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AESGP Issue 384 | May 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • CMDh Report - 21-22 APR 2026 ___________________________________________________________________________ 2 • CMDh Minutes - 24-25 MAR 2026 _________________________________________________________________________ 2 • 131st EMA Management Board Meeting - 12 MAR 2026 – Minutes ________________________________________________ 5 • 103rd meeting of the EC Pharmaceutical Committee – Summary record ____________________________________________ 7 Herbal medicines ____________________________________________________________________________________________ 9 • EMA - Revised Q&A on implementation of Ph. Eur. Medicinal Product Monographs (MPM) _____________________________ 9 FOOD __________________________________________________________________________________ 10 Setting Maximum Levels for Vitamins & Minerals _________________________________________________________________ 10 • Timelines on EC Webpage ______________________________________________________________________________ 10 MEDICAL DEVICES _______________________________________________________________________ 11 Borderline & Classification WG ________________________________________________________________________________ 11 • MDCG Guidance 2021-24 Rev.1 published _________________________________________________________________ 11 • Borderline Manual under MDR and IVDR - Updated Version (Version 5) Published ___________________________________ 11 CIEPS WG _________________________________________________________________________________________________ 11 • Member States-specific national requirements for clinical investigations and performance studies _______________________ 11 MDR/IVDR Simplification _____________________________________________________________________________________ 12 • AESGP Final Position Published on AESGP Website __________________________________________________________ 12 • AESGP Final Position Submitted to EC Public Consultation _____________________________________________________ 12 MDR/IVDR Annex VII NB Requirements _________________________________________________________________________ 12 • Commission Implementing Regulation (EU) 2026/977 Published in OJ ____________________________________________ 12 MDR/IVDR Implementation ____________________________________________________________________________________ 12 • Revised Team-NB Best Practice Guidance for the Submission of TD Published _____________________________________ 12 Nomenclature WG ___________________________________________________________________________________________ 13 • Updated EMDN documents _____________________________________________________________________________ 13 Post Market Surveillance and Vigilance Medical Devices WG _______________________________________________________ 13 • MIR 7.3.1. PDF publication update ________________________________________________________________________ 13 • MIR publication update _________________________________________________________________________________ 13 EMA expert panel support for BtX medical devices _______________________________________________________________ 14 • Pilot programme ______________________________________________________________________________________ 14 Team NB __________________________________________________________________________________________________ 14 • Updated Code of Conduct for NBs under the MDR/IVDR _______________________________________________________ 14 • Clinical Evaluation Based on Non-Clinical Data ______________________________________________________________ 14 ENVIRONMENT __________________________________________________________________________ 15 WFD+GWD+EQSD - Entry into force on 11 May 2026 ______________________________________________________________ 15 EU Deforestation Regulation - EC report and supportive materials___________________________________________________ 15 CROSS-SECTORIAL NEWS _________________________________________________________________ 17 Shortages - Updated ESMP User guide for MAHs _________________________________________________________________ 17 AESGP OTC News | May 2026 2 | 18 Regulatory News CMDh Report - 21-22 APR 2026 The report from the CMDh meeting held on 21-22 APR 2026, has been published. Among the items reported, the following may be noted: CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure) The CMDh agreed an update of its guidance on PSUFU procedures to bring it in line with the new EC guidelines on the details of the various categories of variations and operation of the procedures. The updated document will be published on the CMDh website. [Post-meeting note: The clean and tracked versions of the updated document have been published on the CMDh website.] CMDh Presidency meeting under the Cypriot Presidency of the Council of the EU The CMDh convened for a Presidency meeting on 8 and 9 April 2026 in Larnaca, Cyprus, held as part of a programme of events organised under the Cypriot Presidency of the Council of the EU. In the meeting the CMDh discussed, amongst others, topics related to the future of the CMDh, the new pharmaceutical legislation, well-established use applications, workflow management systems, antimicrobial resistance, environmental risk assessment, reduction of medicine waste, ePL projects and use cases of AI. CMDh Minutes - 24-25 MAR 2026 The minutes of the CMDh meeting held on 24-25 MAR 2026 have been published. Among the items reported, the following may be noted: Working Party on Pharmacovigilance Procedures Worksharing The WP Chair reported from the March 2026 WP meeting. The WP Chair informed the CMDh about the changes in the EURD list regarding NAP entries. MSs were reminded to review the updated list. In addition, the template for requesting amendments of or addition of active substances/combinations to the EURD list has been amended to reflect that synonymous terms of the active substances/combinations should also be included. The WP adopted the LoSCs for several products while awaiting the new web-based system for its publication. The CMDh was informed about the progress of the small temporary group created to improve the implementation of patient cards following referral procedures. The WP will establish a DG to develop a CMDh BPG on aRMM in MRP/DCP that will incorporate the work of the small temporary group (activity foreseen in the CMDh MAWP to 2028). A call for interest/rapporteur will be launched shortly. Medicines https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_April_2026.pdf https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202505045 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202505045 https://www.hma.eu/human-medicines/cmdh/pharmacovigilance/psur/psur-follow-up.html#c7151 https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/CMDh_367-2017_Rev8_2026_04_clean_-_Guidance_on_PUSFU_procedure.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/CMDh_367-2017_Rev8_2026_04_TC_-_Guidance_on_PUSFU_procedure.pdf https://www.hma.eu/human-medicines/cmdh/pharmacovigilance/psur/psur-follow-up.html#c7151 https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_03_CMDh_Minutes.pdf AESGP OTC News | May 2026 3 | 18 The work on a Q&A to provide guidance on PhV obligations and responsibilities in MRP/DCP will be temporarily postponed. The group reviewed the responses to a NUI on issues identified during linguistic review in PSUSA procedures. It was noted that unclear English wording should be corrected when identified. Inconsistencies were also identified between CMDh position/EC decision and the PRAC AR. The WP recommended that EMA introduce a final double-check to ensure accurate transfer of PRAC recommendations and correct wording for linguistic review. RMSs/LMSs should also carefully check final documents and verify consistency, including procedures other than PSUSAs (e.g. referrals). Meeting with Interested Parties in June 2026 A first draft agenda for the CMDh meeting with Interested Parties in June 2026 was presented. The draft agenda will be shared with Interested Parties for their input before the May CMDh meeting. ROG PMS operational group DE presented the preliminary results of the feasibility study on the PMS Data Qualification process that aims to assess the feasibility of implementing a data qualification process for nationally authorised products by National Competent Authorities (NCAs) and to provide recommendations for EU-wide implementation. NCAs are encouraged to prioritise mapping their databases to RMS and OMS for the basic PMS data elements. Collaborative qualification (e.g., RMS/CMS data responsibility sharing) could significantly improve efficiency and use of resources. Quarterly Strategic Portfolio Review DE reported from the Quarterly Strategic Portfolio Review, a ceremony of the Network Portfolio within the Agile framework, which also includes industry representatives. DE outlined the network’s current priorities, focusing on stakeholder engagement, ongoing parallel legislative initiatives, and digitalisation. It was also noted an ongoing project exploring the use of databases to update purely administrative information, replacing the need for type IA notifications. New Pharmaceutical Legislation (NPL) The EC provided a brief oral update on the NPL timeline, its application and planned implementation (including the need to prepare implementing and delegated acts). The CMDh stressed the need for consistent interpretation within the network, close involvement in all relevant workstreams, and alignment through the mapping of provisions to avoid overlap and ensure timely handling of these topics. Member States were reminded to submit any questions or expectations in advance to the EC, in preparation for the next CMDh plenary meeting. Questions and Answers on QP declaration The CMDh discussed an update of the Q&As on QP declaration to bring the document in line with the new Variations Guideline and remove references to the previous guideline. During the update also other minor changes were introduced to add clarification. Comments from MSs were discussed and taken into consideration, where appropriate. The CMDh agreed the update. As the document is a joint document with CMDv and some of the proposed changes also affect questions and answers for veterinary medicinal products, the CMDh will forward the proposal for update to CMDv for agreement before publication. Variation-related questions from Interested Parties The CMDh discussed and agreed answers to variation-related questions from Medicines for Europe, mainly related to conditions of quality-related changes and variation worksharing. The answers were prepared jointly by the EMA and the VRWP chair. Some of the questions will be further discussed in a future VRWP meeting. AESGP OTC News | May 2026 4 | 18 CEP 2.0 The CMDh discussed questions to QWP in relation to the practical implementation of CEP 2.0 based on issues raised by Medicines for Europe (as discussed in February 2026, item 3.10). The questions were agreed and will be sent to QWP. Multiple use of legal base Art. 10b NL informed the CMDh about the submission of pre-judicial questions to the Court of Justice of the European Union (CJEU) about the possibility for multiple use of legal basis Article 10b of Directive 2001/83/EC for the same combination of active substances. The questions follow a previous judgement of a national court in NL which excluded multiple applicants from obtaining a marketing authorisation for the same combination through this legal basis. It was noted that many MSs accept the multiple use of Art. 10b for the same fixed dose combination and the EC has expressed their agreement with this approach in the past. The judgement has been appealed by NL and a MAH and the necessity for asking pre-judicial questions to the CJEU to ensure consistent interpretation of EU law across all Member States was confirmed. MSs were informed that written observations can be submitted to the court until 21 April 2026. It was further noted that the wording of the legal basis has been updated in the proposal for the New Pharmaceutical Legislation. FR and ES informed the CMDh that they had national rulings in the past allowing the use of Article 10b for the same combination of active substances by multiple applicants. FR and ES were asked to share their court outcome with the CMDh. It was proposed that the case could also be brought to the attention of EMACOLEX. The judgement of the CJEU will be brought back to the attention of the CMDh once available. Medical Device Regulation Following the discussions in the CMDh in May/June 2024, NL informed the CMDh of the outcome of the discussions in the MDCG Borderline & Classification Working Group on the classification of micro-enemas with a long nozzle as medical device or as container closure system. The WG concluded that the package would fall under the definition of a medical device: The package for a medicinal product, used as laxative, is made to be used for rectal insertion and administration of the medicine. The package is a single dose mini-tube, with a long nozzle. In this case, the packaging for a medicinal product, used as laxative, is designed for rectal insertion and administration of the medicinal product into the body, thereby falling under the definition of a medical device. Thus, it cannot be considered to being purely a “simple” packaging solution. Because the product forms a single integral medicinal product, which is intended exclusively for use in the given combination and which is not reusable, the medical device part (the packaging) must comply with the requirements of the MDR in accordance with article 117 MDR. Proof of conformity with annex I MDR must be provided in the marketing authorisation dossier of the integral medicinal product. Article 117 is implemented in the Annex I to Directive 2001/83/EC, point 12 of section 3.2. The outcome will be published in the Manual on Borderline & Classification for Medical Devices. The outcome has also been shared with QWP. Acceptability of an UK reference medicinal product The CMDh discussed the acceptability of an UK reference medicinal product (RefMP) and the concept of same applicant/MAH in a generic application. The application was submitted in 2022 and used a UK RefMP for the BE studies. The BE studies were finalised in 2009 and 2015 and would therefore be acceptable for submissions in the EU. However, the applicant did not provide yet evidence that the MAH(s) of the RefMP used for data protection and the MAH of the UK RefMP used for the BE studies can be considered the same (i.e. the RefMP(s) belong to the same GMA). As in the meantime there have been changes of the MAHs, the CMDh confirmed a previous agreement that the relevant time for the evaluation of the same global marketing authorisation is the submission date of the generic application. AESGP OTC News | May 2026 5 | 18 It was noted that generally it’s the applicant’s responsibility to provide information that the RefMP(s) belong to the same GMA. The CMDh agreed that both RefMPs can be considered as belonging to the same GMA and can both be included in the AF. The applicant will be asked to update the AF accordingly. A.O.B. Excipients warnings for isomalt, maltitol and sucrose The CMDh discussed the need to update the warnings for excipients such as isomalt, maltitol, and sucrose, which are sources of sorbitol/fructose and therefore pose a risk to patients with hereditary fructose intolerance (HFI). In order to ensure the safe use of medicines in HFI patients, the CMDh agreed to request the CHMP to review the warnings in the product information of medicinal products containing excipients that are sources of sorbitol/fructose and update the relevant guidance documents to align them with the current warnings for fructose and sorbitol as appropriate. It was also noted that this inconsistency should be also reviewed for other excipients, i.e. lactitol (and any additional relevant sweeteners). Usage patents The CMDh discussed a proposal to amend the information of a generic ongoing application due to a usage patent of the RefMP. The deleted information related to the patent in sections 4.1, 4.2 and 4.4. of the SmPC concerns only information regarding the deleted indication. The proposed deletion of information in section 4.8 was not supported by CMDh as it concerns safety-related information. The CMDh agreed to keep all safety-related information and concluded that it is not necessary to rewrite section 4.8, in line with previous discussions and Q&A 4 of the CMDh Questions & Answers on Usage Patents. Delayed type IA variations submitted after 15 January 2026 DE informed the CMDh of a communication that had been sent to MHRA regarding the CMDh approach for delayed type IA variations submitted after 15 January 2026. Reference was made to previous CMDh discussions as well as to the CMDh press release of January 2026. DE will share the communication for information. 131st EMA Management Board Meeting - 12 MAR 2026 – Minutes The minutes from the131th EMA Management Board meeting held on 12 MAR 2026, have been published. Among the items reported, the following issues of high relevance to our sector may be noted: Highlights of the Executive Director Regarding the conflict in the Middle East, EMA, the MSSG and the SPOC Working Party are closely monitoring the effects on medicine supply in the EU. No critical shortages had been reported to date, though companies had flagged varying degrees of logistical disruption and rising costs. The situation remains dynamic. Coordinated actions were under way and MSSG recommendations were being finalised. The methodology to identify vulnerabilities in supply chains of critical medicines had also been adopted and published on 10 March, with an exercise covering several active substances set to begin in 2026. A few members of the Board stressed the importance of close monitoring of supply chain disruptions in particular with the conflict in the Middle East and requested for regular updates through the MSSG. The Executive Director provided reassurance that extensive supply chain monitoring was under way, with some 500 INNs assessed, and committed to providing a detailed briefing to the Management Board ahead of the MSSG meeting on 23 March. Several Board members also suggested that the potential impact of PFAS restrictions on medicine availability should feature in the planned EMA-ECHA Stakeholder meeting. The DG SANTE representative stated the need for caution on non-core expenditure and encouraged NCAs’ engagement in the forthcoming ECHA public consultation on PFAS. The Executive https://www.ema.europa.eu/en/documents/minutes/minutes-management-board-meeting-12-march-2026_en.pdf AESGP OTC News | May 2026 6 | 18 Director clarified that the EMA-ECHA Stakeholder meeting would focus on ways of working rather than on specific regulatory interventions, but undertook to explore with ECHA whether complementary information sharing with the NCAs on PFAS could be considered. Report from the European Commission The Management Board noted updates from the representatives of DG SANTE and DG RTD. The DG SANTE representative presented the next steps in the adoption of the new EU pharmaceutical legislation, the aspects relevant to EMA in the legal proposals for the Biotech Act and the revision of the EU medical device legislation, and a state of play on the Critical Medicines Act. The new pharmaceutical legislation is expected to enter into force in Q4 2026 and become applicable two years thereafter, except for some specific provisions with earlier applicability. The revision of the medical devices legislation proposes, amongst other aspects, to strengthen EMA’s role in supporting the regulatory framework thanks to its technical and scientific contributions, without altering Member States’ competences. Key proposed changes for EMA include reinforced management of expert panels, broadened panel membership to incorporate regulatory expertise, and an expanded use of the panels’ advice to support national and EU level decisions, such as on product classification and the recognition of breakthrough and orphan devices. EMA would also provide technical support to coordination of national activities on borderline and classification issues, clinical and performance investigation and evaluation, vigilance, market surveillance, and derogations to conformity assessment procedures in emergency situations. In addition, the revision mandates EMA, in collaboration with MDSSG, to develop a Union list of critical devices (including its methodology) and to support, where needed, the European Commission in developing and maintaining a central IT tool for reporting and information exchange regarding cases of interruption or discontinuation of supply. The interinstitutional negotiations on the Critical Medicines Act are ongoing and the Cyprus presidency of the Council is planning to conclude them by June. The Board was also informed that a call for evidence to prepare the Global Health Resilience Initiative will be launched shortly and the initiative will be published as a Commission Communication in Q2 of this year. Update on the preparations for implementation of the new EU pharmaceutical legislation, once adopted The Management Board noted an oral update from the European Commission and from EMA on the preparations for implementation of the new EU pharmaceutical legislation, once adopted. The DG SANTE representative outlined the implementation timeline of the new pharmaceutical legislation, explaining that the majority of provisions in both the regulation and the directive will apply 24 months after entry into force. If adoption occurs in late 2026, most obligations would therefore become binding towards the end of 2028, by which time all regulatory systems and processes at EU and national level must be fully operational. Several provisions, however, apply earlier. Measures related to security of supply, regulatory sandboxes, AMR incentives, and certain provisions for financial and international collaboration will take effect immediately upon entry into force. Provisions concerning availability monitoring and shortages management will apply after six months, while access-related obligations will apply 12 months after entry into force. The environmental risk-assessment prioritisation programme for legacy products authorised before 2005, as well as the register of designated orphan medicines, will become applicable six months after the general date of entry into application. Effective implementation will require close coordination among the European Commission, EMA and national competent authorities. More than 30 implementing and delegated acts must be adopted by the Commission before the date of application, each requiring formal procedures and consultation with Member States and the regulatory network. Joint work, such as on the electronic product information (ePI), was highlighted as essential for meeting legal obligations and ensuring coherent EU-wide implementation. On 6 March, EMA met with the Chairs of the scientific committees and CMDh to discuss their involvement in implementation of the new legislation. The Oversight Group is meeting on 12 March for its first organisational session to discuss working practices and governance arrangements. Delivery streams are analysing the legal text, as a basis to define work plans and integrate them into a consolidated implementation roadmap to support a formal programme launch in the margins of the June Management Board meeting. AESGP OTC News | May 2026 7 | 18 The Chair welcomed the progress and reiterated the need for strong coordination across the EU Medicines Regulatory Network and reaffirmed the importance of the Governance for the effective implementation of such structural changes. A Board member asked about a comparison between the new and existing legislation, to support national implementation activities. EMA indicated that it could present an overview of major changes at the June kick-off meeting. Draft ePI roadmap The Management Board noted an update from Member States and EMA on the draft Road Map for implementation of the electronic Product Information (ePI) for human medicinal products. The Board member from Spain introduced the ePI initiative, which aims to provide authorised, statutory product information for EU medicines - including the SmPC, labelling and package leaflet - in a semi-structured digital format. Using the FHIR standard, ePI can be accessed through web platforms via an application programming interface or printed as a traditional leaflet. The ePI key principles, including the use of a global standard, were jointly agreed by EMA, HMA/NCAs, the European Commission, and representatives of industry, patients and healthcare professionals. The initiative seeks to deliver timely, accurate and continuously updated information to patients and healthcare professionals, while increasing regulatory efficiency. Key advantages include enhanced accessibility, alignment with future EU legislation (which will make ePI mandatory), GDPR compliance, and interoperability with national and global standards. Major milestones so far included publication of the ePI principles (2020), harmonisation of the EU ePI Common Standard (2021), and integration of ePI into the EMA’s Product Lifecycle Management (PLM) Portal FHIR repository. A 2023–24 pilot involving 23 companies and five agencies successfully generated ePIs in real procedures. EMA outlined the ongoing work to prepare processes, guidance and IT systems for implementation. Business processes for centrally authorised products are being adapted, user acceptance testing is ongoing, and ePI functionality is being fully embedded into the PLM Portal. Implementation will start at the end of 2026 with a stepwise approach: vaccines first (due to frequent updates and accessibility needs), followed by oncology products and then other therapeutic areas. Initially, ePI creation will be an additional procedural step after the scientific assessment, with full integration into digital assessment processes planned later. ePI will first be available in English only, with multilingual versions optional and becoming mandatory once the revised legislation becomes applicable. The central EU repository at EMA is ready to scale up as more ePIs are submitted. For national use, Member States will need to undertake preparatory work, including adapting their national systems and developing their own implementation plans and guidance. Spain, as network product owner, will coordinate rollout with EMA support, starting with a workshop at EMA on 10 June to assess NCAs’ readiness, after which Member States’ timelines will be consolidated into a final roadmap by year-end. During the discussion, the Chair welcomed the strong alignment of ePI implementation with the upcoming legislation. Board members praised the work and stressed the need to onboard more NCAs. One Board member asked whether ePI could support shortages management in small markets; it was explained that its multilingual, structured format facilitates cross-border information-sharing, voluntary solidarity mechanisms as well as identification of therapeutic alternatives and analysis of manufacturing options. Industry feedback also indicates that multilingual ePI may help generics launch products in small markets where paper requirements may currently discourage marketing. Other Board members emphasised the importance of readability, integration with national systems and maintaining NCAs as the authoritative source of product information. EMA confirmed that authorities, not marketing authorisation holders, will continue to publish ePI and that the digital format enables significant accessibility improvements, such as adaptable layouts and enhanced navigation. The Commission underscored the need to expand from early adopters to a second wave of NCAs and reiterated its support for coordinated EU-wide implementation. 103rd meeting of the EC Pharmaceutical Committee – Summary record AESGP OTC News | May 2026 8 | 18 The summary record and background documents of the 103rd meeting of the EC Pharmaceutical Committee, held on 27 MAR 2026, have been published on the Commission website. Among the items reported in the summary record, the following may be noted: Main elements of the new EU pharmaceutical legislation and preparatory steps for its implementation after formal adoption The Commission (DG SANTE) presented the main elements of the draft agreement and outlined preparatory work for implementing the new legislation. EMA introduced the New Pharmaceutical Legislation (NPL) oversight group and its delivery streams as a working structure of the network to facilitate the implementation of the legislation. The ensuing discussion covered clarifications on timelines for delegated and implementing acts and Commission and EMA guidance and other implementing actions. The Members of the Committee stressed the importance of timely EU-level implementation to give Member States sufficient time to transpose provisions into national law. The discussion also highlighted the willingness to closely collaborate on the implementation between the Commission, EMA and Committee members. The Commission will define collaboration formats for each deliverable based on input required and its priority, with a preference for using existing fora for policy discussions (Pharmaceutical Committee or STAMP expert group). For the official procedures the Pharmaceutical Committee will be the working group used for Delegated acts and the Standing Committee will be used for Implementing Acts. The Commission highlighted close collaboration as key to anticipating national-level implementation. Preparation for the implementation of the new EU Pharmaceutical legislation a. Electronic package leaflet of medicines The Commission (DG SANTE) presented the electronic product information (ePI) provisions of the new EU Pharmaceutical legislation. EMA followed with an overview of the opportunities offered by ePI, the state of play of the network’s ePI pilot project and how it will support in the implementation. Additional presentations from ES (ePI co-project owner) and SE shared national experiences with the ePI project which were very positive. The discussion included an exchange of questions on the ePI and views on next steps. Clarifications addressed the scope of the provision, the role of paper leaflets, the division of responsibilities, and technical aspects around the centralised database. Committee members stressed the need for timely EU level implementation to allow for sufficient time for national transposition. The EMA will organise a workshop on ePI on the 10th of June 2026. This will be the first opportunity for more technical discussions. b. Regulatory Sandboxes The Commission (DG SANTE) presented the provision on regulatory sandboxes under the new EU pharmaceutical legislation, including its implementation timeline as sandbox provisions will be applicable immediately when the legislation enters into force. This was followed by an exchange of views among Committee members. Discussions highlighted the value of regulatory sandboxes as exceptional tools for medicine authorisation, to be used when no other regulatory option is suitable. Members of the Committee stressed that their development should be driven not only by technological novelty but by specific regulatory questions they can address. The potential value of mapping existing horizon-scanning initiatives was also noted. The Commission stressed the need for a disambiguation of the term ‘regulatory sandboxes’ as there are still many misconceptions. In the context of pharmaceutical policy, regulatory sandboxes are not meant as an additional regulatory pathway, nor are they a new form of enhanced scientific advice. They are a novel regulatory possibility to assess (through monitored testing and control) truly innovative and exceptional medicines that would otherwise pose challenges for the regulatory framework. The standards for quality, safety and efficacy (QSE) of medicines do not change, it is the tools that allow regulators to assess QSE that are adapted to better fit the characteristics of the innovative products placed under a regulatory sandbox. Updates to the Committee on issues linked to pharmaceutical policy https://health.ec.europa.eu/document/download/3b29c79a-a287-4efa-9186-e8ef8930679b_en?filename=mp_20260326_sr_en.pdf https://health.ec.europa.eu/medicinal-products/other-topics/pharmaceutical-committee-veterinary-pharmaceutical-committee-and-expert-groups/human-pharmaceutical-committee-meetings_en https://health.ec.europa.eu/document/download/3b29c79a-a287-4efa-9186-e8ef8930679b_en?filename=mp_20260326_sr_en.pdf AESGP OTC News | May 2026 9 | 18 b. Results of the study on “Updated estimation of the costs of quaternary wastewater treatment in the EU - A comparison of cost models” The Commission (DG ENV) presented some elements of the Urban Wastewater Treatment Directive 2024/3019, this was complemented by a Joint Research Centre (JRC) presentation on the methodology used for the study on “Updated estimation of the costs of quaternary wastewater treatment in the EU - A comparison of cost models”. Committee members raised concerns regarding specific aspects of the study, notably costs to health systems and for operators (especially generics) as well as the need for a level playing field in the application of environmental standards in 3rd countries. Following the request of IE, the Commission (DG SANTE) provided a brief update on the proposal to restrict per- and polyfluoroalkyl substances (PFAS) under the REACH Regulation (EC) No 1907/2006. This update followed a recent risk assessment opinion by ECHA, which supported the proposed restrictions. Committee members expressed concerns regarding the absence of derogations for medicinal products. The Commission (DG SANTE) emphasised that the next step would be a Member State vote on whether to include the PFAS restriction in the REACH committee. Regulation on fees and charges payable to the European Medicines Agency (‘new fee Regulation’) discussion on inflation rate, following the annual monitoring The Commission (DG SANTE) briefed the Committee members on an upcoming revision to the fees and charges payable to the EMA, which will be adjusted in line with inflation. Unlike last year, when no inflation- based adjustments were made due to actual inflation falling below projections, the Commission (DG SANTE) intends to proceed with an inflation-linked update for the next year. To ensure a smooth process, the Commission (DG SANTE) plans to finalise calculations in Q2 2026, allowing sufficient time for the adoption of the delegated act. The inflation-adjusted fees will be applicable as of 1st of January 2027. Herbal medicines EMA - Revised Q&A on implementation of Ph. Eur. Medicinal Product Monographs (MPM) The revised Q&A on implementation of Ph. Eur. Medicinal Product Monographs (MPM) has been published on the EMA website. The document is structured to address, in particular, the demonstration of compliance with European Pharmacopoeia (Ph. Eur.) Medicinal Product Monographs (MPMs), including when and how MPM requirements apply, as well as questions related to variation submissions where changes are needed to align existing products with official monographs. https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-pheur-medicinal-product-monographs-mpm_en.pdf AESGP OTC News | May 2026 10 | 18 Setting Maximum Levels for Vitamins & Minerals Timelines on EC Webpage The Commission updated its website outlining the indicative timelines regarding individual steps pertaining to the initiative to set maximum levels for vitamins or minerals in food supplements and fortified foods. Pursuant to the updated webpage, a Commission adoption is planned for first quarter 2028 while a public consultation is foreseen for third quarter 2026. As regards the expected call for evidence, no specific timeline is indicated. Food https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12750-Food-safety-vitamins-and-minerals-added-to-food-minimum-and-maximum-levels-_en AESGP OTC News | May 2026 11 | 18 Borderline & Classification WG MDCG Guidance 2021-24 Rev.1 published The Commission has published a revision of the MDCG Guidance 2021-24. Updates have been made regarding Rule 2,8,9,10,12,16 and 22. Borderline Manual under MDR and IVDR - Updated Version (Version 5) Published The Commission has published an updated version of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices on its website. The updated document (Version 5) includes the following new entries: • 1.1.9.7 Device used intended to administer a medicinal product • Rule 1 o 1.2.1.2 Penis holster • Rule 3 o 1.2.3.1 Syringe containing glass beads • Rule 6 o 1.2.6.1 Needles for root canal irrigation • Rule 21 o 1.2.21. Saline solutions for nasal irrigation CIEPS WG Member States-specific national requirements for clinical investigations and performance studies The Commission has published an update of the specific national requirements for clinical investigations and performance studies (Articles 62, 74, and 82 MDR). Medical Devices https://health.ec.europa.eu/document/download/cbb19821-a517-4e13-bf87-fdc6ddd1782e_en?filename=mdcg_2021-24_en.pdf https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf https://health.ec.europa.eu/latest-updates/update-member-states-specific-national-requirements-clinical-investigations-and-performance-studies-2026-04-21_en https://health.ec.europa.eu/latest-updates/update-member-states-specific-national-requirements-clinical-investigations-and-performance-studies-2026-04-21_en AESGP OTC News | May 2026 12 | 18 MDR/IVDR Simplification AESGP Final Position Published on AESGP Website AESGP's position paper has now also been published on the website of AESGP. AESGP Final Position Submitted to EC Public Consultation AESGP's position to the Commission’s legislative proposal for amending the MDR as regards simplifying and reducing the burden of the rules on medical devices has been submitted in the enclosed version to the public consultation on the Commission's “Have your say” website. AESGP's feedback can be directly accessed here. MDR/IVDR Annex VII NB Requirements Commission Implementing Regulation (EU) 2026/977 Published in OJ Following the positive vote of the Committee on Medical Devices, please be informed that the Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 has been published in the Official Journal of the European Union. The Implementing Regulation will generally apply from 25 February 2027 with the exception of Article 4(4) requiring notified bodies to draw up annual reports on timelines and costs of conformity assessment activities that will apply from 1 January 2028. As stated in published statement on its website, AESGP welcomes the adoption of Commission Implementing Regulation as its measures will contribute to improved predictability and efficiency in relation to the quality management and processes in the context of conformity assessment activities. MDR/IVDR Implementation Revised Team-NB Best Practice Guidance for the Submission of TD Published Team-NB has published the updated 4th version of its “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745”. The document can be accessed here. https://aesgp.eu/articles/aesgp-position-on-the-european-commissions-proposal-to-simplify-medical-devices-rules https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Dispositifs%20médicaux%20et%20diagnostics%20in%20vitro%20—%20révision%20ciblée%20des%20règles%20de%20l’UE/F33394875_en https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj https://aesgp.eu/articles/aesgp-statement-on-commission-implementing-regulation-eu-2026-977-setting-maximum-timelines-for-conformity-assessment-activities-of-medical-devices https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V4-20260421.pdf AESGP OTC News | May 2026 13 | 18 Nomenclature WG Updated EMDN documents In the context of the annual revision of the European Medical Device Nomenclature (EMDN), please be informed that the European Commission has published and/or updated the following documents: • Summary of EMDN 2025 Submissions and outcome of annual revision • 2025-2026 Annual Revision Change Log • 2026 EMDN Version History Post Market Surveillance and Vigilance Medical Devices WG MIR 7.3.1. PDF publication update The business rules for the field 4.3.1.a on serious similar incidents were revised through the publication of the MIR 7.3.1. PDF version 11010 published on the 26th March 2026 . For that publication only the MIR 7.3.1. PDF was modified. The MIR Helptext was later updated to mainly reflect the revised business rules made for field 4.3.1.a. The Commission has been notified recently that some changes in the XSD files need also to be made in relation to that field. The publication update of 23rd April 2026 provides the updated version (SB-11154) of the XSD-XSL files together with the corresponding Changelog. The MIR 7.3.1. PDF and the XML files remain unchanged. MIR publication update Following the PMSV WG meetings of 29-30 April, the Commission proceeded with a new MIR publication dated of 7 May 2026. This new publication update was necessary as a new identified bug has now been fixed in the PDF file. There is also an editorial change for the XSD and XSL files without impact on the files and the Changelog was updated accordingly (see detailed information below). No change for the XML. MIR 7.3.1. PDF (SB-11154) This update of 06/05/2026 fixes the bug on field 4.2.i. 'Final comments from the manufacturer on cause investigation and conclusion': the bug related to a “User” missed display of box red border while importing XML file with report types "Combined" and "Final Reportable" XSD and XSL files (SB-11154) On all XSD files and XSL files, the date and version number (version 7.3.1 of 06.05.2026 - SB-11154) on the top of the text have been updated and aligned for all files but no change as regards the content. Changelog file (SB-11154) Version: 7.3.1 (06/05/2026) The latest changes made in the PDF and in the XSD and XSL files have been added. https://health.ec.europa.eu/document/download/56772d7d-ce71-4ce5-801e-a82f267e61f4_en?filename=mdcg_2026-1_en.pdf https://health.ec.europa.eu/document/download/5e21e80e-2fdf-4ff7-873d-a2ffddf618ff_en?filename=mdcg_2026-2_en.xlsx https://health.ec.europa.eu/document/download/67c60ba0-32fb-498d-9b05-a6cefe08919c_en?filename=mdcg_2026-3_en.xlsx https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en AESGP OTC News | May 2026 14 | 18 As agreed at PMSV WG meetings, the publication update also underlines that any of the MIR 7.3.1. versions published from the December 2025 publication can be used by operators. EMA expert panel support for BtX medical devices Pilot programme The EMA is set to launch the pilot programme for expert panel support to manufacturers of breakthrough medical devices (BtX) on 28 April 2026. The pilot is designed to provide free advice to selected manufacturers of high-risk medical devices on: • possible breakthrough medical device status - for medical devices seeking this type of designation; • additional advice on how to implement the guidance that the Medical Device Coordination Group provided - for designated breakthrough medical devices. As part of the pilot, manufacturers seeking breakthrough designation submit a request for an opinion to the medical device expert panels. The pilot is set to run in three phases until 2027, subject to available resources. Additionally, the EMA has made available application templates, for information purposes only before the launch of the pilot: • Breakthrough status request: template for applicant for breakthrough medical devices pilot • Advice request: template for applicants for breakthrough medical devices pilot The dedicated EMA page is available here. Team NB Updated Code of Conduct for NBs under the MDR/IVDR The version 5.2 of the Team NB Code of Conduct has been published on the Team NB website. This new version aligns the timelines to review software between the MDR and the IVDR and includes the addition of a table of contents. Clinical Evaluation Based on Non-Clinical Data Team-NB members have adopted, a paper aimed to outline the approach taken by the NB when considering the acceptability of a manufacturer’s justification for relying on non-clinical data for the purpose of demonstrating safety and performance of a device. It provides guidance on best practice for preparing a robust justification for its use. https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf https://www.ema.europa.eu/en/documents/other/breakthrough-status-request-template-applicants-breakthrough-medical-devices-pilot_en.pdf https://www.ema.europa.eu/en/documents/other/advice-request-template-applicants-breakthrough-medical-devices-pilot_en.pdf https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/expert-panel-support-breakthrough-medical-devices-pilot-programme https://www.team-nb.org/wp-content/uploads/2026/04/Code-of-Conduct-Team-NB-V5-2-20260421.pdf https://www.team-nb.org/ https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-Article61-10-V1-20260421.pdf https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-Article61-10-V1-20260421.pdf https://www.team-nb.org/wp-content/uploads/2026/04/Team-NB-PositionPaper-Article61-10-V1-20260421.pdf AESGP OTC News | May 2026 15 | 18 WFD+GWD+EQSD - Entry into force on 11 May 2026 The revised Water Framework Directive (WFD), Environmental Quality Standards (EQSD), and Groundwater Directive (GWD) package (Directive (EU) 2026/805) has now officially entered into force on 11 May 2026. • The press release is available here: Stricter rules for protecting water in EU enter into force - Environment. EU Deforestation Regulation - EC report and supportive materials The European Commission has published a report on the simplification and implementation of the EU Deforestation Regulation (EUDR), together with updated guidance, FAQs, a draft Delegated Act, and updates to the Information System on 4 May 2026. Please find the press release, the EU Commissions’ full report, and the draft Delegated Act below: • Press release • EU Commission full report • Draft Delegated Act on Annex I Key takeaways are available below: Core framework and timeline • The Commission did not propose any further amendments to the EUDR itself, highlighting the need for legal stability and predictability for operator: the focus has now moved towards implementation phase. • The EUDR will fully apply to most operators and traders, including large and medium-sized companies, importers placing relevant commodities / products on the EU market, and exporters from 30 December 2026. • These companies must ensure products are deforestation-free, conduct due diligence, and submit due diligence statements via the EU Information System. • The EUDR will apply to micro and small enterprises (SMEs) from 30 June 2027, benefitting from simplified obligations like one-off declarations instead of full due diligence statements and reduced administrative burden. ➔ However, please note that smaller operators that act in roles that qualify them as ‘operators’ rather than purely downstream users must comply with the earlier obligations (December 2026). Updated guidance & FAQs Environment https://environment.ec.europa.eu/news/stricter-rules-protecting-water-eu-enter-force-2026-05-11_en https://environment.ec.europa.eu/news/stricter-rules-protecting-water-eu-enter-force-2026-05-11_en https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_26_941/IP_26_941_EN.pdf https://environment.ec.europa.eu/document/download/a3c5c3a0-232e-43c4-b0b8-1eecb1df45c7_en?filename=Report%20from%20the%20Commission%20to%20the%20Council%20and%20Parliament%20on%20the%20EUDR.pdf https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/18053-Deforestation-proposal-to-amend-and-simplify-the-rules-and-make-technical-fixes-to-Annex-I_en AESGP OTC News | May 2026 16 | 18 • The Commission’s updated guidance and FAQs clarify the role of downstream operators. • The downstream operators are mainly required to retain supplier information and, where applicable, due diligence references, without re-performing due diligence but responsible to act in case of identified risks. ➔ The overarching message is that, following the 2025 revision and new clarifications, compliance responsibilities are now more clearly concentrated upstream, while downstream obligations are more limited and relatively passive. Refinement of product scope • The Commission also published a draft Delegated Act proposing targeted adjustments to the list of products covered by the EUDR Annex I with the objective of making the scope more coherent, targeted, and feasible based on stakeholder feedback and early implementation experience. • The Commission proposes adding specific downstream or derived products like soluble coffee, certain palm oil derivatives, and particular animal-derived products while excluding from the scope products like leather and re-treaded tyres. ➔ The draft of the Delegated Act is open for public consultation until 1 June 2026. Implementation tools • The Commission strengthened the operational toolkit supporting EUDR implementation through the development of the central EU Information System to submit due diligence statements and creation of centralised EU repositories of producer-country legislation and certification schemes to support companies in meeting legal requirements. Simplification efforts • The Commission estimates that the cumulative simplification measures will reduce compliance costs by around 75%, mainly by shifting due diligence responsibilities upstream, introducing simplified regimes for small operators, applying a more risk-based approach, and clarifying downstream obligations while keeping the core requirements of the EUDR unchanged. AESGP OTC News | May 2026 17 | 18 Shortages - Updated ESMP User guide for MAHs The EMA has just published a new version of the European Shortages Monitoring Platform (ESMP) User Guide for Marketing Authorisation Holders. The new Version 1.4 includes the following updates: Routine reporting of shortages of CAPs (Chapter 3): • Chapter 3.2.2: Reference to readable RMS IDs added. • Chapter 3.3: Addition of further guidance on reporting and updating shortage notifications. • Chapter 3.4: Explanation added on automated notification alert to MAH for outdated shortage reports. Crisis and MSSG-led preparedness submissions (Chapter 4): • Preliminary requirements, point 1: Paragraph edited on mandatory PMS data completeness (including structured package and manufacturing information data). • Preliminary requirements, point 2: clarification that CAP marketing status affects generation of Availability information template only, other submissions not affected by products’ marketing status. • Chapters 4.3.2 and 4.4.2: Reference to readable RMS IDs added. • Chapter 4.5: The inclusion of NAP manufacturing data from PMS, where available, in the data submission templates for Manufacturing information. • Chapter 4.6: Added updated screenshots of the search bar for substances and compositions in the webform for the submission of Alternative therapies. Cross-Sectorial News https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-user-guide-marketing-authorisation-holders_en.pdf https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-user-guide-marketing-authorisation-holders_en.pdf AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu

AESGP Issue 385 | June 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • CMDh April minutes & May meeting report ___________________________________________________________________ 2 • 124th HMA meeting - 27-28 MAY 2026 - meeting report _________________________________________________________ 3 • EMA Management Board - JUN 2026 - Meeting highlights + Publication of EMA 2025 Annual Report _____________________ 4 • Preliminary Ruling - Case C-604/24 - Restriction of Online Sale of NPMs – Judgment _________________________________ 5 Herbal medicines ____________________________________________________________________________________________ 6 • EMA HMPC Meeting Report - 4-6 MAY 2026 _________________________________________________________________ 6 • HMPC RP on data recommendations for (T)HMPs used in paediatric patients published with overview of comments _________ 7 FOOD ___________________________________________________________________________________ 9 Law -13 May 2026 ____________________________________________________________________________________________ 9 • Summary report _______________________________________________________________________________________ 9 MEDICAL DEVICES _______________________________________________________________________ 11 MDCG Eudamed WG_________________________________________________________________________________________ 11 • Production release 2.27.0 deployed _______________________________________________________________________ 11 • Mandatory Use of First EUDAMED Modules from 28 May 2026 __________________________________________________ 11 • MDCG EUDAMED WG Meeting on 2 June 2026 _____________________________________________________________ 12 • MDCG Endorsement of Position Paper on SS(C)P Management in EUDAMED _____________________________________ 12 MDCG Standards WG ________________________________________________________________________________________ 12 • New references harmonised standards MDR/IVDR - Publication in the OJEU & Appendix 'EU REP' _____________________ 12 MDCG Nomenclature WG _____________________________________________________________________________________ 13 • EMDN Annual Update __________________________________________________________________________________ 13 MDR/IVDR Simplification Proposal _____________________________________________________________________________ 13 • Commission presentation to Council on EMA support, borderline & classification ____________________________________ 13 MDR/IVDR Implementation ____________________________________________________________________________________ 14 • Notified Bodies Survey on Certifications & Applications - Data dated 31 December 2025 ______________________________ 14 • Annex VII NB Requirements: AESGP statement and summary of timelines for NBs __________________________________ 14 Team NB Publications _______________________________________________________________________________________ 15 • Sector Survey 2025 ____________________________________________________________________________________ 15 • MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document _____ 16 • IVDR Application and appropriate surveillance Transfer agreement _______________________________________________ 16 • Micro and Small Enterprise Considerations _________________________________________________________________ 16 Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 _______________________________ 17 • Update _____________________________________________________________________________________________ 17 ESIP, AIM, TEAM-NB, CPME, TÜV Verband, IG-NB unified for a better WET approach ___________________________________ 17 CROSS-SECTORIAL NEWS _________________________________________________________________ 18 AI - Omnibus VII legislative package - Provisional agreement reached by the Council presidency and European Parliament negotiators _____________________________________________________________________________________________ 18 New Council of Europe Recommendation sets standards for remote and online medicine provision ______________________ 19 PPWR - EC guidance - 10 JUN 2026 ____________________________________________________________________________ 20 AESGP OTC News | June 2026 2 | 21 Regulatory News CMDh April minutes & May meeting report The minutes of the CMDh meeting held on 21-22 APR 2026 have been published. Among the items reported, the following may be noted: Working Party on Variations Regulation The WP Chair reported from the April 2026 meeting. The EMA presented a draft procedure for the preparation of the report laid down in Article 4 of the Variations Regulation, for adoption of the procedure at the May CMDh plenary meeting. Regarding the ROG proposal to delete the requirement for cover letters for Type IA variations, the WP Chair reported on the agreed changes to the CESP delivery file and eAF. The WP Chair presented updates to several CMDh guidance documents in relation to the deletion of the cover letter for Type IA variations. The publication of the updated documents is foreseen once the CESP delivery file is updated. The WP discussed several proposals to improve the process for requesting worksharing Reference Authorities (RA). It was proposed to clarify in the BPG that MSs acting as RMS or holding national MAs are expected to accept the RA role. MAHs should be reminded to give a list of proposed RAs in the order of priority and not only propose one MS. In addition, it was suggested that MAHs include a justification for the proposed RAs and the order of priority. The WP also discussed the regulatory consequences for products with already approved changes included in a worksharing procedure that is subsequently refused. It was agreed that this situation applies only to worksharing and not to super-grouping. In case of refusal of the worksharing, products retain their former status, and approved changes are not automatically reversed; however, the MAHs should consider the outcome of the worksharing procedure. In relation to the actions included in the new CMDh MAWP to 2028, the WP discussed the proposal from industry to set up a dedicated mailbox for questions about variations. It has been agreed that questions regarding variations should be addressed to the RMS/relevant NCA and answered by them by referring to the relevant guidance. Questions not covered by the guidance may be forwarded by the RMS/relevant NCA to and discussed by the VRWP, which will consider whether to develop new Q&As or update existing ones. Following the February WP meeting, the WP Chair confirmed that an amendment to the eAF has been implemented to add a type IAIN variation E.z to the RMS list. This change will allow the use of the eAF/PLM Portal for national transfers of MAs in specific MSs, where national legislation foresees the use of this procedure. Generally, the E.z code is currently not applicable for other type IA/IAIN notifications. In case any questions arise, it will be considered to prepare a Q&A. The WP discussed whether the approach agreed in February for annual updates (Type IA) including changes for which the variation codes are missing in the eAF, could be applied to Type IB and Type II procedures. It was clarified that this approach cannot be extrapolated to IB/II procedures, as these can be updated during validation or clock-stop. Missing Type IA codes or other changes cannot be added Medicines https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_04_CMDh_Minutes.pdf AESGP OTC News | June 2026 3 | 21 to an ongoing procedure once started but may be submitted in parallel or NCAs may request submission of single Type IA notifications. The WP discussed whether applicants may submit a variation of a higher classification than foreseen in the classification guideline. It was agreed that applicants may request a higher variation type under the same change code if justified, while retaining the correct classification category rather than using a z- category. The responsibility for selecting and justifying the variation type remains with the applicant. Finally, the WP discussed the lack of consistency in how applicants present changes when submitting multiple variations. It was suggested to develop a standardised annex template to improve clarity and consistency. A draft will be prepared for the next meeting. New Pharmaceutical Legislation (NPL) The EC gave a presentation on the simplification of DCP/MRP in the NPL. The final text is expected to be made available to NCAs shortly, and MSs were invited to carefully review the translations. Meetings attended by the CMDh chair 16th ISG Meeting The Commission presented an overview of the NPL, with adoption expected in Q4 2026, and most provisions applying from Q4 2028. The EMA presentation addressed NPL governance, the implementation planning, and a request for industry to provide input on implementation priorities. Industry representatives shared updates on PMS development and data quality. ROG plenary meeting with industry representatives Discussions focused on the impact of the NPL on industry and the EMRN Strategic Portfolio (IT projects and systems) and data interoperability. The ROG also provided an update on ongoing optimisation activities related to PMS data and Type IA variations. Electronic Application Form The EMA presented a summary of proposed changes to the Human Marketing Authorisation Application form (MAA eAF) to align where possible with the PMS IDMP format to improve the quality of product data and to address structural limitations in the current form. It was noted that currently the use of OMS is not proposed to be mandatory for CROs. The CMDh proposed that mandatory use of OMS could also be considered for CROs. It was noted that, once the proposed changes are agreed and implemented, the user guide of the eAF would also need to be updated. The EMA will keep the CMDh informed. Additionally, please be informed that the report from the CMDh meeting held on 19-20 MAY has been published. Among the items reported, the following may be noted: Template for the non-clinical and clinical assessment of a generic application in MRP/DCP The CMDh agreed an update of the template for the non-clinical and clinical assessment of a generic application in MRP/DCP. The wording in relation to the environmental risk assessment has been aligned with the wording used in other templates. The updated template can be found here. 124th HMA meeting - 27-28 MAY 2026 - meeting report The meeting report of the 124th Heads of Medicines Agencies (HMA) meeting, held on 27-28 May 2026, has now been published. Below is a brief overview of relevant items from the meeting. HMA MG Report The HMA Management Group provided updates on strategic and operational priorities across the EMRN, including work from HMA groups, Joint Actions, clinical trials developments, and potential implications of the proposed PFAS restriction. Updates were also given on preparations for the next EMANS and on international cooperation activities. EMA Update https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_May_2026.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_202_2005_Rev7_2026_05_clean_-_NonClinical_Clinical_AR_forGenerics_MRP_DCP.docx https://www.hma.eu/fileadmin/dateien/HMA_joint/03-Stakeholders_Info/2026-05-HMA-II-Paphos-Stakeholders-Information.pdf AESGP OTC News | June 2026 4 | 21 EMA presented updates on crisis preparedness and scientific readiness, including responses related to viral outbreaks and the Middle East context. Additional topics included NPL, international cooperation through ICMRA and with China, vaccine confidence initiatives, collaboration with ECHA, and upcoming network activities. Commission Update The EC provided updates on public health preparedness (hantavirus, Ebola), implementation of the Clinical Trials Regulation via the CTA framework, NPL, the Biotech Act, and the Substances of Human Origin (SoHO) legislation. Cooperation of National Agencies/EMA in the Proposed MDR/IVDR Revision HMA discussed the importance of close cooperation between NCAs and the EMA in the context of the proposed MDR/IVDR revision. The discussion highlighted the need for coordinated regulatory approaches, efficient use of expertise across the network, and strengthened collaboration to support innovation, patient safety, and effective implementation of the revised legislative framework. CAMD Update CAMD updated HMA on discussions regarding the future governance and structure of the European medical devices network. Feedback from CAMD members showed support for strengthening cooperation between medicines and medical devices regulatory systems, while maintaining a dedicated medical devices network in the short term. Opportunities for closer collaboration were identified in training, clinical trials, innovation, enforcement and shared regulatory infrastructures, with a longer-term vision of greater integration across the two sectors. Trio-Theme Megatrends – HMA Concept Paper to Inform the Next EMANS HMA endorsed a Trio Presidency concept paper on megatrends affecting the EMRN, including technological innovation, digital transformation, demographic change, and evolving health needs. The paper provides a strategic basis for the next EMANS (from 2028) and was finalised after consultation with NCAs. Joint Session with EMACOLEX EMACOLEX updated HMA on legal and regulatory developments relevant to the network, supporting coordination, knowledge exchange, and regulatory preparedness. The Subgroup on Horizontal Scanning presented its work on monitoring external policy developments affecting medicines and medical devices, enabling early identification and proactive regulatory response. Upcoming Irish Presidency HMA was introduced to the upcoming Irish Presidency priorities and planned activities, with a focus on continued collaboration across the regulatory network and invitations to upcoming meetings and exchanges among MSs. EMA Management Board - JUN 2026 - Meeting highlights + Publication of EMA 2025 Annual Report The highlights of the EMA Management Board JUN 2026 meeting, have been published. Among the items reported, the following may be noted: Positive assessment of EMA’s activities in 2025 – Annual Report The Board positively assessed the Executive Director’s 2025 annual activity report, which describes the implementation of the Agency’s work programme and the management and control systems in place. The Board noted the work on marketing authorisations via the centralised procedure, both in human and veterinary medicines. EMA delivered 104 positive recommendations for new medicines for human use, including 38 containing a new active substance, many of them addressing unmet medical needs. The Agency issued 30 recommendations for new veterinary medicines – the highest number of recommendations for a second consecutive year. Of these, 13 had a new active substance. https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2026-meeting AESGP OTC News | June 2026 5 | 21 The Board also acknowledged activities carried out to accelerate and optimise assessment processes, as well as the Agency’s continued role in addressing challenges related to the availability of medicines and security of supply. The annual activity report will be published on the EMA website shortly. This complements EMA’s 2025 annual report (see here the digital version and here the PDF) that was published on 11 JUN. Preparations for implementation of the new EU pharmaceutical legislation Preparations for implementing the new EU pharmaceutical legislation (NPL) have progressed. The Board received a comprehensive overview of the activities under the NPL EMA Management Board governance structure. Planning is advancing across the delivery streams, aligned with the European Commission’s work on the delegated and implementing acts. The NPL Oversight Group has also endorsed a network collaboration model to ensure broad expert involvement from across the European medicines regulatory network in the preparations from the outset. Update from Network Data Steering Group EMA, in collaboration with the national medicines agencies, is further developing the product management service (PMS) to support regulatory activities across the EU with structured and standardised medicinal product master data for all human medicines authorised in the EU. These data are routinely used by regulators and industry, e.g. pharmacovigilance and shortages activities, and other targeted regulatory procedures. The Agency is now looking at enabling wider use beyond medicines development and regulation by the public. From 12 JUN 2026, PMS will make additional data publicly accessible through the release of a ‘beta’ version of an Application Programming Interface (API) for public use. PMS data are already available via a web interface, but the API will enable external access in a structured, machine- readable format. This is an important step towards greater transparency, improved accessibility and broader use of trusted EU medicinal product information. With the beta release, EMA and stakeholders can gain experience, test use cases, and further refine the service. Release of a final API version is planned for early 2027. Preliminary Ruling - Case C-604/24 - Restriction of Online Sale of NPMs – Judgment The Court of Justice of the European Union (CJEU) delivered its judgment in the Court proceedings C-604/24 concerning the request for a preliminary ruling by the Greek Council of State to provide clarity as regards the Member States’ discretion to restrict online sales of non-prescription medicines under Article 85c of Directive 2001/83/EC. Dispute in the main proceedings The applicant is a Greek company operating both a physical pharmacy and an online sales channel. In April 2022, Greece adopted a Ministerial Decision, which narrowed the previously unrestricted authorisation to sell all non-prescription medicines (NMPs) online to a single subcategory: over-the- counter (OTC) medicinal products classifiable as such under their marketing authorisation and available for sale outside pharmacies, without the presence of a pharmacist or an auxiliary pharmacist being required. The measure amounted in practice to a ban of online sales of NMPs because no product had been classified in the OTC subcategory on the Greek market. The questions referred by the Greek Council of State asked in essence whether Article 85c(1) and (2) of Directive 2001/83 must be interpreted as precluding national legislation which, on grounds of public health protection, prohibits the online sale of non-prescription medicinal products, with the exception of a subcategory thereof. Court Ruling In its ruling, the Court clarifies that the wording Article 85c(1) of Directive 2001/83 establishes an obligation on part of Member States to offer the online sale of all NPMs. Consequently, the Court finds that the Greek legislation under consideration prohibiting the online sale non-prescription medicinal products, with the exception of a subcategory, fails to fulfil the obligation arising from https://www.ema.europa.eu/assets/en/annual-report/2025/index.html https://www.ema.europa.eu/en/documents/annual-report/2025-annual-report-european-medicines-agency_en.pdf https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:62024CJ0604 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:62024CJ0604 AESGP OTC News | June 2026 6 | 21 Article 85c(1) of Directive 2001/83. The only limitation in Article 85c(1) concerns prescription medicinal products. In addition, the Court specifies that national legislation prohibiting the online sale non-prescription medicinal products, with the exception of a subcategory, cannot be justified under Article 85c(2) as a "condition". Such legislation only partially authorises the offer for online sale of non-prescription medicinal products. The conditions referred to in Article 85c(2) of Directive 2001/83 cannot have the effect of rendering meaningless the obligation on Member States, under Article 85c(1), to ensure that medicinal products, at least all non-prescription medicinal products, are offered for online sale. The Court concludes therefore that Member States cannot rely on Article 85c(2) of Directive 2001/83 in order to impose conditions justified on grounds of public health protection as concerns the online sale of non-prescription medicinal products, where such conditions have the effect of depriving the obligation set out in Article 85c(1) of its effectiveness. At the same time, the Court provides guidance as to what “conditions” under Article 85c(2) may be permissible to regulate the online sale of NPMs. Such conditions must be justified on grounds of public health protection aimed at reducing the risks associated with the online sale of medicinal products and could consist, for example, of putting in place effective mechanisms to monitor the consumption of medicinal products, such as establishing order limits per consumer or the creation of an online system for identification and registration of consumer health data in order to combat overmedication. Nevertheless, in that context the Court stresses that those conditions must not call into question the possibility of offering NPMS for online sale by restricting access. Based on the foregoing, the Court stipulates that Article 85c(1) and (2) of Directive 2001/83/EC precludes national legislation that, on grounds of public health protection, prohibits the online sale of non-prescription medicinal products, with the exception of a subcategory thereof. Herbal medicines EMA HMPC Meeting Report - 4-6 MAY 2026 The report on European Union herbal monographs, guidelines, and other activities from the EMA Committee on Herbal Medicinal Products (HMPC) meeting, held on 4-6 May 2026 has been published. Among the reported items, the following may be noted: Revised European Union herbal monograph – final The HMPC adopted after systematic review, revision and public consultation the following revised monograph: • Revised EU herbal monograph on on Fragariae folium The final revised monograph together with supporting documents will be published on the European Medicines Agency's website. European Union herbal monographs’ review The HMPC adopted after systematic review and revision the following revised monograph (draft) for 3 month public consultation until 31 August 2026: • Draft revised EU herbal monograph on Lecithinum ex soya The review reports will be published as addenda to the existing assessment reports on the European Medicines Agency's website. Guidance documents The HMPC adopted the following reflection paper: https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-4-6-may-2026_en.pdf https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-4-6-may-2026_en.pdf https://www.ema.europa.eu/en/search?f%5B0%5D=ema_search_categories%3A85&f%5B1%5D=ema_search_content_type%3Aema_herbal&landing_from=73303 https://www.ema.europa.eu/en/search?f%5B0%5D=ema_search_categories%3A85&f%5B1%5D=ema_search_content_type%3Aema_herbal&landing_from=73303 AESGP OTC News | June 2026 7 | 21 • Reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in paediatric patients (EMA/HMPC/71333/2023). The reflection paper will be published on the European Medicines Agency's website here. HMPC RP on data recommendations for (T)HMPs used in paediatric patients published with overview of comments The reflection paper on data recommendations for HMPs used in paediatric patients has been published by the EMA, together with the overview of comments received. At a glance, the RP has been minimally changed. The overview of comments responded to the general comments, pointing out the rather strict approach taken by the guideline in comparison with ICH E11, as follows: WEU and PK-PD It is agreed that WEU herbal medicinal products are not excluded from the scope of the ICH E11A extrapolation guideline and that the principles described in this guideline are applicable to WEU HMPs, despite the fact that WEU HMPs usually do not provide comprehensive pharmacokinetic and pharmacodynamic data. This is also acknowledged in the ICH guideline which states that when there is lack of correlation between systemic drug exposures/biomarker and therapeutic response, dose response relationships can rely on a clinical endpoint. The respective parts of the reflection paper have been therefore updated accordingly. [...] Extrapolation concerns safety and efficacy It must be underlined that in line with the ICH E11A guideline, extrapolation concerns both efficacy and safety. Therefore, it is not agreed that the main focus of extrapolation exercise in WEU HMPs should be on safety only. At the same time, in line with the ICH E11A guideline, the use of paediatric extrapolation ensures that the paediatric population only participates in clinical trials when necessary for further scientific understanding of the paediatric use of a medicinal product. First, available published data should be reviewed to confirm the acceptability of WEU status and to identify possible gaps in evidence. If any gaps in evidence are identified, an assessment in line with the ICH E11A guideline should take a place to understand whether it is acceptable to fill these gaps with extrapolation. Only if this is not possible, generation of additional paediatric data should be required. These principles are also described in the ICH E11A guideline; therefore, no additional changes are proposed to the reflection paper. It is agreed that HMPs tend to have good safety profiles with wider safety margins, although this is not always the case. This is also acknowledged in the ICH E11A guideline which states that if the safety margin is wide, it may be acceptable to target higher exposures than in adults. As the applicability of this guideline was acknowledged, no additional changes are proposed to the reflection paper. It is agreed that evidence from similar/same-class products could be included among alternative supportive data sources. This approach is also supported by the ICH E11A guideline. At the same time, the differences between products need to be reviewed critically in line with the guideline. As the applicability of this guideline was acknowledged, no additional changes are proposed to the reflection paper. Conditional approval and absence of unmet medical needs The proposed approach of conditional approval of adjacent paediatric age groups where generation of data in the adjacent paediatric age group would take place only after granting of conditional approval for the respective age group is not supported. This is because according to the current requirements for conditional marketing authorisation, the product has to fulfil an unmet medical need. However, HMPs are generally not used in indications where significant unmet medical need exists. Second, to grant a conditional marketing authorisation, the benefit-risk balance in the respective age group needs to be positive while according to this proposal, no data would be available in the respective age group for benefit-risk assessment. This way of extrapolation is also not in line with the requirements set by ICH https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishment https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-recommendations-herbal-medicinal-products-traditional-herbal-medicinal-products-used-paediatric-patients_en.pdf https://www.ema.europa.eu/en/documents/comments/overview-comments-draft-reflection-paper-data-recommendations-herbal-medicinal-products-traditional-herbal-medicinal-products-used-children-adolescents_en.pdf AESGP OTC News | June 2026 8 | 21 E11A guideline. Third and most importantly, according to the current legal requirements, such a conditional approval does not exist in monograph development. Traditional use As for TU herbal medicinal products, proof of TU requires the gathering of all available evidence for the specific herbal substance/ preparation and based on this evidence of use, the indication is granted. Such an approach ensures that plausibility of TU and safety is established by proven long-term use without any unacceptable reported issues while no actual hard clinical data are available. This means that extrapolation of TU, to age groups which are not explicitly mentioned in TU evidence, is not generally acceptable. AESGP OTC News | June 2026 9 | 21 Law -13 May 2026 Summary report The summary report of the Standing Committee on Plants, Animals, Food and Feed – Section General Food meeting of 13 May 2026 has been published and can be accessed here. The following topics of relevance have been discussed: ▪ Results of Priority Control Area on E-commerce Imports Action: Food Supplements. DG SANTE and DG TAXUD jointly presented the results of the Priority Control Area (PCA) on e-commerce imports of food supplements, integrating findings from food safety authorities (via the Alert and Cooperation Network) and customs controls. The PCA was carried out with a view to strengthening customs controls on food supplements sold online to EU consumers, with a particular focus on low-value consignments (under EUR 150) from major e-commerce platforms. It targeted food supplements containing ingredients unauthorised or prohibited in the EU, grouped into four categories: sexual enhancement; sports performance and bodybuilding; weight loss; and mental distress, pain relief and disease management. Under the PCA, customs authorities suspended suspect products and referred them to food safety authorities, which then decided on release, further examination or refusal of entry to the EU market. Member States requested that the presentation (or report) prepared by DG TAXUD be made available. However, the European Commission clarified that, as the work is still ongoing, these documents are to be treated as confidential and cannot be disclosed at this stage. ▪ Exchange of views and possible opinion of the Committee on a draft Commission Regulation (EU) amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice. The Commission presented to the Committee a draft Commission Regulation, aimed at prohibiting the use of monacolins from red yeast rice in food. This follows a period of Union scrutiny, during which interested parties may submit scientific evidence to demonstrate the safety of the substance in accordance with the procedure laid down in Article 8(4) of Regulation (EC) No 1925/2006. The Commission explained that the draft Regulation was based on the scientific opinion of the European Food Safety Authority (EFSA), adopted on 29 January 2025, which concluded that the safety of the substance could not be established based on the data submitted by interested parties. Furthermore, EFSA reiterated the concerns raised in its opinion of 3 August 2018 on the safety of monacolins in red yeast rice that exposure to monacolins from red yeast rice at intake levels as low as 3 mg/day could lead to severe adverse effects on the musculoskeletal system, including rhabdomyolysis, and on the liver. During the exchange of views, two Member States took the view that the 12-month transition period, as provided for in the draft Regulation for products lawfully placed on the market before the entry into force of the measure, should be extended until existing stocks are exhausted. One Member State noted that Food https://food.ec.europa.eu/document/download/54af8d7d-2d0d-4758-94d0-45412aa2df98_en?filename=reg-com_gfl_20260513_sum.pdf AESGP OTC News | June 2026 10 | 21 studies aimed at demonstrating the safety of monacolins from red yeast rice were being carried out by industry stakeholders. Another Member State considered that the use of monacolins from red yeast rice should be allowed in food, subject to certain conditions of use. The Commission explained that the industry had been given sufficient time to prepare for the possible risk-management actions, given that EFSA’s conclusions on monacolins from red yest rice had been known since 29 January 2025. It further explained that a 12-month transition period would ensure a smooth transition while considering the EFSA’s conclusions in its opinions of 3 August 2018 and 29 January 2025 regarding the severe adverse health effects. Therefore, any further delay in the entry into application of the measure would not be justified. AESGP OTC News | June 2026 11 | 21 MDCG Eudamed WG Production release 2.27.0 deployed The EUDAMED Production release 2.27.0 has been successfully deployed. This release will be the one for mandatory use, which will start on 28 May 2026. The main key additions are: • The Clinical Evaluation Consultation Procedure (CECP) feature in the Notified Bodies & Certificates module • The Mechanism for Scrutiny (MfS) feature in the Notified Bodies & Certificates module • The Market Surveillance module (mainly intended for the EC and CAs – and NBs/DAs in certain circumstances) Production Access: • EUDAMED restricted • EUDAMED public Documentation: See the details in the Release Notes and the updated documentation in the EUDAMED Information Centre. Mandatory Use of First EUDAMED Modules from 28 May 2026 As of 28 May 2026, the first four EUDAMED modules have become mandatory for use: • Actors • UDI/Devices • Notified Bodies & Certificates • Market Surveillance The mandatory use of these modules marks an important milestone in the implementation of the European medical devices regulatory framework and is expected to further support transparency, traceability, and regulatory cooperation across the EU medical devices sector. EUDAMED will be used by manufacturers, authorised representatives, importers, notified bodies, and competent authorities to ensure regulatory compliance, as it serves as the backbone of the MDR. Citizens, Medical Devices https://webgate.ec.europa.eu/eudamed/ https://ec.europa.eu/tools/eudamed/ https://webgate.ec.europa.eu/eudamed-help/en/files/EUDAMED%20-%20release%20notes.pdf https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html AESGP OTC News | June 2026 12 | 21 patients, healthcare professionals, and all key actors in the sector will now have access to a wealth of essential information on devices placed on the EU market. MDCG EUDAMED WG Meeting on 2 June 2026 AESGP participated to the MDCG EUDAMED Working Group on 2 June 2026. The European Commission presented the state of play and upcoming developments of EUDAMED, reporting a significant increase in registrations following the mandatory use of the first four modules, with more than 2.3 million devices now registered. Despite a sharp rise in support requests, system performance remains stable. Development priorities include the finalisation of the Summary of Safety and Clinical Performance (SSCP) management functionality, enhancements to the Vigilance module, and continued work on M&A and UDI-related functionalities. A key topic was the transfer of responsibility for SSCP management in EUDAMED from notified bodies to manufacturers. The new functionality is expected to be available in the Playground environment in the second half of July and in production in October 2026. Until then, notified bodies will continue uploading master SSCPs, while manufacturers will remain responsible for translations. Industry representatives also highlighted the need for transition periods, improved support mechanisms, greater flexibility in the UDI module, and enhanced training and access arrangements for the Vigilance module. The next EUDAMED Working Group meeting is scheduled for 21 October 2026. MDCG Endorsement of Position Paper on SS(C)P Management in EUDAMED At the EUDAMED Working Group meeting which took place on 2 June 2026, one of the points for discussion was the Position Paper on management of SS(C)P in EUDAMED. During the WG discussion, representatives from industry associations raised a point regarding the timeline for uploading SS(C)Ps for devices placed on the market before the mandatory use of the UDI/Devices module. For devices placed on the market before mandatory use, since manufacturers will only be able to provide SS(C)Ps from October 2026 onwards, the original transitional period of 6 months for devices registration is de facto reduced substantially for the SS(C)P. Moreover, many devices may already be registered, but their corresponding certificates/SS(C)Ps might not yet be uploaded by notified bodies, which have a longer transition period (until 27 May 2027). This could create delays and operational bottlenecks, as the manufacturers will have to retrospectively upload those SS(C)Ps by 27 November 2026, deadline according to the transition period for device registration. To address these issues, the Commission amended the Position Paper previously shared with MDCG for endorsement, to allow manufacturers to upload SS(C)Ps for these devices until 27 February 2027 (unless a certificate update occurs after the mandatory use date). The Position Paper was endorsed by the MDCG on 19 June 2026. The MDCG-endorsed Position Paper is currently in the process of being published on the European Commission’s MDCG Guidance webpage. MDCG Standards WG New references harmonised standards MDR/IVDR - Publication in the OJEU & Appendix 'EU REP' https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en AESGP OTC News | June 2026 13 | 21 Publications in the Official Journal of the European Union (OJEU) of new references of harmonised standards in support of the Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) took place on 17 JUN 2026: • For the MDR: Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, symbols to be used with information to be supplied by the manufacturer, medical electrical equipment, transfusion equipment for medical use, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics and sharps injury protection (OJ L, 2026/1231, 17.6.2026, https://eur-lex.europa.eu/eli/dec_impl/2026/1231/oj ). To correct the data of application of Commission Implementing Decision (EU) 2026/1231, a Corrigendum was published on 22 JUN 2026 – reaching 65 references overall • For the IVDR: Commission Implementing Decision (EU) 2026/1313 of 15 June 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer (OJ L, 2026/1313, 17.6.2026, https://eur- lex.europa.eu/eli/dec_impl/2026/1313/oj ) – keeping 23 references overall These publications include also the reference of EN ISO 15223-1:2021/A1:2025, amending the harmonised standard on “Symbols to be used with information to be supplied by the manufacturer”, to introduce the new symbol ‘EU REP’ for authorised representatives, with a transition period of 60 months (5 years) ending on 17 JUN 2031. A supporting guidance document, as Appendix “Transition to the ‘EU REP’ symbol in EN ISO 15223-1” to the main guidance document MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices, has been published as well, as endorsed by the MDCG and updated with the publication references. For further information on harmonised standards for medical devices, the dedicated Commission’s webpage is available here. MDCG Nomenclature WG EMDN Annual Update The EMDN technical team is currently assessing stakeholder requests submitted under the annual EMDN update procedure and will soon provide a summary of the requests and their status. Due to the volume of submissions and ongoing evaluations, the July EMDN meeting may be postponed to November, with the latter expected to focus on validating the annual update. In the meantime, a first draft of the update proposal will be circulated for consultation by the end of July. Regarding translations, the English version has been completed and validated, while translations into the remaining EU languages are expected in September 2026. The current three-year translation project will support annual EMDN updates throughout its duration. MDR/IVDR Simplification Proposal Commission presentation to Council on EMA support, borderline & classification In the context of the ongoing negotiations on the Commission proposal to revise the MDR/IVDR, please find below the presentation delivered by the Commission to Member State representatives in the Council on the provisions related to EMA support to the regulatory system, as well as borderline and classification. https://eur-lex.europa.eu/eli/dec_impl/2026/1231/oj https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202690511 https://eur-lex.europa.eu/eli/dec_impl/2026/1313/oj https://eur-lex.europa.eu/eli/dec_impl/2026/1313/oj https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdf https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdf https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en AESGP OTC News | June 2026 14 | 21 The Commission presentation on cluster 2 - Support to the regulatory system provides further details on the Commission’s rationale for proposing stronger EMA support in the regulatory system and on the envisaged coordination processes for borderline and classification issues. MDR/IVDR Implementation Notified Bodies Survey on Certifications & Applications - Data dated 31 December 2025 The Commission has published on its website the “Notified Bodies Survey on certifications and applications (MDR/IVDR)” based on data collected from notified bodies until 31 December 2025. The survey – accessible here – is based on data from 53 notified bodies designated under the MDR/IVDR. Please note that this data does not seem to be reflected yet in the dashboard of the corresponding study on the monitoring of availability of medical devices on the EU market. According to the data, there are 31.101 MDR applications (the decrease in the number is due to a change in the methodology used by one NB to count applications) and 21.791 MDR certificates issued, with 944 MDR applications refused. As usual, the survey also provides an overview of certifications and applications by annex and by type (QMS vs Product). However, this time, the report does not include data on the number of applications under Rule 14 and Rule 21, first indent. This data will be made available in the dashboard. Regarding timelines, only 32% of NBs have a system for monitoring conformity assessment activities that can provide data on certification timelines. For certification costs, only 30% of NBs have such a system. Please be reminded that, under the new Commission Implementing Regulation (EU) 2026/977, NBs will be required to document and implement a system to monitor the duration and costs of conformity assessment activities. Annex VII NB Requirements: AESGP statement and summary of timelines for NBs On 8 May 2026, the AESGP Secretariat published a statement on its website welcoming the adoption of the Commission Implementing Regulation (EU) 2026/977, highlighting its potential to improve predictability and efficiency in relation to the quality management and processes in the context of conformity assessment activities. Additionally, please find below an overview table of the maximum timelines and allowed clock stops for notified bodies per conformity assessment activity under the new implementing regulation. Please note that the regulation has entered into force on 25 May 2026, with several provisions applying mostly from 25 February 2027. Activity Maximum time Starting on Allowed number of clock stops* Date of application Application review and contract signing 30 days The day the NB receives the complete application One Feb. 25, 2027 https://data.consilium.europa.eu/doc/document/WK-5589-2026-INIT/en/pdf https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj https://aesgp.eu/articles/aesgp-statement-on-commission-implementing-regulation-eu-2026-977-setting-maximum-timelines-for-conformity-assessment-activities-of-medical-devices https://aesgp.eu/articles/aesgp-statement-on-commission-implementing-regulation-eu-2026-977-setting-maximum-timelines-for-conformity-assessment-activities-of-medical-devices AESGP OTC News | June 2026 15 | 21 Quality management system auditing 120 days The day the NB initiates the audit programme’s first activity Four + two for each additional site Feb. 25, 2027 Product verification 90 days The day the NB initiates the assessment of the technical documentation Four Feb. 25, 2027 Decision and certification 20 days The day after the completion of the last review One Feb. 25, 2027 Substantial change – review of proposed planned change 30 days The day the NB receives the information on the planned change Five Feb. 25, 2027 Substantial change – additional conformity assessment activities 90 days The day the NB initiates the audit’s programme first activity or the assessment of technical documentation, whichever is the earlier Five Feb. 25, 2027 Substantial change – certificate issued 20 days The day following that of the notification of the approval of the planned change One Feb. 25, 2027 Re-certification – products 90 days The day the NB receives the complete documentation Three Nov. 25, 2027 Re-certification – QMS 90 days The day the NB receives the complete application Three Nov. 25, 2027 Recertification – certificate decision 20 days The day after the final review One Nov. 25, 2027 * Please note that interruption from EMA opinions do not count as a clock stop. Team NB Publications Sector Survey 2025 Team NB has published a press release outlining the data received from their members for the annual sector survey 2025, as well as a slide deck presenting the data. The survey provides information, amongst others, on the evolution of MDR/IVDR certificates issued, the withdrawal of certificates, the number of ISO 13485 certificates, and the transition process from the Directives to the Regulations. According to the slides, in 2025, there was a slowdown in the growth of certificate issuance, with an increase of two-thirds compared to the doubling observed in 2023 and 2024. Compared with the results of the “Study supporting the monitoring of availability of medical devices on the EU market”, with data up to December 2025: https://www.team-nb.org/wp-content/uploads/2026/05/Team-NB-MD-Sector-Survey-PressRelease-20260518.docx https://www.team-nb.org/wp-content/uploads/2026/05/Survey-2025.pdf AESGP OTC News | June 2026 16 | 21 • Team NB Team-NB certificates represent 81% of the total issued; and • applications received by Team-NB members represent 84% of the total applications. MDR Certification Process (including Pre- application, Application and Post Application phases) – Consensus document Team-NB has published a position paper on the MDR Certification process. The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). The document was developed by reviewing the application process and associated documents of individual Team-NB members and harmonising the processes where possible. This document is applicable to both legacy devices (pursuant to Article 120) transitioning to MDR, and devices that are new to the market and have not been certified under the Directives before. The document also briefly describes the certification activities that are undertaken after the application process is concluded. IVDR Application and appropriate surveillance Transfer agreement Team-NB members have adopted and published , a template Agreement form related to the transfer of IVDR formal application and of appropriate surveillance of legacy devices specifying the terms of the transfer in respect of legacy devices covered by Directives certificates. Micro and Small Enterprise Considerations Team NB has released a position paper commenting the changes brought by the ongoing revision of the European medical device regulatory framework (article 50 on access to notifies bodies and fees). As reminder, among the proposed measures is an expectation that notified bodies offer significantly reduced conformity assessment fees, up to a 50% discount for micro and small enterprises. The Team NB position paper highlight that the challenges faced by these organisations are structural and systemic in nature, extending far beyond notified body fees alone. Measures focused solely on fee reductions risk addressing symptoms rather than root causes, and may unintentionally undermine the capacity, independence, and sustainability of the conformity assessment system. According to them, the analysis presented in this paper demonstrates that the primary barriers encountered by micro and small manufacturers relate to limited regulatory experience, high costs associated with clinical evidence generation and external services, variability in the quality of regulatory advice, and inefficiencies arising from disproportionate or repetitive conformity assessment activities. They believe addressing these challenges requires a more balanced and ecosystem-wide approach. The most effective solutions lie in improving regulatory capability at source, increasing predictability of requirements, and ensuring that oversight activities are applied in a proportionate and risk-based manner. They propose the following measures : • Strengthening and formalising structured dialogue, including pre-submission interactions, to improve early alignment and reduce uncertainty; • Introducing greater flexibility in post-certification surveillance and sampling, enabling notified bodies to apply justified, risk-based approaches and avoid unnecessary duplication; • Establishing EU and Member State-funded programmes to support regulatory capability development and to offset the broader costs of clinical investigations, laboratory testing, and https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-MDR-Certification-Process-Consensus-Document-V2-20260604.pdf https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-IVDR-Application-and-appropriate-surveillance-Transfer-agreement-V1-20260610.pdf https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-Micro-Small-Entreprise-Initiatives-V1-20260616.pdf https://health.ec.europa.eu/document/download/7c4e871e-ebaf-46e0-ae76-93478e3d3fbc_en?filename=md_sector_proposed-amendments-mdr-articles.pdf AESGP OTC News | June 2026 17 | 21 associated services; • Improving transparency, consistency, and assurance in the use of regulatory consultants, including mechanisms for validation of regulatory approaches through structured dialogue; • Expanding the use of remote and hybrid audit models where appropriate, reducing operational burden on smaller organisations; • Advancing harmonisation of guidance, templates, and submission frameworks to improve clarity, consistency, and first-time quality of submissions. Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 Update The Commission has published an update of the planned meeting dates of the MDCG and subgroups for 2026. ESIP, AIM, TEAM-NB, CPME, TÜV Verband, IG-NB unified for a better WET approach The European Social Insurance Platform (ESIP), Team-NB, the Association of Mutual Benefit Societies (AIM), the Standing Committee of European Doctors (CPME), TÜV Verband and the Interest Group of Notified Bodies( IG-NB) have cosigned a joint statement which highlights shared concerns among healthcare insurers, medical doctors and notified bodies regarding the Commission’s Delegated Regulations on well-established technologies (WET) and calls for further refinement to ensure legal certainty and consistent application under MDR. The statement is accessible on Team-NB website. https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://www.team-nb.org/wp-content/uploads/2026/06/Joint-Stakeholder-Statement-MDR-WET.pdf https://www.team-nb.org/esip-team-nb-cpme-tuv-verband-ig-nb-unified-for-a-better-wet-approach/ AESGP OTC News | June 2026 18 | 21 AI - Omnibus VII legislative package - Provisional agreement reached by the Council presidency and European Parliament negotiators On 7 MAY, the Council presidency and European Parliament negotiators reached a provisional agreement on a proposal to streamline certain rules regarding artificial intelligence (AI), which has been published on the Council’s website. The proposal forms part of the so-called ‘Omnibus VII’ legislative package under the EU’s simplification agenda, comprising two proposed regulations intended to simplify the EU’s digital legislative framework and the implementation of harmonised rules on AI. What did the Commission originally proposed? 1. An adjustment of the timeline for the application of rules on high-risk AI systems by up to 16 months, so that the rules would start applying once the Commission confirms that the necessary standards and implementing tools are in place; 2. Targeted amendments to the AI Act to extend certain regulatory exemptions granted to SMEs to small mid-caps (SMCs), reduce requirements in a limited number of cases, extend the possibility to process sensitive personal data for bias detection and mitigation, reinforce the AI Office’s powers and reduce governance fragmentation. What are the main amendments introduced by the co-legislators at political agreement stage? Timelines for high-risk AI systems • The introduction of a fixed timeline for the delayed application of rules for high risk AI systems: ➢ 2 DEC 2027 (new application date) for stand alone high risk AI systems; and ➢ 2 AUG 2028 (new application date) for high risk AI systems embedded in products. Obligations and standard for the processing of personal data • An obligation for providers to register AI systems in the EU database for high-risk AI systems, where they consider their systems to be exempted from classification as high-risk. • The introduction of a standard of strict necessity for the processing of special categories of personal data for the purpose of ensuring bias detection and correction. Regulatory sandboxes and transparency • Postponement of the deadline for the establishment of AI regulatory sandboxes by competent authorities at national level until 2 AUG 2027. • A reduction of the grace period for providers to implement transparency solutions for artificially generated content from 6 months to 3 months, with the new deadline set on 2 DEC 2026. Governance and supervision Cross-Sectorial News https://www.consilium.europa.eu/en/press/press-releases/2026/05/07/artificial-intelligence-council-and-parliament-agree-to-simplify-and-streamline-rules/ AESGP OTC News | June 2026 19 | 21 • Clarification of the competences of the AI Office for the supervision of AI systems based on general-purpose AI models where the model and that system are developed by the same provider by listing exceptions where national authorities remain competent, including law enforcement, border management, judicial authorities and financial institutions. Interaction with sectoral legislation • The introduction of a mechanism allowing the resolution of situations, where sectoral legislation contains AI-specific requirements similar to those of the AI Act, by limiting the latter’s application in such cases through implementing acts. This is particularly relevant to the AI Act’s provisions on industrial AI and their interaction with sectoral legislation governing areas such as medical devices, toys, lifts, machinery, and watercraft. • An exemption of the machinery regulation from direct applicability of the AI act. • An empowerment for the Commission to adopt delegated acts under the machinery regulation which would add health and safety requirements in respect of AI systems that are classified as high-risk pursuant to the AI act, with a aim to effectively addresses any possible overlaps between the high-risk requirements from the AI act and those from sectoral legislation. • The addition of a new obligation for the Commission to provide guidance to assist economic operators of high-risk AI systems covered by sectoral harmonisation legislation in complying with the high-risk requirements of the AI act in a manner that minimises compliance burden. New prohibitions • The addition of a new provision to the AI Act prohibiting AI practices regarding the generation of non-consensual sexual and intimate content or child sexual abuse material (CSAM). Team-NB has released a statement regarding the provisional agreement reached by the Council Presidency and the European Parliament on the AI omnibus. BACKGROUND • In OCT 2024, the European Council called on all EU institutions, member states and stakeholders, as a matter of priority, to take work forward, notably in response to the challenges identified in the reports by Enrico Letta (‘Much more than a market’) and Mario Draghi (‘The future of European competitiveness’). • The Budapest declaration of 8 NOV 2024 subsequently called for ‘launching a simplification revolution’, by ensuring a clear, simple and smart regulatory framework for businesses and drastically reducing administrative, regulatory and reporting burdens, in particular for SMEs. • Since February 2025, as a follow-up to the call by EU Leaders at that and subsequent meetings, the Commission has put forward ten ‘Omnibus’ packages aiming to simplify existing legislation on sustainability, investment, agriculture, small mid-caps, digitalisation and common specifications, defence readiness, chemical products, digital issues including on AI, environment, the automotive sector and food and feed safety. New Council of Europe Recommendation sets standards for remote and online medicine provision The Council of Europe Committee of Ministers has adopted Recommendation CM/Rec(2026)7, setting out best practices for the remote and online provision of medicines. Co-ordinated by the European Directorate for the Quality of Medicines & HealthCare, the Recommendation responds to the expansion of digital healthcare which has highlighted both the benefits of remote access to medicines and the need for robust safeguards. As a Council of Europe Recommendation, the instrument is non-binding and now serves as a framework for Member States to consider and implement through national policies, legislation and regulatory practice. For more details, the following news are available here. https://www.team-nb.org/artificial-intelligence-council-parliament-agree-to-simplify-and-streamline-rules/ https://search.coe.int/cm#{%22CoEIdentifier%22:[%2209125948802b8d9e%22],%22sort%22:[%22CoEValidationDate%20Descending%22]} https://www.edqm.eu/en/-/new-council-of-europe-recommendation-sets-standards-for-remote-and-online-medicine-provision AESGP OTC News | June 2026 20 | 21 PPWR - EC guidance - 10 JUN 2026 The European Commission has published its final, non-binding guidance on the Packaging and Packaging Waste Regulation (PPWR) on 10 June 2026. This guidance document follows the draft guidance endorsed in March 2026 and comes just over two months ahead of the start of PPWR application on 12 August 2026. The link to the guidance document is available here: Commission Notice – Guidance document for Regulation (EU) 2025/40 on packaging and packaging waste https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202603084 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202603084 AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu

AESGP Issue 386 | July 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • CMDh MAY minutes & JUN meeting report ___________________________________________________________________ 2 • EMA and DG SANTE sign Working Arrangement with New Zealand MoH ___________________________________________ 4 Herbal News ________________________________________________________________________________________________ 4 • HMPWG Meeting report - FEB 2026 ________________________________________________________________________ 4 Environment ________________________________________________________________________________________________ 6 • ECGT Directive - EU Commission publication - Common Understanding on old stock situations _________________________ 6 FOOD ___________________________________________________________________________________ 7 EFSA ______________________________________________________________________________________________________ 7 • EREN Food Supplement Project Report published _____________________________________________________________ 7 MEDICAL DEVICES ________________________________________________________________________ 8 Post Market Surveillance and Vigilance Medical Devices WG ________________________________________________________ 8 • Publication update of MIR 7.3.1. XSD files ___________________________________________________________________ 8 MDCG Standards WG _________________________________________________________________________________________ 8 • OJEU Publication of MDR Harmonised Standards - Corrigendum to Commission Implementing Decision (EU) 2026/1231 _____ 8 Expansion of the list of well-established technologies ______________________________________________________________ 9 • Delegated acts published in the OJEU ______________________________________________________________________ 9 MDR/IVDR Implementation _____________________________________________________________________________________ 9 • Overview on Applications for Designation as a NB - Update 01 July 2026 ___________________________________________ 9 • Notified Bodies Survey on Certifications & Applications - Data dated 28 February 2026 ________________________________ 9 • Updated list of notified bodies’ standard fees ________________________________________________________________ 10 • Publication of the European Parliament Draft Report __________________________________________________________ 10 Team NB __________________________________________________________________________________________________ 10 • Proposal for risk adaptive surveillance system (MDR) _________________________________________________________ 10 Study on Availability of MDs __________________________________________________________________________________ 10 • 3rd EO Survey - Survey Results __________________________________________________________________________ 10 Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 _______________________________ 11 • Update _____________________________________________________________________________________________ 11 CROSS-SECTORIAL NEWS _________________________________________________________________ 12 COMBINE programme launches phase 2 of the pilot coordinated assessment procedure for combined studies _____________ 12 Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi - Summary conclusions ____________________________________________________________________________________________ 12 DG HERA RAMP UP - Pilot go-live ______________________________________________________________________________ 13 AESGP OTC News | July 2026 2 | 14 Regulatory News CMDh MAY minutes & JUN meeting report The minutes of the CMDh meeting held on 19-20 MAY 2026 have been published. For MDC members, the only relevant item is the COMBO update. Among the items reported, the following may be noted: Safety Outcome Survey (SOS) Working Group • The WG discussed the project on publishing the outcomes of important safety variations for NAPs. Development is planned to start in the second half of 2026 (to be finalised in 2027). • The WG also discussed the new project on publishing the outcomes of PRAC advice to MS on the CMDh website. It was proposed that the PRAC advice should only be brought back to the CMDh for potential publication once the underlying procedure is finalised. The SOS WG will further develop a proposal based on the discussion. • The WG also noted the publication of a new Q&A (Q31) on PSURs on the EMA website, explaining whether MAHs can extrapolate the PRAC recommendation on a PSUSA to medicinal products not included in the procedure. An update of the CMDh Q&As on PhV will be prepared until the next SOS WG meeting to refer to the new EMA Q&A New Pharmaceutical Legislation (NPL) A presentation was given on the NPL, focusing on the main changes in MRP/DCP, CMDh coordination with the EU governance structure, the CMDh roadmap, preliminary impact assessment and topic leads and how the CMDh can engage with industry during the NPL implementation. EC/EMA Operational Group on Combination Products and Consultation Procedures (COMBO) COMBO was established to clarify and streamline applications and assessments concerning combination products and consultation procedures for medical devices. COMBO aims to provide a regular forum for dialogue, sharing experiences, achieving mutual understanding. The group is working on guidance, e.g. to enhance the role of Notified Body Opinions in complementing the quality assessment of MAAs or guidance to standardise and harmonise the assessment of medical devices with ancillary medicinal substances. Electronic Product Information (ePI) EMA and ES presented an update on the ePI, including the use of PLM portal, the provisions in the NPL and the draft implementation roadmap. Additionally, please be informed that the report from the CMDh meeting held on 23-25 JUN has been published. Among the items reported, the following may be noted: Deletion of the requirement to provide cover letters for type IA variations The CMDh has agreed to delete the requirement to provide cover letters for type IA variations, starting from 1 JUL 2026. The following guidance documents have been updated to reflect the change: • Requirements on submissions for variations and renewals within MRP and national procedures • BPG on the use of eCTD in the MRP/DCP • Cover letter for variation applications in MRP • Questions and answers on variations • BPG for the allocation of the MRP variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1) [Track version] Medicines https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_05_CMDh_Minutes.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure-document-tracked-changes_en.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_June_2026.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_291_2013_Rev24_2026_06_clean_-_Chapter_1_-_BPG_for_the_allocation_of_the_MR_number.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_291_2013_Rev24_2026_06_clean_-_Chapter_1_-_BPG_for_the_allocation_of_the_MR_number.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_291_2013_Rev24_2026_06_TC_-_Chapter_1_-_BPG_for_the_allocation_of_the_MR_number.pdf AESGP OTC News | July 2026 3 | 14 • BPG for the processing of Type IA minor variations (notifications) in MRP (Chapter 3) [Track version] • BPG for the processing of grouped applications in MRP (Chapter 6) [Track version] The tick box regarding annual update of type IA variation(s) has been removed from the cover letter template and will be included in the variation application form. The EMA/CMDh explanatory notes on variation application form (Human medicinal products only) have been updated to reflect the change. The document will be published once the updated variation application form is published. In addition, the document is updated to provide further clarification on how products should be listed in section 2 of the application form and to provide further guidance on the information to be included for grouped variations. Updated version of the MAA eAF The updated version 1.28.0.0 of the MAA eAF is now available on the eAF website for applicants and MAHs to familiarise themselves with the changes. The main reason for the changes in the form is to align the product data with the ISO IDMP model. The form can be used for new MAA submissions to the NCAs for NP, MRP and DCP procedures from 1 SEP 2026. It will be mandatory to use the updated form for all new MAA submissions to the NCAs from 1 JAN 2027. Applicants are reminded that the version of the form should not be changed during an ongoing procedure. Update of Q&As on QP declaration The CMDh and CMDv agreed an update of the joint QP declaration [Track version]. The document has been brought in line with the new Variations Guideline. Other minor changes have been included. Answers for human and veterinary medicinal products have been aligned where possible. Best Practice Guide on Variation Worksharing (Chapter 7) The CMDh agreed an update of the BPG on Variation Worksharing (Chapter 7) [Track version]. Further clarifications on the choice of the reference authority and the pre-submission activities have been added. Update of (Public) Assessment Report Templates The CMDh agreed an update of the following (public) assessment report templates: • DCP D70 Overview AR template (incl. instructions) [Track version] • DCP D70 Overview AR template (empty) [Track version] • Instructions for RMS when preparing the PAR based on the FAR [Track version] • PAR template (empty) when prepared based on FAR [Track version] A new standard wording for the non-clinical aspects has been added to be used, where relevant. Update of Q&As – Post-Brexit The CMDh agreed an update of its Post-Brexit [Track version]. The information on reference medicinal products authorised in the UK has been clarified in the document. Meeting with Interested Parties The CMDh convened a meeting with Interested Parties on 25 JUN 2026. The topics on the agenda included the NPL, the CMDh Multi-Annual Workplan, variations, safety label variations, multilingual packs, and trade name challenges. Change in the Presidency of the Council of the EU The June 2026 CMDh meeting was the last one under the Cypriot Presidency of the Council of the European Union. Ireland will take over the Presidency in July 2026. Nicole Kavanagh will be the appointed Presidency vice-chairperson of the CMDh during the Irish Presidency of the Council of the European Union. CMDh June meeting The following documents have been updated to reflect the decisions reached during the last CMDh meeting. The documents are also now available on the HMA website: • Questions and answers on variations [Track version] • Cover letter for Variation Applications in the Mutual Recognition Procedure [Track version] • CMDh Best Practice Guide on the use of eCTD in the MRP/DCP [Track version] • Requirements on submissions for Variations and Renewals within MRP and National Procedures [Track version] https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_293_2013_Rev.28_2026_06_clean_-_Chapter_3_-_BPG_for_the_Processing_of_Type_IA_Minor_Variations_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_293_2013_Rev.28_2026_06_TC_-_Chapter_3_-_BPG_for_the_Processing_of_Type_IA_Minor_Variations_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_296_2013_Rev32_2026_06_clean_-_Chapter_6_-_BPG_for_the_Processing_of_Grouped_Applications_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_296_2013_Rev32_2026_06_TC_-_Chapter_6_-_BPG_for_the_Processing_of_Grouped_Applications_in_MRP.pdf https://esubmission.ema.europa.eu/ https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_340_2015_Rev.9_2026_06_clean_-_QA_on_QP_Declaration.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_340_2015_Rev.9_2026_06_TC_-_QA_on_QP_Declaration.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_297_2013_Rev.36_2026_06_clean_-_Chapter_7_-_BPG_on_Worksharing.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_297_2013_Rev.36_2026_06_TC_-_Chapter_7_-_BPG_on_Worksharing.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_440_2022_Rev6_2026_06_clean_-_Overview_AR_including_instructions.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_440_2022_Rev6_2026_06_TC_-_Overview_AR_including_instructions.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_200_2007_Rev15_2026_06_clean_-_D70_Overview_AR.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_440_2022_Rev6_2026_06_TC_-_Overview_AR_including_instructions.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_454_2025_Rev3_2026_06_clean_-_Instructions_for_RMS_when_preparing_the_PAR_based_on_the_FAR.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_454_2025_Rev3_2026_06_TC_-_Instructions_for_RMS_when_preparing_the_PAR_based_on_the_FAR.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_453_2025_Rev3_2026_06_clean_-_Empty_PAR_template_when_the_PAR_is_prepared_based_on_the_FAR.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_453_2025_Rev3_2026_06_TC_-_Empty_PAR_template_when_the_PAR_is_prepared_based_on_the_FAR.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_457_2025_Rev1_2026_06_clean_-_Q_A_Post-Brexit.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_457_2025_Rev1_2026_06_TC_-_Q_A_Post-Brexit.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_132_2009_Rev66_2026_06_clean_-_QAs_Variations.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_132_2009_Rev66_2026_06_TC_-_QAs_Variations.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/Variations/CMDh_096_2009_Rev9_2026_06_clean_-_Cover_letter_for_Variation_Applications_in_MRP.docx https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/Variations/CMDh_096_2009_Rev9_2026_06_TC_-_Cover_letter_for_Variation_Applications_in_MRP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_084_2008_Rev8_2026_06_clean_-_BPG_on_the_use_of_eCTD_in_MRP_and_DCP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_084_2008_Rev8_2026_06_TC_-_BPG_on_the_use_of_eCTD_in_MRP_and_DCP.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_006_2008_Rev_29_2026_06_clean_-_eSubmission_for_Variations_and_Renewals.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_006_2008_Rev_29_2026_06_clean_-_eSubmission_for_Variations_and_Renewals.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_006_2008_Rev_29_2026_06_TC_-_eSubmission_for_Variations_and_Renewals.pdf AESGP OTC News | July 2026 4 | 14 EMA and DG SANTE sign Working Arrangement with New Zealand MoH The European Commission’s DG SANTE and the European Medicines Agency (EMA) have signed a Working Arrangement with New Zealand Ministry of Health (incorporating the New Zealand Medicines and Medical Devices Safety Authority - Medsafe) this week, to strengthen collaboration and exchange of information on medicinal products. The agreement was signed by DG SANTE Director-General Sandra Gallina and EMA Executive Director Emer Cooke. Director-General Audrey Sonerson signed for the New Zealand Ministry of Health. The purpose of this Working Arrangement is to strengthen cooperation between signatories across a range of areas in public health, while promoting the timely, secure exchange of information. The working arrangement document is available here. Deliverables from the Arrangement will include: • Facilitate exchange of information regarding medicinal products quality, safety and efficacy. • Increase alignment and coordination on topics related to medicinal products for human-use, in-line with the application legislation. • Mutual learning, capacity building and the sharing of best practices in regulatory science and public health. The Arrangement is running from 6 July 2026, and is valid for an indefinite period of time, unless terminated by either party. Herbal News HMPWG Meeting report - FEB 2026 The public report of the 41st meeting of the Heads of Medicines Agencies’ Homeopathic Medicinal Products Working Group (HMPWG), that took place on 26-27 FEB 2026, has been uploaded to the HMA website. Please keep in mind that, since this meeting took place several months ago, some information may not reflect the latest developments. The following topics were discussed: Safety An overview of sub-working group First Safe Dilution (s-WG FSD) reactivated in March 2025, was presented. The group is composed by experts on FSD and HMPWG (secretariat) members. As the main focus of the s-WG FSD is the assessment of FSDs on new stocks, a draft “6th list FSD” is currently being elaborated. In view of the planned updated EMA guidance on the Establishment of Lactose Allergy Threshold in all Medicinal Products, including Homeopathic Medicinal Products (Annex to "Excipients Guideline"), the HMPWG discussed the potential impact on homeopathic products including the consistency of application across regulatory authorities. Homeophatic use A revised Consolidated List of Stocks for which Homeopathic Use is Justified was adopted for subsequent publication on the HMPWG website. Quality The Chairperson of the Quality Sub-Working Group (Qs-WG) summarised the activities undertaken since the last HMPWG meeting, including the group’s intention to develop new Q&A documents. https://www.ema.europa.eu/en/documents/other/working-arrangement-collaboration-exchange-information-therapeutic-products-medicinal-products-between-dg-sante-ema-new-zealand-ministry-health_en.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/06_2026_Public_Report_41st_HMPWG_Meeting_Cyprus_final.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/HU_rev_consolidated_list_de_1-6_February_2026.pdf AESGP OTC News | July 2026 5 | 14 The draft document Points to Consider on Pyrrolizidine Alkaloids in Homeopathic Medicinal Products was adopted for publication for public consultation on HMA website. Post-meeting note: AESGP submitted its feedback to this public consultation on 8 JUN 2026. Legislation Amendment of the regulations concerning homeopathic medicinal products An update on the New Pharmaceutical Legislation (NPL) was presented. Changes concerning homeopathic medicinal products were reported via detailed comparison to current valid legislation. SoHO Regulation Following a presentation concerning Regulation (EU) 2024/1938 (“SOHO Regulation”), its concrete impact on the regulation of homeopathic medicinal products was discussed among HMPWG members. In order to support a consistent regulatory interpretation and ensure alignment with the SoHO framework for homeopathic medicinal products, HMPWG plans to collect available information on the registration status of relevant products in member states. Status module 1.2 Homeopathic Application form This issue had been discussed, and it was agreed the need to have further clarifications in order to consider the applicability at European level. National Information Following comments received from HMPWG members on the proposed first draft concerning a Q&A on Bach Flower Remedies and Cell Mineral Products, a consolidated update will be elaborated for final agreement among HMPWG members. https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/202602_Draft_Points_to_consider_on__PA_26022026.pdf AESGP OTC News | July 2026 6 | 14 Environment ECGT Directive - EU Commission publication - Common Understanding on old stock situations There have been recent developments in the implementation of the Empowering Consumers for the Green Transition (ECGT) (Directive (EU) 2024/825), particularly the new EU Commission publication of the Common Understanding on ‘old stock’ situations which was agreed by the national authorities of the Consumer Protection Cooperation (CPC) network. • The link of the Common Understanding is available here: Common understanding on old stock situations under Directive (EU) 2024/825 on Empowering Consumers for the Green Transition | European Commission. Key takeaways • This document aims to support a coherent enforcement approach across the EU for products, packaging, and related communications that were manufactured, ordered, distributed, or placed on the market before the ECGT becomes applicable on 27 September 2026. • It acknowledges that some businesses may face transitional challenges where products or packaging bearing environmental claims or sustainability labels remain in the market after the application date due to factors such as packaging cycles, pre-existing production orders, supply chain constraints, stock volumes, or long product shelf-lives. • While the document is not legally binding and does not change companies’ legal obligations under the ECGT or the Unfair Commercial Practices Directive (UPCD), it provides insights into the enforcement approach that national authorities are expected to consider: o Traders are expected to continue working towards compliance without delay. o National authorities may take a phased and proportionate enforcement approach where specific transitional challenges can be demonstrated. o Practical constraints like stock volume, packaging cycles, prior orders, supply chain dependencies, and product shelf-life may be considered on a case-by-case basis. o Businesses are expected to undertake reasonable compliance efforts, including updating online claims, adapting future packaging, and maintaining evidence for their compliance activities. o Authorities may refrain from requiring disproportionate measures, including the destruction or recall of products, where this would result in excessive costs or unnecessary environmental harm. o In justified cases, national authorities may favour a compliance-oriented approach before considering sanctions. BACKGROUND • The ECGT introduces new requirements and prohibitions on environmental claims, sustainability labels, and business-to-consumer communications through amendments to the UPCD. • Member States were required to transpose the Directive by 27 March 2026; however, transposition has not been completed in a harmonised way across the EU and therefore the European Commission has initiated infringement proceedings against many Member States for failing to communicate national measures by the deadline. • Despite the delays, the Directive will apply from 27 September 2026, and companies should continue their compliance preparations accordingly. https://commission.europa.eu/document/264d8c70-2f9a-4955-8e7b-154d55a9b684_en https://commission.europa.eu/document/264d8c70-2f9a-4955-8e7b-154d55a9b684_en https://commission.europa.eu/document/264d8c70-2f9a-4955-8e7b-154d55a9b684_en AESGP OTC News | July 2026 7 | 14 EFSA EREN Food Supplement Project Report published EFSA’s supporting publication on “The European Food Supplement Project – Identification of emerging risks associated with food supplements, other than vitamins and minerals” has now been published. The project looked at possible emerging risks linked to food supplements other than vitamins and minerals, with a view to supporting prioritisation of substances that may be considered under Article 8 of Regulation (EC) No 1925/2006. The report highlights two main strands of work. The vigilance work package identified six ingredients as possible sources of emerging risks: Bifidobacterium, Coleus (Plectranthus barbatus), Guggul (Commiphora mukul), Toothed clubmoss (Huperzia serrata), Black radish (Raphanus sativus L.) and Ginseng (Panax ginseng). The plant work package examined 52 substances predicted to be toxic and their occurrence in food supplements on the EU market. Three substances were identified as being particularly widespread: furfural, emodin and chrysophanol. These substances were associated with a broad range of botanicals commonly found in food supplements, including acerola (Malpighia glabra), passionflower (Passiflora spp.), guarana (Paullinia cupana), grapefruit (Citrus paradisi), lemon (Citrus limon), rhubarb (Rheum spp.), buckthorn (Frangula spp.), Japanese knotweed (Fallopia japonica) and various Rumex species. The report also notes that, due to limitations in product labelling, EFSA assumed that all plant parts may contain the substances of concern, highlighting the need for further analytical and exposure data. As a next step, EFSA has launched a tender to identify a contractor for further work on these substances in food supplements sold across the EU, with EUR 200,000 made available for this activity. This follow-up will be important to better understand actual market presence and exposure, and to inform any further discussion on possible risk management or Article 8 prioritisation. Food https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2026.EN-10226 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2026.EN-10226 AESGP OTC News | July 2026 8 | 14 Post Market Surveillance and Vigilance Medical Devices WG Publication update of MIR 7.3.1. XSD files The Commission was recently notified that there was an inconsistency between the business rules of the MIR 7.3.1. PDF and of the XSD files as regards the field 4.3.3.d. for the report types “Combined” and “Final reportable”. After examination by COM, it was concluded that the above mentioned XSD files should be updated for field 4.3.3.d. These very limited modifications of these XSD files have not impact on the PDF and XML files and therefore the MIR 7.3.1. PDF publication date remains unchanged. The revised XSD files have been published on EUROPA at the following link. MDCG Standards WG OJEU Publication of MDR Harmonised Standards - Corrigendum to Commission Implementing Decision (EU) 2026/1231 The Corrigendum to Commission Implementing Decision (EU) 2026/1231 has been published in the OJEU. It includes the correct application date for EN ISO 15223-1:2021/A1:2025 (introduction of the new ‘EU REP’ symbol), namely 7 JUN 2031. Medical Devices https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202690511 AESGP OTC News | July 2026 9 | 14 Expansion of the list of well-established technologies Delegated acts published in the OJEU The two Commission delegated regulations amending MDR on Well-Established Technologies (WET) have been published in the Official Journal of the European Union today. • 2026/1359 Commission Delegated Regulation (EU) 2026/1359 of 20 March 2026 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device • 2026/1451 Commission Delegated Regulation (EU) 2026/1451 of 20 March 2026 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of implantable devices and class III devices exempted from the obligation to perform clinical investigations These regulations are binding in its entirety and directly applicable in all Member States. MDR/IVDR Implementation Overview on Applications for Designation as a NB - Update 01 July 2026 The overview on the applications for designation as a notified body under the MDR and IVDR has been updated by the Commission. The updated overview is accessible here. The presentation indicates that the MDCG recommendations equal the number of designated notified bodies. Notified Bodies Survey on Certifications & Applications - Data dated 28 February 2026 The Commission has published on its website the “Notified Bodies Survey on certifications and applications (MDR/IVDR)” based on data collected from notified bodies until 28 February 2026. The survey – accessible here – is based on data from 53 notified bodies designated under the MDR/IVDR. Please note that this data does not seem to be reflected yet in the dashboard of the corresponding study on the monitoring of availability of medical devices on the EU market. According to the data, there are 32.898 MDR applications (a decrease of 0.6%, explained by a change in methodology by some NBs, to October 2025 data) and 18.010 MDR certificates issued (an increase of 2.9% compared to October 2025 data). As usual, the survey also provides an overview of certifications and applications by annex and by type (QMS vs Product). Of further relevance, 9.724 applications have been lodged for changes received for already MDR issued certificates – this figure is included in the total number of applications (see slide 25). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 https://health.ec.europa.eu/document/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en AESGP OTC News | July 2026 10 | 14 Furthermore, the survey indicates that 1175 applications under Rule 14 MDR have been filed and 387 certificates have been issued thereof. The survey also indicates that now 162 applications under Rule 21, first indent, have been filed, with no certificates that has been issued thereof (see slide 26). Regarding timelines, for 62% of the NBs, it takes 13-18 months to issue a new QMS certificate under the MDR. For 51% of the NBs, it takes 13-18 months to issue a certificate (QMS+Product) under the MDR and 31% of the NBs need 19-24 months to issue a certificate (QMS+Product) under the MDR. Updated list of notified bodies’ standard fees The list of notified bodies’ standard fees has been updated and published on Commission website. Publication of the European Parliament Draft Report The European Parliament has published its Draft Report on the Commission’s proposal to simplify the MDR/IVDR. The report is available below: • Draft EP Report (PDF version) • Draft EP Report (Word version) AESGP and members have advocated close to MEPs for proportionate amendments to the Commission’s proposal and we are glad to see that many of these have been reflected in the European Parliament’s Draft report. Overall, the targeted amendments introduced in the Draft Report are expected to further enhance predictability, transparency, and legal certainty of the regulatory framework for medical devices. Team NB Proposal for risk adaptive surveillance system (MDR) Team-NB has released a position paper which details their views and proposed amendments on how to adapt the surveillance system considering the Commission proposal to remove the maximum validity of certificates. Study on Availability of MDs 3rd EO Survey - Survey Results The survey results of the third economic operator survey with data status 31 October 2025 within the study “Supporting the Monitoring of Availability of Medical Devices on the EU Market” have been published on the Commission website. The results of this third survey – accessible here – are based on 213 responses from manufacturers of MDs and IVDs and authorised representatives. The dataset provides information, amongst others, concerning: • Written agreements with Notified Bodies • Refusal of applications by Notified Bodies • MDR Implementation (applications, certificates, re-certification, and time periods) https://health.ec.europa.eu/document/download/ff5716d5-fe77-4f45-b883-fcf3da4acd15_en?filename=md_nbs_fees_en.pdf https://health.ec.europa.eu/latest-updates/updated-list-notified-bodies-standard-fees-2026-07-13_en https://www.europarl.europa.eu/doceo/document/SANT-PR-787987_EN.pdf https://www.europarl.europa.eu/doceo/document/SANT-PR-787987_EN.docx https://www.team-nb.org/wp-content/uploads/2026/07/Team-NB-PositionPaper-MDR-Update-Risk_adaptive-surveillance-V1-20260630.pdf https://health.ec.europa.eu/document/download/61b46045-744a-41a7-bbcc-1af40fb92632_en?filename=md_availability_study_presentation_2025_en.pdf AESGP OTC News | July 2026 11 | 14 • Estimates on the completed transition • Discontinuation of medical devices • Manufacturer preparedness Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 Update The Commission has published an update of the planned meeting dates of the MDCG and subgroups for 2026. The update concerns the addition of a market surveillance meeting in November and of a Nomenclature WG meeting (date still needs to be determined). https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf AESGP OTC News | July 2026 12 | 14 COMBINE programme launches phase 2 of the pilot coordinated assessment procedure for combined studies The European Commission and EU Member States are launching the second phase of the COMBINE coordinated assessment pilot. Phase 1 offered the first experience of coordinated assessment for combined studies through the Clinical Trials Information System (CTIS). Phase 2, which is expected to remain open for at least one year, expands the scope of studies eligible to participate and introduces a more agile, rolling process with monthly slots for the submission of expressions of interest. The launch of phase 2 marks a major step towards more streamlined, efficient, and coordinated regulatory pathways across combined medicine-device therapies . By simplifying processes and enabling joint assessment, the pilot aims to support innovation while maintaining robust regulatory oversight across the EU. What’s New in phase 2 • Eligibility for multinational investigational medicinal product (IMP) clinical trials combined with: o Performance studies of IVDs or companion diagnostics requiring authorisation o Clinical investigations of medical devices requiring authorisation • Combined studies with Advanced Therapy Medicinal Products (ATMPs) possible • Options for single or separate sponsors • Procedure for substantial modifications in combined studies authorised in the pilot to be launched later in phase 2 • Exploration of single protocols and joint documents When to express interest for phase 2 Sponsors must submit their expressions of interest by the 23rd of the month preceding the month in which they intend to submit their application. The first monthly application window will open in SEP 2026. To apply to the September round, sponsors must submit their expressions of interest by 23 AUG 2026. For more information and to apply for the pilot COMBINE coordinated assessment procedure, visit the European Commission's website. Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi - Summary conclusions An implementation dialogue on the European Health Data Space Regulation (EHDS Regulation) was held in Brussels on 10 June 2026 with the participation of industry, researchers, healthcare providers and patient organisations. The dialogue pursued two principal objectives. • First, it aimed to take stock of the stakeholders’ state of preparations for the EHDS, including by gathering evidence on measures already being taken to ensure compliance with the Regulation and on the main challenges expected. Cross-Sectorial News https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme_en https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme/combine-project-1-pilot-all-one-coordinated-assessment_en AESGP OTC News | July 2026 13 | 14 • Second, it sought to collect views on possible measures to facilitate and simplify the forthcoming implementation of the EHDS Regulation and to foster innovation, including through actions beyond the scope of the EHDS that could contribute to enhanced efficiency and competitiveness in the digital health sector. Industry representatives reported having started their preparations for the implementation of the EHDS while underlining the importance of the timely adoption of the relevant implementing acts. In addition, they stressed the need to build on existing standards. Many participants asked for harmonised implementation of the EHDS across the EU as much as possible and for further clarification of certain notions and concepts. They also asked for clarification of the interplay with other Union rules. To access the full summary, please check here. DG HERA RAMP UP - Pilot go-live The Commission’s DG HERA has now launched the pilot phase of RAMP UP (Rapid Agile Manufacturing Partnerships for Union Protection), a voluntary preparedness network aimed at strengthening Europe’s ability to rapidly scale up the production and supply of medical countermeasures (MCMs) during health emergencies. The initial launch of RAMP UP is positioned as a pilot phase, focusing on engaging and onboarding stakeholders whose portfolios include medicinal products relevant for medical countermeasure preparedness. While the application process remains open to all eligible members, the first phase will focus on pharmaceutical companies with portfolios covering pharmacological classes identified for the purpose of this initial RAMP UP pilot phase. This will allow DG HERA and participating partners to test and refine the practical arrangements of the initiative, including data requirements, templates and data- sharing processes, while ensuring that these are proportionate and fit for purpose. Applicants whose portfolios include medicinal products falling within the list of pharmacological classes for RAMP UP pilot phase are invited to apply. Why join RAMP UP? By joining the RAMP UP network, your organization can: • Establish a dedicated channel of communication with DG HERA on manufacturing, supply chain, and crisis readiness. • Increase visibility and be included in the RAMP UP registry to help identify key capabilities and potential supply chain bottlenecks. • Shape the initiative by helping develop practical data-sharing templates, formats, and procedures from the ground up. • Network and collaborate via the HERA Stakeholders Hub to explore cooperation opportunities across the MCM ecosystem. Note: RAMP UP is a preparedness partnership designed to improve mutual coordination before a crisis occurs; it does not guarantee future contracts or provide privileged procurement status. Who is eligible? Legal entities with a proven role in ensuring access to crisis-relevant MCMs in the EU/EEA, including: • Marketing authorization holders and manufacturers of medicines • Manufacturers of medical devices, PPE, and IVDs • CDMOs and CMOs • Suppliers of APIs, raw materials, intermediates, and fill-finish services • Innovators of advanced manufacturing technologies How to apply 1. Register your organization on the HERA Stakeholders Hub. 2. Complete the RAMP UP application form, including the eligibility verification. 3. Onboarding: Once DG HERA reviews and confirms your eligibility, you will receive further details during an ad-hoc onboarding meeting. https://health.ec.europa.eu/events/implementation-dialogue-european-health-data-space-regulation-commissioner-oliver-varhelyi-2026-06-10_en https://health-preparedness-industry-hub.ec.europa.eu/ramp-up https://health-preparedness-industry-hub.ec.europa.eu/ramp-up https://health-preparedness-industry-hub.ec.europa.eu/system/files/2026-07/pharmacological-classes-for-ramp-up-pilot.pdf https://health-preparedness-industry-hub.ec.europa.eu/system/files/2026-07/pharmacological-classes-for-ramp-up-pilot.pdf https://health-preparedness-industry-hub.ec.europa.eu/home https://health-preparedness-industry-hub.ec.europa.eu/system/files/2026-06/2026-06-09-eligibility-criteria-final.pdf AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu

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Gemeinsam mit unseren Mitgliedern sowie Vertretern aus Politik, Selbstverwaltung und Wissenschaft möchten wir über die Gestaltung und Chancen eines neuen Primärversorgungssystem diskutieren. Vorab geben uns Expertinnen und Experten Einblick in mögliche Wege, die die einzelnen Akteure im Gesundheitswesen beschreiten können, um die neue Primärversorgung zielgerichtet in das Gesundheitssystem zu verankern. Der Parlamentarische Abend findet in Präsenz am 13. Oktober 2026 ab 18:00 Uhr im DBB Forum Berlin | Friedrichstr. 169 | 10117 Berlin statt. Da die Teilnehmeranzahl begrenzt ist, melden Sie sich zeitnah über unsere Veranstaltungsseite an. Die Plätze werden nach Anmeldung vergeben. Primärversorgung - Quo Vadis? Wie lässt sich ein modernes, effizientes und patientenorientiertes Versorgungssystem für die Zukunft gestalten? Details und Anmeldung

Die gezielte Ansprache von Fachkreisen und der Öffentlichkeit ist für pharmazeutische Unternehmen unverzichtbar, um Produkte erfolgreich am Markt zu positionieren. Angesichts eines wachsenden Wettbewerbs und anhaltenden Kostendrucks nimmt die Bedeutung wirksamer Marketingmaßnahmen stetig zu. Gleichzeitig verändern sich das Heilmittelwerbegesetz und das Wettbewerbsrecht kontinuierlich. Um rechtliche Risiken zu vermeiden und vorhandene Spielräume optimal zu nutzen, laden wir Sie herzlich zu unserer praxisorientierten Fachveranstaltung ein. In unserem Seminar vermitteln wir Ihnen fundierte Kenntnisse zu den rechtlichen Grundlagen sowie zu speziellen Detailfragen der Pharmakommunikation. Ein besonderer Schwerpunkt liegt dabei auf aktuellen Trends wie digitalen Werbeformaten und Online-Kampagnen. Das Programm lebt vom Praxistransfer und setzt auf einen interaktiven Aufbau: Bringen Sie Ihre individuellen Fragen ein und tauschen Sie sich im Rahmen moderierter Diskussionen mit Kolleginnen und Kollegen aus. Die Veranstaltung richtet sich branchenspezifisch an: Geschäftsleitungen der pharmazeutischen Industrie Fach- und Führungskräfte aus Recht und Compliance Teams aus Marketing, Vertrieb sowie Medical Affairs Informationsbeauftragte nach dem Arzneimittelgesetz Das Fachseminar findet am 29. September 2026, von 09:30 Uhr bis 15:30 Uhr in digitalem Format statt Fachseminar: Werbung für Arzneimittel Werbung für Arzneimittel rechtssicher gestalten. Anmeldung & Details