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How the MHRA treats traditional herbal medicines and homeopathic medicines.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
How to determine if you will need to undertake a clinical investigation of a medical device, or if it is exempt under the regulations.
Requirements for sponsor representatives using EHR (electronic health records) in clinical trials.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
Approved countries for batch testing and importation of medicines
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Guidance on infant and follow-on formula, the application form for infant and follow-on formula made from protein hydrolysates, and forms to notify the authority.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
Reforms to ensure that medical device regulation is fit for purpose for software products, including artificial intelligence (AI).
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
Apply for and maintain registrations for the brokering of human medicines.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing, access and growth in 2026.
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
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