VM3: Regulatory exchange and new/future approaches

By Mel Munro2023-12-05T16:00:00

The coordination group for mutual recognition and decentralised procedures veterinary medicinal products (CMDv), represented by its vice chair Beate Gasser, provided an update on the summary of product characteristics (SPC) harmonisation exercise and G.I.18 variations required to align with the quality review of documents (QRD) product information template v.9. Noting that the SPC harmonisation has now started for the first five products (Catosal, Finadyne, Estrumate, Domesedan and Planate), marketing authorisation holders (MAH) were invited to register interest for the 2024 process before 31 May.

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