CMDh and other EU updates – February 2025

Last updated: 7 February 2025

To view updates, click on the ‘+’ sign below.

DateUpdate(s)
7 Feb 2025Links added to documents in section Report from the CMDh meeting held on 28-29 January 2025.
Report from the CMDh meeting held on 28-29 January 2025

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.

The report from the above meeting includes (but is not restricted to) the following items:

1. Template for Request for RMS in DCP

The CMDh agreed an update of the template for request for RMS in DCP.

  • The document has been updated to include a field for the bioequivalence study number (as applicable) and a footnote to add the definition of the European Reference Medicinal Product.
  • The declaration that no other Member State has agreed to become RMS for the procedure has been changed to a tick box and extended to pending requests.
  • The updated document has now been published on the CMDh website under “Templates > Application for MA”.
  • Here, you can view the track changed (Jun 2023) and clean (Jan 2025) versions of the document.

2. Procedural Advice on Repeat-Use

The CMDh agreed an update of the Procedural Advice on Repeat-Use.

  • The main change is to align the guidance with the updated Best Practice Guide on Renewals.
  • Other minor changes, in line with the experience gained, have been included.
  • The updated document has now been published on the CMDh website under “Procedural Guidance > Application for MA > MRP/RUP”.
  • Here, you can view the track changed (sept 2020) and clean (Jan 2025) versions of the document.

3. Questions and Answers on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)

The CMDh together with the EMA has agreed an update of the joint EMA/CMDh Q&As on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746).

  • The document has been updated to state that, when a Declaration of Conformity is not available, in certain cases (for class I (excluding Is and Im) medical devices), a MAH’s statement of compliance with the relevant general safety and performance requirements (GSPRs) of the MDR Annex I can be acceptable.
  • The updated document has now been published on the EMA website. Here, you can view the track changed (3 May 2024) and clean (Jan 2025) versions of the document. (Source: EMA)

4. CMDh Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU reference date is not yet legally binding/followed

The CMDh agreed an update of the Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU reference date is not yet legally binding/followed as prepared by the Working Party on Pharmacovigilance Procedures Work Sharing.

  • The update concerns a general revision of the guidance document and includes, among others, guidance and criteria for exceptional requests of an additional (ad hoc) PSUR upon request of an NCA (in accordance with Article 107c(2) of Directive 2001/83/EC as amended and as described in the GVP module VII section VII.C.3.3.4), i.e. outside of the scheduling or the DLPs set out in the EURD list.
  • The updated document has now been published on the CMDh website under “Pharmacovigilance > PSUR > Informal PSUR Worksharing”.
  • Here, you can view the track changed (May 2023)and clean (Jan 2025) versions of the document.

5. CMDh Best Practice Guides for the Submission and Processing of Variations in MRP (Chapter 3 and 6)

The CMDh agreed an update of Chapter 3 (Type IA Minor Variations (Notifications)) and Chapter 6 ((Super-)Grouped Applications) of the Best Practice Guides for the Submission and Processing of Variations in MRP.

  • The main change to the BPGs is to include information that a justification for the exceptional submission of type IA variations outside of annual updates (listed in Chapter 6 of the BPG on variations) should be clearly indicated in the background/scope section of the eAF.
  • An optional wording to be used has been included in the guidance documents.
  • The updated documents have now been published on the CMDh website under “Procedural Guidance > Variation”.
  • Here, you can view the track changed (Oct 2024) and clean (Jan 2025) versions of Chapter 3 CMDh BPG for the Processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure
  • Here, you can view the track changed (Oct 2024) and clean (Jan 2025) versions of Chapter 6  CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition Procedure.

6. CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity

The CMDh agreed an update of the SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity.

  • As discussed previously and as is current practice, it has been reflected in the document that decisions on an additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh are published in a separate document (besides the CMDh minutes) and how the start date of the non-cumulative period of one year of data exclusivity for a new therapeutic indication granted under Article 10(5) should be calculated.
  • The updated document has now been published on the CMDh website under “Procedural Guidance > Application for MA”.
  • Here, you can view the track changed (June 2023)and clean (Jan 2025) versions of the document.

Overview of timetables 2025 CMDh 60-day procedures for MRP/DCP applications

You can view the timetable here.


PMS User Interface edit functionalities now available for users

The Product Management Service (PMS) User Interface (PUI) edit functionalities – live on the Product Lifecycle Management (PLM) portal – are now available for Industry users.

  • Note that the write access is for now limited to:
    • pack size and
    • manufacturer data for non-Centrally Authorised Products* (non-CAPs). 
  • This data is required for the shortage reporting via the European Shortages Monitoring Platform (ESMP), which went live with full functionalities on 29 January 2025.
  • Please consult this news article for full PMS roadmap and a recap of key current and future actions for MAHs.

Supporting events

You can obtain a timetable of the supporting webinars at the link below.

Source: eSubmission


Q&A Clinic on post authorisation procedure management transition to IRIS

You can view the EMA webinar with the above title held on 8 January 2025 here.

Source: EMA