Freedom of Information request on permit UK doctors to use their judgment about how to treat COVID-19 patients. (FOI 20-575)
Published 24 March 2021
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Thank you for your email.
A link to the current Summaries of Product Characteristics (SmPCs), Patient Information Leaflets (PILs) and Public Assessment Reports (PARs) for hydroxychloroquine products is provided below: https://products.mhra.gov.uk/search/?search=hydroxychloroquine&page=1
Hydroxychloroquine is not currently authorised for use in treating patients with COVID-19 infection. Any change to the indications for a product must be submitted as a variation application by the marketing authorisation holder before it can be assessed and approved by the MHRA. However, although a marketing authorisation defines a medicine’s terms of use, there are clinical situations when the use of a medicine outside the terms of the licence (i.e. ‘off-label’) may be judged by the prescriber to be in the best interest of the patient on the basis of available evidence. Further information on off-label use is published on the MHRA website:
https://www.gov.uk/drug-safety-update/off-label-or-unlicensed-use-of-medicines-prescribers-responsibilities
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk
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If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000