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Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
How the MHRA makes decisions on what is a medicinal product (borderline products).
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.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Section last updated: April 2024.
The government's summary of a EU Commission proposal to amend EU legislation relating to medicinal products for human use and the impact on Northern Ireland.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
The government's summary of an EU Commission proposal to amend EU legislation relating to medicinal products for human use and the impact on Northern Ireland.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Interim guidance and information on the law for healthcare professionals
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
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