We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
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
Register to vote Register by 18 June to vote in the General Election on 4 July.
Information on good laboratory, manufacturing and distribution practice, good pharmacovigilance practice (GPvP), out-of-specification investigations, inspection metrics and fees.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Oct - 31 Dec 2023.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Jan - 31 Mar 2024.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includes information on a recent National Patient Safety Alert...
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information on herbal medicines, how to apply for a traditional herbal registration (THR), banned or restricted herbal ingredients, homeopathic medicines and fees.
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.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
The actions to take for sourcing medicines in different circumstances.
Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab).