FOI release

Freedom of Information request on Does the MHRA take a proactive approach to classifying or taking action against products? (FOI 22/569)

Published 1 June 2022

FOI 22/569

25th March 2022

Dear

Thank you for your email.

Please find below answers to the questions you have raised in blue below.

  1. Does the MHRA take a proactive approach to classifying or taking action against products? In other words, does the MHRA voluntarily and actively engage in market surveillance and subsequently take action on its own volition towards specific products, even when no complaints have been received regarding said products? Can the MHRA act without receiving any complaints? Or must the MHRA receive complaints regarding specific products in order to formally classify or take any action against said products? The MHRA can take a proactive approach as well as act on complaints received in regards to the classification of products.

  2. If a MHRA Borderline Classifier is presented with products that are dangerous, as well as with extensive evidence that said products are dangerous, must he or she take action even if no complaint regarding said products has been received? All referrals and complaints about potential breaches of The Human Medicines Regulations 2012 are reviewed and dealt with by the MHRA.

If you have a query about the information provided, please reply to this email

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Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000