Be prepared for Brexit: The questions you need to ask
Life sciences companies with operations in the UK or Europe are wondering where to even start when it comes to Brexit-related legal issues.
To give you a jumpstart, our colleagues from different practice groups across multiple countries have prepared a series of questions you should ask to better understand how Brexit will impact your business and to clarify what steps need to be taken. In this edition, we discuss questions related to the regulation of medicinal products.
Regulation of medicinal products
For marketing authorisation holders established in the UK:
- How many of your products rely on centralised marketing authorisations granted by the EMA?
- How many supply contracts do you hold?
For all marketing authorisation holders:
- How many of your medicinal products currently on the UK market:
- Rely on a marketing authorisation granted nationally by the MHRA?
- Rely on a marketing authorisation granted through a decentralised procedure for which the MHRA was the Reference Member State authority?
- Rely on a marketing authorisation granted by the MHRA on the basis of mutual recognition of a marketing authorisation granted by another EU member state?
- How many of your medicinal products in the rest of the EU:
- Rely on a marketing authorisation granted by an EU member state through mutual recognition of a marketing authorisation granted by the MHRA?