KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: JANUARY 2024

The new EMA website went live on 5th December. The revised site aims to improve searchability and ease of use, with ongoing improvements planned for 2024. Some entirely new web pages have been published in veterinary medicines regulatory, bringing together information and guidance on specific topics. Some of these are linked in the update below – read on...

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EMA/CVMP

The agenda and highlights from the CVMP meeting that took place 16-18 January 2024 are available online. The CVMP also published their work plan for 2024.

GUIDELINES

• Revision 1 of the Guideline on the conduct of pharmacokinetic studies in target animal species was published in December;
• The Guideline on dose factor calculation to be submitted to the UPD was published in December (effective 15th December 2023).

REGULATORY AND REFERENCE

• The following EU Implementation Guides (Vet EU IG) on VMP data in the UPD were updated in December with additional clarifications and guidance, and to take account of newer features in the UPD:
  • Chapter 2: Format for the electronic submission of veterinary medicinal product information (Version 1.5);

  • Chapter 7: Submission of other post-authorisation data (Version 1.7)

     

• EVVet - EVWEB User Manual and EVVet3 Production – Release notes from 4 December 2023 are now available online;
• The Q&A document on describing adverse events in the product information was updated in December (Link to Revision 4);
• EMA have published a list of acronyms used in scientific committees and relating to EMA regulatory activities (with links to further information where relevant);
• The request form for proposed invented VMP names has been updated (Link to Word document);
• A revision 2 of the document on general principles of acceptability and procedure for QR codes and a revision 1 of the request form for QR codes were published in December;
• The event page for the Academia Info Day that took place on 10th November 2023 has been updated to include links to the presentations;
• The event page for the Third Veterinary Big Data Stakeholder Forum that took place on 23rd November 2023 has been updated with links to the presentations;
• There is a new EMA webpage summarising progress on the Implementing and Delegated Acts of 2019/6 - with the relevant regulations linked where applicable;
• EMA have also published a new webpage with summary guidance relating to Brexit, applicable to human and/or veterinary medicines;
• A revised version (Rev. 1) of the published dates for veterinary submissions to EMA in 2024-2026 is available here.

HMA/CMDV

The latest CMDv Report for release, giving an overview of the activities of the September and October 2023 meetings, is available to view and download. The report includes, amongst other items, discussion of the submission of annual volume of VMP sales data in the UPD, and QR codes in the labelling and/or package leaflet.

• Revision 3 of the Guidance on national-specific labelling/package leaflet information is now available;
• Revision 3 of the summary document for National Authority fees, terms of payment and addresses is available;
• Revision 3 of the CMDv Q&A document was published in January;
• The CMDv Multi-Annual Workplan 2021 to 2025 was updated in December.