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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 380 | April 2026 Euro OTC News Table of Contents MEDICINES _______________________________________________________________________________ 2 Regulatory News _____________________________________________________________________________________________ 2 • EMA Updated guidance on mobile scanning and other technologies in the labelling and/or PL of centrally authorised medicinal products _____________________________________________________________________________________________ 2 • CMDh Minutes - 24-25 FEB 2026 __________________________________________________________________________ 3 • CMDh Meeting Report - 24-25 MAR 2026 ___________________________________________________________________ 5 • CMDh Multi-Annual Workplan (MAWP) to 2028 – Published _____________________________________________________ 6 • EC - EURL ECVAM Status Report on Non-Animal Methods in Science and Regulation ________________________________ 6 • EMA/HMA roadmap on ePI implementation published __________________________________________________________ 7 • HMA/EMA Final Report of the European Medicines Agencies Network Strategy to 2025 – Published ______________________ 7 • Data Quality Framework for EU Medicines Regulation Application to Real-World Data – Published _______________________ 8 Pharmacovigilance ___________________________________________________________________________________________ 9 • EMA - 2025 Annual Report on EudraVigilance – Published ______________________________________________________ 9 • EMA - EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of ICSRs ______________________________________________________________________ 10 Herbal medicines ___________________________________________________________________________________________ 10 • EMA HMPC launches 18 calls for scientific data - FOR INPUT by 1 JUN ___________________________________________ 10 • EMA's Draft Guideline on declaration of herbal substances and herbal preparations in HMPs / THMPs - Revision 2 - For Comments by 16 JUN __________________________________________________________________________________ 11 FOOD __________________________________________________________________________________ 13 EFSA _____________________________________________________________________________________________________ 13 • Safety of carbon dioxide extract from Cannabis sativa L. as a novel food __________________________________________ 13 MEDICAL DEVICES _______________________________________________________________________ 14 Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 _______________________________ 14 • Update _____________________________________________________________________________________________ 14 ENVIRONMENT __________________________________________________________________________ 15 PPWR - EC guidelines on the implementation of PPWR & FAQ document - 30 MAR 2026 ________________________________ 15 WFD+GWD+EQSD - Publication in OJ - 20 APR 2026 ______________________________________________________________ 15 CROSS-SECTORIAL NEWS _________________________________________________________________ 18 European Commission DG SANTE's FAQs on the European Health Data Space Regulation (EU) 2025/327 – Published _______ 18 European Parliament's position on a simplification proposal amending the Artificial Intelligence Act (AIA) – Adopted ________ 18 EC – Launch of Initiatives to Develop Implementing Regulation for the European Health Data Space (EHDS) _______________ 19 EHDS Board operations - Commission Implementing Regulation (EU) 2026/771 – Published _____________________________ 20 Draft Commission Implementing Regulations concerning the European Health Data Space (EHDS) - Published for consultation 20 AESGP OTC News | April 2026 2 | 22 Regulatory News EMA Updated guidance on mobile scanning and other technologies in the labelling and/or PL of centrally authorised medicinal products The revised version of the EMA guidance on “Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products” outlining the general principles of acceptability and rules of procedure, has been published. The updated guidance introduces several changes, including: • Broader scope and terminology updates ❖ Use of “intended users” instead of “patients/users/healthcare professionals.” ❖ Clarification that the guidance applies to labelling and/or package leaflet throughout the document. • Expanded scope of platform ownership ❖ Mobile technology platforms may now be hosted not only by MAHs or NCAs, but also by third parties acting on their behalf. • Earlier regulatory engagement encouraged ❖ Applicants/MAHs are now expected to inform the EMA as early as possible of their intention to use mobile technology features on the packaging materials and/or PL. ❖ Applicants/MAHs should make use of the pre-submission phase to present their strategy and address any potential issues before the procedure starts. • More explicit rules for the URL ❖ The name chosen for the URL should ideally allow proper identification of the medicinal product (e.g. www.productname.eu). If that is not feasible, the name should be simple and easy to type (e.g. avoid using symbols), non-promotional, and as concise as possible. • Clearer MAH accountability/Strengthened responsibilities ❖ MAH must ensure that the information provided electronically is available when the product is launched in a Member State. ❖ It should be kept up to date for as long as the medicinal product is placed in the market. ❖ If different batches coexist with different product information (e.g. differences in excipients, storage conditions or packaging material, co-packaged device, etc.), MAH must ensure the information for those batches is available. • Submission procedure ❖ Applicants/MAHs are required to submit to EMA a completed request/declaration form accompanied by relevant information (material to be linked (video, etc.) as well as the updated mock-ups and product information annexes describing the intended exact location of the mobile technology feature) in Module 1.3.1 of the dossier. Please also note that the request/declaration Medicines https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/mobile-scanning-other-technologies-labelling-or-package-leaflet-centrally-authorised-medicinal-products_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/mobile-scanning-other-technologies-labelling-or-package-leaflet-centrally-authorised-medicinal-products_en.pdf http://www.productname.eu/ AESGP OTC News | April 2026 3 | 22 form for the provision of information via mobile scanning and other technologies in the centralised procedure has been updated (attached). • New explicit handling of deletion/decommissioning ❖ Requests for the deletion of a mobile technology feature are considered as any other post- authorisation change, and the procedural guidance remain applicable. ❖ If the platform/website provided by the mobile technology feature is decommissioned and there are still batches of the product in the market, the MAH is responsible for informing intended users accordingly when they scan the mobile technology feature. CMDh Minutes - 24-25 FEB 2026 The minutes of the CMDh meeting held on 24-25 FEB 2026 have been published. Among the items reported, the following may be noted: Working Party on Variation Regulation The WP Chair reported from the February 2026 WP meeting. The WP discussed the ROG proposal to delete the requirement for cover letters for type IA variations. Some technical aspects need to be implemented before the cover letter can be deleted (minor changes to the CESP delivery file, update of eAF, work-around for mandatory cover letter in eCTD). For the implementation, a Q&A will be prepared to explain the correct completion of the delivery file and to explain that the requirement of the cover letter as mentioned in the variations guidelines will not be applicable anymore for type IA/IAIN variations. With regard to the Variations Guidelines, the WP was informed that EMA will draft a procedure for the annual guidelines update laid down in Article 4 of the Variations Regulation and the collection of the necessary updates to be included in the guidelines. Corrections in the eAF/PLM should be communicated to the EMA contact person. The WP discussed again a possible grouping of related type IA with IAIN variations outside the annual update of Type IA variations. A majority of the WP proposed to update Chapter 6 to allow grouping of type IA with IAIN for “related” changes, similar to the EMA. The update should include a non-exhaustive list of examples and guidance that not related changes will be invalidated without any option to correct the submission. The decision on the validation, if the changes are related, is left to the RMS. The CMDh agreed with the proposal. An update of the BPG will be prepared for the next meeting. The WP also discussed how to handle cases when the present/proposed table of a type IA annual update variation application shows additional changes not covered by the variation(s) submitted. The CMDh agreed by majority that a type IA submission is a one-way process and no updates can be done. The annual update can be approved but the changes related to the missing variation codes have to be deleted from the dossier and resubmitted in a new single or grouped type IA variation (as they cannot wait for the next annual update due to the implementation time). The WP was informed about the actions included in the new CMDh MAWP to 2028 in relation to variations. The actions will be taken forward in the coming meetings. The WP agreed a proposal for update of the EMA/CMDh explanatory notes on variation eAF (human only) to include an example of how the products should be listed in the table “Products concerned by this application” in alphabetical order. The update will be included in the next scheduled update of the guidance in Q2. The update was also agreed by the CMDh. Results of a survey by AESGP related to variations was shared for information. The WP also discussed how to handle nitrosamine risk assessment reports included in non related variation submissions. It was agreed that the nitrosamine risk assessment should not be included and will not be considered in type IA variations within or outside the annual updates. In such cases, a note should be added in the approval letter for type IA variations that the risk assessment was not considered in the procedure, that the assessment needs to be removed from the dossier and has to be submitted separately according to the available guidance on nitrosamines. In type IB and type II variations, a justification needs to be included why the risk assessment is part of that variation or it should be deleted from the dossier. https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_02_CMDh_Minutes.pdf AESGP OTC News | April 2026 4 | 22 Normally, no variation is required for the submission of a risk evaluation. MAHs should consider the correct handling of step 2 and step 3 according to available nitrosamine guidance. Finally, the WP discussed if the update of the combined product information in only two MSs of an MRP/DCP can be submitted as variation worksharing. It was agreed that the update of national versions of combined product information is not applicable for a (mandatory) worksharing procedure. CMDh Multi-Annual Workplan (MAWP) The CMDh was informed that the MAWP to 2028 was sent to Interested Parties for comments as agreed in the January CMDh meeting. The comments will be discussed in the March CMDh meeting. No comments have been received on the summary report of the MAWP to 2025. The CMDh agreed to publish the summary report on the CMDh website. Reference to CEP number and CEP revision number in individual eCTD sections Following a question raised by a company, the CMDh discussed the guidance provided in Q&A 3.2 (General for all sections) of the QWP Questions and answers (Q&A): how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV). The CMDh agreed that including the CEP number and its revision number in every CTD section 3.2.S does not provide additional value. The CMDh agreed to request that the QWP consider this position in the next revision of the guidance. Environmental Risk Assessment (ERA) Following the CMDh January discussion, IT prepared an overview of the feedback received from MSs on the assessment of ERA Phase II data in generic applications. The CMDh agrees that the scientific conclusions reached for the relevant originator ERA remain applicable to the generic product and the applicant can refer to this ERA. Consequently, repetition of ERA studies would generally not be required. Discrepancies were identified regarding the requirement for generic applicants to obtain a Letter of Access. The CMDh also discussed situations in which the reference ERA does not comply with the current ERA guideline. The CMDh acknowledged the EMA publication on the “Second industry stakeholder webinar on the revised guideline on the environmental risk assessment of medicinal products for human use”. The CMDh noted the need for a harmonised approach and referred the outstanding questions to the EMA and the NcWP. The CMDh will continue the discussion once further input and experience is gathered. Reference to studies in hybrid dossier as per Q4 of Q&As on generic applications The CMDh discussed the possibility for a hybrid application using a RefMP to also refer to non-clinical and clinical studies of a dossier of an already approved hybrid application whereas no differences of the clinical particulars listed in Q&A 4 of the CMDh Q&As on generics (indication, strength, route of administration and pharmaceutical form) are present. The CMDh agreed that the application can be validated and it would be determined during the clinical assessment whether the studies are applicable/can be used for this product. The CMDh may rediscuss this topic following completion of the assessment and will consider whether this case should be reflected in the CMDh guidance, as needed. A.O.B. Paracetamol / pseudoephedrine Based on a recent request from a MAH, the CMDh discussed if the outcome of the PSUSA on paracetamol / pseudoephedrine (PSUSA/00002307/202306) can be extrapolated to other fixed-dose combinations (FDC) containing other active substances in addition to paracetamol / pseudoephedrine. The CMDh position on the PSUSA was adopted in February 2024. An extrapolation was not recommended at the time. In October 2024, the EURD list entry for the PSUSA was updated and grouped with two additional FDCs under the same entry. The CMDh agreed that the outcome of the PSUSA should not retrospectively be extrapolated to other FDCs. The inclusion of the outcome of the PSUSA for other FDCs should be discussed in the next upcoming PSUSA for those products. If the MAH intends to implement the changes in their products before the next PSUSA, they can submit a type II variation with relevant supporting documentation. PRAC advice could be sought during the variation assessment. AESGP OTC News | April 2026 5 | 22 A proposal to further liaise between PRAC and CMDh on newly combined EURD list entries will not be taken forward. CMDh Meeting Report - 24-25 MAR 2026 The report from the CMDh meeting held on 24-25 MAR 2026, has been published. Among the items reported, the following may be noted: CMDh guidance documents related to variations The CMDh agreed to update the CMDh Q&A on Variations, the Position paper common grounds seen for invalidation/delaying day 0 for variations, the Examples for acceptable and not acceptable groupings for MRP/DCP products (see also below), and the Preliminary Variation Assessment Report Template. These guidance documents have been revised to reflect the principles of the recently published Q&A 7.3.1 in the European Medicines Agency post authorisation procedural advice for users of the centralised procedure, which addresses the impact of changes in the clinical use of a product on quality documentation. During its February meeting, the CMDh agreed on the possibility of accepting the grouping of Type IA and Type IAIN variations outside the annual update of Type IA variations, provided that the changes are very clear and obviously related. The CMDh has now adopted updates to the CMDh BPG for the Processing of (Super-)Grouped Applications in MRP (Chapter 6) and to the Examples for acceptable and not acceptable groupings for MRP/DCP products to reflect this agreement. In addition, the CMDh agreed to update the CMDh BPG for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1), to clarify the allocation of procedure numbers for annual update of Type IA variations. The updated guidance documents will be published on the CMDh website. Guidance for preparation of Public Assessment Reports The CMDh agreed on an update of its guidance for preparation of Public Assessment Reports: D70 Overview AR template (empty), D70 Overview AR template (incl. instructions), Instructions for RMS when preparing the PAR based on the FAR, and PAR template (empty). The documents have been updated to include reference to the requirement for applicants to comply with the applicable EU legislation on clinical trials of medicinal products for human use, as relevant to their specific application The guidance and template documents will be published on the CMDh website. CMDh position paper on the use of mobile scanning and other technologies to be included in the labelling and/or package leaflet in order to provide information about the medicinal product The CMDh agreed an update of the position paper on the use of mobile scanning and other technologies to be included in the labelling and/or package leaflet, along with its annexes, in order to clarify the conditions under which applicants/MAHs may include links to statutory information hosted on platforms created and operated by third parties. The documents have been revised to provide updated information on all aspects of the inclusion of mobile technologies for products applied for/authorised via MRP/DCP. The EMA QRD Working Group and the EC have been consulted on certain aspects of the update to ensure an aligned approach with products authorised via the centralised procedure, as much as possible. The updated documents will be published on the CMDh website. CMDh Multi-Annual Workplan (MAWP) to 2028 During its March 2026 meeting, the CMDh adopted the final MAWP to 2028. Following a one-month consultation period with Interested Parties, the CMDh reviewed the comments received and concluded that only minor revisions to the MAWP were required. The work plan centres on four key priority areas: • Optimisation of procedures • Information technology and digitalisation • Training • Implementation of the new pharmaceutical legislation The CMDh Multi-Annual Workplan to 2028 will be published on the CMDh website. https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_March_2026.pdf https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation.html https://www.hma.eu/human-medicines/cmdh/templates/assessment-reports/public-ar.html https://www.hma.eu/human-medicines/cmdh/procedural-guidance/general-info.html https://www.hma.eu/human-medicines/cmdh/about-cmdh/cmdh-activities.html AESGP OTC News | April 2026 6 | 22 Summary of CMDh activities in 2025 The CMDh has agreed to publish a summary of the main activities carried out by the CMDh and its working groups/working parties in 2025. A list of new and revised CMDh documents published by the CMDh in 2025 is included as an Annex to the document. The document will be published on the CMDh website. CMDh Multi-Annual Workplan (MAWP) to 2028 – Published The CMDh multi-annual workplan (MAWP) to 2028, outlining the priorities of the CMDh and reflecting the need for a coordinated approach to address the network’s key challenges and opportunities, has been published. CMDh multi-annual workplan (MAWP) to 2028 should be seen as complementary to the multiple routine tasks of the CMDh as laid down in legislation, including providing a forum for discussion between Member States on points of disagreement in procedures, providing regulatory and procedural guidance and fostering harmonisation in the EU regulatory network. The document has been developed in parallel and is complementary to the HMA/EMA European Medicines Agencies Network Strategy (EMANS) to 2028. The following four main priority areas have been included: • Optimisation of procedures • Information technology and digitalisation • Training • Implementation of the new pharmaceutical legislation The paper now introduces “The timelines mentioned in this document (short/medium/long term) serve as a tool for prioritisation of the actions and they roughly correlate to the implementation (or to the start) of the action within year 1/2/3 of the MAWP. Depending on complexity, planning, resources and time for implementation, the (long term) actions might be ongoing in 2028 and will be further considered in the next cycle.” EC - EURL ECVAM Status Report on Non-Animal Methods in Science and Regulation The 2025 EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) Status Report on Non-Animal Methods in Science and Regulation was published on the European Commission website. With the European Commission preparing to publish in 2026 a roadmap for phasing out animal testing, this status report serves as a critical resource documenting scientific, regulatory, societal, and economic progress. The report documents how EU-funded research, regulatory science, and international coordination are helping build the evidence base for a phased transition away from animal testing in chemical safety assessment. In particular, the report presents: • A comprehensive overview of recent advancements of the EURL ECVAM in the development, validation, and regulatory integration of non-animal methods, as well as progress made elsewhere. • Innovative scientific breakthroughs including organ-on-chip technologies, artificial intelligence, and multiomics approaches that collectively enhance the predictivity, efficiency, and ethical standards of safety assessment in line with 3Rs principles. https://www.hma.eu/human-medicines/cmdh/about-cmdh/cmdh-reports.html https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/About_CMDh/CMDh_Activities/Workplans/CMDh_Multi-annual_Workplan_to_2028.pdf https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/About_CMDh/CMDh_Activities/Workplans/CMDh_Multi-annual_Workplan_to_2028.pdf The%20document%20has%20been%20developed%20in%20parallel%20and%20is%20complementary%20to%20the%20HMA/EMA%20European The%20document%20has%20been%20developed%20in%20parallel%20and%20is%20complementary%20to%20the%20HMA/EMA%20European https://publications.jrc.ec.europa.eu/repository/handle/JRC145459 https://publications.jrc.ec.europa.eu/repository/handle/JRC145459 AESGP OTC News | April 2026 7 | 22 • EURL ECVAM’s active participation in Horizon Europe initiatives, international standardisation efforts, and strategic partnerships. EMA/HMA roadmap on ePI implementation published The European Medicines Agency and the network have released a draft roadmap regarding electronic Product Information (ePI) implementation on their website. The roadmap describes features in development for 2026, the phased CAPs go live, the kickoff implementation, the foreseen NCA implementation and what will be ePI public interface. Below the elements of particular relevance are available. Roadmap ❖ For CAPs Following an industry user acceptance testing, there will be a voluntary go live period for vaccines (Q4 2026), oncology products (H1 2027) and all centrally authorized products (H2 2027). ❖ For NAPs A NCA survey and readiness assessment will take place during 2027 followed by NCA implementation in 2027/2028 based on the assessment. Kick Off implementation • Initial implementation will not interfere with the assessment o Applicants will be requested to author / upload ePI at the PLM portal through an extra step in process (alongside current Word/PDF submission) o Future vision: ePI integrated in a fully digitalised assessment • Once a product’s PI is available in electronic format, it will remain electronic in all subsequent variations • CAPs: Initial ePI implementation for English, with all languages optional – fully multilingual at a later stage ePI public interface ▪ ePI to be displayed on the European Medicines Web Portal (EMWP) for all EU medicines (multilingual) once developed ▪ For CAPs, in the interim period until EMWP is available, it will be displayed on EMA website (on EPAR page of each medicine) ▪ For NAPs, in addition to the EMWP, NCAs may decide to also display ePI in their own national websites ▪ ePI will be publicly available for any other third-party use HMA/EMA Final Report of the European Medicines Agencies Network Strategy to 2025 – Published The final report of the European medicines agencies network strategy to 2025, has been published on the EMA website, outlining the main achievements of the network in implementing the strategy from January 2021 to the end of 2025. The strategy identified six priority focus areas, each with clear strategic goals and objectives. The final report presents the main achievements for each strategic focus area, as outlined below: • Availability and accessibility of medicines https://www.ema.europa.eu/en/documents/other/electronic-product-information-epi-roadmap_en.pdf https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/electronic-product-information-epi https://www.ema.europa.eu/en/documents/report/european-medicines-agencies-network-strategy-emans-2025-final-report_en.pdf AESGP OTC News | April 2026 8 | 22 • Data analytics, digital tools and digital transformation • Innovation • Antimicrobial resistance and other emerging health threats • Supply chain challenges • Sustainability of the network and operational excellence For each objective, the report has a section ‘Follow-up actions in EMANS 2028’ which describes further related activities the network will carry out as it implements the next strategy (EMANS 2028) from 2026 to 2028. The achievements described in this report have informed EMANS 2028 strategy, adopted in March 2026 under the overarching theme of ‘seizing opportunities in a changing medicines landscape’. Data Quality Framework for EU Medicines Regulation Application to Real-World Data – Published On 27 MAR, the updated “Data Quality Framework for EU Medicines Regulation application to Real- World Data (RW-DQF)”, as well as the “Outcome of the public consultation on the RW-DQF” were published by the EMA. Outcome of the public consultation on the RW-DQF The European Medicines Regulatory Network (EMRN) Data Quality Framework (DQF) for EU Medicines regulation was first published in 2022 to provide general considerations on data quality that are relevant for regulatory decision-making. The RW-DQF, which focuses on data quality underpinning real-world evidence generation encountered in medicines regulation, underwent public consultation for comments from 29 NOV 2024 to 28 FEB 2025. Overall, respondents expressed strong support for the initiative and its aim to strengthen data quality assurance for real-world data (RWD), while seeking: (1) greater clarity and consistency in terminology, (2) more precise definitions (e.g., RWD vs RWE, primary vs secondary use), (3) practical guidance and threshold requirements for data quality metric assessment, (4) feasible, proportionate expectations for data providers and sponsors. The feedback received has materially shaped revisions to the aforementioned RW-DQF. The updated RW-DQF had been adopted by the Methodology Working Party (MWP), the Network Data Steering Group (NDSG) and the Committee for Medicinal Products for Human Use (CHMP) and was published on the EMA website. Data Quality Framework for EU Medicines Regulation application to Real-World Data (RW-DQF) This document describes the Real-World Data (RWD) specific recommendations as derived from the EMRN DQF for EU Medicines regulation. The EMRN DQF for EU Medicines regulation sets out the principles, concepts, and definitions as intended to be applied widely across datasets used in medicine regulatory use cases. It also provides examples and in-depth clarifications on the developed framework elements for characterising, assessing, and assuring Data Quality (DQ) in the regulatory context. It is therefore recommended to use the EMRN DQF as a companion document when reading the updated RW-DQF. The application of RW-DQF, which is strongly encouraged by the EMA as a best practice framework for guiding the assessment of RWD quality, sets out the specificities of RWD and enable regulators to evaluate the quality of data underpinning Real-World Evidence (RWE) as used in the regulatory assessment. It builds upon existing regulatory guidance, such as EMA’s recommendations on RWE and ICH E6 (2) DQ principles, by offering specific methodological approaches tailored to secondary data use in regulatory decision-making. It also provides guidance on the relevance assessment of such data, as well as data reliability assessment to a research question based on DQ metrics and evidence of systems and processes underpinning data. These parts provide actionable and focused recommendations for assessing DQ of RWD, with the goal of supporting both the regulatory submission and assessment process and ultimately facilitate the use of RWE for regulatory purposes. Scope of the RW-DQF https://www.ema.europa.eu/en/documents/other/seizing-opportunities-changing-medicines-landscape-european-medicines-agencies-network-strategy-2028-final_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/smop/outcome-public-consultation-data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/smop/outcome-public-consultation-data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf AESGP OTC News | April 2026 9 | 22 RW-DQF applies to RWD recorded within routine clinical practice when used in the context of a specific research question and in line with the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) guide on Methodological Standards in Pharmacoepidemiology and the ICH M14 Guideline, including datasets available through the Data Analysis and Real-World Interrogation Network (DARWIN EU) and the EHDS. The following are examples of clinical practice data which could be considered in scope: administrative or claims data, Electronic Medical/Health Records (EMRs/EHRs), pharmacy/prescription data, patient registries, etc. Existing guidance specific to particular data types (e.g., guidance on registry-based studies for the use of patient registry data) still applies and the RW-DQF should be read in conjunction with any other relevant guidance documents. RW-DQF is intended to serve as a structured guide on the DQ elements to be assessed and documented for regulatory purposes. It is not designed to function as a detailed SOP or methodology manual. Methodological guidance is already covered in other existing guidance documents. Next Step • Future iterations of the RW-DQF may expand to address additional data types and emerging technologies that are increasingly relevant to regulatory decision-making. These could include direct- from-patient (or direct-from-user) data such as PROs, patient engagement and preference data, or non-prescription medicinal products. • The evolving landscape of RWD will likely be also shaped by innovations in artificial intelligence, wearable technologies, mobile health inputs, and social media-derived insights. • While all these areas are not within the scope of the current version, they represent important frontiers for future guidance, which will be addressed in the future, in alignment with regulatory needs and scientific advancements. Pharmacovigilance EMA - 2025 Annual Report on EudraVigilance – Published The EMA has published its 2025 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission; highlighting the continued central role of EudraVigilance in EU pharmacovigilance and patient safety. This annual report is produced in accordance with Regulation (EC) No. 726/2004, Article 24(2) and summarises the EudraVigilance-related activities for medicines for human use performed in 2025, including: • Operation of EudraVigilance, including its new functionalities, • Collecting and processing suspected adverse drug reaction reports, • Screening for, and review of, potential safety signals, • Supporting the central role of the PRAC in assessing and monitoring the safety of human vaccines and medicines in the EU, • Transparency and public access to aggregated EudraVigilance data, • Training and support activities. Several annexes are provided throughout the document, namely: • Annex I – Summary of EudraVigilance related activities • Annex II – EudraVigilance data-processing network and number of suspected adverse reaction reports processed by the EudraVigilance database • Annex III - Total number of medicinal product submissions by MAHs • Annex IV - EudraVigilance data quality activities • Annex V – Signal detection • Annex VI - Signal management process and methods • Annex VII - Requests for information and documents https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://encepp.europa.eu/document/download/f6e403a6-8033-4c22-a5ff-195ba3666299_en?filename=01.ENCePPMethodsGuideRev.11.pdf https://encepp.europa.eu/document/download/f6e403a6-8033-4c22-a5ff-195ba3666299_en?filename=01.ENCePPMethodsGuideRev.11.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m14-guideline-general-principles-planning-designing-analysing-reporting-non-interventional-studies-utilise-real-world-data-safety-assessment-medicines-step-5_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-registry-based-studies_en.pdf https://www.ema.europa.eu/en/documents/other/data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf https://www.ema.europa.eu/en/documents/report/2025-annual-report-eudravigilance-european-parliament-council-commission_en.pdf AESGP OTC News | April 2026 10 | 22 The report briefly highlights several key developments in EudraVigilance, including sustained increase in reporting volume, with continued growth in ICSRs reinforcing its role as a central EU safety database. The report also underlines the system’s core role in signal detection, supporting the work of PRAC and national competent authorities. In addition, enhanced data analytics and monitoring are emphasised, with increasing use of large datasets and statistical tools to strengthen proactive safety surveillance. Ongoing system and process improvements are also noted, particularly regarding optimisation of functionalities, guidance, and data quality. The full report is available here. EMA - EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of ICSRs The EMA published the EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports, following its adoption by the PRAC. The document aims to provide instructions on the practical implementation of the ICH E2D(R1) Guideline - Post-approval safety data: definitions and standards for management and reporting of individual case safety reports in the European Union (EU). It is intended to provide guidance for Marketing Authorisation Holders (MAHs), as well as for National Competent Authorities and Inspectors. The document provides guidance and clarification, in particular on: • Implementation of ICH E2D(R1) in the EU • Implementation of the definition for Patient Support Program • Implementation of the detailed documentations required for Organised Data Collection Systems not conducted according to a protocol The implementation strategy in detail is available here. Herbal medicines EMA HMPC launches 18 calls for scientific data - FOR INPUT by 1 JUN Further to the adoption by the EMA Committee on Herbal Medicinal Products (HMPC) on 4 March 2026, the calls for scientific data have been published in the context of the periodic review of several herbal medicinal product monographs. The HMPC invites the submission of relevant scientific literature published since the end date of the respective public consultations on these monographs and their supporting documents. The submission period will remain open until 15 JUN 2026. Current and recent calls for scientific data • Absinthii herba https://www.ema.europa.eu/en/documents/report/2025-annual-report-eudravigilance-european-parliament-council-commission_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishment https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishment https://www.ema.europa.eu/en/documents/herbal-monograph/call-scientific-data-periodic-review-monograph-absinthii-herba_en.pdf AESGP OTC News | April 2026 11 | 22 • Arctii radix • Chamomillae romanae flos • Filipendulae ulmariae flos • Filipendulae ulmariae herba • Herniariae herba • Leonuri cardiacae herba • Menthae piperitae aetheroleum • Menthae piperitae folium • Millefolii flos • Millefolii herba • Phaseoli fructus (sine semine) • Quercus cortex • Tanaceti parthenii herba • Taraxaci folium • Taraxaci radix cum herba • Thymi aetheroleum • Tormentillae rhizoma ACTION: • Any scientific data on EU herbal monographs listed above can be sent by 1 JUN in accordance with the guidance outlined in the procedure for calls for scientific data for use in HMPC assessment work for the submission of data. EMA's Draft Guideline on declaration of herbal substances and herbal preparations in HMPs / THMPs - Revision 2 - For Comments by 16 JUN On 1 APR, the EMA published the draft second revision of Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products. The draft guideline is open for public consultation until 30 JUN 2026. Scope and background This guideline outlines the principles for the uniform declaration of herbal substances/preparations when being the active substance of herbal medicinal products (HMPs) as well as traditional herbal medicinal products (THMPs). It focuses on the different types of herbal substances/preparations in relation to the quality documentation given. Examples of declaration of such active substances, including standardised, quantified, and other herbal substances/preparations are provided. While the main guideline describes only the declaration of herbal substances/preparations in HMPs (including fixed combinations) in the SmPC, detailed guidance on package leaflets, labelling and other herbal specific provisions, for SmPC, package leaflets and labelling, is provided in Annex 1. This guideline supports applications for marketing authorisations or registrations according to Directive 2001/83/EC and Regulation (EU) 2019/6 as amended as well as the simplified registration procedure for THMPs for human use under Directive 2001/83/EC as amended by Directive 2004/24/EC. The principles for declaration of herbal substances/preparations in HMPs apply equally to such THMPs for human use. THMPs may additionally contain vitamins and/or minerals. Declaration of these chemically defined substances is not covered by this guideline. Reference is given to the INN-system and to “A Guideline on Summary of Product Characteristics (SmPC)”. This guideline should also be read in conjunction with current EU/(V)ICH guidelines and the relevant QRD templates. The main changes in Revision 2 • General guidance and examples for declaration of extracts and other herbal drug preparations have been updated, to specify that in European procedures, declarations with both of two options (the genuine drug extract ratio; DERgenuine and the corresponding mass of herbal substance) should now be stated in the common SmPC. It is noted that application of the preferred one of the two options for the national SmPC is considered a national issue to be solved after the end of the procedure. https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-arctii-radix_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-chamomillae-romanae-flos_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-filipendulae-ulmariae-flos_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-filipendulae-ulmariae-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-herniariae-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-leonuri-cardiacae-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-menthae-piperitae-aetheroleum_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-menthae-piperitae-folium_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-millefolii-flos_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-millefolii-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-phaseoli-fructus-sine-semine_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-quercus-cortex_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-tanaceti-parthenii-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-taraxaci-folium_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-taraxaci-radix-cum-herba_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-thymi-aetheroleum_en.pdf https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-tormentillae-rhizoma_en.pdf https://www.ema.europa.eu/documents/regulatory-procedural-guideline/procedure-calls-scientific-data-use-hmpc-assessment-work_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-declaration-herbal-substances-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-2_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-declaration-herbal-substances-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-2_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-declaration-herbal-substances-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-2_en.pdf AESGP OTC News | April 2026 12 | 22 • Chapters 5 and 6 have been updated to elaborate the guidance on declaration of herbal substances and herbal preparations, most notably regarding naming of herbal substances, and declaration of fresh and frozen herbal substances, extraction solvents, excipients, and combination products. • Editorial changes have been made throughout the guideline, primarily to take account of updated legislation, revisions of relevant Ph. Eur. provisions, and EU guidelines. ACTION: • Major comments, together with their rationale, can be sent by using this template to AESGP- medicines@aesgp.eu by 16 JUN 2026. https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Ftemplate-form%2Fform-submission-comments-scientific-guidelines_en.doc&wdOrigin=BROWSELINK mailto:AESGP-medicines@aesgp.eu mailto:AESGP-medicines@aesgp.eu AESGP OTC News | April 2026 13 | 22 EFSA Safety of carbon dioxide extract from Cannabis sativa L. as a novel food On 30 MAR, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) published its Safety of carbon dioxide extract from Cannabis sativa L. as a novel food pursuant to Regulation (EU) 2015/2283 The opinion was delivered following a request from the European Commission concerning the proposed novel food (NF) intended for use in food supplements at maximum use levels ranging from 1.12 mg/day for children above 3 years of age to 3.60 mg/day for adults, excluding pregnant and lactating women. The NF contains cannabidiol (CBD) as well as other cannabinoids. The Panel notes that a substantial proportion of the NF remains uncharacterised. The absence of adequate stability and of toxicological studies performed with a representative test item prevents the Panel from drawing conclusions on the safety assessment of the NF. Additionally, no data were provided by the applicant to address the safety of the NF in the general population above 3 years of age. Therefore, the safety of the NF under the proposed conditions of use cannot be established. Food https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10004 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10004 AESGP OTC News | April 2026 14 | 22 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 MDCG Nomenclature and market surveillance WG. AESGP Position on MDR Revision Proposal 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 to the public consultation on the Commission's “Have your say” website. The position has also been published on the website of AESGP and may be accessed here. Medical Devices 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://aesgp.eu/articles/aesgp-position-on-the-european-commissions-proposal-to-simplify-medical-devices-rules AESGP OTC News | April 2026 15 | 22 PPWR - EC guidelines on the implementation of PPWR & FAQ document - 30 MAR 2026 On 30 March 2026, the European Commission published its guidelines on the implementation of the Packaging and Packaging Waste Regulation (PPWR) and the FAQ document. • the press release here. • the guidelines on the implementation of PPWR here. • the FAQ document here. The guidelines explain several aspects of the PPWR, including definitions and roles, which items fall under the definition of ‘packaging’, application of the restrictions on single-use packaging, enforcement of the PFAS limits in food-contact materials, interpretations of the new re-use targets, and guidance on EPR obligations for setting up deposit and return systems. Alongside the guidance, the EC also shared a FAQ document addressing practical questions raised since the adoption of the PPWR and which will be updated periodically. OFFICIAL NEXT STEPS • The guidelines will now be translated into all EU languages before its formal adoption. • EC will continue to support MS and stakeholders to ensure an effective roll-out of the new rules. • Several delegated and implementing acts are under preparation, notably on harmonised registration and reporting formats for EPR schemes, consumer waste-sorting labelling, recycled content in plastic packaging, and recyclability criteria. WFD+GWD+EQSD - Publication in OJ - 20 APR 2026 The revised Water Framework Directive (WFD), Environmental Quality Standards (EQS), and Groundwater Directive (GWD) package (Directive (EU) 2026/805) has been published in the Official Journal on 20 April 2026. The Directive was formally adopted on 30 March and will enter into force 20 days after publication, approximately 10 May 2026. The publication is available here: Directive (EU) 2026/805 of the European Parliament and of the Council of 30 March 2026 amending Directive 2000/60/EC establishing a framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of groundwater against pollution and deterioration and Directive 2008/105/EC on environmental quality standards in the field of water policy (Text with EEA relevance). While the final text will be assessed in more detail, a few elements of relevance have been highlighted below: Extended producer responsibility (EPR) • As anticipated, the final text does not introduce an EPR system, but it requires the Commission to prepare a report by 2029 on the feasibility of introducing EPR under the WFD. Environment https://ec.europa.eu/commission/presscorner/detail/en/ip_26_664 https://environment.ec.europa.eu/document/download/3d59ca88-539c-4b6b-a623-0f61068e853e_en?filename=Annex%20to%20the%20Communication%20to%20the%20Commission.pdf file:///C:/Users/Ville-WaltteriVirtan/Downloads/packaging%20and%20packaging%20waste%20regulation%20ppwr-KH0126006ENN.pdf https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600805 AESGP OTC News | April 2026 16 | 22 • The Directive also explicitly refers to monitoring costs linked to substances listed under the EQS and GWD. ➔ This keeps EPR relevant in the EU water policy, but without immediate legal or financial obligations for producers; instead, the scope remains exploratory and politically sensitive with clear parallels to UWWTD. ‘Total pharmaceuticals’ vs. substance-specific approach • The Directive introduces binding standards for a limited number of individual pharmaceuticals, notably in groundwater, and explicitly defers decisions on ‘total pharmaceuticals’ or grouped standards to future reviews. • The Directive adds ‘sum(s) of selected pharmaceuticals by mode of action’ only to lists for future considerations, not as enforceable standards. ➔ This confirms that currently the legislators have not endorsed a blanket approach on pharmaceuticals, preferring substance-specific approach with pilots on mixtures and effect-based monitoring. Pharmaceuticals used in self-care products • Diclofenac and ibuprofen are listed as priority substance with binding EQS for surface water. ➔ As an important outcome from the trilogue, OTC medicinal substances like paracetamol, acetylsalicylic acid, naproxen, and caffeine are not listed as priority substances, not listed in groundwater standards, nor have assigned EQS. PFAS prioritisation • The Directive expands PFAS coverage by prioritising certain PFAS explicitly in surface water and groundwater and by introducing ‘PFAS total’ as a future monitoring concept not yet binding to EQS. • Trifluoroacetic acid (TFA) receives particular attention, including a mandate to consider setting a standalone standard for this substance at the next review. ➔ Importantly, all these PFAS are environmental degradation products rather than substances placed on the market. Bishpenol A • Bisphenol A (BPA) is listed as a priority substance with binding EQS for surface water and assumes possible future review of bisphenols as a substance group (for example, ‘sum of bisphenols’), without binding EQS at this stage. ➔ Bisphenols are not used as APIs, but their relevance relates to packaging and materials use and their endocrine-disrupting properties. ‘Metabolites’ or degradation products • The Directive continues to use the concept of ‘metabolites’ in places, but in practice refers more to degradation and transformation products in water. • Some of the substances like TFA are formed in the environment, not intentionally manufactured; this weakens the analytical link between chemical regulation at source and environmental concentration control. ➔ This also potentially complicates any future discussion on EPR or producer accountability. Links with the Drinking Water Directive (DWD) & Urban Wastewater Treatment Directive (UWWTD) DWD • The Directive does not introduce new obligations for the self-care sector; however, it does frame groundwater quality standards to support compliance with drinking water parametric values and references methodologies used in DWD for certain substances like PFAS. UWWTD • The Directive links to the UWWTD by monitoring and pollution control along the entire water cycle (surface water, groundwater, wastewater, reuse). • The Directive draws experience from EPR under UWWTD as a reference point for future assessment under WFD. ➔ However, the Directive does not introduce no EPR mechanism under the water acquis, no new obligations related to sewage sludge or sludge quality standards and refers to UWWTD primarily as a context and precedent. OFFICIAL NEXT STEPS • The Directive will enter into force 20 days after the publication in the Official Journal which would be around 10 May 2026. AESGP OTC News | April 2026 17 | 22 • Member States must transpose the Directive into national law by 21 December 2027. • Following entry into force, the Commission is formally empowered to adopt a significant number of implementing and delegated acts notably on: o Monitoring methods and technical specifications for effect-based monitoring and watchlist sampling and reporting formats o Watchlists for surface water and groundwater (first updates are due from mid-2028) o Reporting formats and indicators of progress to be used by MS. • For newly introduced or revised substances: o Monitoring obligations generally apply first (from 2027) o Programs of measures follow (from 2030) o Achievement of good status is expected by 2033 or 2039, depending on the substance and concerned annex. • EU agencies are working in several preparatory workstreams: o ECHA will prepare scientific reports to support future reviews and provide input to watchlist prioritization and substance grouping. o EEA will align reporting streams and increase public availability of monitoring data. • Two formally mandated EU Commission reports will be prepared: o By 11 November 2027 – Commission report on the feasibility of a joint EU monitoring facility. o By 11 May 2029 – Commission report on the possible introduction of an EPR mechanism in WFD, explicitly referring to experience under UWWTD and waste regulation. • The next comprehensive EU-level review of pollutant lists and standards is scheduled for 11 May 2032, and every six years thereafter. AESGP OTC News | April 2026 18 | 22 European Commission DG SANTE's FAQs on the European Health Data Space Regulation (EU) 2025/327 – Published The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has published an updated version (version 1.1) of the Frequently Asked Questions (FAQs) on the European Health Data Space (EHDS) Regulation (EU) 2025/327. This living document provides answers to frequently asked questions (FAQs), complements other information related to the EHDS Regulation, and may be updated in the future. Compared to the previous version, the updated FAQs introduce the following changes: • Corrections of typos and cross-references throughout the document, • Expanded content for questions 22, and 55-56, • The addition of questions 24, 40, 48, 66, and 67. Please also note that, any views expressed in this document are the preliminary views of the European Commission services and may not under any circumstances be regarded as stating an official position of the European Commission. The replies to the frequently asked questions do not extend or restrict in any way the rights and obligations deriving from applicable legislation nor introduce any additional requirements. The expressed views are not authoritative and cannot prejudge any future actions the European Commission may take, including potential positions before the Court of Justice of the European Union. Only the Court of Justice of the European Union is competent to authoritatively interpret EU law. European Parliament's position on a simplification proposal amending the Artificial Intelligence Act (AIA) – Adopted On Thursday, 26 MAR 2026, the European Parliament adopted its position on a simplification (“omnibus”) proposal amending the Artificial Intelligence Act (AIA), by 569 votes in favour, 45 against, and 23 abstentions. The proposal aims to simplify existing artificial intelligence rules and introduce clear application timelines for high-risk system requirements, as well as a ban on AI “nudifier” systems. It would also delay the application of certain rules on high-risk artificial intelligence (AI) systems to ensure that guidance and standards to support implementation are in place. In particular, Members of the European Parliament have agreed on proposals to: • Introduce fixed dates for application to ensure predictability and legal certainty, namely: ➢ For high-risk AI systems specifically listed in the regulation (including those involving biometrics, and those used in critical infrastructure, education, employment, essential services, law enforcement, justice and border management), 2 DEC 2027 as the proposed date of application. Cross-Sectorial News https://health.ec.europa.eu/latest-updates/frequently-asked-questions-european-health-data-space-2026-03-26_en https://health.ec.europa.eu/latest-updates/frequently-asked-questions-european-health-data-space-2026-03-26_en https://www.europarl.europa.eu/news/en/press-room/20260323IPR38829/artificial-intelligence-act-delayed-application-ban-on-nudifier-apps https://www.europarl.europa.eu/news/en/press-room/20260323IPR38829/artificial-intelligence-act-delayed-application-ban-on-nudifier-apps AESGP OTC News | April 2026 19 | 22 ➢ For AI systems that are covered by EU sectoral legislation on safety and market surveillance, 2 AUG 2028 as the proposed date of application. • Provide for a transitional period allowing providers until 2 NOV 2026 to comply with rules on watermarking AI-created audio, image, video or text content to indicate its origin. • Ban “nudifier” systems/apps that use AI to create or manipulate images that are sexually explicit or intimate and resemble an identifiable real person without that person’s consent. The ban would not apply to AI systems with effective safety measures preventing users from creating such images. • Introduce measures aimed at increasing flexibility and supporting small mid-cap enterprises (SMCs), including: ➢ Allowing service providers to process personal data for the purposes of detecting and correcting biases in AI systems, subject to appropriate safeguards, and only where such processing is strictly necessary. ➢ Extending certain support measures currently available to small and medium-sized enterprises (SMEs) to small mid-cap enterprises (SMCs), in order to support EU companies as they scale up beyond SME status. ➢ Reducing the risk of overlapping regulatory requirements by allowing obligations under the Artificial Intelligence Act to be less stringent for AI systems integrated into products already regulated under EU sectoral legislation (e.g. medical devices, radio equipment, toy safety, and others). NEXT STEP • Negotiations with the Council on the final form of the law can now begin. BACKGROUND • The legislation voted is part of the seventh omnibus package on simplification proposed by the European Commission on 19 NOV 2025 (“the digital omnibus”). • Parliament is also currently working on the other proposals in the package: the digital omnibus on amending laws on data use and data protection, and the proposal establishing European business wallets. EC – Launch of Initiatives to Develop Implementing Regulation for the European Health Data Space (EHDS) The two initiatives related to the implementing regulation on European Health Data Space (EHDS) have been launched and published on the European Commission website, as outlined below: • European Health Data Space – common specifications for the European digital testing environment • European Health Data Space – specifications for the European electronic health exchange format (EEHRxF) European Health Data Space – common specifications for the European digital testing environment The EHDS Regulation requires electronic health record (EHR) systems to have the two harmonised software components tested in a digital testing environment. This initiative sets out the common specifications, functional and non-functional requirements for the European digital testing environment. The European Commission will provide this European digital testing environment as an open-source reference implementation. The Member States will deploy and operate their digital testing environments. The adoption of the implementing regulation by the European Commission is currently planned for Q1 2027. European Health Data Space – specifications for the European electronic health exchange format (EEHRxF) https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0360(COD) https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0358(COD) https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0358(COD) https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17513-European-Health-Data-Space-common-specifications-for-the-European-digital-testing-environment_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17513-European-Health-Data-Space-common-specifications-for-the-European-digital-testing-environment_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17512-European-Health-Data-Space-specifications-for-the-European-electronic-health-exchange-format-EEHRxF-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17512-European-Health-Data-Space-specifications-for-the-European-electronic-health-exchange-format-EEHRxF-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17513-European-Health-Data-Space-common-specifications-for-the-European-digital-testing-environment_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17513-European-Health-Data-Space-common-specifications-for-the-European-digital-testing-environment_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17512-European-Health-Data-Space-specifications-for-the-European-electronic-health-exchange-format-EEHRxF-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17512-European-Health-Data-Space-specifications-for-the-European-electronic-health-exchange-format-EEHRxF-_en AESGP OTC News | April 2026 20 | 22 The European electronic health record exchange format (EEHRxF) will be the format to be used for cross-border exchanges of electronic health data. This initiative sets out the specifications for the EEHRxF. It will cover the exchange of patient summaries, electronic prescriptions, electronic dispensations, medical imaging studies and related imaging reports, medical test results (including laboratory and other diagnostic results and related reports), and discharge reports. The adoption of the implementing regulation by the European Commission is currently planned for Q4 2026. EHDS Board operations - Commission Implementing Regulation (EU) 2026/771 – Published On 8 APR, Commission Implementing Regulation (EU) 2026/771 of 7 April 2026 laying down the necessary measures for the establishment and operation of the European Health Data Space Board, was published on the Official Journal of the European Union (OJEU). This Regulation lays down the necessary rules for the establishment, the management and the functioning of the European Health Data Space Board (the ‘EHDS Board’). This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall be binding in its entirety and directly applicable in all Member States. Draft Commission Implementing Regulations concerning the European Health Data Space (EHDS) - Published for consultation The European Commission has published three draft Implementing Regulations concerning the European Health Data Space (EHDS), as outlined below. 1. European Health Data Space – dataset descriptions • As part of the European Health Data Space, health data holders will have to provide descriptions of their datasets to the health data access bodies so they can be included in the dataset catalogues. This initiative lays down the minimum metadata elements for dataset descriptions, and the characteristics of those elements, that health data holders are required to provide to health data access bodies pursuant to Article 60(3) of Regulation (EU) 2025/327 for the secondary use of electronic health data, as well as the metadata framework to be used for that purpose. • The draft implementing regulation is currently open for public consultation until 12 MAY 2026. The Commission adoption is planned for Q3 2026, and the implementing regulation is anticipated to apply from 26 MAR 2029. 2. European Health Data Space – requirements for cross-border exchange of personal health data (MyHealth@EU) • MyHealth@EU is the infrastructure set up under the European Health Data Space that supports the cross-border exchange of personal electronic health data, such as patient summaries and prescriptions. This initiative sets out detailed requirements for this infrastructure including cybersecurity, technical interoperability, semantic interoperability, operations and service management in relation to the processing by the Commission as processor for MyHealth@EU and its responsibilities towards the joint controllers. • The draft implementing regulation is currently open for public consultation until 07 MAY 2026. The Commission adoption is planned for Q2 2026, and the implementing regulation is anticipated to apply from 26 MAR 2027. 3. European Health Data Space – identity management https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202600771 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202600771 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202600771 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15673-European-Health-Data-Space-dataset-descriptions_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15594-European-Health-Data-Space-requirements-for-cross-border-exchange-of-personal-health-data-MyHealth@EU-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15594-European-Health-Data-Space-requirements-for-cross-border-exchange-of-personal-health-data-MyHealth@EU-_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15353-European-Health-Data-Space-identity-management_en AESGP OTC News | April 2026 21 | 22 • This initiative lays down the requirements for the interoperable, cross-border identification and authentication mechanism for natural persons, health professionals and healthcare providers for the purposes of cross-border exchange of electronic health data, in line with the eIDAS Regulation. These requirements provide the foundation for EU countries and the Commission to implement the mechanism in MyHealth@EU, supporting the cross-border exchange of personal electronic health data. • The draft implementing regulation is currently open for public consultation until 07 MAY 2026. The Commission adoption is planned for Q2 2026, and the implementing regulation is anticipated to apply from 26 MAR 2027, whereas Article 3(3) and Article 5(2) are anticipated to apply from 26 MAR 2029. AESGP — Association of the European Self-Care Industry Avenue de Tervuren, 7 1040 Brussels Belgium info@aesgp.eu www.aesgp.eu

Die ECHA hat am 24. August 2026 eine gezielte Konsultation ("targeted consultation") im Rahmen eines laufenden Verfahrens zur harmonisierten Einstufung und Kennzeichnung (CLH) einer Stoffgruppe von Ortho-Phthalaten gestartet. Die Konsultation läuft bis zum 4. September 2026. Anlass für die gezielte Konsultation sind neue Informationen, die während der regulären öffentlichen Konsultation eingereicht wurden. Der Industrieverband Valtris hatte Studien zur Stoffgruppe „S278“ (EC 701-008-3) vorgelegt. Die Untersuchungen zu einer Reaktionsmasse bestimmter Benzyl-Ortho-Phthalate ergaben nach Angaben der ECHA keine Hinweise auf reproduktionstoxische oder endokrinschädigende Wirkungen. Der Dossiereinreicher Frankreich bewertete die vorgelegten Studien als zuverlässig und überprüfte daraufhin die ursprünglich vorgeschlagene Stoffgruppenbezeichnung. Ziel ist es, die als „S278“ bezeichneten Verbindungen von der geplanten harmonisierten Einstufung auszunehmen. Die ECHA hat deshalb eine gezielte Konsultation zur vorgeschlagenen Neufassung der Stoffgruppenbezeichnung eröffnet. Die vorgeschlagene Stoffgruppe umfasst Mono- und Di-Ortho-Phthalatester mit mindestens einer der folgenden Esterfunktionen: lineare oder verzweigte Alkylgruppen mit einem Kohlenstoffgerüst von C4 bis C6 und möglichen Methyl- oder Ethylsubstituenten, Benzylgruppen, deren benzylenständiges Kohlenstoffatom gegebenenfalls durch Methyl- oder Ethylgruppen substituiert ist, Cyclopentyl- oder Cyclohexylgruppen mit möglichen Methyl- oder Ethylsubstituenten. Für Di-Ortho-Phthalate gelten zusätzliche Kriterien für die zweite Esterfunktion. Durch die überarbeitete Formulierung sollen bestimmte Stoffe, darunter die als S278 bezeichneten Verbindungen, nicht mehr vom Anwendungsbereich des Eintrags erfasst werden. Für die verbleibende Stoffgruppe schlägt Frankreich weiterhin eine harmonisierte Einstufung als reproduktionstoxisch (Repr. 1B, H360D) sowie als endokriner Disruptor für die menschliche Gesundheit (ED HH 1, EUH380) und die Umwelt (ED ENV 1, EUH430) vor. Darüber hinaus enthält der Entwurf eine besondere Anmerkung für Gemische und Mehrstoffprodukte. Danach sollen Konzentrationen aller unter den Eintrag fallenden Stoffe für die Bewertung reproduktionstoxischer und endokrinschädigender Eigenschaften addiert werden. Dies könnte dazu führen, dass Gemische bereits bei niedrigeren Einzelkonzentrationen die entsprechenden Einstufungsgrenzen erreichen. Die aktuelle gezielte Konsultation bezieht sich ausschließlich auf die vorgeschlagene Bezeichnung des Stoffeintrags. Die im Konsultationsverfahren eingehenden Informationen werden vom Ausschuss für Risikobeurteilung (RAC) bei der Erarbeitung seiner Stellungnahme berücksichtigt. Unternehmen, die Ortho-Phthalate herstellen, importieren oder in Gemischen verwenden, sollten prüfen, ob ihre Stoffe von der vorgeschlagenen Gruppendefinition erfasst werden. Insbesondere für Hersteller von Gemischen könnten sich durch die vorgesehene Summationsregel künftig weitergehende Einstufungs- und Kennzeichnungspflichten ergeben. Hintergrund Gezielte Konsultationen werden von der ECHA durchgeführt, wenn im Verlauf eines CLH-Verfahrens zusätzliche wissenschaftliche Informationen zu einzelnen Gefahrenklassen oder spezifischen Aspekten eines Vorschlags benötigt werden. Anders als die reguläre öffentliche Konsultation konzentrieren sie sich auf klar abgegrenzte Fragestellungen und laufen in der Regel über einen kürzeren Zeitraum. Die eingegangenen Stellungnahmen fließen in die wissenschaftliche Bewertung des Ausschusses für Risikobeurteilung (RAC) ein und können Auswirkungen auf die endgültige Fassung eines CLH-Eintrags haben.

Das Sozialgericht (SG) Frankfurt hat einen Eilantrag auf weitere Versorgung mit Cannabisblüten zu Lasten der Gesetzlichen Krankenversicherung abgelehnt. Die Antragstellerin wird seit rund drei Jahren wegen einer schweren neurologischen Erkrankung mit Cannabisblüten behandelt. Nach der gesetzlichen Änderung, mit der Cannabisblüten aus der GKV-Versorgung gestrichen wurden, begehrte sie im Wege des einstweiligen Rechtsschutzes die Fortführung der Therapie. Sie verwies unter anderem auf eine unbefristete Genehmigung ihrer Krankenkasse, fehlende Behandlungsalternativen, mögliche schwerwiegende gesundheitliche Folgen sowie ihre fehlenden finanziellen Mittel zur Selbstfinanzierung der Therapie. Das Gericht stellte fest, dass seit Inkrafttreten GKV-Beitragsstabilisierungsgesetzes keine Anspruchsgrundlage für die Versorgung mit Cannabisblüten mehr bestehe. Eine Übergangsvorschrift sei nicht vorgesehen worden. Der Gesetzgeber habe die Streichung unter anderem mit finanzwirtschaftlichen Erwägungen zur Beitragsstabilisierung, einer höheren Suchtgefahr bei inhalativer Anwendung sowie Wirkstoffschwankungen des Naturprodukts begründet. Aus medizinischer Sicht seien standardisierte Fertigarzneimittel und Rezepturen grundsätzlich vorzugswürdig. Auch die verfassungsrechtlichen Einwände der Antragstellerin hatten nach summarischer Prüfung keinen Erfolg. Das Sozialgericht verwies auf den Gestaltungsspielraum des Gesetzgebers bei der Ausgestaltung des GKV-Leistungskatalogs. Die gesetzlichen Krankenkassen seien verfassungsrechtlich nicht verpflichtet, jede verfügbare medizinische Leistung zu finanzieren. Der Leistungskatalog dürfe auch von Wirtschaftlichkeits- und Finanzierungsaspekten geprägt sein. Ein unmittelbarer verfassungsrechtlicher Leistungsanspruch komme nur in eng begrenzten Ausnahmefällen in Betracht, etwa bei einer lebensbedrohlichen oder regelmäßig tödlich verlaufenden Erkrankung und fehlenden Behandlungsalternativen. Diese Voraussetzungen sah das Gericht hier nicht als erfüllt an. Zwar leide die Antragstellerin an einer schwerwiegenden neurologischen Erkrankung; diese sei jedoch nicht lebensbedrohlich. Ihr bleibe zudem ein erneuter Therapieversuch mit cannabishaltigen Fertigarzneimitteln. Nach dem Inkrafttreten des GKV-Beitragsstabilisierungsgesetzes und damit auch des Ausschlusses von Cannabisblüten aus der GKV-Erstattung haben sich eine Reihe von Fragestellungen ergeben. Dies ist eine erste Entscheidung in einem Eilverfahren in diesem Kontext. Das Urteil (S 14 KR 409/26 ER) kann auf der Website des Bürgerservices Hessenrecht eingesehen werden.

Quelle: Börse Express Assembly Biosciences Aktie: 37 Prozent Kursgewinn in 30 Tagen Assembly Biosciences verringert Nettoverlust auf 3,9 Mio. USD und kündigt neue klinische Studien für Leber- und Herpes-Therapien an. Originalbeitrag lesen Quelle: Hessische Niedersächsische Allgemeine Gynäkologe klärt auf und bricht mit Tabu rund um die Wechseljahre Erste Beschwerden zeigen sich durch schlechteren Schlaf, Gereiztheit oder Wortfindungsstörungen. Viele Frauen bringen diese Symptome zunächst nicht mit hormonellen Veränderungen in Verbindung. Originalbeitrag lesen Quelle: aeroTELEGRAPH HB-JNF: Swiss untersucht Boeing 777 nach Ausweichlandung auf den Azoren Swiss untersucht die Boeing 777-300 ER, die am Dienstag (25. August) auf dem Weg von Chicago nach Zürich wegen eines stechenden Geruchs in der Economy Class auf die Azoren ausweichen musste. Flug LX9 mit 222 Passagieren und 16 Crewmitgliedern landete sicher auf dem Flughafen Lajes. Fünf Reisende und ein Crewmitglied ließen sich wegen vorübergehender Beschwerden wie gereizten Augen, Übelkeit oder Kopfschmerzen untersuchen. Eine weitere Behandlung war nicht nötig. Originalbeitrag lesen Quelle: BR24 Schauspieler und Musicalstar Tim Curry ist tot Der britische Schauspieler und Musiker Tim Curry ist im Alter von 80 Jahren gestorben. Bekannt wurde der Musicalstar unter anderem als Dr. Frank N. Furter in der "Rocky Horror Picture Show". Nach einem Schlaganfall im Jahr 2012 saß er im Rollstuhl. Originalbeitrag lesen Quelle: Börse Express Novo Nordisk Aktie: Entscheidet die Wegovy-Pille über den nächsten Kurstrend? Der dänische Pharmakonzern startet die entscheidende OASIS-5-Studie zur Wegovy-Pille. Analysten sehen Potenzial, doch die Aktie verliert heute an Wert. Originalbeitrag lesen Quelle: Neue Westfälische Neue Impfung gegen schwarzen Hautkrebs: Studie mit Patienten aus Minden macht Hoffnung Moderna hat einen Impfstoff gegen schwarzen Hautkrebs entwickelt. Der Direktor der Universitätsklinik für Dermatologie in Minden ordnet die neue Therapie ein. Originalbeitrag lesen Quelle: merkur.de Günstiger Asphalt statt teures Pflaster? Anwohner streiten mit Stadt Anwohner der Nicolaus-Gallus-Straße protestieren gegen die Asphaltierung ihrer gepflasterten Straße. Sie warnen vor den Folgen für das Mikroklima. Originalbeitrag lesen Quelle: Tagesspiegel Parade auf Potsdams Pflaster: Die KAP läuft sich warm fürs Jubiläum Mit einem Wandelkonzert durch die Einkaufsmeile hat die Kammerakademie Potsdam ihre Jubiläumsspielzeit begonnen. Zu feiern sind musikalische Exzellenz und ein Vierteljahrhundert Durchhaltevermögen. Originalbeitrag lesen Quelle: Frankfurter Neue Presse Zwei Mitarbeiter am Flughafen Frankfurt sterben nach Malaria-Infektion - Mücke reiste im Flieger ein Am Flughafen Frankfurt sind zwei Mitarbeiter an Malaria gestorben. Zuvor hatten sich mehrere Beschäftigte infiziert. Der Flughafenbetreiber reagiert. Originalbeitrag lesen Quelle: Wallstreet Online Dermapharm Holding Aktie heute deutlich schwächer - was Anleger wissen sollten - 26.08.2026 26.08.2026 - Am 26.08.2026 ist die Dermapharm Holding Aktie, bisher, um -4,93 % gefallen. Lesen Sie hier alle wichtigen Informationen zum Kursgeschehen der Dermapharm Holding Aktie. Originalbeitrag lesen Quelle: Promiflash.de Nach Krebs-OP: Vanessa Trump geht es endlich wieder besser Vanessa Trump kämpfte sich durch harte Monate. Jetzt verrät ihre Tochter Kai, wie es ihrer Mutter nach der Brustkrebs-OP geht. Originalbeitrag lesen Quelle: Offenbach-Post Tödliche Malaria-Fälle in Frankfurt: Gibt es einen Impfstoff? Ja, aktuell gibt es einen Impfstoff, aber es gibt auch einen Haken. echo24 klärt die Frage, ob sich Reisende jetzt impfen lassen sollten. Lesen Sie hier: Originalbeitrag lesen Quelle: RTL Online Standing Ovations für Krebskranken Johann Lafer bei „Grill den Henssler” Lange hält Johann Lafer seine Krebs-Erkrankung geheim. Doch im Mai macht er sie öffentlich. Auch wenn der Star-Koch von der Chemotherapie gezeichnet ist, nimmt er nun wieder an TV-Shows wie dem „Grill den Henssler Sommer-Special“ teil. Das Publikum dankt es ihm. Originalbeitrag lesen Quelle: n-tv NACHRICHTEN Standing Ovations für Star-Koch: Krebskranker Johann Lafer beehrt "Grill den Henssler" Lange hält Johann Lafer seine Krebs-Erkrankung geheim. Doch im Mai macht er sie öffentlich. Auch wenn der Star-Koch von der Chemotherapie gezeichnet ist, nimmt er nun wieder an TV-Shows wie dem "Grill den Henssler Sommer-Special" teil. Das Publikum dankt es ihm. Originalbeitrag lesen Quelle: DER SPIEGEL Frankreich: Gericht stuft Brustkrebs von Flugbegleiterin als Berufskrankheit ein Rund 30 Jahre arbeitete eine Frau als Flugbegleiterin für Air France und erkrankte in dieser Zeit an Brustkrebs. Jetzt hat sie ein wegweisendes Urteil erstritten. Originalbeitrag lesen Quelle: Berliner Morgenpost Akne & Isotretinoin: Hautarzt warnt vor Risiken und Nebenwirkungen Isotretinoin wird in sozialen Medien als Wundermittel für schöne Haut gefeiert. Ein Dermatologe warnt jedoch vor ernsten Nebenwirkungen. Originalbeitrag lesen Quelle: Promiflash.de 25 Kilo abgenommen: Torsten Sträter möchte wieder zulegen Statt Diät steht Zunehmen auf dem Plan: Nach Diabetes-Diagnose und radikaler Ernährungsumstellung will Torsten Sträter nun wieder zunehmen. Originalbeitrag lesen Quelle: Abendzeitung (Az) Pflaster gegen die Hitze: München soll Klimasteine nach Nürnberger Vorbild testen Wie die ÖDP-Stadtratsfraktion mit einem speziellen Pflaster die Hitzeinseln in München kühlen und Regenwasser speichern will. Originalbeitrag lesen Quelle: Pforzheimer Zeitung Öschelbronn hat Leukämie: Freunde suchen dringend einen Stammzellspender Freunde und Bekannte organisieren große Hilfsaktion in Niefern-Öschelbronn für Betroffene. Originalbeitrag lesen Quelle: Berliner Morgenpost Schmerzen: Neues Medikament Exilby bald erhältlich - mit „Pluspunkt“ „Exilby“, das bei starken Rückenschmerzen helfen soll, wird ab 1. September am Markt eingeführt. Ärzte erklären die Vor- und Nachteile. Originalbeitrag lesen Quelle: WELT Longevity: Das verrät das biologische Alter unserer Organe über unsere Gesundheit Nicht jedes Organ folgt derselben inneren Uhr. Forscher zeigen nun, wie sich das biologische Alter einzelner Organe bestimmen lässt und was das über die Gesundheit verrät. Originalbeitrag lesen Quelle: merkur.de Diese Länder haben andere Modelle Die geplante Abgabe auf Softdrinks soll Diabetes bekämpfen. Ein Blick ins Ausland zeigt, wie unterschiedlich andere Länder das Problem lösen. Originalbeitrag lesen Quelle: BR24 Corona-Impfstoff: Sputnik-Hersteller in Bayern vor dem Aus Die deutsche Tochter des russischen Medikamentenherstellers R-Pharm hat Insolvenz angemeldet. Hauptgrund ist der Krieg in der Ukraine. Zu Corona-Zeiten hatte sich unter anderem Markus Söder für die Impfstoffproduktion in Illertissen eingesetzt. Originalbeitrag lesen Quelle: Börse Express Gossamer Bio Aktie: 12-Prozent-Crash auf 0,1560 Euro Gossamer Bio sichert sich bis zu 250 Mio. US-Dollar für die Seralutinib-Entwicklung. Die FDA-Zulassung ist zentraler Meilenstein der Kapitalstrategie. Originalbeitrag lesen Quelle: RP ONLINE Frankreich: Gericht erkennt Brustkrebs von Flugbegleiterin an Nach 30 Jahren bei Air France gilt Sophie Lainaults Brustkrebs als Berufskrankheit. Nachtarbeit und Strahlung könnten ihn befördert haben. Nun soll ihr Fall anderen Frauen helfen. Originalbeitrag lesen Quelle: noz.de - Neue Osnabrücker Zeitung Ohne Impfung: Zwei Menschen sterben an Masern in Pennsylvania Erstmals seit 35 Jahren sind im US-Bundesstaat Pennsylvania zwei ungeimpfte Menschen an Masern gestorben. Warum die Infektionen in den USA zunehmen. Originalbeitrag lesen Quelle: Focus Bruce Willis' Tochter Rumer testet sich auf Alzheimer-Risiko Rumer Willis lässt sich wegen ihrer Familiengeschichte auf ihr Alzheimer-Risiko testen. Der Schritt steht auch im Zusammenhang mit der Demenzerkrankung ihres Vaters Bruce Willis. Originalbeitrag lesen Quelle: BUNTE.de Rumer Willis über ihren an Demenz erkrankten Vater Bruce: „Ich vermisse ihn so sehr“ Rumer Willis spricht offen über ihren Vater Bruce Willis. Die Demenzdiagnose habe auch ihr Leben verändert, sagt die Schauspielerin. Originalbeitrag lesen Quelle: Berliner Morgenpost Torsten Sträter über Diabetes: „Habe sofort aufgehört, Süßes zu essen“ Erst die Krebsdiagnose, dann erfuhr Comedian Torsten Sträter, dass er an Diabetes leidet. Was er heute beim Thema Gesundheit anders macht. Originalbeitrag lesen Quelle: Nordkurier „Im Krankenhaus wurde ich allein gelassen“: Alexanders schmerzhafte Odyssee zurück ins Leben Mitten in der Corona-Pandemie verlor Alexander aus der Nähe von Güstrow sein Bein. Heute steht er im Rampenlicht – und will anderen zeigen, dass ein neues Leben möglich ist. Originalbeitrag lesen Quelle: Business Insider Germany Rihannas Personal-Coach verrät: Dieser Fitness-Wert ist am wichtigsten Die Erfassung von Kennzahlen wie der VO2-max und dem Cardio-Training in Zone 2 wird in der Longevity-Szene immer beliebter. Harley Pasternak rät davon ab. Originalbeitrag lesen Quelle: Berliner Morgenpost Aufregung im Berliner Promi-Lokal: Feuerwehr rückt zum „Borchardt“ aus Im Traditionsrestaurant Borchardt in Berlin-Mitte sorgte ein Brand in der Küche für einen Feuerwehreinsatz. Verletzt wurde bei dem Vorfall niemand. Originalbeitrag lesen Quelle: CHIP Online Deutschland Apotheker empfehlen: Diese Pflege-Klassiker sollte in keinem Badezimmer fehlen Seit mehr als 100 Jahren steht die blaue Dose von Nivea in vielen Badezimmern. Eine spanische Apothekerin hält die klassische Creme für einen besonders vielseitigen Helfer bei trockener Haut. Doch was macht die Rezeptur eigentlich so besonders – und gibt es günstigere oder bessere Alternativen? Originalbeitrag lesen Quelle: Frankfurter Allgemeine Zeitung (Faz) Abnehmspritze: Ozempic verändert die ganze Welt Millionen Menschen nehmen Abnehmmittel, auch in Deutschland. Das hat auch Folgen für die Partnersuche, Bewerbungsgespräche und die allgemeine Gesundheit. Originalbeitrag lesen Quelle: Berliner Morgenpost Kann Kaffee ADHS-Symptome lindern? Was ein Experte zu Koffein sagt Viele trinken Kaffee, um wacher zu werden. Doch bei ADHS-Betroffenen kann Koffein anders wirken als erwartet. Ein Experte klärt auf. Originalbeitrag lesen Quelle: Augsburger Allgemeine Vitamin-D-Mangel: Für wen ist das Risiko besonders hoch? Mehr als die Hälfte der Deutschen ist mit Vitamin D unterversorgt. Für manche ist das Mangelrisiko besonders hoch. Originalbeitrag lesen Quelle: Heilpraxisnet.de Borreliose-Risiko vor allem von Mäusen abhängig? Das Risiko für Borreliose-Infektionen ist offenbar stark abhängig von der Mäusepopulation. Denn Mäuse sind eine gute Nahrungsquelle für Zecken und geben zudem häufig Borrelia burgdorferi an die blutsaugenden Parasiten weiter. Originalbeitrag lesen Quelle: Berliner Morgenpost ADHS: Arzt empfiehlt dieses simple Kinderspiel gegen Vergesslichkeit Viele Menschen mit ADHS haben im Alltag mit Vergesslichkeit zu kämpfen. Ein Psychiater erklärt, wie gezieltes Gedächtnistraining helfen kann. Originalbeitrag lesen Quelle: Heilpraxisnet.de Reizdarm: Diese pflanzlichen Präparate zeigen signifikante Wirkung Bei dem Reizdarmsyndrom können verschiedene natürliche Behandlungsansätze einen Beitrag zur Linderung leisten. Nachweisbare Wirkung zeigen vor allem Pfefferminzöl und Präparate aus der Traditionellen Chinesischen Medizin (TCM). Originalbeitrag lesen Quelle: Heilpraxisnet.de Diabetes: Probiotikum eine vielversprechende neue Behandlungsoption Bei Diabetes könnten Probiotika mit dem Bakterium Lactobacillus plantarum einen signifikanten Beitrag zur Behandlung leisten. In ersten Untersuchungen verbesserten die Milchsäurebakterien nicht nur die Blutzuckerwerte, sondern auch die Blutfettwerte und die Zusammensetzung der Darmflora. Originalbeitrag lesen Quelle: Augsburger Allgemeine Vitamin D und Kalzium bei Osteoporose: Wie wichtig sind die Nährstoffe für starke Knochen? Fehlen wichtige Nährstoffe, kann die Knochengesundheit leiden. Besonders wichtig sind Vitamin D und Kalzium – doch auch andere Vitamine spielen eine Rolle. Originalbeitrag lesen Quelle: WEB.DE News Psychiaterin: "Das ist keine fehlende Disziplin - das ist ADHS" Warum ADHS oft erst spät erkannt wird und weshalb sie nichts mit fehlender Disziplin zu tun hat, erklärt Psychiaterin Swantje Matthies. Originalbeitrag lesen Quelle: Hamburger Abendblatt Ist mein Cholesterin zu hoch? In diesen Fällen gelten niedrigere Grenzwerte Ab wann der Cholesterinspiegel zu hoch ist, hängt von verschiedenen Faktoren ab. Diese Grenzwerte sind entscheidend. Originalbeitrag lesen Quelle: Heilpraxisnet.de Bluthochdruck: Wirksame Pflanzenstoffe zur Prävention & Behandlung Verschiedene Pflanzenstoffe können einen signifikanten Beitrag zur Prävention und Therapie von Bluthochdruck leisten. Dabei wirken die pflanzlichen Verbindungen wie Quercetin und Curcumin über mehrere miteinander verknüpfte Effekte. Originalbeitrag lesen Quelle: WELT Aktie: Vierter Tag ohne Veränderung Mit einer Seitwärtsbewegung von 0,39 Prozent schafft es das Papier von der Merck KGaA gerade mal in das mittlere Drittel des Dax. Originalbeitrag lesen Quelle: WELT Aktie: Kurs erholt sich Mit einer Aufwärtsbewegung von 0,81 Prozent schafft es das Papier von der Fresenius SE & Co. KGaA gerade mal in das mittlere Drittel des Dax. Originalbeitrag lesen Quelle: Frankfurter Neue Presse Erste Pille gegen hohes Cholesterin auf dem Markt - für wen sie geeignet ist Die US-Gesundheitsbehörde FDA lässt das Mittel Lipfendra zu. Das neue Medikament senkt das Cholesterin als tägliche Tablette wirksam. Originalbeitrag lesen

Klingbeil reagierte mit seiner Klarstellung auf erheblichen Wirbel, den ein am Dienstag bekanntgewordenes internes Papier aus seinem Ministerium ausgelöst hatte. Darin wurde vorgeschlagen, neben Colas und Limonaden unter anderem Zero- und Light-Getränke, Biermischgetränke, Haferdrinks und Fertigkaffees der neuen Steuer zu unterwerfen. Die Rede ist von Getränken «mit Zucker und/oder Süßungsmitteln» sowie «Zucker-/süßungsmittelhaltigen Granulaten». Nicht betroffen wären 100-prozentige Fruchtsäfte und reine Milch. Papier nur ein «Arbeitsstand» Klingbeil machte deutlich, dass es sich um einen «Arbeitsstand» handele, der in den Medien aufgetaucht sei. Es seien Dinge, die er nie auf seinem Schreibtisch gehabt habe. Der Finanzminister betonte jedoch zugleich auf Instagram, seine Mitarbeiter müssten auch offen diskutieren und Vorschläge machen können, die am Ende nicht umgesetzt würden. Auch Merz wandte sich dagegen, fachliche Erwägungen, die für oder gegen eine bestimmte Entscheidung sprechen, sofort zum Streit in der Koalition hochzujazzen. «Das ist grober Unfug.» Union und SPD hatten die Einführung einer Steuer auf gezuckerte Getränke wie Colas und Limonaden ab 2027 im Zuge des beschlossenen Gesetzes für stabile Krankenkassenbeiträge verabredet. Hintergrund sind Empfehlungen einer vom Gesundheitsministerium eingesetzten Kommission, die Reformvorschläge vorgelegt hatte. Die Experten schlugen unter anderem auch die Einführung einer gestaffelten Steuer auf zuckergesüßte Erfrischungsgetränke vor. Klingbeil erläuterte: «Ich finde es richtig, dass wir etwas gegen die negativen Folgen eines zu hohen Zuckerkonsums tun. Gerade Kinder müssen wir besser schützen.» Ärzte und Verbraucherschützer werben seit langem für eine Zuckersteuer als Anreiz, um zu gesünderer Ernährung und weniger Übergewicht und Diabetes vor allem bei Kindern zu kommen - über weniger Konsum, aber auch dadurch, dass Hersteller Rezepturen verändern und den Zuckergehalt verringern («Reformulierung»). Die Lebensmittelbranche macht Front dagegen. CDU-Ministerpräsident gegen «Teuer-Steuer» Einwände gegen die Zuckersteuer meldete auch Hessens Ministerpräsident Boris Rhein an. «In einer Zeit, in der viele Menschen mit hohen Preisen zu kämpfen haben, darf der Staat Lebensmittel und Getränke nicht noch teurer machen», sagte der CDU-Politiker der Deutschen Presse-Agentur. Die Politik müsse die aktuelle Preiskrise abfedern und dürfe sie nicht verschärfen. Er erwarte eine «klare Absage an eine weitere Teuer-Steuer auf Lebensmittel». Aus der Wirtschaft kam angesichts des aufgeflammten Streits erneut Kritik. Die Bundesvereinigung der Deutschen Ernährungsindustrie monierte, es herrsche nun mehr Verwirrung als Klarheit. Daher brauche es einen Neustart der Debatte, sagte Hauptgeschäftsführer Christoph Minhoff. «Bevor über neue Steuern entschieden wird, müssen Ziele, wissenschaftliche Evidenz, wirtschaftliche Folgen und Belastungen für die Verbraucher sauber auf den Tisch.» Der Präsident des Bundesverbands des Deutschen Lebensmittelhandels, Björn Fromm, forderte: «Wenn es der Politik zumindest in Ansätzen um die Gesundheit der Bürger geht, dann müssen Industrie und Handel die Möglichkeit und Zeit zur Reformulierung über Süßstoffe haben.» Aus Sicht des Deutschen Brauer-Bundes verschärfte eine Zuckersteuer die Krise der Branche. Viele der 1400 Brauereien in Deutschland stellten alkoholfreie Erfrischungsgetränke her, auch als Antwort auf rückläufigen Bierkonsum. Aus dem Handel gebe es jetzt schon Signale, dass die Getränkehersteller die Steuer alleine tragen sollen. Foodwatch für schnelle Umsetzung Die Verbraucherorganisation Foodwatch forderte indes, statt sich weiter über Süßstoffe, alkoholfreies Bier oder Hafermilch zu zerlegen, müsse die Regierung die Steuer auf zuckrige Limos schnellstmöglich umsetzen. In der Koalition gebe es einen ausgehandelten Konsens, die Hersteller in die Verantwortung zu nehmen, sagte Expertin Luise Molling. «Das muss jetzt passieren.» Der SPD-Gesundheitsexperte Christos Pantazis sagte: «Wir brauchen keine immer weiter ausgreifende Besteuerung unterschiedlichster Getränke.» Es gehe um eine zielgenaue Steuer mit einer klaren Lenkungswirkung. «Wir wollen den übermäßigen Zuckerkonsum reduzieren – wir wollen den Menschen nicht vorschreiben, wie süß ihr Getränk schmecken darf», sagte Pantazis. Er betonte: «Zero bleibt Zero». Auch die Unions-Gesundheitsexpertin Simone Borchardt (CDU) hatte zuvor erklärt, eine Besteuerung von Zero-Getränken lehne sie ab.

Welche Daten stehen im FDZ Gesundheit für Forschungsprojekte zur Verfügung – und was sollte bereits bei der Entwicklung einer Fragestellung beachtet werden? In unserem Datenwebinar geben wir einen praxisnahen Einblick in den Datenbestand des FDZ Gesundheit, zeigen Best Practices und typische Fallstricke bei der Entwicklung von Forschungsfragen und geben einen Ausblick auf kommende Daten.

Quelle: WELT Mitarbeiter stirbt an Malaria Anfang Juli haben sich vier Flughafen-Mitarbeiter in Frankfurt mit Malaria infiziert – inzwischen sind sechs Menschen betroffen. Einer von ihnen ist gestorben. Ursache der Infektion sollen importierte Mücken sein. Originalbeitrag lesen Quelle: Hamburger Abendblatt ADHS-Symptome lindern: Dr. Riedl empfiehlt ein bekanntes Getränk Viele ADHS-Betroffene essen oft ungesund. Doch ein bekanntes Getränk könnte helfen, die Darmflora zu stärken und Symptome spürbar zu lindern. Originalbeitrag lesen Quelle: ZEIT ONLINE Corona-Pandemie: Mütter arbeiteten wegen Pandemie-Schulschließungen weniger Mütter mit Grundschulkindern haben während der Schulschließungen in der Corona-Pandemie ihre Beschäftigung reduziert. Gleichzeitig bauten Väter ihre Erwerbstätigkeit aus. Originalbeitrag lesen Quelle: Berliner Zeitung Flughafenmalaria in Frankfurt: Fraport-Mitarbeiter tot - sechs Infektionen bestätigt Am Frankfurter Flughafen ist ein Beschäftigter an einer Malaria-Infektion gestorben. Insgesamt haben sich nach Angaben von Fraport sechs Mitarbeiter bei der Arbeit angesteckt. Originalbeitrag lesen Quelle: Augsburger Allgemeine Nach Insolvenz: R-Pharm in Illertissen wird stillgelegt Für das Pharmaunternehmen aus Illertissen gab es nach der Insolvenz bis zuletzt Hoffnung auf einen Käufer. Nun herrscht traurige Gewissheit: Die Verhandlungen sind gescheitert. Originalbeitrag lesen Quelle: Focus Flughafenmalaria: Fraport-Mitarbeiter an Malaria gestorben Am Flughafen Frankfurt ist ein Mensch an der sogenannten „Flughafenmalaria” gestorben – weitere Mitarbeiter sind durch die importierten Mücken infiziert. Originalbeitrag lesen Quelle: merkur.de Demenz-WG in Oberschleißheim belegt - noch vor Eröffnung des Quartiers Alle zehn Appartements der neuen Wohngemeinschaft für demenzkranke Menschen sind vergeben. Die Bewohner sind bereits eingezogen, obwohl das gesamte Wohnquartier noch gar nicht eröffnet ist. Originalbeitrag lesen Quelle: Frankfurter Allgemeine Zeitung (Faz) Hautkrebs-Impfstoff: War der Hype überzogen? Der mRNA-Impfstoff zweier US-Firmen ist eine Tumortherapie, wie es sie noch nie gegeben hat. Ein Sieg über den Krebs ist sie allerdings nicht. Wie ist die weltweite Aufregung dann zu erklären? Originalbeitrag lesen Quelle: Berliner Morgenpost ADHS & Geld: Schulden trotz gutem Einkommen? Expertin gibt wertvolle Tipps Für Menschen mit ADHS ist der richtige Umgang mit Geld oft besonders schwierig. Eine Expertin erklärt Ursachen und verrät ihre besten Tipps. Originalbeitrag lesen Quelle: Frankfurter Allgemeine Zeitung (Faz) Mitarbeiter am Flughafen Frankfurt stirbt an Malaria Am Frankfurter Flughafen haben sich zwei weitere Mitarbeiter mit Malaria infiziert, die Zahl der Infizierten steigt damit auf sechs. Das Unternehmen ruft Mitarbeiter auf, bei Symptomen frühzeitig zum Arzt zu gehen. Originalbeitrag lesen Quelle: t-online.de Wichtig für frühe Behandlung: Bluttest soll Alzheimer-Diagnose erleichtern Ein einfacher Bluttest könnte die Abklärung von Alzheimer deutlich erleichtern. Die US-Arzneimittelbehörde FDA hat den Test nun zur einfacheren Vermarktung freigegeben. Originalbeitrag lesen Quelle: Neue Presse Coburg Forschung: Chemie steckt Rekordgelder in Forschung Die Chemie- und Pharmaindustrie investiert so viel wie noch nie in Forschung. Doch China holt im globalen Rennen schnell auf. Vor allem ein Trend macht der Branche Sorge. Originalbeitrag lesen Quelle: WEB.DE News Chemie steckt Rekordgelder in Forschung - und fürchtet China Die Chemie- und Pharmaindustrie investiert so viel wie noch nie in Forschung. Doch China holt im globalen Rennen schnell auf. Vor allem ein Trend macht der Branche Sorge. Originalbeitrag lesen Quelle: Hessische Niedersächsische Allgemeine Kick gegen Parkinson: Beim Boxen trainieren Erkrankte Kraft, Balance und Reaktion Beate Schönwald hat eine Mission: Die sportlich engagierte Parkinson-Fachfrau will Kickboxen als Sport für Patienten verbreiten. Besuch bei den ungewöhnlichen Kampfsportlern im „Hard Workers Club“. Originalbeitrag lesen Quelle: tz.de Chihuahua Gollum sucht ein ruhiges Zuhause - und braucht täglich Medikamente gegen Epilepsie Gollum ist ein menschenbezogener Chihuahua, der ein ruhiges Zuhause sucht – und tägliche Medikamente gegen Epilepsie braucht. Originalbeitrag lesen Quelle: Hamburger Abendblatt Demenz-Studie: Diese Art von Bewegung schützt das Gehirn wirklich Freizeitbewegung kann vor Demenz schützen. Körperliche Anstrengung im Beruf wirkt dagegen offenbar anders. Was steckt dahinter? Originalbeitrag lesen Quelle: Mitteldeutsche Zeitung Rückenschmerzen bei Kindern: Der Schulranzen ist meist nicht schuld, der wahre Auslöser überrascht Viele Eltern verdächtigen sofort den schweren Schulranzen, wenn Kinder über Rückenschmerzen klagen. Experten sagen jedoch: Häufig stecken Bewegungsmangel und die intensive Nutzung von Tablet und Smartphone dahinter. Mit drei einfachen Maßnahmen lässt sich das Risiko deutlich senken. Originalbeitrag lesen Quelle: Hamburger Abendblatt Lebensmittel mit Omega-3: Wichtig fürs Herz - Das sind die besten Quellen Es gibt nur wenige Lebensmittel, die den Tagesbedarf an Omega-3 decken können. Hier steckt am meisten drin. Originalbeitrag lesen Quelle: Offenbach-Post Für wen ein PKV-Wechsel jetzt wichtig wird Die JAEG steigt 2027 deutlich. Wer heute knapp darüber verdient, sollte GKV und PKV jetzt sorgfältig prüfen Originalbeitrag lesen Quelle: Augsburger Allgemeine Für wen kann eine Vitamin-C-Infusion sinnvoll sein? Und zahlt die Krankenkasse? Vitamin-C-Infusion: Wellness für die Haut oder reine Geldmacherei? Für wen sie wirklich sinnvoll sein kann und ob die Krankenkasse die Kosten übernimmt. Originalbeitrag lesen Quelle: Frankfurter Allgemeine Zeitung (Faz) Einnahme von Magnesium und Co: Das gute Gefühl von Supplementen Ein Großteil der Menschen nimmt Nahrungsergänzungsmittel, doch die wenigsten brauchen sie. Überdosen können sogar schädlich sein. Es ist höchste Zeit für einheitliche Vorgaben. Originalbeitrag lesen Quelle: WELT Longevity: Was das unterschiedliche Alter der Organe über die Gesundheit verrät Nicht jedes Organ folgt derselben inneren Uhr. Forscher zeigen nun, wie sich das biologische Alter einzelner Organe bestimmen lässt und was das über die Gesundheit verrät. Originalbeitrag lesen Quelle: merkur.de Wechseljahre und Gelenkschmerzen: Warum der Östrogenmangel Knie, Hüfte und Finger quält Plötzlich schmerzen Knie, Hüften oder Finger, morgens fühlen sich die Gelenke steif an: In den Wechseljahren erleben viele Frauen solche Beschwerden. Welche Rolle die Hormone spielen – und was wirklich hilft. Originalbeitrag lesen Quelle: RP ONLINE Rudi Assauer: Staatsanwaltschaft scheitert mit Anklage gegen Tochter und Vertraute Die Staatsanwaltschaft in Essen warf drei Beschuldigten vor, sich an Rudi Assauers Vermögen bereichert zu haben. Es ging um eine Vollmacht des an Demenz erkrankten Schalke-Managers. Jetzt ist klar: Das Landgericht Essen lässt die Anklage gegen Bettina Michel und zwei weitere Beschuldigte nicht zu. Die Hintergründe. Originalbeitrag lesen Quelle: RTL Online Zwei Masern-Tote in Pennsylvania: Ungeimpfte sterben nach 35 Jahren Die Masern waren in den USA beinahe ausgerottet, seit Jahrzehnten gab es nur noch sporadische Ausbrüche. Seit der Impfskeptiker Kennedy Jr. das Gesundheitsministerium leitet, ist die Krankheit zurück. In Pennsylvania gibt es jetzt zwei Todesfälle. Originalbeitrag lesen Quelle: Ruhr Nachrichten Magersucht-Patientin aus Werne kritisiert Methoden in LWL-Klinik Eine junge Frau aus Werne kritisiert ihre Behandlung wegen Magersucht in einer LWL-Klinik. Der LWL erklärt, nach welchen Kriterien er therapiert. Originalbeitrag lesen Quelle: n-tv NACHRICHTEN Fast 30.000 Personen untersucht: Diese Art der Rauchentwöhnung funktioniert am besten Sich das Rauchen abzugewöhnen, fällt vielen sehr schwer. Dabei mangelt es nicht an Methoden: Manche nutzen Kaugummis oder Pflaster, andere setzen auf E-Zigaretten. Eine Übersichtsstudie klärt nun auf, was davon am besten funktioniert. Originalbeitrag lesen Quelle: Augsburger Allgemeine B-Vitamine: Welche Konsequenzen hat eine Überdosierung? Vitamin B ist nicht nur ein Vitamin, sondern ein gesamter Komplex an Vitaminen. Was mit dem Körper bei einer Überdosierung passiert und auf welche Sie besonders achten sollten. Originalbeitrag lesen Quelle: Augsburger Allgemeine Welcher Vitamin-D-Wert ist optimal? - mit Tabelle Vitamin D ist ein lebenswichtiges Vitamin. Aber welcher Wert im Blut gilt als optimal? Hier lesen Sie die Antwort. Originalbeitrag lesen Quelle: Augsburger Allgemeine Vitamine bei Arthrose: Diese Nährstoffe unterstützen den Körper Bei Arthrose ist eine ausreichende Nährstoffversorgung der Knochen, Knorpel und Muskeln besonders wichtig. Auf diese Vitamine sollten Sie als Arthrose-Patient achten. Originalbeitrag lesen Quelle: Tagesspiegel Frei spricht von „Jahrhundertprojekt“: Rentenreform soll trotz Widerständen bis Jahresende stehen SPD-Chef Lars Klingbeil und Kanzleramtschefin Nina Warken zeigen sich entschlossen: Die Rentenreform soll noch 2026 stehen. Wie die Koalition Widerstände im Detail überwinden will, ist Thema der aktuellen Kabinettsklausur. Originalbeitrag lesen Quelle: Augsburger Allgemeine Warum Bad Wörishofen plötzlich zur „Longevity“-Adresse wird - und was das neue Angebot für Frauen verspricht Kurort statt Kurklischee: Fasten, Schlafkuren, Heilwald – und ein neues Format, das gezielt auf Auszeit und Alltagspause setzt. Originalbeitrag lesen Quelle: Börse Express Novo Nordisk Aktie: OASIS-5-Studie läuft bis 2028 Novo Nordisk setzt im Abnehmkampf auf orale Wegovy-Studien und Differenzierung. Produktionsrisiken und uneinheitliche Analystenurteile trüben jedoch... Originalbeitrag lesen Quelle: Börse Express Intuitive Surgical Aktie: 35 Prozent Minus seit Jahresbeginn Intuitive Surgical verliert 35% an Börsenwert, Analysten senken Kursziele. Johnson & Johnson tritt mit kompakterem System in den Markt ein. Originalbeitrag lesen Quelle: DER SPIEGEL Rudi Assauer: Gericht lässt Anklage gegen Tochter nicht zu Nutzten seine Tochter und seine frühere Sekretärin Rudi Assauers Alzheimer-Erkrankung aus und verkauften seine Immobilien? Das Landgericht Essen sieht dafür keinen hinreichenden Tatverdacht. Originalbeitrag lesen Quelle: n-tv NACHRICHTEN Zum ersten Mal seit 35 Jahren: Zwei Menschen in Pennsylvania an Masern gestorben Die Masern waren in den USA beinahe ausgerottet, seit Jahrzehnten gab es nur noch sporadische Ausbrüche. Seit der Impfskeptiker Kennedy Jr. das Gesundheitsministerium leitet, ist die Krankheit zurück. In Pennsylvania gibt es jetzt zwei Todesfälle. Originalbeitrag lesen

Digitale Lösungen, Apotheken, Selbstmedikation und Patientensteuerung: Diskutieren Sie mit Expertinnen und Experten aus Politik, Wissenschaft und Praxis über die Weichenstellungen für die Primärversorgung von morgen.