Last updated on 18 March 2022
See updates at the end of the post
Q & A for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
This document has been updated from the version of 14 October 2021 EMA/409815/2020 Rev.6 to the version of 31 January 2022 EMA/409815/2020 Rev.7.
The following changes have been made to the document:
- Q 10. Which limits apply for nitrosamines in medicinal products? (pages 10-14)
- A new Annex 1: Decision tree with control options for products containing multiple N-nitrosamines has been added (page 20)
Although the Table of Contents of Rev. 7 states that there have been updates made to Q 8 and Q 14, it seems likely that these changes were made to Rev.5 to update it to Rev. 6.
Source: CMDh
CMDh Multi-annual Workplan (MAWP) to 2025 – For public consultation
Since 2015, the CMDh operates with a 5-year multi-annual workplan (MAWP). The previous MAWP finished in 2020. By the end of 2020 and during 2021, the CMDh has been analysing the actions of the previous MAWP and worked on a new MAWP to 2025, which outlines the priorities of the CMDh for the coming years.
The 14 page document has been developed in parallel and is complementary to the HMA MAWP and the HMA/EMA European Medicines Regulatory Network (EMRN) strategy 2025. The following five main priority areas have been included:
- Availability of essential medicines and coordination during crisis
- Optimisation of procedures
- Innovative project
- Preparation for legislative changes
- Optimisation of communication/relationship/meetings with interested parties and stakeholders
Consultation end date: Comments should be sent to the CMDh Secretariat
(H-CMDhSecretariat@ema.europa.eu) by 4 April 2022, coordinated by trade associations where possible
Source: CMDh
Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
CMDh has published a slide deck of 38 slides on 2021 statistics for the above application types. You can view it here.
EU Electronic Application Forms
| Form | Electronic form version | Mandatory from |
|---|---|---|
| MAA-Human | MAA-Human Form 1.26.0.0 (01-12-2021) | 1 Jan 2022 |
| Variation Human | Variation Form 1.26.0.0 (20-01-2022) Updated | 1 Jan 2022 |
| Renewal | Renewal Form 1.26.0.0 (01-12-2021) | 1 Jan 2022 |
Update: Technical issue on the eAF webpage affecting availability of the latest versions of the eAF v1.26.0.0 has been fixed.
Source: Europa website
Report and minutes from the CMDh meeting held on 25-27 January 2022
Included in the above report and minutes are the following items:
United Kingdom’s withdrawal from the European Union
Following the publication of the Commission Notice 2021/C 524/02, on the application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the United Kingdom other than Northern Ireland the CMDh discussed and agreed updates of the CMDh Practical guidance (PG) for procedures related to Brexit and IE/NI Protocol. The updates take into account the information provided in the Commission Notice, among others, that for MR/DC procedures which include the MSs IE, CY, MT or UK(NI), continued use of sites located in the UK for batch control and batch release, MAH, local representative and, for UK(NI) only, QPPV or PSMF, may be permitted under the conditions stated in the Notice.
Two updated guidances are now available:
- Here you can view the track changed and clean versions of the guidance entitled Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
- Here, you can view the track changed and clean versions of the guidance entitled Practical guidance on the implementation of the Protoco on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP
The CMDh discussed how to handle UK(GB) sites in procedures without UK(NI), IE, CY and MT as CMS, that should have been deleted by end of 2021, via a submission of a type IA variation. The CMDh agreed that MAHs that still have UK(GB) sites mentioned in the dossier in addition to EU sites, e.g. alternative batch release or batch control sites (except for procedures where IE, CY, MT and/or UK(NI) are CMS and have granted an exemption for their
markets), should remove these alternative sites from the MA, using the respective variation procedure type IA, category A.7. The CMDh noted that this should be done immediately for all procedures not including IE, CY, MT and/or UK(NI) as CMS, as the timeframe for submission of these variations had already expired on 31 December 2021. Further regulatory activity might be possible on a national level in case these variation submissions are further delayed
Update to Questions and Answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
Q&A 10 has been amended to provide guidance on control options when more than one nitrosamine is identified in the same product and to address the calculation of acceptable limits. The updated Q&A document is available here.
Working Party on Pharmacovigilance Procedures Work Sharing
The CMDh adopted an update of the mandate of the Working Party on Pharmacovigilance Procedures Work Sharing. The mandate has been reviewed to reflect the changing tasks of the Working Party over time.
The updated document is availoable here.
Update on the End of Procedure template for DCP
Following the agreement on the new template for the End of Procedue for MRP/RUP in November 2021, the CMDh has also reviewed its template for the End of Procedure for DCP and the templates have been aligned as much as possible.
The updated template is available on this page.
Requirements on submissions for new marketing authorisation applications within MRP/DCP/National procedures and for variations and renewals within MRP and national procedures
The CMDh greed to an update of its guidance documents on requirements on submissions for new MAAs, variations and renewals. the format of the documents has been revised to be clearer on the national requirements with regard to signatures.
The updated documents will be published on the CMDh website under “Procedural guidance>eSubmissions”.
Decentralised procedure – Request to act as RMS
The Heads of Medicines Agencies task force on resources in DCP in cooperation with the CMDh has developed a common request form when asking a National Competent Authority to act as a a Reference Member State. You can download the form from this page.
Source: HMA
Blue-Box requirements
This guide has been updated from version February 2021 CMDh/258/2012, Rev.23 to the version January 2022 CMDh/258/2012, Rev.24.
The main changes appear to be to the information for The Netherlands and the UK in respect of Northern Ireland, on pages 46 and 67 respectively of the track changed document.
Here you can view the track-changed and clean versions of the document
Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
This guide has been updated from the version April 2021 CMDh/373/2018, Rev.8 to the version December 2021 CMDh/373/2018, Rev.9.
The main change appears to be to the response to the following question:
Question 34. Can I use a reference medicinal product (RefMP) authorised in the UK for my generic/hybrid/biosimilar application?
Here, you can view the track changed and clean versions of the document.
Q&A – QP Declaration
This document has been updated from the version CMDh/340/2015/Rev.6 July 2020 to the version CMDh/340/2015/Rev.7 December 2021.
There are significant changes to the document and many of these changes apply to veterinary products.
Here, you can view the track changed and clean versions of the document.
CMDh Questions & Answers on implementation of outcome of Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
This document has been updated from the version to the version CMDh/400/2019, Rev.4, June 2021 to the version CMDh/400/2019, Rev.5 December 2021.
The main changes appear to be to the reponse to the following question:
7. Which variations are necessary to lift the conditions on the MA?
Here you can view the track changed and clean versions.
EMA/CMDh explanatory notes on variation application form (Human medicinal products only)
This document has been updated from the version CMDh/EMA/133/2010/, Rev.7 to the version December 2021 CMDh/EMA/133/2010, Rev.8.
There are significant changes throughout the document.
Here, you can view the track changed and clean versions of the document.
Module 1: Administrative information Application form – User guide for the electronic application form for a Marketing Authorisation
This document has been updated from the version July 2018 CMDh/332/2017/Rev.2 to the version December 2021 CMDh/332/2017/Rev.3.
Whilst there are minor changes thoughout the document, the only significat changes appear to be to the following section:
2.2.4. Medical devices i.e. 2.2.41 – 2.2.4.5
The following new section appears to have been added to the document:
2.2.5. Companion diagnostic (2.2.5.1 – 2.2.5.4)
Here you can view the track changed and clean versions of the document.
Source: HMA website
Updates:
| Date | Update |
|---|---|
| 18 March 2022 | -Links added to documents that were not previously available. -Link added to the minutes under the heading Report and minutes from the CMDh meeting held on 25-27 January 2022 |