KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: FEBRUARY 2023
Many will already have noticed that the veterinary regulatory pages on the EMA website have been re-organised, with information and guidance collated by subject. Of particular note are the pages dedicated to the UPD, and to referrals.
The EMA has posted the minutes of the CVMP meetings that took place on 8-10 November and 6-8 December 2022, and the meeting highlights from 14-16 February 2023 is also available. EMA has also published Veterinary medicines: highlights of 2022 - an overview of its key recommendations of 2022 regarding the authorisation and safety monitoring of VMPs.
Guidance and Guidelines
- The Guideline on the application of Article 34 of Regulation 2019/6, with regard to prescription status of VMPs, has been adopted. The overview of comments is also available;
- Revision 1 of the Reflection Paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances in VMPs, has been adopted;
- There is also a Revision 1 of the Guideline on the chemistry of active substances for VMPs (covering new and existing active substances);
- A Reflection Paper on resistance in ectoparasites has been adopted by CVMP; see also overview of comments received;
- CVMP have issued a Q&A document on the Guideline on assessment and control of DNA reactive (mutagenic) impurities in VMPs (EMA/CVMP/SWP/377245/2016).
- The guidance document on dossier requirements for submission of MAA and MRL applications to the EMA and CVMP has been updated.
- Consultation has opened on a draft guideline on quality, safety and efficacy of bacteriophages as veterinary medicines. Comments are invited until 29 April 2023;
- A new draft scientific guideline on plasmid DNA vaccines for veterinary use has been published for consultation - comments invited until 23rd June 2023.
REFERENCE AND OTHER DOCUMENTS
- A procedural advice document relating to vaccine platform technology master file (vPTMF) certification is now available.
- The referral on VMPs containing procaine benzylpenicillin has commenced; the summary of the referral at the start of the review can be viewed via this page.
- EMA will deliver a system demo live online on 22nd March, to demonstrate the developments achieved in the previous three months and collect stakeholder feedback for a number of EMA systems (including UPD, UPhV, PMS, etc.);
- Version 1.3 of the EVVet user manual has been published (as have the release notes);
- Presentations from the second Veterinary Big Data stakeholder forum, that took place on 23rd November 2022, have been uploaded to the event page;
- The out-of-scope list for substances not requiring MRLs has been updated (revision 57).
Work plans for the CVMP’s
- Safety Working Party
- Immunologicals Working Party, and
- The joint CHMP/ CVMP Quality Working Party
in 2023 have been published.
The latest CMDv Report for release, giving an overview of the activities of the December 2022 and January 2023 meetings, is available to view and download. The report includes, amongst other items:
- Summary of MAA procedures;
- Clarifications of certain aspects of the New Regulation;
- A summary of co-operation between CMDv and CMDh;
- An update on SPC harmonisation;
- Links to revised and updated reference documents.
- The list of products nominated for SPC harmonisation in 2023 has been published on CMDv's dedicated page. More information will be provided as it becomes available.
- CMDv have published a useful reference document containing links to the national product databases of the Member States. The relevant links are also available via this EMA landing page.
- There are new forms available for making borderline classification requests to CMDv. The Q&A document on classification of teat dips within the Union has also been updated.
- Member States' additional national requirements for submissions are summarised in this CMDv document published late January.
- CMDv have issued a revised version of the practical guidance document for procedures related to Brexit for VMPs approved via MRP/DCP.
- Minutes of CMDv's Interested Parties January 2023 meeting have been published. Key topics included national divergance and differences for certain regulatory requirements, and transition to QRD version 9.
- A January 2023 update to the CMDv's Multi-Annual Work Plan (2021 to 2025) has been published.