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NHS: Drugs

Department of Health and Social Care written question – answered on 8th October 2019.

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Photo of Baroness Afshar Baroness Afshar Crossbench

To ask Her Majesty's Government what assurance, if any, they have received that medication brought from new sources other than the EU will meet the same standards as present.

Photo of Baroness Blackwood of North Oxford Baroness Blackwood of North Oxford The Parliamentary Under-Secretary for Health and Social Care

All human medicines marketed in the United Kingdom must meet stringent requirements for quality, safety and efficacy set out in UK medicines legislation and supporting guidelines. These apply regardless of the source of the medicine.

The Medicines and Healthcare products Regulatory Agency (MHRA), the Government body responsible for the safety and licensing of medicines in the UK, regularly inspect pharmaceutical manufacturing plants in the UK and in third countries.

Regardless of the location of the site of manufacture, the manufacturer must demonstrate to the MHRA that the product is manufactured according to the registered UK licence (marketing authorisation) and to at least the minimum standard detailed in the European Union Guide to Good Manufacturing Practice.

In addition, each batch of medicine manufactured in a third country is tested within the UK on import and the manufacturing document reviewed by the license holders Qualified Person before being certified for release to the market.

All these measures will remain in place if the UK leaves the EU.

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