Last updated: 22 October 2026
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Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the versions 1.2.1.19 (released to production on 14 September) and 1.2.1.20 (released to production on 28 September 2026) is now available on the PLM portal and eSubmission PLM Portal eAF.
Source: eSubmission
Member states contact points for translations review
This document is version 7.2 of 7 September 2026.
Source: EMA
Co-ordinating GMP inspections for centrally authorised products
This guideline should be read in conjunction with the terms of the standard contract between the European Medicines Agency (EMA) and the Competent Authorities of the EU Member States.
- The scope of the guideline is ror GMP inspections carried out by Competent Authorities of the Member States of the European Economic Area (EEA) at the request of the EMA.
- It supersedes version 2 of January 2025.
- It came into force on 19 September 2026.
- Revisions concern minor amendments made for clarification purposes with regard to the conduct of inspections without the need of a Supporting Authority. Minor editorial changes were made to the table of contents.
Source: European Commission
Procedure for coordinating GCP inspections requested by the CHMP
This procedure describes the coordination process of Good Clinical Practice (GCP) inspections requested by the Committee for Medicinal Products for Human Use (CHMP), with a particular focus on the roles of National Competent Authorities (NCA) of the Member States (MS) and European Medicines Agency (EMA).
This document was revised on 17 June 2026.
Source:: EMA
Updated “blue-box” requirements
Here, you can view the track changed (July 2024) and clean (September 2026) versions of the document.
Source: CMDh
New version of the eSubmission Gateway XML delivery file to enable future inclusion of ePI details
From 2 October 2026, the eSubmission Gateway XML delivery file user interface will include an optional ePI (electronic product information) section, featuring a toggle and corresponding field for ePI selection.
- This functionality is being introduced in preparation for the upcoming ePI go-live and will be used by applicants submitting ePI for centrally authorised products (CAPs).
- For further information, please refer to the ePI go-live timelines and the guidance on declaring ePI details in centralised procedures .
- Additional communications regarding the ePI go-live for CAPs will be published through the relevant channels in due course.
Source: eSubmission
Agenda – 104th meeting of the Pharmaceutical Committee (6 October 2026)
You can view the agenda here.
Source: European Commission
Report and minutes from the CMDh meeting held on 15-17 September 2026
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes.
The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
Acronyms and abbreviations used in the report and minutes are available here.
The report and minutes from the above meeting include (but are not restricted to) the following items:
1. Best Practice Guide for the processing of (super-)grouped applications in MRP (Chapter 6)
The CMDh agreed a minor update of the BPG for the processing of (super-)grouped applications in MRP (Chapter 6).
- It was agreed that it may also be acceptable to submit individual type IA variations to
- update the regulatory dossier prior to the submission of a MRP or line extension (in addition to e.g. RUP).
- The updated document has now been published under “Procedural Guidance > Variation”.
- Here, you can view the track changed (June 2026) and clean (September 2026) versions of the document.
Source: HMA
2. Timetables for MRP/DCP applications referred to the CMDh for the 60-days referral procedure in 2027
The CMDh has adopted an updated guidance document for MRP/DCP applications referred to the CMDh for the 60-days referral procedure in 2027, in accordance with Article 29(1) of Directive 2001/83/EC, as amended, and Article 13 of Regulation (EC) No 1234/2008.
- The updated guidance document has now been published on the CMDh website under “CMDh-Referrals”. You can view it here.
Source: HMA
3. Recommendations on submission dates for applicants of the DCP and MRP
The CMDh has adopted updated guidance documents with the timetables for MRP/DCP applications to be submitted in 2027.
- The updated guidance documents have now been be published on the CMDh website under “Procedural guidance > Application for MA > MRP/DCP”.
- Here, you can view the Recommendations on submission dates in 2027 for Applications of the DCP and the – Recommendations on submission dates in 2027 for Applications of the MRP
4. New applications in the MRP and DCP starting July-August 2026
You can view the stats for the above on pages no 3 and 4 of the report.
Source: HMA
5. Working Party on Variation Regulation
- Regarding the removal of the cover letter requirement for Type IA variations,
- The WP agreed that this change applies not only to MRP/DCP procedures and super-groupings, but also to purely national Type IA variations, as the relevant variation framework and CMDh guidanceapply equally to purely nationally authorised medicinal products.
- The CMDh endorsed the interpretation that cover letters are no longer required for purely national Type IA variations.
- A few MSs reported that they are still requesting the cover letter for purely nationalvariations at national level and indicated that this would need to be discussed internally.
- For the submission of Type IA variations implemented before 15 January 2026 under the previous variation classification framework,
- The CMDh was informed that the previous version of the eAF, containing the former classification scopes, remains available through the PLM Portal and can still be used for the submission of such variations.
- MAHs would be encouraged to use the PLM Portal as the preferred submission route and, in case of problems with a submission through the portal, contact the respective National Competent Authority, if necessary.
- MAHs are strongly recommended to submit such outdated variation as soon as possible.
- The WP also discussed technical limitations when submitting large super-groupings involving a high number of MAs.
- MSs noted that the submission of multiple interactive PDF eAFs within the same variation procedure could create significant technical and system compatibility issues.
- It was noted that the PLM Portal should be used, as it can accommodate a higher number of MAs than the interactive PDF eAF.
- The eAF maintenance group also endorsed this interpretation, and it was noted that the number of MAs allowed in the PLM portal will continue to increase.
- A proposal was presented to update Chapter 6 of the CMDh Best Practice Guide for the processing of (super-)grouped applications in MRP to clarify the exceptional circumstances under which individual Type IA variations may be submitted outside the annual update.
- It was agreed that it may also be acceptable to submit individual type IA variations to update the regulatory dossier prior to the submission of a MRP or line extension (in addition to e.g. RUP).
- The proposal was supported by the CMDh, and the updated guidance document will be published on the CMDh website.
- The WP Chair provided an update on the Type IA digitalisation pilot and discussions withinthe dedicated working group.
- The project is being developed in a phased approach.
- Initial work is focused on changes to the name and/or address of manufacturers not impacting the product information for CAPs, and later it will be extended to administrative changes impacting the product information.
- Originally, it was intended to have a pilot with CAPs and later on a pilot with NAPs, considering the experience made with CAPs.
- However, MSs will play an important role in shaping the future approach, particularly for NAPs, and were invited to discuss the topic internally and provide all MSs position for the next steps (Action: MSs).
- Discussions are also ongoing regarding the future handling of Module 3 information and the use of PMS as a source of product data.
- Several options are under consideration. It was highlighted that these discussions have broader regulatory implications and the need for broader MS involvement and input as the work progresses.
- The WP discussed situations where MAHs submit separate parallel worksharing applications with the same intended outcome because differences in the approved dossiers require different variation classification codes.
- The group agreed that different classification codes cannot be included within a single worksharing application. However, where a common assessment and harmonised outcome are applicable, the use of a single worksharing procedure based on the highest (“worst case”) applicable classification may be acceptable.
- The acceptability of a single worksharing application remains at the discretion of the Reference Authority.
- The group discussed the handling of letters of intent for worksharing procedures that include both MRP/DCP and purely national products.
- It was noted that, while MSs generally agree to act as Reference Authority for worksharing procedures involving only national MAs, applicants are usually referred to the RMS when at least one MRP/DCP product is included in the worksharing.
- The group agreed that this approach is consistent with the recommendations set out in Chapter 7 of the CMDh Best Practice Guide.
- Some requests for clarification on the interpretation of variation classification Q.II.b.1.e concerning the addition or replacement of manufacturing sites have been received.
- The WP discussed whether a single Type IB variation could cover the addition of a site performing manufacturing, primary packaging and secondary packaging activities, or whether separate variation scopes are required for each activity.
- As no consensus could be reached, it was agreed to refer the issue to the drafting group responsible for updating the Variation Classification Guideline in order to provide further clarification in the guideline text in the next regular update.
6. Procedural advice on Validation of MR / Repeat-use / DC Procedures
The CMDh discussed a proposal from the MAWP drafting group on validation to empower the
RMS to start the DCP or MRP if a CMS does not react to validation responses within the given timeframe.
- Currently, the guidance foresees that CMSs that have previously raised validation issues, should inform the RMS within 7 days after receipt of the missing information, if the application has become valid.
- It is now proposed to add that after this time, the RMS will inform the CMS that the procedure will be started unless the CMS informs the RMS within 4 days that the issue has not been resolved.
- It was clarified that the approach is meant to avoid blocking the procedure start. Missing information can still be requested during the procedure.
- The proposal was agreed by the CMDh and it was agreed that a standard wording and email heading should be used.
- An update of the procedural advice for discussion in the October CMDh meeting will be prepared.
- MSs were reminded that, according to the CTS Good Practice Guide, emails related to all
- procedures should include the following email header: “Procedure number – Product name – RMS – Purpose”.
7. Data requested for New Applications, Variations and/or Renewals in the MRP/DCP
The CMDh discussed a proposal to identify in the published tables containing national
requirements for new applications, variations and/or renewals in the MRP/DCP, which
requirements are validation issues and which ones can be solved after the procedure has
started.
- The proposal is linked to an action point in the MAWP and will enhance transparency
- for applicants and make it easier for NCAs to apply their requirements consistently.
- The proposal was agreed by the CMDh.
- MSs were asked to review the requirements included in the two CMDh guidance documents (for new applications and for variations and/or renewals) via Sharepoint and categorise them as validation or non-validation issue before the October CMDh meeting.
8. Procedural simplifications
The CMDh discussed several proposals for procedural simplifications.
- The CMDh discussed if a tick box for purely national procedures should be included in the common request form for RMS in a DCP to allow the use also for national slot bookings.
- Some MSs requested that a footnote should be included to state that the request form is not accepted by all MSs for purely national procedures.
- As the national practices vary, it was concluded not to include the tick box. MSs could consider using national request forms, as needed.
- It was further discussed if information should be requested via the common request form for RMS in a DCP, in case of WEU applications, namely if a suitable RefMP for Art. 10 applications is available in the EU.
- The proposal, in line with the NtA stating that Article 10a applications should not be considered as an alternative to other legal basis such as Article 10 of Directive 2001/83/EC, was agreed.
- The form should also be updated to ask for the date of completion of the bioequivalence study.
- An update of the common request form for RMS in a DCP will be prepared for discussion in October.
- The CMDh also discussed a possible update of the DCP overview AR template.
- It was proposed to not use the QRD template for the assessment of the user testing in the template and instead just use the standard sentences.
- It was agreed that it will be optional for the RMS to use the template or just the standard sentences and therefore the QRD template will not be deleted.
- It was further proposed that for Art. 10(1) applications a separate quality and clinical/nonclinical assessment report part would not be needed anymore and instead the overview AR would be completed, if needed with some additional information that would normally be included in the quality and clinical/non-clinical assessment report.
- A majority of the CMDh was against this procedural simplification as these assessment reports were considered important for CMSs to approve a product.
- However, the need for simplification and reduction of duplication was acknowledged. DE will further elaborate on the proposal and come back to the CMDh in a future meeting with an updated proposal.
- Finally, it was proposed that the quality risk assessment template in CTS should only be completed if a risk is identified.
- It was stressed that even in the case where no risk has been identified, the relevant tick box has to be ticked to confirm that the risk assessment has been done.
- However, the HMA RA group will be asked if any additional information can be omitted in such a case (Action: HR, DE). It could also be considered that at national level the
- information is added in CTS by case managers instead of quality assessors.
- Further statistics on the use of the template will be prepared for the next meeting.
9. Bioequivalence requirements following nitrosamine-related formulation changes for oral medicinal products
The CMDh discussed the need for a harmonised EU approach for BE requirements following
nitrosamine-related formulation changes involving antioxidants and/or pH modifiers.
- Different views were expressed.
- Overall, it was considered that further guidance from QWP and MWP would be useful to assess formulation changes. Formulation changes related to nitrosamines could be taken as an example, but the questions to the WPs should be broader, encompassing formulation changes in general.
- It was agreed to send a question to QWP and MWP.
- MSs were asked to comment on the proposal circulated by DE within one week. In cased no major objections are received, the question will be sent to the WPs.
10. Need for Art 46. assessment when MAs are withdrawn
Based on a recent example, the CMDh discussed if there is a need to assess submitted Art.
46 data, when the MAH confirms that all MAs are intended to be withdrawn and no other
products are approved. Products with a different strength and a different indication remain on
the market.
The CMDh confirmed that assessing the submitted data remains useful, as the data could also be relevant to the remaining strength and to products authorised in the future.
11. Art. 45 worksharing
The CMDh discussed the internal guidance document for Art. 45 assessment to support MSs
becoming Rapporteur, including the comments received since July.
- The comments will be implemented as appropriate.
- The document should be seen as a living document and will be updated with the experience gained. It was noted that currently it is too premature to organise trainings or Q&A sessions, but MSs can always approach the CMDh secretariat in case of questions.
- The EMA also presented an updated comparison of the Art. 45 list with data from the Art. 57 database.
- For products that are only authorised in one MS, this MS will automatically be appointed as rapporteur for a national assessment.
- For products authorised in 2-3 MSs, these MSs are asked to agree among themselves, who will become rapporteur for the worksharing assessment. Entries in the Art. 45 list for which no line listings have been identified will be closed.
- MSs were asked to consult the comparison document and provide any comments, as appropriate, by 6 October 2026.
12. Template letter to request Art. 45 data from MAHs
The CMDh discussed a proposal to combine the currently used template letters to request
MAHs to submit Art. 45 data (for the full assessment procedure and for the reduced
assessment pilot procedure) into one letter.
- In principle, all active substances could be eligible for the reduced assessment procedure.
- With the new template the Rapporteur will receive the whole data package and the summary table. Based on this information, they can determine if full assessment is needed or if the reduced assessment pilot can be followed.
- The CMDh agreed the update of the template letter with some minor changes.
13. Repeat-use procedure following line extension
The CMDh discussed if a MAH can submit a RUP, which is based on a MA issued as part of a
line extension, in any MS or if the MS needs to have the product authorised on which the line
extension is based.
- It was agreed that the line extension does not have to be applied for in all MSs that have the original forms/strengths.
- With regard to a RUP in MSs that do not have the original forms/strengths, reference was
- made to previous discussions on the topic and different practices in MSs. It was agreed that a RUP could be possible in such cases, if both the RMS and CMS agree to it.
- The applicant would have to provide the full documentation to the new CMSs and the RMS should share the assessment of the original MA.
- The new CMS would have the possibility to comment on all aspects of the submission.
- An alternative proposal would be to consider parallel (or subsequent) submissions of a RUP for the original form/strength in the new CMS together with the line extension.
Guidance published by Member States on the implementation of the Falsified Medicines Directive
Here is a compilation of links to guidance published by Members States on implementation of Falsified Medicines Directive.
Source: HMA
EudraVigilance – European database of suspected adverse reactions related to medicines: User Manual for online access via the adrreports.eu portal
You can veiw version 2.2 of the manual with the above title here.
This manual provides instructions on how to use the adrreports.eu portal to obtain access in EudraVigilance to reports of suspected adverse reactions (also referred to as undesirable effects or side effects) related to medicines.
Source: EMA