CMDv provides updates on the NVR, Brexit, COVID-19, variations, extraneous agents testing, Part 2 harmonisation and more.

CMDv Report for Release July / September 2020

The latest CMDv Report for Release, giving an overview of the activities of the July and September 2020 meetings, is available to view and download (Link). The meetings discussed amongst other items:

• Continued planning for the new veterinary regulation (NVR)
• COVID-19, including guidance for industry
• Brexit and implementation of the Northern Ireland Protocol of the Withdrawal Agreement
• CMDv/CMDh cooperation and update of variation guidance for:
  • Q&A List for QP declaration (Link)
  • Acceptable and non-acceptable groupings for MRP-DCP, update relating to  product information updates following PSUR assessments (Link)
• Position paper on the implementation of the revised European Pharmacopeia (EP) requirements for extraneous agents testing (Link)
• Products available for bees and fish (Link)
• Revision of the electronic application forms
• EP certificate of suitability (CEP) update consultation (Link)
• Regulatory Rapporteur article on the CMDv Part II harmonisation pilot (Link)
• Update of the regulator addresses and contact points document (Link)

The CMDv has also updated the guidelines on format and number of copies of the dossier for new procedures (CMDv-GUI-022-12) and post-authorisation procedures (CMDv-GUI-023-016).