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

País/Territorio
Reino Unido
Tipo de documento
Legislación
Fecha
2021
Fuente
FAO, FAOLEX
Título completo
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.
Materia
Ganado, General
Palabra clave
Salud pública Acceso-a-la-información Sanidad animal Institución Infracciones/sanciones Medicamentos
Área geográphica
Islas del Océano Atlántico, Europa, Europa y Central Asia, Atlántico Norte, Mar del Norte, Atlántico Nordeste, Europa Septentrional
Resumen

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.

Texto completo
Inglés
Página web
www.legislation.gov.uk