The following Life Sciences guidance note provides comprehensive and up to date legal information covering:
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.
The wide-ranging implications of Brexit for the regulation of medicinal products will be discussed in the following sections:
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
Paediatric medicines—no deal
Manufacturing and batch release
Parallel imports, parallel distribution and parallel export—no deal
Packaging and safety features
Supplementary protection certificates (SPCs)
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