CMDv Report for Release November - December 2019

The latest CMDv Report for Release, giving an overview of the activities of the November and December 2019 meetings, is available to view and download (Link). The report includes amongst other items:

Implementation of the New Veterinary Regulation

Discussion continued on the practicalities of implementing the NVR, in particular variations requiring and not requiring assessment, and SPC harmonisation.

Co-operative working between CMDv and CMDh

A joint CMDv and CMDh variations working party has been set up. This group met in December, and further discussions were planned for January 2020.

Question to the CMDv regarding classification of antiparasitic repellents in the new Veterinary Regulation

The CMDv discussed a question from an Applicant regarding the classification of antiparasitic repellents, and whether this is likely to change with the coming onto force of Regulation (EU) 2019/6. The CMDv sought clarification from the Commission: there is to be no change in classification of Veterinary Medicinal Products despite new wording present in 2019/6.

Updated guidance documents

• Best Practice Guide for Renewals – updated regarding the MRP common renewal date (Link)
• Payment terms and addresses for National Authority fees (Link)