Last updated: 6 May 2026
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COMMISSION IMPLEMENTING REGULATION (EU) 2026/977 of 4 May 2026 laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council
This Regulation was published on 4 May 2026.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 25 February 2027. However, Article 4(4) shall apply from 1 January 2028.
Report from the CMDh meeting held on 21-22 April 2026
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.
Acronyms and abbreviations used in the report and minutes are available here.
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 (PSUFU procedure) updated
The CMDh agreed an update of its guidance on PSUFU procedures to bring it in line with the new EC guidelines on the details of the various categories of variations and operation of the procedures.
- The updated document has now been published on the CMDh website under “Pharmacovigilance > PSUR > PSUSA Follow-up”.
- Here, you can view the track changed (November 2024) and clean (April 2026) versions of the document.
Source: CMDh
2. Best Practice Guide for Article 45 and 46 – Paediatric Regulation – EU Worksharing Procedure updated
The CMDh agreed an update of the BPG for Art. 45 and 46 paediatric worksharing procedure to specify that in case the MAH indicates that an Art. 46 study will result in product information changes, which will be submitted and assessed in a type II variation or type II variation worksharing, no rapporteur needs to be appointed and no further feedback will be given to the MAH.
- The updated document has now been published on the CMDh website under “Paediatric Regulation > Guidance Documents”.
- Here, you can view the track changed (March 2026) and clean (April 2026) versions of the document.
Source: CMDh