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
Advice on ingredients in nicotine-containing liquids in electronic cigarettes and refill containers.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
How to comply with the exemption from the Veterinary Medicines Regulations that allow certain animal medicines to be sold without an authorisation.
Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one.
Guidance on medicines for food and non-food horses and record keeping requirements including the horse passport.
Section last updated: April 2024.
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.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
If you import, manufacture, process, distribute or sell plant protection products (PPPs) for professional use in Great Britain, register to comply with regulations.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Check the tariff classification for surface-active preparation for washing the skin and the hair (gel 2-in-1).
Apply to manufacture Extemporaneous preparations, Autogenous vaccines, authorisations for Equine Stem Cell Centre (ESCCA) or Non-Food Animal Blood Bank (NFABBA).
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
If you’re a business, organisation or sole trader that uses PPPs and adjuvants professionally in Great Britain, register to comply with regulations.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
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. We’ll send you a link to a feedback form. It will take only 2 minutes to fill in. Don’t worry we won’t send you spam or share your email address with anyone.