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Medicines and Medical Devices Act 2021 (Chapter 3 of 2021).

Country/Territory
United Kingdom
Document type
Legislation
Date
2021
Source
FAO, FAOLEX
Long title
An Act to make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices; confer power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices; make provision about the enforcement of regulations, and the protection of health and safety, in relation to medical devices; and for connected purposes.
Subject
Livestock, General
Keyword
Public health Access-to-information Animal health Institution Offences/penalties Drugs
Geographical area
Atlantic Ocean Islands, Europe, Europe and Central Asia, North Atlantic, North Sea, North-East Atlantic, Northern Europe
Abstract

The Medicines and Medical Devices Act 2021 (the Act): 1) establishes a Patient Safety Commissioner, with the core duties of promoting patient safety and the importance of the patient voice in relation to the regulation of human medicines and medical devices; 2) introduces targeted delegated powers in the fields of human medicines, veterinary medicines and medical devices to enable the existing regulatory frameworks to be updated following the United Kingdom’s (UK) departure from the European Union (EU); 3) provides information sharing gateways to enabling sharing with outside of the UK in order to give effect to international agreements and arrangements concerning the regulation of human medicines, veterinary medicines and medical devices; 4) provides a delegated power to establish one or more information systems in relation to medical devices; 5) provides a delegated power to establish on a legislative basis a medical device expert advisory committee; 6) and consolidates the enforcement provisions for medical devices and introduces civil sanctions.

Full text
English
Website
www.legislation.gov.uk