The European Commission, EMA and the Coordination Group for Mutual Recognition and Decentralised Procedure – Veterinary (CMDv) have issued guidance on adaptations to the regulatory framework to companies that develop, manufacture and distribute veterinary medicines in order to address some of the constraints posed by the COVID-19 pandemic.
According to the jointly developed question-and-answer (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 guidance aims to ensure that high-quality, safe and effective veterinary medicines that are essential for protecting public and animal health continue to be available during the public health crisis.
The Q&A 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 within the context of the pandemic. These measures cover different areas of regulation, including:
- marketing authorisation procedures;
- safety monitoring; and
- inspections of manufacturing facilities and good manufacturing practice (GMP) for veterinary medicines.
The Q&A document was also endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, which provides strategic leadership for urgent and coordinated action on possible shortages within the EU during this pandemic.