Medicines and Healthcare products Regulatory Agency

Encyclopedia : M : ME : MED : Medicines and Healthcare products Regulatory Agency

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The Medicines and Healthcare products Regulatory Agency (abbreviated MHRA) is a statutory body in the United Kingdom that seeks to find and eliminate harm in a medicinal product or medical device at any stage of its development or use thereby permitting graded (i.e. either the product is licensed to be a prescription only medicine [POM], authorised by a pharmacist [P], or a General Sales List (GSL) product) legality of that product, or a licence. MHRA is an executive agency of the Department of Health.

The roles of the MHRA are:

1. Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and medical devices.
2. Assessment and authorisation of medical products for sale and supply in UK.
3. Oversee the Notified Bodies that audit medical device manufacturers
4. Operate a quality surveillance system to sample and test medicines
5. *to address quality defects
6. *to moniter the safety and quality of unlicensed products.
7. *Investigate internet sales and potential counterfeiting of medicines
8. Regulate clinical trials of medicines and medical devices
9. Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
10. Promote safe use of medicines and devices
11. Manage the GPRD, British Pharmacopoeia and the Devices Evaluation Service.

MHRA hosts and supports a number of expert advisory bodies, including the Commission on Human Medicine which replaced the Committee on the Safety of Medicines in 2005, and the British Pharmacopoeia Commission.

As part of the European system of approval, MHRA or other national bodies can be the rappoteur or co-rappoteur for any given pharmaceutical application, taking on the bulk of the verification work on behalf of all members, while the documents are still sent to other members as and where requested.

See also

• [MHRA homepage]
• European Medicines Agency (EMEA)
• Regulation of therapeutic goods
• [Discussion group on the Traditional Herbal Medicinal Products Directive]

 

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