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There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Terms of reference of the expert reference group advising the review of prescribed medicines.
Information on carrying medicine containing controlled drugs for individual travellers entering or leaving the UK.
Check what side effects people have reported when they've taken a medicine.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
Terms of reference relating to the independent review of drugs led by Professor Dame Carol Black.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Specialist reference laboratory services for mycobacteriology available in the UK.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
These are the agreed terms of reference for the Advisory Council on the Misuse of Drugs.
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.
Outlining what part 2 of the independent review will cover.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
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