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Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
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.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Information for patients, healthcare professionals and developers of new medicines
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How veterinary medicines can be advertised.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
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.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
Information on good laboratory, manufacturing and distribution practice, good pharmacovigilance practice (GPvP), out-of-specification investigations, inspection metrics and fees.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
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