Encouraging progress has been made on the implementation of Article 106(1) of the Regulation (EU) 2019/6 on Veterinary Medicinal Products, often referred to as the “SPC issue”.

Following a constructive meeting on Friday 24th April between the European Commission, Member States, the Federation of Veterinarians of Europe and allied Stakeholders, important clarification has been achieved on the interplay between Article 106(1) and the “cascade” provisions (Articles 112–114), particularly for justified deviations in dose and duration.
Thanks to strong scientific input from FVE, EBVS diplomates, and veterinary experts across Europe, several practical cases were successfully assessed, demonstrating how the cascade can be applied alongside Article 106(1). As a result, concrete recommendations were issued to provide veterinarians and Member States with greater legal certainty and practical guidance — resolving many of the concerns regarding dose and duration deviations for non-antimicrobials.  A background presentation is also available for more information.

FVE will update its cascade guidance leaflet accordingly.

Discussions so far have focused only on non-antimicrobials. A further meeting is planned at the end of June to discuss antimicrobial-related cases.

This important achievement was made possible thanks to the collective scientific expertise, practical examples, and collaboration from veterinarians across Europe!