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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 to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
Interim guidance and information on the law for healthcare professionals
Importing investigational medicinal products for use in clinical trials
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
A list of herbal ingredients which are banned or restricted for unlicensed medicines.
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'
The actions to take for sourcing medicines in different circumstances.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The Home Secretary has formally commissioned the Advisory Council on the Misuse of Drugs (ACMD) to conduct a longer-term review of cannabis-based products for medicinal use.
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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