Brexit—the regulation of medicinal products
Brexit—the regulation of medicinal products

The following IP guidance note provides comprehensive and up to date legal information covering:

  • Brexit—the regulation of medicinal products
  • The Brexit scenarios
  • Relationship with EU Law
  • Overview of the implications of Brexit for the regulation of medicinal products
  • The EMA and MHRA
  • Marketing authorisations—general considerations
  • Marketing authorisations—Withdrawal Agreement scenario—the implementation period
  • Centralised procedure—no deal
  • Decentralised and mutual recognitions procedures—no deal
  • National procedure—no deal
  • more

This Practice Note deals with the key issues that are likely to affect the regulation of medicinal products as a result of the UK’s withdrawal from the EU. It briefly considers the relevance of EU law to the pharmaceutical sector, the main Brexit scenarios and respective roles of the EU and UK medicines regulators. It then considers the potential impact of Brexit on the fundamental aspects of the medicinal products regulatory framework, namely: marketing authorisations (MAs), orphan medicines, manufacturing of medicinal products, quality assurance, product safety and paediatric medicines.

For considerations on the potential impact of Brexit on the life sciences sector more generally, including on clinical trials and funding, see Practice Note: Brexit—general implications for the life sciences sector; the impact of Brexit on medical devices is discussed in the Practice Note: Brexit—medical devices. To follow the key Brexit developments and updates of interest to the life sciences sector, see Practice Note: Life sciences—Brexit tracker.

See the Brexit toolkit to access our full range of Brexit materials.

The Brexit scenarios

The draft Withdrawal Agreement and political declaration

The new draft Withdrawal Agreement and the political declaration on the framework for the future relationship between the UK and the EU were endorsed by the EU-27 leaders on 17 October 2019 (see: LNB News 20/10/2019 1).

The draft Withdrawal Agreement includes provisions for a