KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: JULY 2022
EMA/CVMP
The EMA has posted details of the CVMP's meeting of 12-14 July 2022: the agenda and meeting highlights (minutes to follow).
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CONSULTATIONS
- CVMP has issued a draft guideline on the application of Art. 34 of Regulation 2019/6 (classification of VMPs prescription status). Consultation is open until 31st October.
- A joint EMA-EFSA consultation has opened on development of a harmonised approach to exposure assessment methodologies for residues from VMPs, feed additives and pesticides in food of animal origin (see the draft report). Comments invited until 31st August.
- A draft concept paper is out for consultation on the revision of the guideline for VMPs for zootechnical purposes; comments invited until 31st October.
EVENTS
Registration is now open for the second Veterinary Big Data Stakeholder Forum (taking place online on 23rd November 2022). Registration is via this page.
ADMINISTRATIVE AND REFERENCE
- The EVVET3 release notes for version 1.4 of the platform have been published.
- The list of substances out-of-scope for MRL has been updated again.
HMA/CMDV
The latest CMDv Report for Release, giving an overview of the activities of the May and June 2022 meetings, is available to view and download. The report includes a reminder to Applicants that dossier update prior to SRP must now incorporate a variation to change the Product Information text to QRD version 9 (Link).
The minutes of the CMDv Interested Parties meeting that took place in June are now available.
NEW GUIDANCE
- New CMDv guidance on National-specific Labelling and Package Leaflet information (replacing so-called ‘blue box’ requirements) has been issued;
- Best Practice Guide (BPG) for classification of a product or group of products has been published on the CMDv website;
- Another BPG is now available, for collaboration between Member States in relation to GMP non-compliance issues and CEP withdrawals;
- Technical and procedural Q&As on replacement/removal of titanium dioxide in medicines were posted online in July.
UPDATED GUIDANCE
- Guidance on the details of the classification of VRAs and on the documentation to be submitted: Revised version published;
- CMDv have published a Revision 1 of the document containing recommendations for administrative handling of products including solvents (and how such solvents should be referenced in the SPC);
- The BPG for VNRAs was updated at the end of May, following practical experience of the new submission procedure;
- The Q&A for variations under Regulation 2019/6 has been revised;
- The transitional arrangements document for Regulation 2019/6 changes has also been updated.
ADMINISTRATIVE AND REFERENCE
- A template cover letter for new MAAs was added to the CMDv website;
- CMDv procedural contact points: Revised version published.