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Data, Freedom of Information releases and corporate reports
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Information for patients, healthcare professionals and developers of new medicines
You must get permission to export certain drugs and medicines.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Guidance on how to reclassify your medicine and how to name medicines.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Information on herbal medicines, how to apply for a traditional herbal registration (THR), banned or restricted herbal ingredients, homeopathic medicines and fees.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
How veterinary medicines can be advertised.
The medicines regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the continued need for COVID-19 medicines that are safe, effective and of high quality
Information on granted EAMS scientific opinions, including the public assessment report and treatment protocols.
Report a problem ('adverse incident') with a medical device or medicine to MHRA using the Yellow Card Scheme
Update about the developing role of biosimilar medicines in the NHS in England and the safe, effective and consistent use of biosimilar medicines.
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