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 life sciences sector as a result of the UK’s withdrawal from the EU. It outlines the possible impact of Brexit on clinical trials, research and development, data protection, employment, education and import-export.
For considerations on the possible Brexit scenarios (ie leaving the EU with a withdrawal agreement in place or leaving without an agreement—a no deal Brexit), the respective roles of the EU and UK medicines regulators and 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.
The requirements for the conduct of clinical trials currently stems from EU directives which have been incorporated into UK law via implementing legislation, namely the Medicines for Human Use (Clinical Trial) Regulations 2004, SI 2004/1031. Regulation (EU) 536/2014, the Clinical Trials Regulation entered into force on 16 June 2014 and will repeal and replace the existing Directive 2001/20/EC (consolidated version 07.08.2009), the Clinical Trials Directive. The Clinical Trials Regulation provides for a single application for clinical trials across the EU (through a single portal) with an associated EU-wide database. This regulation was supposed to have been applicable from
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