New European guidance on veterinary medicines

The European Commission, European Medicines Agency (EMA), and Coordination Group for Mutual Recognition and Decentralised Procedure – Veterinary have issued guidance on adaptations to the regulatory framework.

Guidance is aimed at companies that develop, manufacture and distribute veterinary medicines, and has been issued to address some of the constraints posed by the COVID-19 pandemic.

Flexibility

According to the jointly developed Q&A document, regulatory rules for veterinary medicines should be applied with greater flexibility in the context of COVID-19 when necessary to mitigate the risk of supply disruptions caused by the pandemic.

The document sets out areas where regulatory flexibility is possible to address some of the constraints marketing authorisation holders in the veterinary sector may be faced with in the context of the pandemic.

Areas covered

Specific guidance in the document includes:

• marketing authorisation procedures
• safety monitoring
• inspections of manufacturing facilities and good manufacturing practice for veterinary medicines

Steering group

The Q&A document will be continuously updated and was also endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.

Veterinary stakeholders are advised to check updates on the main EMA veterinary page for regulatory information on the impact of the COVID-19 pandemic on veterinary medicines.