BREXIT – ITS IMPACT ON REGULATORY ASPECTS OF HEALTH AND LIFE SCIENCES

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"Much UK regulatory law originates from the EU. Most of it comes from EU Directives which the UK has implemented into our national law. Examples are Directive 2001/83/EC on the Community code relating to medicinal products for human use (as amended) and Directive 89/105/EEC, regulating the pricing of medicinal products for human use and their inclusion in national health insurance schemes. Some of it is derived from EU Regulations which are directly applicable in the UK, without the need for any implementing legislation here. An example is Regulation 726/2004 on the authorisation and supervision of medicinal products and establishing the European Medicines Agency.

This briefing considers some potential impacts of a vote to leave the EU (“Brexit”) on regulatory aspects of healthcare and life sciences."

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