EMA/PSUR/0000321506 6.1.3. Atogepant – AQUIPTA (CAP) – EMA/PSUR/0000321517 6.1.4. Brolucizumab – BEOVU (CAP) – EMA/PSUR/0000321518 6.1.5. Chenodeoxycholic acid – CHENODEOXYCHOLIC ACID LEADIANT (CAP) – EMA/PSUR/0000321503 6.1.6. Chikungunya vaccine (live) – IXCHIQ (CAP) – EMA/PSUR/0000327923 6.1.7. Concizumab – ALHEMO (CAP) – EMA/PSUR/0000321510 6.1.8. Dibotermin alfa – INDUCTOS (CAP) – EMA/PSUR/0000321514 6.1.9. Etrasimod – VELSIPITY (CAP) – EMA/PSUR/0000321519 6.1.10. Futibatinib – LYTGOBI (CAP) – EMA/PSUR/0000321515 6.1.11. Herpes zoster vaccine (recombinant, adjuvanted) – SHINGRIX (CAP) – EMA/PSUR/0000321507 6.1.12. Histamine dihydrochloride – CEPLENE (CAP) – EMA/PSUR/0000321522 6.1.13. Inavolisib – ITOVEBI (CAP) – EMA/PSUR/0000321509 6.1.14. Lasmiditan – RAYVOW (CAP) – EMA/PSUR/0000321508 6.1.15. Macitentan / Tadalafil – YUVANCI (CAP) – EMA/PSUR/0000321504 6.1.16. Maralixibat – LIVMARLI (CAP) – EMA/PSUR/0000321513 6.1.17. Marstacimab – HYMPAVZI (CAP) – EMA/PSUR/0000321516 6.1.18. Mirikizumab – OMVOH (CAP) – EMA/PSUR/0000321511 6.1.19. Nemolizumab – NEMLUVIO (CAP) – EMA/PSUR/0000321530 6.1.20. Olipudase alfa – XENPOZYME (CAP) – EMA/PSUR/0000321501 6.1.21. Selumetinib – KOSELUGO (CAP) – EMA/PSUR/0000321505 6.1.22. Tobramycin – VANTOBRA (CAP) – EMA/PSUR/0000321512 6.1.23. Trabectedin – YONDELIS (CAP) – EMA/PSUR/0000321523 6.1.24. Vilobelimab – GOHIBIC (CAP) – EMA/PSUR/0000321533 6.2. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) and nationally authorised products (NAPs) 6.2.1. Choriogonadotropin alfa – OVITRELLE (CAP), NAP; Chorionic gonadotrophin (NAP); Human chorionic gonadotropin (NAP) – EMA/PSUR/0000321521 6.2.2. Midazolam – BUCCOLAM (CAP); NAP – EMA/PSUR/0000321529 6.2.3. Sodium oxybate – XYREM (CAP); NAP – EMA/PSUR/0000321502 6.3. PSUR single assessment (PSUSA) procedures including nationally authorised products (NAPs) only 6.3.1. Allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) – EMA/PSUR/0000321532 6.3.2. Bivalirudin – EMA/PSUR/0000321527 6.3.3. Lactitol – EMA/PSUR/0000321534 6.3.4. Lisinopril, lisinopril / hydrochlorothiazide – EMA/PSUR/0000321531 6.3.5. Progesterone – EMA/PSUR/0000321526 6.3.6. Silver sulfadiazine – EMA/PSUR/0000321525 6.3.7. Terizidone – EMA/PSUR/0000321528 6.4. Follow-up to PSUR/PSUSA procedures 6.5. Variation procedure(s) resulting from PSUSA evaluation 6.5.1. Sapropterin – KUVAN (CAP) – EMA/VR/0000301983 6.6. Expedited summary safety reviews 7. Post-authorisation safety studies (PASS) 7.1. Protocols of PASS imposed in the marketing authorisation(s) 7.1.1. Lecanemab – LEQEMBI (CAP) – EMA/PASS/0000267311 7.1.2. Obecabtagene autoleucel – AUCATZYL (CAP) – EMA/PASS/0000300590 7.1.3. Volanesorsen – WAYLIVRA (CAP) – EMA/PASS/0000334506 7.2. Protocols of PASS non-imposed in the marketing authorisation(s) 7.2.1. Abaloparatide – ELADYNOS (CAP) – EMA/PAM/0000281538 7.2.2. Garadacimab – ANDEMBRY (CAP) – EMA/PAM/0000267718 7.2.3. Tofacitinib – XELJANZ (CAP) – EMA/PAM/0000294280 7.3. Results of PASS imposed in the marketing authorisation(s) 7.4. Results of PASS imposed and non-imposed in the marketing authorisation(s) 7.4.1. Conestat alfa – RUCONEST (CAP) – EMA/VR/0000326016 7.4.2. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000332196 7.4.3. Emicizumab – HEMLIBRA (CAP) – EMA/VR/0000302494 7.4.4. Enfortumab vedotin – PADCEV (CAP) – EMA/VR/0000333033 7.4.5. Eslicarbazepine acetate – ZEBINIX (CAP) – EMA/VR/0000332409 7.4.6. Linaclotide – CONSTELLA (CAP) – EMA/VR/0000281586 7.4.7. Ofatumumab – KESIMPTA (CAP) – EMA/VR/0000315689 7.4.8. Ropeginterferon alfa-2b – BESREMI (CAP) – EMA/VR/0000332690 7.4.9. Tacrolimus – ADVAGRAF (CAP); MODIGRAF (CAP); NAP – EMA/VR/0000315125 7.5. Interim results and other post-authorisation measures for imposed and non-imposed studies 7.5.1. Abatacept – ORENCIA (CAP) – EMA/PAM/0000334018 7.5.2. Abrocitinib – CIBINQO (CAP) – EMA/PAM/0000333269 7.5.3. Atogepant – AQUIPTA (CAP) – EMA/PAM/0000334196 7.5.4. Atogepant – AQUIPTA (CAP) – EMA/PAM/0000334182 7.5.5. Diroximel fumarate – VUMERITY (CAP) – EMA/PAM/0000334226 7.5.6. Etuvetidigene autotemcel – WASKYRA (CAP) – EMA/PAM/0000334844 7.5.7. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000323622 7.5.8. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000326084 7.5.9. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000327550 7.5.10. Inotersen – TEGSEDI (CAP) – EMA/PAM/0000326086 7.5.11. Iptacopan – FABHALTA (CAP) – EMA/PAM/0000331969 7.5.12. Iptacopan – FABHALTA (CAP) – EMA/PAM/0000331978 7.5.13. Lasmiditan – RAYVOW (CAP) – EMA/PAM/0000332938 7.5.14. Naldemedine – RIZMOIC (CAP) – EMA/PAM/0000320323 7.5.15. Niraparib / Abiraterone acetate – AKEEGA (CAP) – EMA/PAM/0000302057 7.5.16. Risdiplam – EVRYSDI (CAP) – EMA/PAM/0000310307 7.5.17. Rurioctocog alfa pegol – ADYNOVI (CAP) – EMA/PAM/0000326983 7.5.18. Ustekinumab – STELARA (CAP) – EMA/PAM/0000310166 8. Renewals of the marketing authorisation, conditional renewal and annual reassessments 8.1. Annual reassessments of the marketing authorisation 8.1.1. Glucarpidase – VORAXAZE (CAP) – EMA/S/0000322329 8.1.2. Pegzilarginase – LOARGYS (CAP) – EMA/S/0000326830 8.1.3. Susoctocog alfa – OBIZUR (CAP) – EMA/S/0000324538 8.1.4. Tabelecleucel – EBVALLO (CAP) – EMA/S/0000326533 8.2. Conditional renewals of the marketing authorisation 8.2.1. Avapritinib – AYVAKYT (CAP) – EMA/R/0000335342 8.2.2. Dorocubicel / Allogeneic umbilical cord-derived CD34- cells, non-expanded – ZEMCELPRO (CAP) – EMA/R/0000333327 8.2.3. Elafibranor – IQIRVO (CAP) – EMA/R/0000335590 8.2.4. Epcoritamab – TEPKINLY (CAP) – EMA/R/0000334812 8.2.5. Larotrectinib – VITRAKVI (CAP) – EMA/R/0000335017 8.2.6. Odronextamab – ORDSPONO (CAP) – EMA/R/0000333139 8.2.7. Tafasitamab – MINJUVI (CAP) – EMA/R/0000334308 8.3. Renewals of the marketing authorisation 8.3.1. Adalimumab – LIBMYRIS (CAP) – EMA/R/0000326540 8.3.2. Adalimumab – HUKYNDRA (CAP) – EMA/R/0000326487 8.3.3. Diroximel fumarate – VUMERITY (CAP) – EMA/R/0000327345 8.3.4. Pegcetacoplan – ASPAVELI (CAP) – EMA/R/0000326756 8.3.5. Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) – VAXNEUVANCE (CAP) – EMA/R/0000326976 8.3.6. Ripretinib – QINLOCK (CAP) – EMA/R/0000326982 8.3.7. Rivaroxaban – RIVAROXABAN VIATRIS (CAP) – EMA/R/0000327079 8.3.8. Sacituzumab govitecan – TRODELVY (CAP) – EMA/R/0000326788 8.3.9. Sugammadex – SUGAMMADEX MYLAN (CAP) – EMA/R/0000327067 8.3.10. Zanubrutinib – BRUKINSA (CAP) – EMA/R/0000326587 9. Product related pharmacovigilance inspections 9.1. List of planned pharmacovigilance inspections 9.2. Ongoing or concluded pharmacovigilance inspections 9.3. Others 10. Other safety issues for discussion requested by the Member States, CHMP or the EMA 11. Scientific advice procedures 12. Organisational, regulatory and methodological matters 12.1. Mandate and organisation of the PRAC 12.1.1. PRAC membership 12.1.2. Nominated proxy 12.2. Coordination with EMA Scientific Committees or CMDh-v 12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups 12.4. Cooperation within the EU regulatory network 12.4.1. PRAC strategic review and learning meeting (SRLM) under the Cyprus presidency of the European Union (EU) Council – Pafos, Cyprus, 12 – 13 May 2026 - update 12.5. Cooperation with International Regulators 12.5.1. International Conference on Harmonisation (ICH) E23 guideline - update 12.6. Contacts of the PRAC with external parties and interaction with the Interested Parties to the Committee 12.7. PRAC work plan 12.8. Planning and reporting 12.8.1. Marketing authorisation applications (MAA) and technology forecast: April 2026 – December 2028 12.9. Pharmacovigilance audits and inspections 12.9.1. Pharmacovigilance systems and their quality systems 12.9.2. Pharmacovigilance inspections 12.9.3. Pharmacovigilance audits 12.10. Periodic safety update reports (PSURs) & Union reference date (EURD) list 12.10.1. Periodic safety update reports 12.10.2. Granularity and Periodicity Advisory Group (GPAG) 12.10.3. PSURs repository 12.10.4. Union reference date list – consultation on the draft list 12.11. Signal management 12.11.1. Signal management – feedback from Signal Management Review Technical (SMART) Working Group 12.12. Adverse drug reactions reporting and additional reporting 12.12.1. Management and reporting of adverse reactions to medicinal products 12.12.2. Additional monitoring 12.12.3. List of products under additional monitoring – consultation on the draft list 12.13. EudraVigilance database 12.13.1. Activities related to the confirmation of full functionality 12.14. Risk management plans and effectiveness of risk minimisations 12.14.1. Risk management systems 12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations 12.15. Post-authorisation safety studies (PASS) 12.15.1. Post-authorisation Safety Studies – imposed PASS 12.15.2. Post-authorisation Safety Studies – non-imposed PASS 12.16. Community procedures 12.16.1. Referral procedures for safety reasons 12.17. Renewals, conditional renewals, annual reassessments 12.18. Risk communication and transparency 12.18.1. Public participation in pharmacovigilance 12.18.2. Safety communication 12.19. Continuous pharmacovigilance 12.19.1. Incident management 12.20. Impact of pharmacovigilance activities 12.20.1. Study on the implementation of controlled access to and distribution of medicinal products in EU Member States (SC02/EMA/2020/46/TDA/L4.02) - regulatory follow-up 12.21. Others 13. Any other business 14. Explanatory notes

Vom 4. – 7. Mai hält das PRAC seine monatliche Sitzung bei der EMA ab. Im Rahmen dieses Meetings werden wie üblich auch neue Signale diskutiert. Laut Agenda wurden keine neuen dringenden Verfahren (EU referral procedures for safety reasons: urgent EU procedures) und auch keine other EU referral procedures eröffnet. Die EMA informiert regelmäßig vorab (noch vor Publikation der Agenda) die QPPVs der Zulassungsinhaber welche Sicherheitssignale bei der kommenden PRAC-Sitzung diskutiert werden. Die Signale können jedoch zusätzlich der Agenda unter Punkt 4 entnommen werden. Über die Meeting-Highlights wird im nächsten Pharmakovigilanz-Wochenbericht informiert. Die Agenda wurde auf der Webseite der EMA veröffentlicht.

DURCHFÜHRUNGSVERORDNUNG (EU) 2026/977 DER KOMMISSION vom 4. Mai 2026 zur Festlegung bestimmter einheitlicher Anforderungen an das Qualitätsmanagement und die Verfahren für die Konformitätsbewertungstätigkeiten, die von einer Benannten Stelle durchgeführt werden, welche gemäß den Verordnungen (EU) 2017/745 und (EU) 2017/746 des Europäischen Parlaments und des Rates benannt wurde (Text von Bedeutung für den EWR) DIE EUROPÄISCHE KOMMISSION — gestützt auf den Vertrag über die Arbeitsweise der Europäischen Union, gestützt auf die Verordnung (EU) 2017/745 des Europäischen Parlaments und des Rates vom 5. April 2017 über Medizinprodukte, zur Änderung der Richtlinie 2001/83/EG, der Verordnung (EG) Nr. 178/2002 und der Verordnung (EG) Nr. 1223/2009 und zur Aufhebung der Richtlinien 90/385/EWG und 93/42/EWG des Rates (1), insbesondere Artikel 36 Absatz 3, gestützt auf die Verordnung (EU) 2017/746 des Europäischen Parlaments und des Rates vom 5. April 2017 über In-vitro- Diagnostika und zur Aufhebung der Richtlinie 98/79/EG und des Beschlusses 2010/227/EU der Kommission (2), insbesondere Artikel 32 Absatz 3, in Erwägung nachstehender Gründe: (1) Mit den Verordnungen (EU) 2017/745 und (EU) 2017/746 des Europäischen Parlaments und des Rates wurde ein Rechtsrahmen geschaffen, der das reibungslose Funktionieren des Binnenmarkts für Medizinprodukte und In-vitro- Diagnostika gewährleisten soll, wobei ein hohes Gesundheitsschutzniveau für Patienten und Anwender zugrunde gelegt wird. Außerdem sind in diesen Verordnungen hohe Standards für die Qualität und Sicherheit von Medizinprodukten und In-vitro-Diagnostika festgelegt, durch die allgemeine Sicherheitsbedenken hinsichtlich dieser Produkte ausgeräumt werden sollen. (2) Gemäß den Verordnungen (EU) 2017/745 und (EU) 2017/746 werden Benannte Stellen dafür benannt, die Konformitätsbewertungstätigkeiten für die Zertifizierung von Medizinprodukten bzw. In-vitro-Diagnostika durchzuführen. Zu diesem Zweck sollten diese Benannten Stellen bestimmte Anforderungen erfüllen, die zur Wahrnehmung ihrer Aufgaben erforderlich sind, nämlich die Anforderungen in Anhang VII der Verordnung (EU) 2017/745 in Bezug auf Medizinprodukte und die Anforderungen in Anhang VII der Verordnung (EU) 2017/746 in Bezug auf In-vitro-Diagnostika. (3) Bei der Anwendung der Verordnungen (EU) 2017/745 und (EU) 2017/746 hat sich gezeigt, dass bestimmte Anforderungen in Anhang VII der Verordnung (EU) 2017/745 und in Anhang VII der Verordnung (EU) 2017/746 in Bezug auf die den Herstellern von den Benannten Stellen übermittelten Angebote, die Fristen für den Abschluss der Konformitätsbewertungstätigkeiten und die erneute Zertifizierung uneinheitlich und unterschiedlich ausgelegt werden. Die Anforderungen an das Qualitätsmanagement und die Verfahren sollten weiter präzisiert und verdeutlicht werden, um sicherzustellen, dass sie einheitlich umgesetzt werden. (4) Die individuellen Verfahrensweisen der Benannten Stellen in Bezug auf die Anforderungen an das Qualitätsma nagement und die Verfahren weichen erheblich voneinander ab, was zu ungleichen Positionen der Hersteller im gesamten Binnenmarkt führt. Dies gilt insbesondere für Hersteller, bei denen es sich um kleine und mittlere Unternehmen handelt. Solche Verfahrensweisen wirken sich auf die Planbarkeit und den fristgerechten Abschluss der Konformitätsbewertungstätigkeiten aus, was erhebliche Folgen und Verzögerungen mit Blick auf die Innovations tätigkeit und die Gesundheit der Patienten mit sich bringt. (5) Die Benannten Stellen haben deutlich unterschiedliche Verfahrensweisen bei der Abgabe von Angeboten für spezifische Konformitätsbewertungstätigkeiten an die Hersteller an den Tag gelegt. Infolgedessen erhalten die Hersteller keine zuverlässige Schätzung der insgesamt angeforderten Leistungen und Kosten. Um die Verfahrensweisen der Benannten Stellen zu harmonisieren, sollte in dieser Verordnung festgelegt werden, welche Amtsblatt der Europäischen Union DE Reihe L 2026/977 5.5.2026 ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj 1/10 (1) ABl. L 117 vom 5.5.2017, S. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj. (2) ABl. L 117 vom 5.5.2017, S. 176, ELI: http://data.europa.eu/eli/reg/2017/746/oj. http://data.europa.eu/eli/reg/2017/745/oj http://data.europa.eu/eli/reg/2017/746/oj Mindestinformationen die Benannten Stellen für die Abgabe von Angeboten verlangen sollten, damit die entsprechenden Anträge auf Konformitätsbewertungstätigkeiten nicht abgelehnt werden, weil sie unvollständig sind oder weil das Produkt nicht in den Geltungsbereich der Benennung einer Benannten Stelle fällt. Die Benannten Stellen sollten Informationen über das/die Produkt(e), seine/ihre Zweckbestimmung, besondere Merkmale oder spezifische Technologien oder Verfahren anfordern, damit sie überprüfen können, ob sie für die entsprechenden Codes gemäß der Durchführungsverordnung (EU) 2017/2185 der Kommission (3) benannt sind. (6) Um ein Angebot zu erhalten, sollten die Hersteller den Benannten Stellen Informationen zur Verfügung stellen, anhand deren diese feststellen können, ob ein Hersteller als Kleinstunternehmen, kleines oder mittleres Unternehmen anzusehen ist, wobei die Empfehlung 2003/361/EG der Kommission betreffend die Definition der Kleinstun ternehmen sowie der kleinen und mittleren Unternehmen zu berücksichtigen ist (4). (7) Auf der Grundlage vollständiger Informationen über den Umfang der Konformitätsbewertung sollten die Benannten Stellen Angebote abgeben, die eine klare Schätzung der Kosten enthalten, mit denen der Hersteller rechnen sollte. Diese Kosten sollten dem Hersteller anhand einer klar dargestellten Aufschlüsselung vorgelegt werden und gegebenenfalls die Kosten für die Überwachungstätigkeiten umfassen, sofern solche Tätigkeiten während des Zertifizierungszyklus erforderlich sind. (8) Um Angebote gemäß dieser Verordnung auf der Grundlage hinreichend genauer Informationen abgeben zu können, sollten die Benannten Stellen die verfügbaren Möglichkeiten nutzen, um die Effizienz und Planbarkeit ihrer Konformitätsbewertungstätigkeiten zu verbessern, z. B. durch strukturierte Dialoge mit den Herstellern, insbesondere in der Phase vor der Antragstellung. (9) Die Benannten Stellen haben unterschiedliche Verfahrensweisen für die Interaktion mit den Herstellern entwickelt, was zu unterschiedlichen Verfahren für die Festlegung von Fristen für die Konformitätsbewertungstätigkeiten geführt hat. In der Folge werden Konformitätsbewertungstätigkeiten innerhalb verschiedenster Fristen abgeschlossen, wobei es häufig an einer klaren Begründung dafür fehlt, wie diese Fristen festgelegt werden. (10) Im Interesse der Förderung einer sicheren und kontinuierlichen Versorgung der Öffentlichkeit sollten die Benannten Stellen die Konformitätsbewertungstätigkeiten für ein Medizinprodukt oder In-vitro-Diagnostikum innerhalb der kürzest möglichen Frist, die für die erforderliche Bewertung benötigt wird, oder spätestens innerhalb einer maximalen Frist abschließen. (11) Auf der Grundlage der einzelnen Konformitätsbewertungstätigkeiten, die für die Produktzertifizierung erforderlich sind, sollten sich die Benannten Stellen und Hersteller auf Fristen für den Abschluss dieser Tätigkeiten einigen, um sicherzustellen, dass sie die maximalen Fristen nicht überschreiten. (12) Unter Berücksichtigung der Vielfalt der Produkte und der Besonderheiten der Konformitätsbewertungstätigkeiten, die die Benannten Stellen durchführen müssen, sollten maximale Fristen festgelegt werden. Für die Bewertung des Antrags auf ein Konformitätsbewertungsverfahren und die Unterzeichnung des Vertrags zwischen der Benannten Stelle und dem Hersteller sollte eine maximale Frist festgelegt werden. Besteht zwischen Benannter Stelle und Hersteller ein Rahmenvertrag, gilt als Unterzeichnung des Vertrags die Unterzeichnung des Vertrags über die konkrete Konformitätsbewertungstätigkeit. (13) Da Tätigkeiten in den Räumlichkeiten des Herstellers oder gegebenenfalls in den Räumlichkeiten bestimmter Lieferanten oder Unterauftragnehmer des Herstellers durchgeführt werden müssen, sollten für die Audits des Qualitätsmanagementsystems andere Fristen als für die Produktprüfung gelten. Eine solche Unterscheidung sollte kein Hindernis dafür sein, dass Konformitätsbewertungstätigkeiten für die Produktprüfung und für das Qualitätsma nagementsystem parallel erfolgen können, wenn sie gemäß Anhang IX der Verordnung (EU) 2017/745 und Anhang IX der Verordnung (EU) 2017/746 durchgeführt werden und sofern die erforderlichen Hinweise aus der Bewertung der technischen Dokumentation bei der Ausarbeitung des Auditprogramms berücksichtigt werden. DE ABl. L vom 5.5.2026 2/10 ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj (3) Durchführungsverordnung (EU) 2017/2185 der Kommission vom 23. November 2017 über das Verzeichnis der Codes und der ihnen entsprechenden Produktarten zur Bestimmung des Geltungsbereichs der Benennung einer Benannten Stelle auf dem Gebiet der Medizinprodukte im Rahmen der Verordnung (EU) 2017/745 des Europäischen Parlaments und des Rates sowie auf dem Gebiet der In-vitro-Diagnostika im Rahmen der Verordnung (EU) 2017/746 des Europäischen Parlaments und des Rates (ABl. L 309 vom 24.11.2017, S. 7, ELI: http://data.europa.eu/eli/reg_impl/2017/2185/oj). (4) Empfehlung 2003/361/ΕG der Kommission vom 6. Mai 2003 betreffend die Definition der Kleinstunternehmen sowie der kleinen und mittleren Unternehmen (ABl. L 124 vom 20.5.2003, S. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj). http://data.europa.eu/eli/reg_impl/2017/2185/oj http://data.europa.eu/eli/reco/2003/361/oj (14) Die Fristen für die Produktprüfung sollten für implantierbare Produkte der Klasse III oder der Klasse IIb sowie für In-vitro-Diagnostika der Klasse D spezifisch sein. Fristen sollten auch gelten, wenn die technische Dokumentation für ein repräsentatives Produkt stichprobenartig für andere Produkte der Klasse IIb oder IIa sowie für Produkte der Klasse B und der Klasse C ebenso wie für spezifische In-vitro-Diagnostika, wie etwa therapiebegleitende Diagnostika, patientennahe Tests und Produkte zur Eigenanwendung, bewertet wird. (15) Bei den maximalen Fristen für das Audit des Qualitätsmanagementsystems und die Produktprüfung, einschließlich der Bewertung, sollte auch berücksichtigt werden, dass mögliche Nichtkonformitäten, die während der Prüfung festgestellt wurden, angemessen weiterverfolgt werden müssen. (16) Für die Konformitätsbewertung geplanter wesentlicher Änderungen am Qualitätsmanagementsystem oder an der Produktpalette und -art sowie der Änderungen an dem genehmigten Produkt sollten Fristen festgelegt werden. Es sollte eine maximale Frist für die Bewertung der Mitteilung durch die Benannte Stelle festgelegt werden, damit diese entscheiden kann, ob zusätzliche Konformitätsbewertungstätigkeiten durchzuführen sind. Auch für diese eventuell durchzuführenden zusätzlichen Konformitätsbewertungstätigkeiten sollte eine maximale Frist festgelegt werden. (17) Auch für die Entscheidung und für die Ausstellung der Bescheinigung(en) oder des Nachtrags/der Nachträge zu (einer) bereits ausgestellten Bescheinigung(en), hinsichtlich welcher der Hersteller die Benannten Stellen über eine geplante Änderung unterrichtet hat, sollte eine maximale Frist festgelegt werden. Innerhalb dieser Frist sollte es den Benannten Stellen möglich sein, ihre Entscheidung auf der Grundlage der durchgeführten Bewertung zu treffen. (18) Die Benannten Stellen sollten die Frist für eine Konformitätsbewertungstätigkeit aussetzen, wenn der Abschluss einer solchen Tätigkeit von weiteren Informationen abhängt, die vom Hersteller bereitzustellen sind. Die Frist sollte auch dann ausgesetzt werden, wenn der Abschluss der Tätigkeit vom Beitrag der Europäischen Arzneimittel-Agentur (EMA), einer Regulierungsbehörde, eines Expertengremiums oder eines EU-Referenzlaboratoriums abhängt, sofern die Tätigkeiten der Benannten Stellen ausschließlich von diesen Beiträgen abhängen. (19) Die Benannten Stellen sollten im Rahmen ihrer Qualitätsmanagementsysteme geeignete Vorkehrungen treffen, um ihre Leistung in Bezug auf die Einhaltung der Fristen und die Übereinstimmung der in den Angeboten angegebenen Kosten mit den tatsächlichen Kosten, die für Konformitätsbewertungstätigkeiten in Rechnung gestellt werden, zu überwachen. Um sicherzustellen, dass solche Informationen von öffentlichem Interesse verfügbar sind und in klarer und einheitlicher Weise dargestellt werden, sollten die Benannten Stellen Berichte erstellen, die Daten über die Überwachung der Fristen und Kosten enthalten. Die Benannten Stellen sollten die Berichte auf ihren Websites veröffentlichen, um die Transparenz ihrer Leistung zu gewährleisten und es den Herstellern zu ermöglichen, die Informationen der einzelnen Benannten Stellen untereinander zu vergleichen, und sie sollten die für die Benannte Stelle zuständige Behörde und die Kommission unterrichten. (20) Die Benannten Stellen führen die erneute Zertifizierung von Medizinprodukten und In-vitro-Diagnostika auf unterschiedliche Weise durch. Die praktische Anwendung der Anforderungen im Zusammenhang mit der einschlägigen Herstellerdokumentation und dem Umfang der damit verbundenen Überprüfung führt zu einem breiten Spektrum unterschiedlicher Verfahrensweisen, die von der gezielten Bewertung von bestimmten Dokumenten bis hin zu umfassenderen Bewertungen reichen, die einen ähnlichen Umfang wie die ursprüngliche Produktprüfung aufweisen. Dies führt zu großen Unterschieden bei den Verfahren zur erneuten Zertifizierung und den entsprechenden Fristen und Kosten. (21) Die Benannten Stellen sollten die erneute Zertifizierung innerhalb von vorhersehbaren Fristen durchführen, ohne die bei der Erstzertifizierung durchgeführte Bewertung zu wiederholen. Informationen und Auszüge aus der technischen Dokumentation, die bewertet werden sollten, sollten sowohl für die Erneuerung von Bescheinigungen des Qualitäts managementsystems als auch des Produkts eindeutig angegeben werden. (22) Die Benannten Stellen sollten sich bei der Bewertung des Qualitätsmanagementsystems, für das eine erneuten Zertifizierung erfolgen soll, insbesondere auf Angaben im Zusammenhang mit Überwachungstätigkeiten, der Einhaltung der geltenden Stichprobenpläne, Nichtkonformitäten, Korrektur- oder Präventivmaßnahmen und etwaigen Bedingungen für die Zertifizierung konzentrieren. Bei der Bewertung sollte auch der Stand der Technik berücksichtigt werden. (23) Die Benannten Stellen sollten sich bei der Bewertung der Informationen über das Produkt, für das eine erneute Zertifizierung erfolgen soll, insbesondere auf die vom Hersteller bereitgestellten Informationen über die Überwachung nach dem Inverkehrbringen, Änderungen an dem Produkt, auch im Zusammenhang mit der Entwicklung des Stands der Technik, und Aktualisierungen der Risikoanalyse konzentrieren. (24) Die in dieser Verordnung vorgesehenen Maßnahmen entsprechen der Stellungnahme des Ausschusses für Medizinprodukte — ABl. L vom 5.5.2026 DE ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj 3/10 HAT FOLGENDE VERORDNUNG ERLASSEN: Artikel 1 Angebote (1) Für die Zwecke der Abgabe von Angeboten an die Hersteller gemäß Anhang VII Abschnitt 4.2 Buchstabe d der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.2 Buchstabe d der Verordnung (EU) 2017/746 verfügt die Benannte Stelle über dokumentierte Verfahren, mit denen sichergestellt wird, dass sie nur dann Angebote abgibt, wenn sie vom Hersteller die folgenden Informationen erhalten hat: a) die Identität des Herstellers, d. h. seinen Namen und seine Anschrift, b) die Informationen, die die Benannte Stelle benötigt, um festzustellen, ob es sich bei dem Hersteller um ein Kleinstun ternehmen, ein kleines oder ein mittleres Unternehmen im Sinne der Empfehlung 2003/361/EG der Kommission handelt, d. h. die Zahl der Beschäftigten und den Jahresumsatz, c) ggf. den Namen und die Anschrift des Bevollmächtigten des Herstellers, d) Anschriften, Anzahl der Beschäftigten, Anzahl der Arbeitsschichten und Beschreibungen der durchgeführten Tätigkeiten für jeden vom Qualitätsmanagementsystem des Herstellers erfassten Standort, e) Namen und Anschriften der Lieferanten und Unterauftragnehmer des Herstellers, bei denen für die Konformitätsbe wertungstätigkeiten relevante Auslegungs- und Herstellungstätigkeiten durchgeführt werden, einschließlich einer Beschreibung der von ihnen durchgeführten Tätigkeiten, f) Beschreibung des Produkts/der Produkte, seiner/ihrer Zweckbestimmung, etwaiger spezifischer Merkmale oder verwendeter spezifischer Technologien oder Verfahren sowie der Risikoklassifizierung, g) das/die Konformitätsbewertungsverfahren gemäß dem Antrag des Herstellers, h) für die in Anhang VII Abschnitt 4.9 der Verordnung (EU) 2017/745 bzw. in Anhang VII Abschnitt 4.9 der Verordnung (EU) 2017/746 genannten Änderungen und Modifikationen eine detaillierte Beschreibung der geplanten Änderungen oder Modifikationen, i) für die erneute Zertifizierung eine Angabe der betroffenen Bescheinigung(en), einschließlich etwaiger Änderungen des Geltungsbereichs, die gemäß Buchstabe h beschrieben werden, j) alle sonstigen Informationen über den Hersteller, z. B. seine Organisationsstruktur oder gültige Bescheinigungen, und über das Produkt, die für die Einschätzung der durchzuführenden Tätigkeiten erforderlich sind. Wenn sie Angebote für Konformitätsbewertungstätigkeiten betreffend Änderungen und Modifikationen gemäß Buchstabe h oder eine erneute Zertifizierung gemäß Buchstabe i abgibt, verzichtet die Benannte Stelle darauf, die Angaben gemäß den Buchstaben b bis g einzuholen, sofern der Hersteller bestätigt, dass keinerlei Änderungen an den übermittelten Angaben eingetreten sind. (2) Die Benannte Stelle stellt sicher, dass sich der Austausch technischer Informationen und regulatorischer Leitlinien, insbesondere der strukturierte Dialog mit den Herstellern, im Rahmen der in Absatz 1 genannten dokumentierten Verfahren auf Aspekte erstreckt, die für die Übermittlung von Angeboten relevant sind, einschließlich der in Absatz 1 aufgeführten Informationen. (3) Die Benannte Stelle gibt ein Angebot ab, das mindestens Folgendes enthält: a) die geschätzten Gesamtkosten, die für die Bewertung des Qualitätsmanagementsystems und gegebenenfalls der technischen Dokumentation detailliert aufgeführt sind und die üblicherweise für Überwachungstätigkeiten und unangekündigte Audits anfallenden Kosten umfassen, b) eine Schätzung der zusätzlichen Kosten, die während der Bewertungstätigkeiten entstehen könnten; solche Schätzungen dürfen nur dann auf Stundensätzen beruhen, wenn die Dauer der spezifischen Tätigkeit nicht im Voraus bestimmt werden kann, c) die geschätzten Fristen. (4) Die Benannte Stelle unterrichtet den Hersteller vorab über jede Erhöhung der geschätzten Kosten um mehr als 10 % und begründet diese Erhöhung. DE ABl. L vom 5.5.2026 4/10 ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj Artikel 2 Fristen (1) Für die Zwecke des Anhangs VII Abschnitt 4.5.1 Absatz 2 dritter Gedankenstrich der Verordnung (EU) 2017/745 sowie des Anhangs VII Abschnitt 4.5.1 Absatz 2 dritter Gedankenstrich der Verordnung (EU) 2017/746 verfügt die Benannte Stelle über dokumentierte Verfahren, um sicherzustellen, dass die kürzest mögliche Frist mit dem Hersteller vereinbart wird, wobei Folgendes zu berücksichtigen ist: a) die Produktpalette und die Art(en) der Produkte, b) die spezifischen Merkmale der Produkte und der verwendeten Technologien, c) die Risikoklasse(n) der Produkte, d) die Konformitätsbewertungstätigkeiten, die die Benannte Stelle durchführen wird. (2) Die Benannte Stelle stellt sicher, dass die Konformitätsbewertungstätigkeiten innerhalb der folgenden maximalen Fristen abgeschlossen werden: a) 30 Tage für die Überprüfung des Antrags und die Unterzeichnung des Vertrags, gerechnet ab dem Tag, an dem die Benannte Stelle den vollständigen Antrag erhält, bis zu dem Tag, an dem der Vertrag mit dem Hersteller gemäß Anhang VII Abschnitt 4.3 Absatz 2 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.3 Absatz 2 der Verordnung (EU) 2017/746 unterzeichnet wird, b) 120 Tage für die Audits des Qualitätsmanagementsystems gemäß Anhang VII Abschnitt 4.5.2 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.5.2 der Verordnung (EU) 2017/746, gerechnet ab dem Tag, an dem die Benannte Stelle die erste Tätigkeit des Auditprogramms aufnimmt, bis zu dem Tag, an dem die abschließende Prüfung gemäß Anhang VII Abschnitt 4.7 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.7 der Verordnung (EU) 2017/746 abgeschlossen ist, c) 90 Tage für die Produktprüfung gemäß Anhang VII Abschnitt 4.5.3 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.5.3 der Verordnung (EU) 2017/746, gerechnet ab dem Tag, an dem die Benannte Stelle die Bewertung der technischen Dokumentation jedes Produkts oder jedes repräsentativen Produkts aufnimmt, bis zu dem Tag, an dem die abschließende Prüfung gemäß Anhang VII Abschnitt 4.7 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.7 der Verordnung (EU) 2017/746 abgeschlossen ist, d) 20 Tage für die Entscheidung und Zertifizierung, gerechnet ab dem Folgetag des Tags, an dem die letzte einschlägige abschließende Prüfung gemäß Buchstabe b oder c, je nach dem beantragten Konformitätsbewertungsverfahren, abgeschlossen wird, bis zu dem Tag, an dem die Bescheinigungen gemäß Anhang VII Abschnitt 4.8 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.8 der Verordnung (EU) 2017/746 ausgestellt und in die europäische Datenbank für Medizinprodukte (Eudamed) eingetragen wird. Die Konformitätsbewertungstätigkeiten gemäß Unterabsatz 1 Buchstaben b und c werden parallel durchgeführt, wenn sie gemäß Anhang IX der Verordnung (EU) 2017/745 bzw. Anhang IX der Verordnung (EU) 2017/746 erfolgen, sofern die erforderlichen Hinweise aus der Bewertung der einschlägigen technischen Dokumentation bei der Ausarbeitung des Auditprogramms berücksichtigt werden. Sofern zwischen der Benannten Stelle und dem Hersteller nicht anders vereinbart, beginnen die Tätigkeiten gemäß Unterabsatz 1 Buchstaben b und c am Tag nach Unterzeichnung des Vertrags gemäß Unterabsatz 1 Buchstabe a. (3) Die Benannte Stelle schließt die Bewertung einer geplanten wesentlichen Änderung am Qualitätsmanagementsystem oder der hiervon erfassten Produktpalette, für die eine EU-Qualitätsmanagementbescheinigung oder eine EU-Qualitätssiche rungsbescheinigung vorliegt, sowie die Bewertung einer Änderung am genehmigten Produkt, für das eine EU-Bescheinigung über die Bewertung der technischen Dokumentation oder eine EU-Baumusterprüfbescheinigung vorliegt, innerhalb der folgenden maximalen Fristen ab: a) 30 Tage für die Überprüfung der beabsichtigten geplanten Änderung, gerechnet ab dem Tag, an dem die Benannte Stelle vom Hersteller Informationen über die geplante Änderung mit vollständigen Unterlagen erhält, bis zu dem Tag, an dem die Benannte Stelle dem Hersteller ihre Entscheidung darüber, ob zusätzliche Konformitätsbewertungstä tigkeiten erforderlich sind, oder die Genehmigung der geplanten Änderung mitteilt, ABl. L vom 5.5.2026 DE ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj 5/10 b) 90 Tage für die zusätzlichen Konformitätsbewertungstätigkeiten im Zusammenhang mit der geplanten Änderung, gerechnet ab dem Tag, an dem die Benannte Stelle erforderlichenfalls die erste Tätigkeit des Auditprogramms aufnimmt, oder ab dem Tag, an dem die Benannte Stelle die Bewertung der technischen Dokumentation aufnimmt, je nachdem, welcher Zeitpunkt früher liegt, bis zu dem Tag, an dem die Benannte Stelle dem Hersteller die Genehmigung der geplanten Änderung mitteilt, c) 20 Tage für die Ausstellung des Nachtrags zu der/den betreffenden Bescheinigung(en), sofern erforderlich, gerechnet ab dem Folgetag des Tags, an dem die Genehmigung der geplanten Änderung gemäß Buchstabe a oder b mitgeteilt wird, bis zu dem Tag, an dem der Nachtrag zu der/den betreffenden Bescheinigung(en) gemäß Anhang VII Abschnitt 4.8 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.8 der Verordnung (EU) 2017/746 ausgestellt und in die europäische Datenbank für Medizinprodukte (Eudamed) eingetragen wird. Ist ein neues Konformitätsbewertungsverfahren erforderlich, so gelten die in Absatz 2 genannten Fristen. (4) Die Benannte Stelle setzt die Konformitätsbewertungstätigkeiten fort, bis sie eine Entscheidung über die Ausstellung oder Verweigerung einer Bescheinigung trifft. Ein Ablauf der maximalen Fristen gemäß den Absätzen 2 und 3 oder die Inanspruchnahme der größtmöglichen Anzahl von Fristaussetzungen gemäß Artikel 3 stellen keinen hinreichenden Grund für die Benannte Stelle dar, die Ausstellung einer Bescheinigung oder die Genehmigung einer Änderung zu verweigern. Artikel 3 Fristaussetzungen (1) Muss sich ein Hersteller mit Fällen von Nichtkonformität oder ordnungsgemäß begründeten und für ihre Bewertung erforderlichen Rückfragen und Anfragen seitens der Benannten Stelle befassen, so kann die Benannte Stelle die Frist für die Konformitätsbewertungstätigkeiten aussetzen, und zwar höchstens: a) einmal in der Phase gemäß Artikel 2 Absatz 2 Buchstabe a, b) viermal in der Phase gemäß Artikel 2 Absatz 2 Buchstabe b, c) viermal in der Phase gemäß Artikel 2 Absatz 2 Buchstabe c, d) insgesamt fünfmal in den Phasen gemäß Artikel 2 Absatz 3 Buchstaben a und b, e) insgesamt dreimal bei den Bewertungen und Überprüfungen gemäß den Artikeln 5 und 6, f) einmal in den Phasen gemäß Artikel 2 Absatz 2 Buchstabe d, Artikel 2 Absatz 3 Buchstabe c und Artikel 7 Absatz 2, falls die Benannte Stelle den Hersteller ersucht, zu überprüfen, ob die Angaben auf der/den Bescheinigung(en) korrekt sind, und, sofern erforderlich, die maßgeblichen Angaben zu den erfassten Produkten in Eudamed einzutragen. Vereinbaren die Benannte Stelle und der Hersteller eine fortlaufende Überprüfung der technischen Dokumentation, so vereinbaren sie ebenfalls einen Plan für die Vorlage von Teilen der technischen Dokumentation und mögliche weitere Fristaussetzungen, zusätzlich zu jenen gemäß Unterabsatz 1 Buchstaben b und c. Für jeden zusätzlichen Standort, der dem Qualitätsmanagementsystem des Herstellers unterliegt, welches einem Vor-Ort- Audit zu unterziehen ist, kann die Benannte Stelle die Frist zusätzlich zu den Aussetzungen gemäß Unterabsatz 1 Buchstabe b zwei weitere Male aussetzen. Die Benannte Stelle vereinbart mit dem Hersteller die Dauer der Aussetzung und unterrichtet den Hersteller schriftlich darüber. (2) Die Frist der Konformitätsbewertungstätigkeit wird an dem Tag ausgesetzt, an dem die Benannte Stelle dem Hersteller ihre Anfragen mitteilt, und sie läuft, sofern nicht anders vereinbart, am Folgetag des Tages wieder weiter, an dem die Benannte Stelle die angeforderten Informationen vom Hersteller erhält. (3) Zusätzlich zu den in Absatz 1 genannten Aussetzungen setzt die Benannte Stelle die Frist für die Konformitätsbewer tungstätigkeit aus, wenn eine Stellungnahme der Europäischen Arzneimittel-Agentur (EMA), einer Regulierungsbehörde, eines Expertengremiums oder eines EU-Referenzlaboratoriums erforderlich ist. DE ABl. L vom 5.5.2026 6/10 ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj Eine solche Aussetzung wird nicht auf die Fristaussetzungen gemäß Absatz 1 angerechnet. Die Benannte Stelle unterrichtet den Hersteller schriftlich über den Grund für die Aussetzung gemäß Unterabsatz 1 sowie deren voraussichtliche Dauer. (4) Die Dauer jeder Fristaussetzung gemäß Absatz 1 wird nur verlängert, wenn dies hinreichend begründet ist und die Benannte Stelle und der Hersteller die Verlängerung schriftlich vereinbaren. Artikel 4 Überwachung der Dauer und der Kosten (1) Die Benannte Stelle errichtet, dokumentiert und implementiert im Rahmen ihres Qualitätsmanagementsystems gemäß Anhang VII Abschnitt 2.1 der Verordnung (EU) 2017/745 und Anhang VII Abschnitt 2.1 der Verordnung (EU) 2017/746 ein System zur Überwachung der Dauer und der Kosten der Konformitätsbewertungstätigkeiten. (2) Das in Absatz 1 genannte Überwachungssystem liefert folgende Informationen: a) über die Dauer der Konformitätsbewertungstätigkeiten: i) den prozentualen Anteil der Konformitätsbewertungstätigkeiten, die innerhalb der in Artikel 2 festgelegten maximalen Fristen abgeschlossen wurden; ii) den Median der Dauer der Konformitätsbewertungstätigkeiten vom Zeitpunkt der Antragstellung bis zum Zeitpunkt der Zertifizierung, in Tagen; b) über die Kosten der Konformitätsbewertungstätigkeiten: den Median der Gesamtkosten abgeschlossener Konformitätsbewertungstätigkeiten in Euro. Die Gesamtkosten von Konformitätsbewertungstätigkeiten sind als die Summe aller Gebühren einschließlich aller Verwaltungsabgaben zu verstehen, die eine Benannte Stelle einem Hersteller für die innerhalb der Fristen durchgeführten Tätigkeiten in Rechnung stellt. (3) Das in Absatz 1 genannte Überwachungssystem liefert die in Absatz 2 Buchstaben a und b aufgeführten Informationen für die folgenden Tätigkeiten: a) Konformitätsbewertungstätigkeiten, die gemäß Anhang IX Kapitel I und II, Anhang X und Anhang XI Teil A oder B der Verordnung (EU) 2017/745 bzw. Anhang IX Kapitel I und II, Anhang X und Anhang XI der Verordnung (EU) 2017/746 durchgeführt werden, b) Bewertung der Änderungen gemäß Artikel 2 Absatz 3. (4) Bis zum 30. April jedes Jahres erstellt die Benannte Stelle einen jährlichen Bericht über die Fristen und Kosten der Konformitätsbewertungstätigkeiten, der die in den Absätzen 2 und 3 genannten Informationen enthält. Sie berücksichtigt in diesem Bericht die Konformitätsbewertungstätigkeiten, die sie im Vorjahr abgeschlossen hat. Die Benannte Stelle veröffentlicht den Bericht auf ihrer Website und unterrichtet die für die Benannte Stelle zuständige Behörde sowie die Kommission. Artikel 5 Erneute Zertifizierung von Produktbescheinigungen (1) Die Benannte Stelle stellt sicher, dass der Hersteller im Rahmen der dokumentierten Verfahren für die Erneuerung von Produktbescheinigungen gemäß Anhang VII Abschnitt 4.11 Absatz 2 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.11 Absatz 2 der Verordnung (EU) 2017/746 verpflichtet ist, einen Antrag auf Überprüfung im Hinblick auf die erneute Zertifizierung zu stellen und die folgenden Informationen aus der ursprünglichen oder der letzten erneuten Zertifizierung vorzulegen: a) eine Liste, in der die mitgeteilten oder nicht mitgeteilten Änderungen gemäß Anhang VII Abschnitt 4.11 Absatz 2 Buchstaben a und f der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.11 Absatz 2 der Verordnung (EU) 2017/746 an dem ursprünglich genehmigten Produkt beschrieben werden, einschließlich der Änderungen an den Produktanforderungen und den Produktkomponenten, ABl. L vom 5.5.2026 DE ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj 7/10 b) den jüngsten regelmäßig aktualisierten Bericht über die Sicherheit des Produkts und eine Zusammenfassung der Sicherheitskorrekturmaßnahmen im Feld, die aufgrund der aus der Überwachung nach dem Inverkehrbringen gewonnenen Erfahrungen gemäß Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe b der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe b der Verordnung (EU) 2017/746 in Bezug auf das Produkt ergriffen wurden, c) eine Zusammenfassung der Änderungen der Risikobewertung, die ein anderes Nutzen-Risiko-Verhältnis eines Produkts ergeben hat, einschließlich der Änderungen im Zusammenhang mit Sicherheitskorrekturmaßnahmen im Feld, die aufgrund der Erfahrungen aus dem Risikomanagement gemäß Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe c der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe c der Verordnung (EU) 2017/746 ergriffen wurden, d) Angabe der Änderungen, die aufgrund der Erfahrungen gemäß Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe d der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe d der Verordnung (EU) 2017/746 an dem Produkt vorgenommen wurden, um dem Stand der Technik Rechnung zu tragen, e) den jüngsten Bericht über die klinische Bewertung oder den jüngsten Bericht über die Leistungsbewertung des Produkts aufgrund der Erfahrungen gemäß Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe e der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe e der Verordnung (EU) 2017/746, f) Angabe der an dem Produkt vorgenommenen Änderungen gemäß Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe g der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.11 Absatz 2 Buchstabe g der Verordnung (EU) 2017/746. (2) Die Benannte Stelle stellt sicher, dass der Hersteller im Rahmen der in Absatz 1 genannten dokumentierten Verfahren verpflichtet ist, auch eine Liste der Änderungen an dem genehmigten Produkt vorzulegen, die noch nicht mitgeteilt wurden und erforderlich sind, um a) sicherzustellen, dass das Produkt neuen rechtlichen Anforderungen oder neuen gemeinsamen Spezifikationen entspricht; b) neue wissenschaftliche Erkenntnisse und neue Normen, einschließlich harmonisierter Normen, gemäß Anhang VII Abschnitt 4.11 Absatz 2 Buchstaben g und h der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.11 Absatz 2 Buchstaben g und h der Verordnung (EU) 2017/746 zu berücksichtigen. (3) Sind die Änderungen gemäß Absatz 2 aufgrund neuer wissenschaftlicher Erkenntnisse erforderlich, so gibt der Hersteller in der Liste gemäß Absatz 2 an, welcher der folgenden Gründe für die Änderungen vorliegt: a) ein neuer medizinischer, wissenschaftlicher und technischer Wissenstand, z. B. neue medizinische Verfahren, b) neue oder überarbeitete Testmethoden für die Eigenschaften und Leistungen des Produkts, c) neue wissenschaftliche Erkenntnisse zu Materialien, einschließlich Erkenntnissen in Bezug auf ihre physikalischen, chemischen und mikrobiologischen Eigenschaften sowie ihre Biokompatibilität, d) Ergebnisse klinischer Prüfungen oder Leistungsbewertungen zu vergleichbaren Produkten und öffentlich zugängliche Daten aus Registern und Registrierstellen. (4) Die Benannte Stelle bewertet die in den Absätzen 1 und 2 genannten Unterlagen, die sie vom Hersteller erhalten hat, innerhalb von höchstens 90 Tagen nach deren Eingang. Im Rahmen dieser Bewertung ist von der Benannten Stelle a) zu prüfen, ob die Änderungen an dem Produkt mit den bei der Überwachung nach dem Inverkehrbringen gesammelten Informationen im Einklang stehen, b) zu prüfen, ob die Änderungen an dem Produkt mit den Änderungen des Stands der Technik und dem Ergebnis der aktualisierten Risikoanalyse im Einklang stehen, c) zu prüfen, ob alle festgestellten Fälle von Nichtkonformität entweder behoben oder durch einen geeigneten und akzeptierten Plan mit Korrektur- und Präventivmaßnahmen innerhalb eines angemessenen Zeitraums weiterverfolgt wurden, d) falls die Zertifizierung an Bedingungen oder Beschränkungen geknüpft war, zu prüfen, ob diese Bedingungen oder Beschränkungen noch gültig sind, geändert werden müssen oder ob sie hinfällig geworden sind, e) zu prüfen, ob der Geltungsbereich der Bescheinigung geändert werden muss, f) die abschließende Prüfung gemäß Anhang VII Abschnitt 4.7 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.7 der Verordnung (EU) 2017/746 fertigzustellen. DE ABl. L vom 5.5.2026 8/10 ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj (5) Stellt die Benannte Stelle fest, dass die für die Überprüfung im Hinblick auf die erneute Zertifizierung vorgelegten Unterlagen nicht ausreichen, um die Bewertung abzuschließen, fordert sie den Hersteller auf, nähere Erläuterungen zu übermitteln. Wird um Vorlage zusätzlicher technischer Unterlagen über die Unterlagen gemäß den Absätzen 1 und 2 hinaus ersucht, bleiben diese auf die konkreten Informationen beschränkt, die für den Abschluss der Bewertung erforderlich sind. Artikel 6 Erneute Zertifizierung von Qualitätsmanagementbescheinigungen (1) Die Benannte Stelle stellt sicher, dass im Rahmen der dokumentierten Verfahren für die Erneuerung der Qualitätsma nagementbescheinigungen gemäß Anhang VII Abschnitt 4.11 Absatz 1 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.11 Absatz 1 der Verordnung (EU) 2017/746 der Hersteller verpflichtet ist, einen Antrag auf erneute Zertifizierung zu stellen, und dass die Benannte Stelle verpflichtet ist, innerhalb von höchstens 90 Tagen nach Eingang eines solchen Antrags a) zu prüfen, ob alle einschlägigen Anforderungen an die Durchführung von Audits gemäß Anhang VII Abschnitt 4.5.2 und Anhang IX Abschnitte 2.2 und 2.3 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.5.2 und Anhang IX Abschnitte 2.2 und 2.3 der Verordnung (EU) 2017/746 mindestens einmal nach dem Datum der Ausstellung der Bescheinigungen und vor ihrem Ablaufdatum vollständig bewertet wurden, b) zu prüfen, ob die Ergebnisse aller im Zertifizierungszyklus durchgeführten angekündigten oder unangekündigten Überwachungstätigkeiten gemäß Anhang VII Abschnitt 4.10 der Verordnung (EU) 2017/745 bzw. gemäß Anhang VII Abschnitt 4.10 der Verordnung (EU) 2017/746, insbesondere Vor-Ort-Audits beim Hersteller und bei seinen Unterauftragnehmern/Lieferanten, und der durchgeführten Produktprüfungen, sowie die Ergebnisse der Bewertungen der technischen Dokumentation auf Stichprobenbasis weiterhin den einschlägigen Bestimmungen der Verordnung (EU) 2017/745 bzw. der Verordnung (EU) 2017/746 entsprechen, c) zu prüfen, ob das Auditprogramm und der Stichprobenplan, die gemäß Anhang VII Abschnitt 4.5.2 Buchstabe a der Verordnung (EU) 2017/745 bzw. gemäß Anhang VII Abschnitt 4.5.2 Buchstabe a der Verordnung (EU) 2017/746 erstellt wurden, noch aktuell sind oder geändert werden müssen, d) zu prüfen, ob alle festgestellten Fälle von Nichtkonformität entweder behoben oder durch einen geeigneten und akzeptierten Plan mit Korrektur- und Präventivmaßnahmen innerhalb eines angemessenen Zeitraums weiterverfolgt wurden, e) falls die Zertifizierung an Bedingungen oder Beschränkungen geknüpft war, zu prüfen, ob diese Bedingungen oder Beschränkungen noch gültig sind, geändert werden müssen oder ob sie hinfällig geworden sind, f) zu prüfen, ob der Geltungsbereich der Bescheinigung geändert werden muss, g) die abschließende Prüfung gemäß Anhang VII Abschnitt 4.7 der Verordnung (EU) 2017/745 bzw. Anhang VII Abschnitt 4.7 der Verordnung (EU) 2017/746 fertigzustellen. (2) Stellt die Benannte Stelle fest, dass über die Angaben des Herstellers gemäß Absatz 1 Buchstaben b bis f hinaus weitere Angaben erforderlich sind, um die Bewertung für die Überprüfung im Hinblick auf die erneute Zertifizierung abzuschließen, fordert sie den Hersteller auf, diese Informationen vorzulegen. Wird um Vorlage dieser zusätzlichen Angaben ersucht, bleiben sie auf die konkreten Informationen beschränkt, die für den Abschluss der Bewertung erforderlich sind. Artikel 7 Entscheidung über eine erneute Zertifizierung (1) Für die Zwecke der Entscheidung über eine erneute Zertifizierung gemäß Anhang VII Abschnitt 4.11 Absatz 4 der Verordnung (EU) 2017/745 und Anhang VII Abschnitt 4.11 Absatz 4 der Verordnung (EU) 2017/746 beschränkt die Benannte Stelle ihre Tätigkeiten zur erneuten Zertifizierung im Rahmen ihrer dokumentierten Verfahren auf die Bewertung der Unterlagen gemäß Artikel 5 Absätze 1 und 2 bzw. Artikel 6 Absatz 1. (2) Die Benannte Stelle stellt sicher, dass innerhalb eines Zeitraums von höchstens 20 Tagen, gerechnet ab dem Folgetag des Tages, an dem die abschließende Prüfung gemäß Artikel 5 Absatz 4 Buchstabe f bzw. Artikel 6 Absatz 1 Buchstabe g abgeschlossen wird, bis zu dem Tag, an dem die Bescheinigungen ausgestellt und in Eudamed eingetragen werden, im Rahmen ihrer dokumentierten Verfahren gemäß Anhang VII Abschnitt 4.8 der Verordnung (EU) 2017/745 bzw. gemäß Anhang VII Abschnitt 4.8 der Verordnung (EU) 2017/746 die Entscheidung getroffen wird und die Bescheinigungen erneut ausgestellt werden. ABl. L vom 5.5.2026 DE ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj 9/10 (3) Fällt die Entscheidung über die Erneuerung der Bescheinigung früher als drei Monate vor Ablauf der Bescheinigung, so beginnt der Zeitraum von höchstens 20 Tagen abweichend von Absatz 2 drei Monate vor Ablauf dieser Bescheinigung. Artikel 8 Übergangsbestimmungen (1) Die Artikel 1, 2 und 3 gelten nicht für Konformitätsbewertungsverfahren, für die die Benannte Stelle und der Hersteller vor dem 25. Februar 2027 eine schriftliche Vereinbarung unterzeichnet haben. (2) Artikel 4 Absätze 1, 2 und 3 gilt nicht für Konformitätsbewertungsverfahren, für die die Benannte Stelle und der Hersteller nach dem 25. Mai 2027 eine schriftliche Vereinbarung unterzeichnet haben. (3) Die Artikel 5, 6 und 7 gelten nicht für Überprüfungen im Hinblick auf die erneute Zertifizierung von Bescheinigungen, die vor dem 25. November 2027 ablaufen. Artikel 9 Inkrafttreten und Anwendung Diese Verordnung tritt am zwanzigsten Tag nach ihrer Veröffentlichung im Amtsblatt der Europäischen Union in Kraft. Sie gilt ab dem 25. Februar 2027. Artikel 4 Absatz 4 gilt jedoch ab dem 1. Januar 2028. Diese Verordnung ist in allen ihren Teilen verbindlich und gilt unmittelbar in jedem Mitgliedstaat. Brüssel, den 4. Mai 2026 Für die Kommission Die Präsidentin Ursula VON DER LEYEN DE ABl. L vom 5.5.2026 10/10 ELI: http://data.europa.eu/eli/reg_impl/2026/977/oj Durchführungsverordnung (EU) 2026/977 der Kommission vom 4. Mai 2026 zur Festlegung bestimmter einheitlicher Anforderungen an das Qualitätsmanagement und die Verfahren für die Konformitätsbewertungstätigkeiten, die von einer Benannten Stelle durchgeführt werden, welche gemäß den Verordnungen (EU) 2017/745 und (EU) 2017/746 des Europäischen Parlaments und des Rates benannt wurde

Bei der Anwendung der Verordnungen (EU) 2017/745 über Medizinprodukte (MDR) und (EU) 2017/746 über In-vitro-Diagnostika (IVDR) hat sich gezeigt, dass bestimmte Anforderungen des Anhangs VII MDR und des Anhangs VII IVDR uneinheitlich ausgelegt werden. Dies betrifft insbesondere die von Benannten Stellen an Hersteller übermittelten Angebote, die Fristen für den Abschluss von Konformitätsbewertungstätigkeiten sowie die erneute Zertifizierung. Mit der Durchführungsverordnung (EU) 2026/977 der Kommission vom 4. Mai 2026 werden die Anforderungen an das Qualitätsmanagement und die Verfahren Benannter Stellen präzisiert und klargestellt, um eine einheitliche Umsetzung sicherzustellen. Die Durchführungsverordnung enthält konkrete Regelungen zu verschiedenen Aspekten des Konformitätsbewertungsverfahrens: Angebote (Artikel 1): Benannte Stellen müssen die Mindestinformationen anfordern, um ein Angebot für Konformitätsbewertungsmaßnahmen zu erstellen. Dazu gehören Details zum Produkt, seiner Zweckbestimmung und spezifischen Technologien, um sicherzustellen, dass die Benannte Stelle für die entsprechenden Codes benannt ist. Hersteller müssen zudem Angaben machen, um ihre Einstufung als Mikro-, kleines oder mittleres Unternehmen zu ermöglichen. Die Benannten Stellen sind verpflichtet, ein transparentes und detailliertes Angebot zu erstellen, das auch mögliche Kosten für Überwachungsaktivitäten umfasst. Zur Optimierung der Effizienz sollten strukturierte Dialoge mit Herstellern bereits in der Vorantragsphase geführt werden. Fristen (Artikel 2): Es werden verbindliche Fristen für die Konformitätsbewertung festgelegt, z. B. eine maximale Frist von 30 Tagen für die Prüfung des Antrags und die Unterzeichnung des Vertrags zwischen der Benannten Stelle und dem Hersteller (Artikel 2 Absatz 2a). Für die Audits des Qualitätsmanagementsystems sind 120 Tage vorgesehen, während für die Produktprüfung eine Frist von 90 Tagen gilt (Artikel 2 Abs. 2b und 2c). Die Audits des Qualitätsmanagementsystems und die Produktprüfung sind parallel durchzuführen, sofern die erforderlichen Hinweise aus der Bewertung der einschlägigen technischen Dokumentation bei der Ausarbeitung des Auditprogramms berücksichtigt werden. Es werden klare Vorgaben für die Bewertung geplanter wesentlicher Änderungen an Produkten oder Qualitätsmanagementsystemen festgelegt. Auch für Änderungen an bereits zertifizierten Produkten sind Fristen zur Überprüfung und Entscheidung über zusätzliche Konformitätsbewertungsmaßnahmen vorgesehen (Artikel 2 Abs. 3). Fristaussetzungen (Artikel 3): Die Durchführungsverordnung sieht vor, dass die Frist der Konformitätsbewertungstätigkeit ausgesetzt werden kann, wenn diese von weiteren Informationen abhängt, die der Hersteller bereitstellen muss, oder wenn Beiträge von externen Instanzen wie der EMA erforderlich sind. Überwachung der Dauer und der Kosten (Artikel 4): Benannte Stellen werden verpflichtet, innerhalb ihres Qualitätsmanagementsystems geeignete Maßnahmen zur Überwachung ihrer Leistungen hinsichtlich Fristen und der Übereinstimmung der in Angeboten prognostizierten Kosten mit den tatsächlich berechneten Kosten für Konformitätsbewertungsaktivitäten zu treffen (Artikel 4 Absatz 1, 2 und 3). Um die Transparenz zu gewährleisten, müssen Benannte Stellen Berichte erstellen, die Daten zur Überwachung der Fristen und Kosten enthalten (Artikel 4 Absatz 4). Diese Berichte sind öffentlich zugänglich zu machen, damit Hersteller die Leistungen der Benannten Stellen vergleichen können. Erneute Zertifizierung von Produktbescheinigungen, von Qualitätsmanagementbescheinigungen und Entscheidung über eine erneute Zertifizierung (Artikel 5, 6, und 7): Benannte Stellen sollten die Rezertifizierung nach vorhersehbaren Fristen durchführen, damit die Zertifikate rechtzeitig vor Ablauf erneuert werden können, ohne die ursprüngliche Zertifizierung zu wiederholen. Die relevanten Informationen und Auszüge aus der technischen Dokumentation, die überprüft werden müssen, sollten klar für die Rezertifizierung des Qualitätsmanagementsystems und der Produktzertifikate identifiziert werden. Die Überprüfung des Qualitätsmanagementsystems des Produkts, das einer Rezertifizierung unterzogen wird, sollte sich insbesondere auf Informationen zu Überwachungsaktivitäten, Einhaltung anwendbarer Stichprobenpläne, Nichtkonformitäten sowie Korrektur- und Vorbeugemaßnahmen konzentrieren und auch eventuelle Bedingungen für das Zertifikat berücksichtigen (Artikel 6). Zudem sollte der Stand der Technik berücksichtigt werden. Für die Bewertung der Informationen zum Produkt, das einer Rezertifizierung unterzogen wird, sollten Benannte Stellen besonders auf Änderungen am Produkt, auch im Hinblick auf die Weiterentwicklung des Standes der Technik, sowie auf Aktualisierungen der Risikobewertung achten (Artikel 6). Übergangsbestimmungen sind in Artikel 8 festgelegt. Gemäß dieser Bestimmung gelten die Artikel 1, 2 und 3 nicht für Konformitätsbewertungsverfahren, für die die Benannte Stelle und der Hersteller vor dem 25. Februar 2027 eine schriftliche Vereinbarung unterzeichnet haben. Die Artikel 5, 6 und 7 gelten nicht für Überprüfungen im Hinblick auf die erneute Zertifizierung von Bescheinigungen, die vor dem 25. November 2027 ablaufen. Artikel 9 regelt das Inkrafttreten und den Anwendungsbeginn . Die Durchführungsverordnung ist am 5. Mai 2026 im Amtsblatt der Europäischen Union veröffentlicht worden. Diese Verordnung tritt am zwanzigsten Tag nach ihrer Veröffentlichung im Amtsblatt der Europäischen Union in Kraft und gilt ab dem 25. Februar 2027. Artikel 4 Absatz 4 gilt jedoch ab dem 1. Januar 2028.

Am Montag, den 4. Mai 2026 informierte die Europäische Kommission auf Ihrer Webseite über die Billigung des ersten Joint Clinical Assessment Reports durch die HTA - Koordinierungsgruppe. Dabei handelt es sich um das Orphan Drug Ojemda mit dem Wirkstoff Tovorafenib zur Behandlung des pädiatrischen niedriggradigen Glioms bei Kindern. Das Verfahren wurde am 27. März 2025 gestartet und wird nun der Europäischen Kommission zur Prüfung vorgelegt. Sofern der Bericht den Verfahrensvorschriften entspricht, wird die Kommission den Bericht, den Kurzbericht sowie das Dossier des Entwicklers der Gesundheitstechnologie auf dem Europa‑Portal veröffentlichen. Verantwortlich als Assessor und Co-Assessor des ersten JCA waren das National Centre for Pharmacoeconomics, Irland, und das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Deutschland. Mit Abschluss dieser Bewertung wurde ein wichtiger Meilenstein im Etablierungsprozess des EU-HTA-Verfahrens erreicht. Der Bericht über die klinische Bewertung, muss nun von den Mitgliedstaaten im Rahmen der nationalen HTA-Bewertungen berücksichtigt werden.

Country National registration obligations for distributors National registration obligation for importers Notification of placing medical devices on the market Notification of the distribution of MDs already registered in another EEA MS (by distributors or importers) Notifications in the field of clinical investigations Other requirements Austria Yes. Distributors must register in the Austrian Medical Devices Register (Medizinprodukte­regis ter) operated by Gesundheit Österreich GmbH in accordance with § 91 MPG 2021 and the Medical Devices Notification Ordinance 2024. Registration includes company details, activity type and product categories. Yes. Importers must register in EUDAMED according to MDR/IVDR. Until EUDAMED is fully functional, an additional registration in the Austrian Medical Devices Register is required. No. No additional national notification for placing devices on the market beyond MDR/IVDR requirements. No. No separate national notification required. Only distributor/ importer registration obligations apply. Yes. Clinical investigations must be notified to the Austrian competent authority (AGES/BASG) in accordance with MDR and national provisions under MPG 2021. Yes. Distributors must comply with the reporting and update obligations defined in the Austrian Medizinproduktem eldeverordnung 2024 (Medical Devices Notification Ordinance 2024) regarding the national medical device register. Belgium Yes. In accordance with Article 4 of the Royal Decree of November 15, 2017, medical devices distributors are required to register on the digital platform of the FAHMP. No. Importers should register on EUDAMED. Yes, for distributors. No. If information about medical devices is already included in EUDAMED in one Member State, there is no need for a separate registration in another Member State. No. No additional national obligations beyond the MDR requirements. Exception: pursuant to Article 44 of the Belgian Royal Decree of 22 December 2020 on medical devices, clinical investigations involving class I devices or non- invasive class IIa/IIb devices may only commence after authorization has been granted by the Minister or their delegate, in accordance with the procedure set out in Articles 45 to 48. No. No specific Belgian legislation related to the advertisement of medical devices. Bulgaria Yes. The Bulgarian drug agency (BDA) requires registration of wholesalers and keeps a register for the categories of devices the wholesaler has applied for. There is no new information from the competent authority on new local requirements after 28 May 2026. http://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&table_name=loi&cn=2017111506 http://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&table_name=loi&cn=2017111506 Croatia Yes. Distributors are subject to national oversight and must be registered to perform distribution activities of medical devices. Relevant under Zakon o medicinskim proizvodima (Official Gazette NN 76/13, 90/14, 46/18) and related laws, the competent authority is HALMED. Yes. Importers must be registered as economic operators and notified to HALMED, within a maximum of 15 days after placing the devices on the market. Obligations derive from Regulation (EU) 2017/745 (Article 13) and national implementation via the Croatian law. Yes. There is an obligation to notify certain categories of devices before placing them on the market via national systems (until EUDAMED becomes fully functional). Based on national provisions and MDR transitional arrangements. No. There is no general obligation for additional notification if the device is compliant with MDR and already lawfully placed on the EEA market. However, HALMED may request information as part of market surveillance activities (MDR Articles 93-100). Yes. Clinical investigations require approval from HALMED and an ethics committee. Relevant provisions: Regulation (EU) 2017/745 (Articles 62–82) and national rules on clinical investigations of medical devices. Yes. Vigilance and post- market surveillance obligations (incident reporting, FSCA) are handled via HALMED in line with MDR (Articles 83-92). National systems are still used in parallel with EUDAMED, and additional administrative requirements may apply (e.g. local contact point, language requirements). Cyprus Yes, distributors will continue to notify medical devices to CYMDA. Czechia Yes. Act No. 375/2022 Obligation to notify the State Institute for Drug Control (SÚKL) via the Medical Device Information System (hereinafter referred to as „ISZP“) Yes. Obligation to notify SÚKL via the Registry of Medical Devices (RZPRO) until the EUDAMED database becomes fully operational. Yes. Distributors - via the Medical Device Information System (hereinafter referred to as „ISZP“) - as part of the notify of Distributor's operations, a list of Yes. The Czech Republic requires national notification regardless of whether the MD has already been notified in another EEA Member State. Yes. Sponsors must notify SÚKL of their operation and submit clinical investigation applications via the national Registry of Medical Devices (RZPRO), per Act on before commencing their operations, in accordance with Sections 23 of Act on Medical Devices. This obligation shall not apply to a distributor who supplies exclusively risk class I medical devices or risk class A in vitro diagnostic It was created under Act No. 268/2014 Sb. and continues to operate under the transitional provisions of Act No. 375/2022 Sb. MDs it supplies to the market must be included. For each MD, the following Information must be provided: its name, intended purpose, risk class, basic UDI- DI (if assigned) and the name and address of the manufacturer. Importers - the Registry of Medical Devices (RZPRO) until the EUDAMED database becomes fully operational. Medical Devices and SÚKL procedures. Act No. 375/2022. Denmark No. No. No. No. Yes. Notification to be made to the Danish CA in accordance with the relevant MDR provisions (Articles 62–82) . TBC Estonia Yes. According to the Estonian Medical Devices Act § 26, distributors of medical devices (except Class I) shall notify the State Agency of Medicines within 10 days after distribution of the relevant medical device for the first time. No. After EUDAMED becomes mandatory as of 28 May 2026, the registration of all economic operators and their devices will take place in EUDAMED. No. After EUDAMED becomes mandatory as of 28 May 2026, the registration of all economic operators and their devices will take place in EUDAMED. No. After EUDAMED becomes mandatory as of 28 May 2026, the registration of all economic operators and their devices will take place in EUDAMED. Finland Yes. E-submission to CERE database. No Only to EUDAMED. Yes. Only by distributors. Yes. Only by distributors. Yes. Notification to FIMEA medicines agency is required. France No. No. Pending the full operational status of the EUDAMED database, and therefore its mandatory use, operators have the option of either voluntarily using EUDAMED or using the national form to declare their devices and activities to the No. Either using the form or via EUDAMED, EUDAMED recommended. No. TBC. Yes, advertising. ANSM, in accordance with Article 123 paragraph 3.d of Regulation (EU) 2017/745. The ANSM encourages operators to directly use the EUDAMED database for their device and activity records. Germany No. The German Medical Devices Law Implementation Act (MPDG) authorises the Federal Ministry of Health to adopt national rules on the registration of distributors (including pharmacies) by ordinance (Section 88(1) no. 9 MPDG). To date, no such ordinance has been adopted. Therefore, there is currently no registration obligation for distributors in Germany. No. German importers are required to register in EUDAMED. At national level, there is no legal basis for, nor obligation to, register in the German Medical Devices Information and Database System (DMIDS). Yes. Pursuant to Section 25 MPG in combination with Section 96 MPDG. The notification should be done in DMIDS, until the date referred to in Article 123(3)(e) of Regulation (EU) 2017/745. No. If a product is CE- marked and registered in an EEA Member State, no additional notification in Germany (e.g. in DMIDS) is required. Yes. These include, in particular: applications for authorisation, notifications of PMCF investigations and other clinical investigations, substantial modifications, as well as notifications of temporary halt, early termination, or end of a clinical investigation. All these should be done in DMIDS. Furthermore, the reporting of serious adverse events (SAEs) and device deficiencies (DDs) should be done to BfArM. Greece Yes. Mandatory registration of distributors in GREMDIS. No. Yes. Yes. No. No. Hungary Yes. Economic operators with a registered seat in Hungary that distribute medical devices (or medical aids) must register with the National Public Health and Pharmaceutical Centre (NNGYK) before starting their distribution activities. Yes. These obligations are governed by both NNGYK and the MDR. Yes. New product: Before the placement on the market. Change in a product: 90 days to report it, and MFs can start selling in the meantime. Yes There are notification and registration obligations for economic operators with a registered seat in Hungary who distribute or import medical devices, even if those devices are already registered in another EEA Member State. The specific obligations depend on the role of the economic operator (distributor or importer). Yes. There are several notification obligations in the field of clinical investigations and performance studies under EU MDR, as well as within the Hungarian national framework. Yes. Special product category: Medica aid, with additional advertising requirements. National systems are still used in parallel with EUDAMED, and additional administrative requirements may apply (e.g. English Master copy might need to be provided along with the local AWs for notification; All products on the market needs to re- notify in every round, when a new product is added to the MD portfolio). Ireland Yes. Distributors established in Ireland must register their organisation details and device types nationally with the HPRA using an online registration form. No. Importers established in Ireland must register their organisation details on Eudamed. Following validation on EUDAMED, the HPRA will contact registered importers to provide further information on the imported devices. No. No. Yes. For detailed guidance, please refer to the ‘Guide to Clinical Investigations Carried Out in Ireland’ HPRA 16 May 2024’ No. Italy Yes. The Italian Competent Authority has established, pursuant to Article 30(2) of the MDR, the obligation for distributors who make medical devices available on the Italian territory to register. This obligation is set out in Article 14 of Legislative Decree 2022/137. This article provides that distributors must register in a national database, providing their information and No (but with exceptions). The registration obligation applies to distributors. However, Article 14(5) of Legislative Decree 2022/137 allows, on a voluntary basis, all other economic operators to register and submit information not available in EUDAMED concerning the devices they make available on the Italian market, in order to ensure the most complete level of No. If you place on the market, you are the manufacturer and therefore you must register in EUDAMED and not in the national database. Yes, for distributors. The fact that devices are already registered in other countries does not exempt the distributor from the registration obligation if they fall under the conditions explained in the first point (i.e. they make the devices available in Italy). The Competent Authority has procedures in place for clinical investigations here (https://www.salute.g ov.it/new/it/tema/dis positivi- medici/indagini- cliniche-con- dispositivi-non- marcati-ce/ ). There is no specific information system for the management and notification of clinical investigations. To date the obligation exists in the legislative decree but is not yet in force, as we are still awaiting the implementation of the database for distributors. We have been informed by the Ministry of Health that this database will be interoperable with EUDAMED, as it will retrieve the UDIs of the devices from EUDAMED (i.e. those for which the https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticolo?art.versione=1&art.idGruppo=0&art.flagTipoArticolo=0&art.codiceRedazionale=22G00145&art.idArticolo=14&art.idSottoArticolo=1&art.idSottoArticolo1=10&art.dataPubblicazioneGazzetta=2022-09-13&art.progressivo=0#art https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticolo?art.versione=1&art.idGruppo=0&art.flagTipoArticolo=0&art.codiceRedazionale=22G00145&art.idArticolo=14&art.idSottoArticolo=1&art.idSottoArticolo1=10&art.dataPubblicazioneGazzetta=2022-09-13&art.progressivo=0#art https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticolo?art.versione=1&art.idGruppo=0&art.flagTipoArticolo=0&art.codiceRedazionale=22G00145&art.idArticolo=14&art.idSottoArticolo=1&art.idSottoArticolo1=10&art.dataPubblicazioneGazzetta=2022-09-13&art.progressivo=0#art https://www.salute.gov.it/new/it/tema/dispositivi-medici/indagini-cliniche-con-dispositivi-non-marcati-ce/ https://www.salute.gov.it/new/it/tema/dispositivi-medici/indagini-cliniche-con-dispositivi-non-marcati-ce/ https://www.salute.gov.it/new/it/tema/dispositivi-medici/indagini-cliniche-con-dispositivi-non-marcati-ce/ https://www.salute.gov.it/new/it/tema/dispositivi-medici/indagini-cliniche-con-dispositivi-non-marcati-ce/ https://www.salute.gov.it/new/it/tema/dispositivi-medici/indagini-cliniche-con-dispositivi-non-marcati-ce/ https://www.salute.gov.it/new/it/tema/dispositivi-medici/indagini-cliniche-con-dispositivi-non-marcati-ce/ https://www.salute.gov.it/new/it/tema/dispositivi-medici/indagini-cliniche-con-dispositivi-non-marcati-ce/ identifying the devices they make available on the market. It is important to note that this obligation is not yet in force, as the database intended for this purpose has not yet been implemented. information for the National Health Service (SSN). Furthermore, there is a case in which registration is mandatory for importers, namely under Article 16(2)(a) and (b) (repackaging and relabelling). In this case, importers and distributors must register and submit to the Ministry of Health the information and documentation relating to relabelled and repackaged devices. manufacturer has indicated “Italy” in the market distribution, and this is potentially a critical aspect). Latvia Yes. In accordance with the Regulation No. 461 of the Cabinet of Ministers of Latvia Medical Devices Regulation Article No. 9, distributors of medical devices must register with he State Agency of Medicines (ZVA) and, for Yes. No. Manufacturers will only need to register medical devices in Eudamed. Distributors and importers remain subject to the same requirements under the MDR as before, with the exception that there will no No. https://likumi.lv/ta/id/344674 https://likumi.lv/ta/id/344674 medium/high-risk devices (Class IIa, IIb, III, and certain IVDs), submit notification forms via the LATMED system. longer be a notification procedure for placing medical devices on the market. Lithuania No. No further action in addition to EUDAMED. No. Luxembourg No. Currently, no registration is planned for distributors in Luxembourg, however this could change in the future. No. Economic operators (manufacturers, agents, importers, system and equipment suppliers) established in Luxembourg can register via EUDAMED. No. No. TBC. Maybe. Advertising TBC. Malta Based on the available information, a database of medical devices being marketed in Malta will be created, although there is no indication as to when this will be up and running yet Netherlands No. No. Yes. Only Class I devices. No. Yes. MDR Art 62/74.1/74.2/82. No. Norway No. Distributors and importers of medical devices are not obligated to register. No. Distributors and importers of medical devices are not obligated to register. No. No. Yes. Notification to be made to NoMA. Poland Yes. No. Yes. Yes. Yes. Yes. Article 21 in Polish Act of medical devices from 7.04.2022, Distributors have to register in Polish database of distributors. List of distributors is published but without information on the distributed devices. Importers should register in EUDAMED. Article 21 point 5 in Polish Act of medical devices from 7.04.2022, Each distributor registers in the Polish database of distributors every medical device, system or procedure pack introduced for the first time, within 7 days from the date of placing the first device on the territory of the Republic of Poland. Distributors have to make a notification according to article 21 in Polish Act of medical devices from 07.04.2022 in Polish database of distributors. Article 33 point 3 in Polish Act of medical devices from 07.04.2022, A sponsor who intends to conduct a clinical investigation on the territory of the Republic of Poland, referred to in Article 82(1) of Regulation (EU) 2017/745, shall submit an application to the President of the National Registration Office for authorization to conduct such a clinical investigation. The sponsor shall attach to the application the information and documents specified in Chapter II of Annex XV to Regulation (EU) 2017/745, with the exception of the data and documents listed in Sections 1.5, Article 139 in Polish Act of medical devices from 07.04.2022 “Until 1 January 2031, entities that have submitted a notification or made a registration in accordance with Article 58 of the Act repealed by Article 147 shall be obliged, within 7 days from the date on which they become aware of a change, to notify the President of the National Registration Office of any change to the data covered by that notification or registration.” 1.15, and 3.1.1 of that Annex.’’ Portugal Yes. Distributors must comply with the registration with INFARMED. This registration mt be carried out at least 60 days before the start of the activities of wholesale distribution of medical devices and their accessories in Portugal. Yes. Yes. Yes. Yes. It is only required for studies conducted in Portugal, including cases where the sponsors are foreign and in international multicenter trials where Portugal is the involved member state. • Authority to be no tified: Infarmed  • Platform: Registo Nacional de Estudos Clínicos (RNEC)  • Guide: Regulatory Guidel ines for Clinical In vestigations of M edical Devices – Submissions in Portugal Yes. Decree- Law No. 145/2009, establishes in particular the rules governing the adver tising of medical de vices and their acc essories. PORTARIA No. 256/2016, of Septe mber 28, approves t he principles and st andards of Good Di stribution Practices for medical devices, to be observed by e ntities engaged in t he wholesale distri bution of medical d evices.  Distance Selling: There are no specific channel s or applicable rule s for the sale and pur chase of medical d evices by consumer https://www.rnec.pt/faqs1 https://www.rnec.pt/faqs1 https://www.rnec.pt/faqs1 https://www.rnec.pt/faqs1 s, except in the cas e of in vitro diagnostic me dical devices, whic h, under Decree- Law No.145/2009, may only be made a vailable to the publi c through dispensin g at pharmacies or at locations selling over-the counter medication , including via the in ternet. Decree-Law No. 29/2024, ensures the implementation, within the national legal framework, of Regulation (EU) 2017/745 in the Portuguese market. Romania Yes. Obligation to register with the NAMMDR into the national database. Yes. Yes. Yes. Yes The sponsor/authorised representative submits an application to the NAMMDR. No. The current available information, based on an official announcement issued by NAMMDR, suggests Romania might align with the EUDAMED framework. Slovakia No. No. Only to EUDAMED. Yes. Yes. Not mandatory for Class I devices. Slovenia Yes. Distributors based in the Republic of Slovenia (RS) must register as economic operators with JAZMP (competent authority) to perform distribution activities of medical devices on the market of the RS. Relevant under Zakon o medicinskih pripomočkih (ZMedPri- 1) (Official Gazette of the RS, No. 40/25 with amendments). Yes. Importers based in the RS must register as economic operators with JAZMP before starting to carry out activities on the market of the RS. Obligations derive from Zakon o medicinskih pripomočkih (ZMedPri- 1) (Official Gazette of the RS, No. 40/25 with amendments). Yes. There is an obligation for manufacturers and authorized representatives based in RS to register medical devices with JAZMP, while importers must submit compliance documentation to JAZMP upon each first supply of the imported device and subsequently notify JAZMP of every purchase of such device and any relevant changes (until EUDAMED becomes fully functional). Based on national provisions and MDR No. There is no general obligation for additional notification if the device is compliant with MDR and already lawfully placed on the EEA market. However, JAZMP may request information as part of market surveillance activities (MDR Articles 93–100). Yes. Clinical investigations require notification to JAZMP (until EUDAMED becomes fully functional), a positive opinion from the ethics committee, and confirmation or approval from JAZMP. Relevant provisions: Regulation (EU) 2017/745 (Articles 62–82) and Zakon o medicinskih pripomočkih (ZMedPri-1) (Official Gazette of the RS, No. 40/25 with amendments). Yes. Importers and distributors must appoint a person responsible for compliance and a person responsible for vigilance within their organization. Vigilance and post- market surveillance obligations (incident reporting, FSCA) are handled via JAZMP in line with MDR (Articles 83–92). National systems are still used in parallel with EUDAMED, and additional administrative requirements may apply (e.g. local transitional arrangements. contact point, language requirements). Spain Yes. In Spain, distributors must notify to the regional government where their registered office is located of the start of their business activity as well as to the health authority of the community where the warehouse or warehouses are located, if these are not located in the same region (RD 192/2023, Article 24). No prior authorization is required; it is a "responsible declaration" that allows the activity to begin immediately upon notification, without prejudice to a subsequent inspection. Yes. In Spain, pursuant to Article 7 of Royal Decree 192/2023, natural and legal persons involved in the manufacture, import, grouping, or sterilisation of medical devices and in vitro diagnostic medical devices (MD/IVMD), as well as the facilities where these activities are carried out, are required to hold a prior operating licence issued by the AEMPS (Spanish Agency for Medicines and Health Products). Yes. Currently, economic operators placing a medical device or in vitro diagnostic medical device (MD/IVMD) on the Spanish market for the first time are required to submit a prior notification of placing on the market for all devices, with the exception of Class I medical devices, via the AEMPS CCPS application. In the near future, the CCPS application will be replaced by the new National Marketing Registry for MD/IVMDs (Royal Decree 192/2003, Article 18, and Royal Decree 942/2025, Article 15). Yes. Currently, economic operators placing a medical device or in vitro diagnostic medical device (MD/IVMD) on the Spanish market for the first time are required to submit a prior notification of placing on the market for all devices, with the exception of Class I medical devices, via the AEMPS CCPS application. In the near future, the CCPS application will be replaced by the new National Marketing Registry for MD/IVMDs (Royal Decree 192/2003, Article 18, and Royal Decree 942/2025, Article 15). The new registry will be directly linked to EUDAMED. Following notification in Yes. Royal Decree 192/2023 (Chapter VII) In clinical research with medical devices, there are different situations that must be clearly differentiated in order to know the requirements applicable to each of them: Clinical investigations with medical devices without CE marking as defined in Article 62 of the Regulation: In order to initiate these clinical trials in Spain at a participating center, the sponsor must have authorization from the AEMPS, the single and binding favorable opinion for Yes. ADVERTISING: RD 1591/2009, Art. 38 and RD 1662/2000, Art. 25 (these articles have not been repealed by the new Royal Decrees of MD and IVMD, respectively): “Advertising messages inserted in any of the general media, including the Internet, as well as any other promotional material directed to the public, will be subject to prior authorization by the health authorities of the autonomous communities.” There is a new Royal Decree about PS advertising, which is expected The new registry will be directly linked to EUDAMED. Following notification in EUDAMED, economic operators will have a six-month period to submit their products to the National Marketing Registry. Once the new registry becomes operational, all economic operators—including all distributors— placing medical devices and in vitro diagnostic medical devices (MD/IVMD), including Class I devices, on the Spanish market will be required to notify their products. EUDAMED, economic operators will have a six-month period to submit their products to the National Marketing Registry. Once the new registry becomes operational, all economic operators - including all distributors - placing medical devices and in vitro diagnostic medical devices (MD/IVMD), including Class I devices, on the Spanish market will be required to notify their products. carrying out the clinical trial at said center issued by a Research Ethics Committee with medicines (CEIm), as established in Royal Decree 1090/2015, and the agreement of the management of said participating center. If the medical device has the CE marking and is used according to its instructions for use and within the intended purpose approved when it obtained the CE marking, the following is required: The single and binding favourable opinion of a CEIm and the agreement of the Management of the centres that will participate in the clinical research. When it is intended to to be approved shortly. Regarding the procedures for authorizing advertising of products aimed at the public, the new Royal Decree includes a substantial modification to the advertising control procedures. Specifically, it allows for the possibility of submitting a declaration of responsibility prior to the dissemination of the advertising message for products listed in Annex II (no fees required), whose advertising has a low impact on health (i.e. products for the fixation, cleaning and disinfection of carry out a clinical investigation with a medical device without CE marking or with CE marking, but outside the scope of its intended purpose, even if the intention of the promoter is not to use the investigation for the assessment of the conformity of the product with a view to obtaining CE marking, the AEMPS should be consulted on the procedure to follow. dental prostheses; non-prescription self-diagnostic test: pregnancy, fertility; or absorbent products for incontinence, among others) . For all other products not included in the aforementioned annex, the text requires prior authorization of the advertising by the corresponding regional authority, as is currently the practice (fees required). Sweden Yes. Registration with Swedish MPA is mandatory in Sweden and comes with an annual fee. Yes. Registration with Swedish MPA is mandatory in Sweden and comes with an annual fee. Yes. In certain situations (suspected or verified serious risks associated with a device). Yes. Yes. Switzerland No. Not required. Yes. It is mandatory to register importers in Swissdamed. Yes. Starting 1 July 2026, products, systems and procedure packs shall be registered in Not relevant for Switzerland. Depends. Depending on the category of the clinical investigation, notification to Ethics the swissdamed UDI Devices module, if they continue to be made available on the market after that date. The registration requirement applies for devices under the current legislation (MedDO, IvDO) as well as devices complying with the old legislation which are still being made available on the market (according to Art. 101 MedDO or Art. 82 IvDO, respectively). Committee via the BASEC portal and to Swissmedic via Swissmedic eGov services. Great Britain/ Northern Ireland GB: distributors are not required to be registered with the MHRA. NI: distributors established in Ireland must register their organisation details and device types No. NI: only EUDAMED registration. Yes. GB: It is a requirement of the UK MDR 2002 tha t you inform the MHRA before you place your device on the market in Great Britain. Yes. No. https://www.fedlex.admin.ch/eli/cc/2020/552/en https://www.fedlex.admin.ch/eli/cc/2022/291/en?version=20230901 https://www.fedlex.admin.ch/eli/cc/2020/552/en#art_101 https://www.fedlex.admin.ch/eli/cc/2022/291/en#art_82 https://www.legislation.gov.uk/uksi/2002/618/contents nationally with the HPRA https://www.hpra.ie/re gulation/medical- devices/registration/di stributors. NI: From 28 May 2026, all medical devices (other than custom-made devices) must be registered on the European Database on Medical Devices (EUDAMED) prior to placement on Northern Ireland markets. From this point, MHRA registration will not be required. Last update : 04/05/2026 https://www.hpra.ie/regulation/medical-devices/registration/distributors https://www.hpra.ie/regulation/medical-devices/registration/distributors https://www.hpra.ie/regulation/medical-devices/registration/distributors https://www.hpra.ie/regulation/medical-devices/registration/distributors https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf