KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: MAY 2023
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.
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EMA/CVMP
EVENT PAGES
- 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.
Guidance
- The regulatory and procedural guideline, Implementation Guide on VMP data - Chapter 2: Format for the e-submission of VMP information into the UPD - has been updated.
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
- There are revised implementing rules to the EMA's Fee Regulation as of 1 May 2023 (see Link)
- The EMA have published their Annual Report for 2022, available in multiple electronic formats.
HMA/CMDv
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.