Last updated: 21 December 2023
See updates at the end of the post.
Meeting with Interested Parties – 15 November 2023
These meetings appear not to have any minutes published which would be very useful. Instead, the individual presentations from the meetings are shared. Presentation titles and links to the presentations are provided in the table provided below:
| Organisation | Presentation title and link |
|---|---|
| CMDh | Multilingual Labelling in MRP/DCP CMDh Multilingual Packaging Group – update Nov 2023 |
| AESGP | AESGP Position on Variation Regulation framework – changes needed |
| EFPIA | EMRN Strategic Priorities & NCA Network Portfolio Strategy (i.e., data/technology) Readiness |
| EUCOPE | Duration of the national phase of MRP/DCP and adherence to timelines |
| EUCOPE | Touch Point on the Upcoming Revision of the Variations Regulation |
| Medicines for Europe | CMDh meeting: Revision of EU Variation Regulation |
All presentations have been published on the CMDh website under “About CMDh > Contact with Representative Organisations”.
Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/ Recommendation papers
The document with the above title has been updated. Here, you can view the track changed and clean (November 2023) versions.
Report and minutes from the CMDh meeting held on 7-8 November 2023
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 and minutes from the above meeting include (but are not restricted to) the following items:
1. Q&A on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
The CMDh in liaison with the EMA and the European Commission has agreed an update of the joint EMA/CMDh Q&As on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746).
Questions 2.10 has been updated to specify that for MRP/RUP, the previously assessed documentation according to MDD for legacy devices can be accepted in the absence of device related significant changes of the integral Drug Device Combination (DDC) authorised in the RMS since the entry into application of the MDR.
The updated Q&A document has now been published on the EMA website.
Here, you can view the track changed (June 2021) and clean (Nov 2023 Rev 3) versions of the document.
A further, more comprehensive update of the Q&As is currently ongoing and will be published in the near future.
2. Data requested for Variations and/or Renewal Applications in the MRP/DCP
The CMDh updated its guidance document “Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/ Recommendation papers”.
- The update takes into account the new renewal process, published in February 2023.
- It is also now specified in the document if a requirement is related to variations or renewals or both.
- A new line has been included to indicate which Member States require full documentation for standard renewals for legislative reasons.
- The existing national requirements have been reviewed and reduced by Member States, as far as possible.
- The updated document has now been published on the CMDh website under “Procedural Guidance> Variation”.
Here, you can view the track changed (April 2021)and clean (November 2023) versions of the document.
3. Working Party on Paediatric Regulation
The CMDh agreed to discontinue the Working Party on Paediatric Regulation. All topics previously discussed in the Working Party, like Art. 45 and 46 worksharing, will continue to be discussed in the CMDh plenary meetings.
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
The above document was updated on 13 November 2023. It includes updates to responses to the following questions:
1.4. How shall I present and submit my Type IA/IAIN Variation(s)?
5.4. What procedure number will be given to grouped variation applications?
6.3. What pre-submission steps will apply to a worksharing procedure?
You can view the updated document here.
Source: EMA
Electronic product information (ePI) published for selected human medicines for the first time
The Heads of Medicines Agencies, the European Commission and the European Medicines Agency have published for the first time, electronic product information (ePI) for selected human medicines harmonised across the European Union (EU).
You can view the ePI on the Product Lifecycle Management Portal. In addition, ePI data can be accessed via a public application programming interface (API) where developers can explore the potential of this new format within existing digital platforms.
The product information of a medicine includes its:
- summary of product characteristics,
- labelling and
- package leaflet.
These documents accompany every medicine authorised in the EU and explain how they should be prescribed and used. They can all be found, often as a PDF document, on the websites of EU regulators, with a printed package leaflet also provided in the medicine’s box.
Digital platforms open new possibilities to share this information electronically, keep it constantly updated and make it more accessible to end users such as healthcare professionals and patients.
- The creation and testing of ePIs in real regulatory procedures is being explored through a one-year pilot initiative by HMA, EMA and the EC to enable the transition to the electronic system for medicines evaluated both nationally and at European level.
- The published ePIs are for medicines evaluated by EMA or by national authorities in
- Denmark
- The Netherlands
- Spain
- Sweden
- Companies participating in the pilot create and submit the ePI as part of their regulatory application.
- The pilot, which involves 25 medicines, will conclude in July 2024, and the outcomes will inform how to integrate the ePIs into common practice and expand their use across the EU.
Comment: In its first iteration, the published ePI does not look particular visually appealing. Hopefully this will change over time, with subsequent iterations.
Source: EMA
Updates
| Date | Update(s) |
|---|---|
| 21 Dec 2023 | Link added to updated Q & A Document referred to in point no 1 under the heading Report and minutes from the CMDh meeting held on 7-8 November 2023 |
| 19 Dec 2023 | Report and minutes from the CMDh meeting held on 7-8 November 2023 1) Heading ‘Report from the CMDh meeting held on 7-8 November 2023‘ updated to ‘Report and minutes from the CMDh meeting held on 7-8 November 2023‘. 2) Link to minutes added under the above heading. 3) Under point no 2. Data requested for Variations and/or Renewal Applications in the MRP/DCP, links added to the the track changed and clean guidance document. |
| 24 Nov 2023 | Heading Meeting with Interested Parties – 15 November 2023 plus relevant content added. |
| 23 Nov 2023 | Added heading Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/ Recommendation papers plus relevant content. |
| 17 Nov 2023 | Heading Report from the CMDh meeting held on 7-8 November 2023 added plus relevant content. |
| 13 Nov 2023 | Section entitled European Medicines Agency post-authorisation procedural advice for users of the centralised procedure added. |