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
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
List of substances recognised as medicinal by function.
How to register as a manufacturer, importer or distributor of active substances.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to comply with the exemption from the Veterinary Medicines Regulations that allow certain animal medicines to be sold without a marketing authorisation.
Using an ecological momentary assessment to evaluate your digital health product.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
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 and requires JavaScript).