Last updated: 28 February 2023
See updates at the end of the post.
Report and minutes from the CMDh meeting held on 24-26 January 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/or minutes from the above meeting include (but are not restricted to) the following items:
1. CMDh position paper on the use of mobile scanning and other technologies to be included in labelling and package leaflet (PL) in order to provide information about the medicinal product
The CMDh agreed an update of the position paper on the use of mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product.
- The document has been revised to provide updated information on all aspects of the inclusion of mobile technologies for products applied for/authorised via MRP/DCP.
- The EMA QRD Working Group has been consulted on certain aspects of the update to ensure an aligned approach with products authorised via the centralised procedure, as much as possible.
- The updated document has been published on the CMDh website under “Procedural Guidance > General Information”. Here, you can view the track changed (Nov 2021) and clean (Jan 2023) versions of the document. The document has been substantially updated. The declaration template entitled ‘Application for the inclusion of mobile technology feature in MRP/DCP procedures’ can be downloaded here.
2. Decentralised procedure Member States’ standard operating procedure
The CMDh agreed an update of the CMDh Best Practice Guide on Variation Worksharing (Chapter 7).
- The guidance document has been updated to state that type II variations included in a worksharing and not affecting the SmPC, labelling or package leaflet may be implemented by the MAH immediately following receipt of the finalisation letter from the reference authority.
- The updated document has now been published on the CMDh website under “Procedural Guidance > Variations”. Here you can view the track changed (Dec 2022) and clean (Jan 2023) versions of the document.
3. Guidance on Oral Explanations to CMDh
The CMDh agreed an update of the guidance on oral explanation to CMDh (Annex to CMDh SOP – Disagreement in Procedures – Referral to CMDh).
The practical information for applicants included in the guidance document has been updated, including the possibility that oral explanations can be held remotely.
The updated document has now been published on the CMDh website under “CMDh Referrals”. Here, you can view the track changed and clean (Jan 2023) versions of the document.
4. Call for review for chemically synthesised and biological medicinal products regarding nitrosamine impurities
The CMDh agreed an update of the CMDh practical guidance for MAHs of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) referral on nitrosamines.
- The document has been updated to provide further guidance on the approach concerning MRP, RUP and line extensions (question 1.7).
- The updated document has now been published on the CMDh website under “Advice from CMDh > Nitrosamine impurities”. Here, you can view the track changed (July 2022) and clean (Jan 2023) versions of the document.
The CMDh agreed that:
- agreed that nitrosamine documentation (including documentation already submitted within the nitrosamine call for review) should not be requested by CMSs during MRP/RUP (except in exceptional cases where a risk has been recently identified or not sufficiently mitigated by the MAH
- In case of scenario B (nitrosamines above 10% of AI) for already approved MAs, in general, release testing would be acceptable. Retrospective testing is usually only considered in case the root cause is not yet sufficiently clear (especially regarding finished product risk factors / possibility that level of nitrosamines increases during shelf life). For scenario A, in general retrospective testing of all batches on the market is needed to determine the need for a full or batch specific recall.
The approach for interim limits as described in Q&A 21 (new nitrosamines for which a
substance specific AI has not yet been established) and Q&A 22 (exceedance of AI during
CAPA implementation) cannot be combined. The adjustment factors as included in Q&A 22
only apply after an AI for the nitrosamine has been established. Until this limit is available the
temporary AI (t-AI) of 178 ng/day should be applied.
5. Best Practice Guide on Variation Worksharing
The CMDh discussed and agreed an update of the CMDh Best Practice Guide on Variation
Worksharing (Chapter 7).
- The guidance document has been updated to state that type II variations included in a worksharing and not affecting the SmPC, labelling or package leaflet may be implemented by the MAH immediately following receipt of the finalisation letter of the reference authority.
- The update is in line with the wording of the Variation Regulation which allows an earlier implementation of variation worksharing procedures compared to type II variations.
The updated document has now been published on the CMDh website. Here, you can view the track changed and clean versions of the document.
6. Best Practice Guide on the processing of renewals in MRP
A proposal was presented for an update of the BPG on the processing of renewals in MRP/DCP. The proposal foresees that the currently used concept of shortened renewal for generics is extended to other products and becomes the standard process.
- An expanded renewal procedure with full documentation is still possible in exceptional cases, e.g. related to the benefit/risk balance of the product.
- It was also proposed that a clinical expert statement should suffice for the clinical documentation, confirming that the benefit/risk balance is positive and that the PI is up to date, instead of the current addendum to the clinical overview.
- It was noted that further guidance might be needed on cases where an expanded renewal would be applied.
- The next discussion, based on the comments received, is foreseen for the February CMDh meeting.
7. The Need for the inclusion of an indication of the Reference Medicinal Product (RefMP) in the SmPC of a hybrid product which is not suitable for this indication due to its strength(s)
The CMDh discussed the case of a hybrid application with different strengths compared to the
RefMP (CAP). The posology for one of the indications of the RefMP is not possible with the
hybrid product due to the different strengths compared to the RefMP.
- In principle, the SmPC of a generic product for which the RefMP is authorised through the centralised procedure should be identical to the SmPC of the RefMP. However, in this case the application is for a hybrid product, which can deviate from the RefMP.
- The CMDh agreed that in case the strength of a hybrid product is not suitable for a certain indication approved for the RefMP, this indication should not be included in the SmPC section 4.1 of the hybrid product.
- In case the strength of a hybrid product is not suitable for part(s) of the intended patient population due to the corresponding dosage regimen of an indication approved for the RefMP, the indication in SmPC section 4.1 should be retained and the patient group(s)/dosages for which the strength is not suitable should be mentioned in section 4.2 (in line with the outcome of the Article 29(1) referral of Deferasirox 900 mg film-coated tablets).
CMDh meeting with representatives of Interested Parties (IP) – Minutes of meeting on 9 Nov 2022
You can read the minutes of the meeting here. At the very least, this is a fascinating document as it is packed with very useful information and highlights a range of what might be considered administrative issues that are causing delays with the progression and approval of applications. This document is a must read. Amongst the topics discussed were the following:
- Improvement of the Repeat Use Procedure (RUP)
- Availability of updated PI following safety reviews
- Resource availability at NCAs
- Use of variation worksharing
- Possible meeting dedicated to CMDh workplan
Biosimilar medicines – Multistakeholder Event
Here, you can view documents, presentations and video recordings from the above event held on 13 December 2022. The meeting agenda is available here.
Q&A on the Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU
This Q&A responds to questions raised by the publication of a statement on biosimilar interchangeability by EMA and the Heads of Medicines Agency last September.
Specifically, it addresses the following three questions:
- Q1. Does the interchangeability of biosimilars also cover situations where multiple switches are taking place – independent of frequency of switches and number of products involved?
- Q2. Does interchangeability – including the possibility for multiple switches as discussed in Q1 – apply to all kinds of biosimilars, e.g. also those with a more complex molecular structure?
- Q3. Does the joint EMA-HMA statement on interchangeability of biosimilars mean that switching to orbetween biosimilars are allowed in my country?
EMA certificates of medicinal products – instructions on how to fill the application form
Revision 15 (of 16 January 2023) of the above instructions has now been published and you can view it here. The document states that amended and added text in revision 15 appears in Italics. This is not very helpful is it is not easy to pick out easily, the italicised from the unitalicised text!
Information note on the format and validity features of electronic certificates for medicines issued by the European Medicines Agency
Revision 2 of 16 January 2023 of the above information note has now been published and you can view it here.
Validation Checklist for Type II (non)clinical variations
A validation checklist for the above has been published and you can download it here.
Updates
| Date | Update(s) |
|---|---|
| 28 Feb 2023 | Heading Report from the CMDh meeting held on 24-26 January 2023 updated to Report and minutes from the CMDh meeting held on 24-26 January 2023 and a link to the minutes included. This section was further updated as follows: -Point no 4 was substantially updated -Points no 5, 6 and 7 were added. |
| 10 Feb 2023 | 1) Link to validation checklist for Type II quality variations added. 2) Link added to Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 – 9 February 2023 |
| 3 Feb 2023 | Added links to relevant documents to points no 2, 3 and 4 under the heading Report from the CMDh meeting held on 24-26 January 2023 |
| 2 Feb 2023 | Added links to relevant documents to point no 1 under the heading Report from the CMDh meeting held on 24-26 January 2023 |
| 1 Feb 2023 | Added heading Report from the CMDh meeting held on 24-26 January 2023 and relevant content. |
| 31 Jan 2023 | 1) Added heading Biosimilar medicines – Multistakeholder Event plus relevant content. 2) Added heading CMDh meeting with representatives of Interested Parties (IP) – Minutes of meeting on 9 Nov 2022 and relevant content. |
| 30 Jan 2023 | Added heading Q&A on the Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU plus relevant content. |