Drugs: Licensing

Department of Health and Social Care written question – answered on 6th July 2018.

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Photo of Wera Hobhouse Wera Hobhouse Liberal Democrat Spokesperson (Housing, Communities and Local Government)

To ask the Secretary of State for Health and Social Care, if he will close the legal loopholes to make the market for unlicensed medicinal products less restricted.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

The Medicines and Health products Regulatory Agency (MHRA), the Government body responsible for the safety and licensing of medicines in the United Kingdom, is not aware of any legal loopholes for the supply of human unlicensed medicinal products.

Before a human medicine can be marketed or sold in the UK, a number of licences are required. The product itself must have a licence called a ‘marketing authorisation’ unless an exemption applies.

UK medicines legislation contains a provision for the supply of an unlicensed medicine (commonly known as ‘specials’) which is provided for by way of an exemption from the requirement for a marketing authorisation. In the interests of public health this exemption is narrowly drawn because these products, unlike products holding a marketing authorisation, will not have been assessed and approved against the criteria of safety, quality and efficacy in the UK.

Unlicensed medicines can be manufactured in the UK under European Union good manufacturing practice or imported into the UK by the holder of an appropriate licence issued by the MHRA.

Notifications prior to importation of unlicensed medicines are required and are assessed by the MHRA and objections may be raised where there are prohibitive safety or quality concerns. Any person that sells or supplies an unlicensed medicine is required to keep records and report suspected adverse drug reactions.

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