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

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

  • Brexit—the regulation of medicinal products
  • Overview of the implications of Brexit for the regulation of medicinal products
  • Marketing authorisations—general considerations
  • Marketing authorisations—Withdrawal Agreement scenario—the implementation period
  • Marketing authorisations and medicines—no-deal guidance and legislation
  • Contingency planning—no deal
  • Centralised procedure—no deal
  • Decentralised and mutual recognitions procedures—no deal
  • National procedure—no deal
  • Orphan medicines—no deal
  • more

This Practice Note deals with key issues that are likely to affect the regulation of medicinal products as a result of the UK’s withdrawal from the EU. It 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, paediatric medicines, packaging and safety features.

For considerations on the potential impact of Brexit on the life sciences sector more generally, including the relevance of EU law to the sector, the main Brexit scenarios, the respective roles of the EU and UK regulators, 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.

Overview of the implications of Brexit for the regulation of medicinal products

The wide-ranging implications of Brexit for the regulation of medicinal products will be discussed in the following sections:

  1. Marketing authorisations—general considerations

  2. Marketing authorisations—Withdrawal Agreement scenario—the implementation period

  3. Marketing authorisations and medicines—no-deal guidance and legislation

  4. Contingency planning—no deal

  5. Centralised procedure—no deal

  6. Decentralised and mutual recognitions procedures—no deal

  7. National procedure—no deal

  8. Orphan medicines—no deal

  9. Paediatric medicines—no deal

  10. Manufacturing and batch release

  11. Pharmacovigilance

  12. Parallel imports, parallel distribution and parallel export—no deal

  13. Packaging and safety features

  14. Supplementary protection certificates (SPCs)