Last update: 26 November 2024
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Report from the CMDh meeting held on 12-14 November 2024
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. CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs
The CMDh agreed an update of the CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure).
- The guidance document has been updated to reflect the new approach for “other considerations” after the deletion of section 6 of the PSUSA AR.
- The updated document has now been published on the CMDh website under “Pharmacovigilance > PSUR > PSUSA Follow-Up”
- Here, you can view the track changed (Oct 2022) and clean (NOv 2024) versions of the document.
2. EMA/CMDh explanatory notes on variation application form
The CMDh agreed an update of the EMA/CMDh explanatory notes on the variation application form (human medicinal products only).
- Following the October revision, the document has been further updated to align the wording of the Variation Application Form and the amended Variation Regulation.
- The updated document Has now been published on the CMDh website under “Procedural Guidance > Variations > Amended Variation Regulation”.
- Here, you can view the track changed and clean (Nov 2024) versions of the document.
Source: CMDh