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Medicines And Healthcare Products Regulatory Agency




The roles of the MHRA are:

#Operate post-marketing Surveillance for Report ing, investigating and monitoring of adverse drug reactions to medicines and medical devices.
#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 medical devices

#Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
#Promote safe use of Medicines and Device s
#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.


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