EMA/CVMP

The meeting highlights and agenda from the CVMP meeting of 4-6 October 2022 are now available. As well as the usual business of managing ongoing regulatory procedures, the CVMP also appointed two new co-opted members.

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• CVMP have adopted the Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6. 

REFERENCE AND ADMINISTRATIVE DOCUMENTS

• The IRIS Guide for Applicants has been updated: the current version is 2.13.
• The list of substances out-of-scope for MRL has also been updated; current version is v55.
• EMA has published an annex to the V9 of the annotated Veterinary QRD template, with details of national reporting systems to be included in the product information texts.

HMA/CMDv

The latest CMDv Report for release, giving an overview of the activities of the July and September 2022 meetings, is available to view and download. The report includes amongst other items a list of recently updated guidance documents, with hyperlinks.

REFERENCE AND ADMINISTRATIVE DOCUMENTS

• The Requirements on submissions for post-authorisation applications (variations and renewals) via national or mutual recognition procedures has been revised and re-issued (rev. 1);
• The CMDv summary document of general Questions and Answers was updated at the end of September.