May – June news updates from HMA and CMDv

21 June, 2017

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:

  • 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)
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