The following Life Sciences practice note provides comprehensive and up to date legal information covering:
This Practice Note provides an overview of the Medicines and Medical Devices Bill (the Bill) as introduced which, in summary, enables the existing UK regulatory frameworks for medicines and medical devices to be updated following the end of the implementation period, consolidates the enforcement provisions on medical devices and allows the sharing of information on medical devices. The Practice Note outlines the legal context and the purposes of the Bill, tracks the steps of its legislative procedure and examines the key provisions on human medicines, clinical trials and medical devices:
Background and purposes of the Bill
Overview of the Bill
Timeline of legislative procedure
Part 1—Human medicines
Part 3—Medical devices
A large part of the UK legal framework for medicinal products and medical devices originates from EU law (regulations and directives), which has been given effect and implemented in the UK through the European Communities Act 1972 (ECA 1972). ECA 1972 was repealed on exit day by the European Union (Withdrawal) Act 2018 (EU(W)A 2018), however its effect in relation to EU law (as well as to decisions and case law) is preserved.
The UK is still subject to EU law during the implementation period because of the saving provisions inserted into the EU(W)A 2018 by the European Union (Withdrawal Agreement) Act 2020. At the end of the implementation period (IP
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