During the Maltese presidency, the CMDv held a stakeholders’ meeting on 10th May (Link), with notes from that meeting now available (Link). The following regulatory topics were discussed:
- CESSP
- QRD issues
- Common Baltic Package project
- Additional national requirements / issues
- Feedback on guideline on partial MAH transfer (GUI 34) and guideline on MA transfer (GUI 31)
- Update on merge and split of products in MRP / DCP
- Situation of unavailable Reference VMP
- Transfer to MRP after an Article 34 referral
- Feedback on Nordic mock-up approval process
Also available is the HMA stakeholders’ information report (Link). Specific veterinary updates highlighted include:
- Brexit preparation,
- The new Regulation on VMPs,
- VMPs containing potential PBT/vPvB substances,
- Update from the Regulatory Optimisation Group (ROG)
The CMDv has issued the following updated guidance and other webpages:
- Best Practice Guide (BPG 021) for Changing the RMS (Link)
- Best Practice Guide (BPG 007) for Renewals in the MRP / DCP (Link), together with the track changes version (Link)
- Guidance (GUI/002) for Administration of the Sunset Clause (Link), together with the track changes version (Link).
- Guidance for Packaging ‘blue-box’ requirements and additional information on labelling/package leaflet for products authorised via NO, MRP, DCP or CP (Link), together with the track changes version (Link)
- CMDv journal articles list – Autogenous vaccines in Europe: National approaches to authorisation (Link)
- CMDh-CMDv 'Q&A list for the submission of variations' and 'Examples for Acceptable and Not Acceptable Groupings for MRP/DCP Products' (Link)
