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Drugs and Medical Equipment: EU Law

Question for Department of Health and Social Care

UIN 114177, tabled on 11 November 2020

To ask the Secretary of State for Health and Social Care, whether, through the Medicines and Medical Devices Bill 2019-21, his Department plans to amend the definitions of (a) medicines, (b) medical devices and (c) biocides, as set out in Article 1 of Directive 2001/83/EC through the European Medicines Agency framework.

Answered on

24 November 2020

There are currently no plans to amend the definitions of medicines and medical devices through the Medicines and Medical Devices Bill. The Bill does not enable amendments to be made to the definition of ‘medicinal product’ in the Human Medicines Regulation 2012.The Bill does provide the powers to amend the definition in the Medical Devices Regulation 2002 for ‘medical device’, should a future need arise, for example to reflect innovative technologies not yet captured in the definition. Biocides are outside the scope of the Bill and are regulated by the Health and Safety Executive.