KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: NOVEMBER/DECEMBER 2023

Highlights from the CVMP meeting on 7-9 November 2023 are available, among the topics discussed a were the reflection paper on ERA for ectoparasiticidal VMPs used in dogs and cats, and a concept paper on the revision of the 3Rs guideline (both linked in this update), and the procedure for checking proposed invented names for VMPs being amended from January 2024. The EMA’s pre-authorisation guidance under the VMP-Reg (Regulation (EU) 2019/6) is also to be updated shortly.

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EMA/CVMP

Maximum Residue Limits

• A European public MRL assessment report (EPMAR) on praziquantel in fin fish has been issued, with the MRL having been successfully extended to this species. The CVMP opinion is also available;
• Varroa destructor calmodulin gene-specific double-stranded interfering RNA EP15 (naked unmodified dsRNA) can be included in the list of chemical-unlike biological substances considered as not requiring an MRL evaluation

CONSULTATIONS AND GUIDELINES

• Consultation has opened for a joint CHMP/CVMP Concept paper on revision of the 3Rs (replacement, reduction, refinement) testing approaches, with comments invited until 28 February 2024;
• A draft guideline VICH GL60 on GMP for active ingredients used in VMPs is open for consultation, with comments invited until 25th March 2024;
• The reflection paper on the environmental risk assessment of ectoparasiticidal VMPs used in cats and dogs has been adopted following consultation.

PHARMACOVIGILANCE

• An EMA Best Practice Guide for Eudravigilance Veterinary has been published, available on the Veterinary Good Pharmacovigilance Practices page;
• A new version of the EVVet3 Production Release notes (Release date: 21 November 2023) is available; 
• The EVWEB User Manual Version 1.7 is available.

REGULATORY AND REFERENCE

• Issue 60 (November 2023) of EMA's SME Newsletter, relevant to human and veterinary medicines, is now available - containing useful advice and links to relevant documents;
• The EMA Veterinary Scientific Advice submission dates and timelines for 2024 have been published;
• There is an updated version of the Veterinary pre-submission meeting request form, in accordance with Regulation 2019/6 (Link to Word document); 
• EMA announced in November that consumption of antimicrobials in animals has reached its lowest level ever in Europe. The final ESVAC antimicrobial sales report, and sales reports by country can be accessed via EMA’s dedicated page;
• The EMA relaunched its website on 5 December 2023 - see the news page for details;
• Version 3.0 of the IRIS guide for applicants has been made available; 
• A Version 1.4 of the Implementation Guide (Vet EU IG) on VMP product data in the UPD has been issued;
• The recordings from the EMA Veterinary Awareness Day that took place on 12-13 September are available via the event page.
   

HMA/CMDV

The procedural contact points at the National Competent Authorities and the list of CMDv members were updated in November.