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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.