During the COVID-19 pandemic, much focus has been placed on the importance of non-disruption to the EU medicines supply chain for humans, and the development of new medicines for the fight against COVID-19.
Steps have, however, also been taken in respect of veterinary medicines, which face the same concerns regarding supply chain disruption as their human counterparts. In this vein, the European Commission, European Medicines Agency (“EMA”), the Coordination Group for Mutual Recognition and Decentralised Procedure – Veterinary and the Heads of Medicines Agencies network has published a guidance note on regulatory flexibility for veterinary medicines during the COVID-19 pandemic. The guidance note details an adapted regulatory framework applicable to companies that develop, manufacture and distribute veterinary medicines. It is aimed at addressing some of the supply chain obstacles that have been caused by the pandemic.
As with other medicines, the EU has confirmed that veterinary medicines should be regulated with greater flexibility to decrease the risk of supply disruptions that the industry is currently facing. The reasoning behind the flexible measures is that the veterinary sectors “plays an integral and fundamental role in maintaining the health and safety of animals, as well as the security and sustainability of our food supply and thus contributes in an essential way to public health.”
The guidance aims to ensure that safe and effective veterinary medicines of high quality that are essential in protecting public and animal health are made available during the pandemic.
The guidance note, which takes the form of a Q&A document, identifies the specific areas where the EU envisions regulatory flexibility to be imposed, namely in relation to:
- marketing authorisation procedures – under the new flexible rules, marketing authorisation holders may apply for certain extensions of deadlines to submit certain mandatory documents;
- good manufacturing practice (“GMP”) certificates and inspections – under the new flexible rules, the validity of GMP certificates may be extended and remote assessments of sites/facilities may be undertaken in lieu of on-site inspections until such inspections can be performed; and
- safety monitoring – under the new flexible rules, marketing authorisation holders may apply to the EMA to postpone their submission of periodic safety update reports, and exemptions to certain labelling and packaging requirements may be imposed.
The guidance is subject to further updates as the pandemic, and the EU’s response to it, develops.