Brexit—implications of the Withdrawal Agreement for the life sciences sector
Brexit—implications of the Withdrawal Agreement for the life sciences sector

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

  • Brexit—implications of the Withdrawal Agreement for the life sciences sector
  • Relationship with EU law—the Withdrawal Agreement
  • Overview of the implications of the Withdrawal Agreement and Political Declaration for the life sciences sector
  • The end of the transition period
  • Protocol on Ireland/Northern Ireland
  • The EMA and MHRA
  • MHRA role during the implementation period
  • MHRA role in the UK-EU future relationship
  • Continued circulation of goods placed in the market
  • Marketing authorisations
  • More...

This Practice Note deals with key issues that are likely to affect the life sciences sector as a result of the UK’s withdrawal from the EU. It briefly considers the relevance of EU law and the Withdrawal Agreement to the sector and the respective roles of the EU and UK regulators. It outlines the impact of the Withdrawal Agreement on marketing authorisations (MAs) and medicinal products regulatory framework, medical devices, clinical trials, research and development, data protection, and import-export.

Relationship with EU law—the Withdrawal Agreement

The life sciences sector is one of the most highly regulated and globally harmonised industry sectors. A large amount of the regulation originates from the EU in the form of directives or regulations and is supplemented by guidance issued by the European Commission and the European Medicines Agency (EMA), the decentralised agency of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

The Withdrawal Agreement, which was approved by the UK Parliament by way of the European Union (Withdrawal Agreement) Act 2020 (EU(WA)A 2020), includes provisions for a transitional period (known in the UK as the implementation period) which is set to last until 31 December 2020. During the transition period, the UK maintains access to the UK single market and customs union and is bound by EU law as if it were a Member

Popular documents