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As the days are getting longer, the news update is getting shorter. But there are still a few significant items to take note of in May....

Meeting highlights from the CVMP meeting of 15-16 May 2023 are available. As well as the usual business of the CVMP, The Committee finalised the preparation of the CVMP/CMDv Informal meeting to be held on 30-31 May 2023. Among other topics, the discussions will focus on antiparasitic resistance, Big data, real world evidence and artificial intelligence, Limited Markets and readability of the package leaflet.




  • The event page for the Volume of sales webinar for UPD industry users that took place on 24th April has been updated to include the presentation slides and a recording of the webinar;
  • The event page for the Focus Group Meeting on Bacteriophages that took place on 11 May has been updated to include the programme from the day.


Revised versions of the following VICH Guidelines have been published:

  • GL42 - Pharmacovigilance of VMPs: data elements for submission of AERs
  • GL35 - Pharmacovigilance of VMPs: electronic standards for transfer of data

Reference and administrative




Reference and administrative

A new version (Rev.1) of the template for signal assessment report submissions has been published by HMA and EMA.



european commission

delegated regulations

COMMISSION DELEGATED REGULATION (EU) 2023/905 of 27 February 2023, supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union, is available in all EU languages.

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