The following Corporate guidance note provides comprehensive and up to date legal information covering:
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 the EU law to the sector, the main Brexit scenarios and respective roles of the EU and UK regulators. It outlines the possible impact of Brexit on clinical trials, research and development, data protection, employment, education and import-export.
For considerations on the potential impact of Brexit on the fundamental aspects of the medicinal products regulatory framework, see Practice Note: Brexit—the regulation of medicinal products.
The impact of Brexit on the regulation of 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.
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 Commission and by 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 European Union (Withdrawal) Act 2018 (EU(W)A 2018), which enables the government to use delegated legislative
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