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KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: FEBRUARY 2023

Many will already have noticed that the veterinary regulatory pages on the EMA website have been re-organised, with information and guidance collated by subject. Of particular note are the pages dedicated to the UPD, and to referrals.

The EMA has posted the minutes of the CVMP meetings that took place on 8-10 November and 6-8 December 2022, and the meeting highlights from 14-16 February 2023 is also available. EMA has also published Veterinary medicines: highlights of 2022 - an overview of its key recommendations of 2022 regarding the authorisation and safety monitoring of VMPs.

EMA/CVMP

Guidance and Guidelines

NEW CONSULTATIONS

REFERENCE AND OTHER DOCUMENTS

  • A procedural advice document relating to vaccine platform technology master file (vPTMF) certification is now available.
  • The referral on VMPs containing procaine benzylpenicillin has commenced; the summary of the referral at the start of the review can be viewed via this page
  • EMA will deliver a system demo live online on 22nd March, to demonstrate the developments achieved in the previous three months and collect stakeholder feedback for a number of EMA systems (including UPD, UPhV, PMS, etc.);
  • Version 1.3 of the EVVet user manual has been published (as have the release notes);
  • Presentations from the second Veterinary Big Data stakeholder forum, that took place on 23rd November 2022, have been uploaded to the event page;
  • The out-of-scope list for substances not requiring MRLs has been updated (revision 57).

Work plans for the CVMP’s

in 2023 have been published.

 

HMA/CMDV

The latest CMDv Report for release, giving an overview of the activities of the December 2022 and January 2023 meetings, is available to view and download. The report includes, amongst other items:

  • Summary of MAA procedures;
  • Clarifications of certain aspects of the New Regulation;
  • A summary of co-operation between CMDv and CMDh;
  • An update on SPC harmonisation;
  • Links to revised and updated reference documents.

 

 

 

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