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If you want to catch up with the activities of the CVMP over the last few months, the highlights from the CVMP meeting of 6-8 September, and the minutes from the CVMP meeting of 12-14 July, were published this month.




  • Consultation has opened on AMR surveillance as a post-marketing authorisation commitment. The concept paper can be found via the consultation page, and comments are invited until the end of January 2023;
  • A consultation has begun with the aim to establish a guideline on the development and manufacture of synthetic oligonucleotides. Comments can be submitted until 20 December;
  • A consultation has begun with the aim to establish a guideline on the development and manufacture of synthetic peptides. Comments can be submitted until 20 December.


  • EMA has initiated an Article 82 referral for suspensions for injection containing procaine benzylpenicillin as a single active substance. For more information, see the relevant referral page;
  • EMA has started a review of veterinary medicines containing the excipient N-methyl pyrrolidone (NMP). See the relevant referral page.



  • There will be a webinar on requesting access to and using EMA's SPOR application programming interface (API) on 11 October. See the event page for details and registration;
  • The second Veterinary Big Data stakeholder forum will take place online on 23rd November. Details and registration via the event page;
  • A refresher webinar on signal management in the Union Pharmacovigilance Database is scheduled to take place on 27th October; see the event page to register.

Reference and Administrative

  • On September 8th, CVMP adopted an MRL summary opinion recommending inclusion of praziquantel in all ruminants (except bovine), Equidae and fin fish in Table 1 (allowed substances);
  • Presentations from the EMA online event 'Union Product Database: webinar on VNRAs for MAHs', which took place on 8th September, are now available via the event page;
  • There is now a version 3 of the guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA
  • The Veterinary Medicinal Products Regulation newsletter Issue 11 has been published.
  • EMA has launched a communication perception survey to collect feedback on EMA’s external communication, with responses invited until 30 September.



  • HMA and EMA have published their Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use, and the terms of reference for this;
  • CMDv and EMA have issued Procedural advice for requests for the classification of unlisted variations;
  • There is a revised version of the Guidance document from CMDv on national-specific labelling/package leaflet information.



The Commission Mandate to the EMA, relating to Article 93(2) of Regulation 2019/6 as regards the good manufacturing practice for VMPs and active substances used as starting materials, has been published.


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