Last updated 25 October 2022
See list of updates at the end of the post.
Recommendations on submission dates in 2023 for Applications of the MRP
This document was produced by the Coordination Group (CMDh) in order to facilitate planning of submission dates of new applications for Mutual Recognition. You can view it here.
Recommendations on submission dates in 2023 for Applications of the DCP
This document was produced by the Coordination Group (CMDh) in order to facilitate planning of submission dates of new applications going through the decentralised procedure. You view it here.
Overview of timetables 2023 CMDh 60-day procedures for MRP/DCP applications
Rev.12 of the above timetables has been published and you can view it here.
List of safety concerns per approved Risk Management Plan (RMP) of active substances per product – updated
The above updated list of September 2022 can be downloaded here.
Report and minutes from the CMDh meeting held on 13-14 September 2022
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 includes the following items:
1. Template for Applicants to prepare similarity report on potential similarity with authorised orphan medicinal product(s) under market exclusivity in the EU – applicable from 1 Nov 2022
The CMDh agreed a new template for applicants to prepare their report on potential similarity with authorised orphan medicinal product(s) under market exclusivity in the EU.
- The template is based upon (and will replace) the template for the RMS Assessment Report on Similarity.
- It will allow the RMS to easily reuse the information provided by the applicant.
- The filled-in template should therefore be provided in PDF and Word format.
- Information on the use of the template has been included in the document.
- The following CMDh guidance documents have been updated to reflect the use of the new template:
- Applicant’s response document in Mutual Recognition and Decentralised procedures for Marketing Authorisation Applications – Here you can view the track changed and clean versions of the document.
- RMS Validation Checklist for human medicinal products in DCP -You can download it here.
- Request for MRP/RUP / Update assessment report – You can download it here.
- CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures – You can view the track changed and clean versions of the guide here.
The new template has been published on the CMDh website under “Templates > Application for MA” and the updated guidance documents have been published under the relevant sections of the website and links are provided above.
The CMDh strongly recommends the use of the new template. It has to be used for submissions as of 1 November 2022, but it can be used before that date on a voluntary basis.
2. Template for Applicant’s response during type II variations – applicable from 1 Nov 2022
The CMDh agreed a new template for applicants to provide their responses to questions in the
Preliminary Variation Assessment Report and CMS comments, if applicable, during type II variations or variation worksharing procedures.
- The template is based on the template for the type II Variation Assessment Report and will allow the RMS to easily reuse the responses provided by the applicant when drafting the final assessment report.
- The filled-in template should therefore be provided in PDF and Word form.
- Information on the use of the template has been included in the document.
- An update of the CMDh Best Practice Guide for the handling of Type II Variations in the Mutual Recognition Procedure to reflect the use of the template is ongoing and will be published in due course.
The new template has published on the CMDh website under “Templates > Variations” and can be downloaded here.
The CMDh strongly recommends the use of the new template. It has to be used for submission of responses in type II variations and variation worksharing procedures as of 1 November 2022, but it can already be used before that date on a voluntary basis.
3. Harmonisation of RMP Project (HaRP)
The aim of the HaRP project is to harmonise the Risk Management Plans of the same active substances for which marketing authorisations for which marketing authorisations
have already been granted with different RMPs in place.
As part of the Harmonisation of RMP Project (HaRP), the HaRP peer review group has finalised 15 new assessment reports including an agreed harmonised list of safety concerns per active substance.
- The CMDh adopted the assessment reports, which will be published on the CMDh website under “Pharmacovigilance > RMP > HaRP Assessment Reports”.
- The “list of safety concerns per approved RMP of active substances per product” will be updated to delete the currently published lists of safety concerns of products containing these active substances and links to the assessment reports with the harmonised list of safety concerns will be added.
4. Regulation (EC) No 1234/2008 on variations
The CMDh discussed a recommendation for the classification of an unforeseen variation.
- The CMDh agreed that the proposed change (“Change from “novel excipient” (3.2.P.4.6) to EU Pharmacopoeial excipient (3.2.P.4.1)”) should be submitted as a type IA variation under B.III.2.z (certain conditions apply).
- The outcome has been published on the CMDh website under “Procedural Guidance > Variation > Article 5 recommendations”. You can view it here.
Source: CMDh
5 National court case concerning Article 10b of Directive 2001/83/EC
The CMDh was informed of the outcome of a national court case where a MAH of a fixed dose combination appealed against the granting of another MA for the same fixed dose combination under Art. 10b, based on the wording in Art. 10b “medicinal products containing active substance used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes”.
- The court ruled in favour of the MAH, despite the fact 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.
- According to the court it would be up to the European or national legislator to adjust the article or section in legislation, if required.
- An appeal to the judgement is still possible.
In a survey, only 3 MSs (that replied) stated that they do not allow the multiple use of the legal basis Article 10b for the same combination of active substances. Information on finalised and pending court cases, where available, was and will be shared for information.
The CMDh agreed to ask the EC to confirm their previous feedback on the multiple use of the legal basis Article 10b for the same combination of active substances. A proposal will be drafted and circulated for comments
It was noted that the discussion should also be taken into account in the future revision of the legislation.
Updates
| Date | Update |
|---|---|
| 25 Oct 2022 | The following headings (and information) were added: – CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs – Recommendations on submission dates in 2023 for Applications of the MRP – Recommendations on submission dates in 2023 for Applications of the DCP |
| 23 Oct 2022 | The following changes were made under the heading Report and minutes from the CMDh meeting held on 13-14 September 2022: 1) A Link was added to the minutes of the meeting. 2) Item 5 concerning a national court case was added. |
| 5 Oct 2022 | Link added to Overview of timetables 2023 CMDh 60-day procedures for MRP/DCP applications |
| 4 Oct 2022 | Link added to the Article 5 recommendations spreadsheet (see point no 4 above). |
| 29 Sept 2022 | Link added to updated list of safety concerns per approved Risk Management Plan (RMP) of active substances per product of September 2022. |
| 27 Sept 2022 | Link added to the template mentioned in point no 2 under the heading Report from the CMDh meeting held on 13-14 September 2022. |
| 23 Sept 2022 | Links added to documents mentioned in points no 1 and 3 under the heading Report from the CMDh meeting held on 13-14 September 2022 |