CMDv updates: the new veterinary regulation, Brexit, national requirements and new pictograms for some very minor species

16 December, 2020

Numerous updates from the CMDV have recently been released, covering the new veterinary regulation (NVR), Brexit and national requirements. New pictograms have also been approved for some (very) minor species.

CMDv Report for Release

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

  • Continued planning for the NVR
  • Detailed discussions about Brexit and implementation of the Northern Ireland Protocol of the Withdrawal Agreement
  • October virtual presidency meeting, hosted by Germany
  • Variation groupings for the addition or change in impurity specifications
  • Cooperation between CMDv and EDQM relating to standard terms for pharmaceutical forms
  • MRP transfer following positive conclusion of an Article 34 referral
  • The so-called “Partial MAH transfer” procedure has been finalised without amendment
  • New pictograms have been approved for elephants, ferrets, parrots, rats and snakes; the proposed pictogram for guinea pigs still needs more work.

Document updates for national requirements: blue box, dossier format & copies, fees and databases 

Various CMDv documents were recently updated, as follows:

  • Requirements on Submissions (number and format) for New Marketing Authorisation Applications within MRP, DCP and National Procedures (Link)
  • Format and number of copies of the dossier for post-authorisation applications (variations and renewals) via national, mutual recognition or decentralised procedures (Link)
  • Packaging ‘blue-box’ requirements and additional information on labelling/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures (Link)
  • Link to National Databases of Authorised Products (Link)
  • National Authority Fees Terms of payment and addresses (Link)

VMPs fors pet rabbit

The Q & A on VMPs intended for pet rabbits has also been updated (Link).

Interested Parties Meeting

The minutes from the October interested parties meeting are also now available (Link). There was extensive discussion about the NVR, but with a particular focus the following aspects:

  • SPC harmonisation
  • Variations
  • Protection of Technical Documentation

Besides the NVR, the minutes also report discussions on new substance name confidentiality, categorisation of antibiotics, Brexit preparedness and additional national requirements.

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