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 is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
Register as a manufacturer, importer or distributor of active substances for use in veterinary medicines.
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.
Using an ecological momentary assessment to evaluate your digital health product.
Submission dates and how the submissions using the EC decision reliance procedure work.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Product Safety Report for Makari Exclusive Active Intense Tone Boosting Body Milk sold via eBay presenting a serious chemical risk.
How to comply with the exemption from the Veterinary Medicines Regulations that allow certain animal medicines to be sold without a marketing authorisation.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Register as a manufacturer, importer or distributor of active substances.
Check the tariff classification for a defined daily dose of active substances.
A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.
How to renew marketing authorisations for products granted through different routes and at different times.
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).