Europe – Euro Roundup

A “large number” of centrally authorized products (CAPs) contain UK sites and activities that need to be removed by early next year due to Brexit. Companies have until the end of February to submit the required Type IA variation.

The European Medicines Agency (EMA) identified the continued presence of UK sites and activities on the marketing authorization dossiers of CAPs as an area in which the industry still needs to act on a recent webinar. EMA used the webinar to discuss preparations for the end of the transition period that has kept the UK subject to EMA rules in recent months.

EMA also emphasized the need to replace UK representatives with people based in the European Economic Area or Northern Ireland. The agency wants companies to make the change during the first regulatory procedure affecting annexes of 2021. CAPs for human use should only use the Article 61(3) procedure if no amendments to the annexes are planned for 2021.

Other required changes will need to take place in narrower time windows. This week, EMA began allowing companies with UK nationally authorized medicinal products to change the country code in their marketing authorizations. Ideally, EMA wants companies to change to “United Kingdom (Northern Ireland)” by the end of the year. The final deadline is the end of January.

While there is still work to do, many preparations for the end of the transition period are already complete. EMA said marketing authorization holders for all human CAPs have indicated they will be compliant with EU law and able to place their products on the market by the end of the year. A “very small number” of veterinary medicine manufacturers are yet to confirm compliance.

As of the end of November, 23 human and veterinary CAPs still needed to transfer manufacturing activities or change the Qualified Person Responsible For Pharmacovigilance. Companies have until the end of the year to make the changes…