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 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. A statute is a formal, written law of a country or state, written and enacted by its legislative authority, perhaps to then be ratified by the highest executive in the government, and finally published. ...
The roles of the MHRA are:
Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and devices related to medicines.
Assessment and authorisation of medical products for sale and supply in UK.
Oversee the Notified Bodies that audit medical device manufacturers
Operate a quality surveillance system to sample and test medicines
to address quality defects
to moniter the safety and quality of unlicensed products.
Investigate internet sales and potential counterfeiting of medicines
Regulate clinical trials of medicines and devices
Monitor and ensure compliance with statutory obligations relating to medicines and devices.
Manage the GPRD, British pharmacopoeia and the Devices Evaluation Service.
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. Surveillance is the monitoring of behavior. ... A report is a type of document written by someone or a group of people. ... A medication is a licenced drug taken to cure or reduce symptoms of an illness or medical condition. ... A Device can be taken to mean: an electrical device designed to carry power, but not use it. ...
The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ... The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. ...
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