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Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Submissions related to human medicines need to be submitted directly to the MHRA.
Urgent safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
Register as a manufacturer, importer or distributor of active substances.
How to contact MHRA for specific services or enquiries.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
The CMU is part of the Medicine, Pharmacy and Industry Group of DHSC which looks at supply and procurement in hospitals.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Torrent Pharma (UK) Limited is recalling certain batches of Ramipril 1.25mg tablets as a precautionary measure due to these batches having a low assay and high related substances test results after their release to the market.
Licence and registration application information for companies that deal in precursor chemicals.
Covering thalidomide, lenalidomide, and pomalidomide: temporary guidance for pregnancy prevention arrangements for patients taking them during COVID-19
The Advisory Council on the Misuse of Drugs makes recommendations to government on the control of dangerous or otherwise harmful drugs, including classification and scheduling under the Misuse of Drugs Act 1971 and its regulations. ACMD is an advisory non-departmental...
Information for patients, healthcare professionals and developers of new medicines
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Submission dates and how the submissions using the EC decision reliance procedure work.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
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