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Approval of a change to the licence of Comirnaty COVID-19 vaccine will enable thawing and re-labelling of the vaccine outside of the NHS
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
Advice for manufacturers of Class I medical devices for placing products on the UK market
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Guidance on Animal Test Certificates (ATCs) required to carry out the field trial of a veterinary medicine in animals (clinical trial) in the UK.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Importing investigational medicinal products for use in clinical trials
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Apply to manufacture Extemporaneous preparations, Autogenous vaccines, authorisations for Equine Stem Cell Centre (ESCCA) or Non-Food Animal Blood Bank (NFABBA).
The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months
Find out which COVID-19 test products have been approved.
Approved countries for batch testing and importation of medicines
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
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