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.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Placing a veterinary medicine on the market, including non-medicinal products, medicinal words and phrases, how to obtain advice, report non-compliance.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
For manufacturers and distributors of intermediate and final feedingstuffs containing a medicinal premix or specified feed additives.
Information about the EU Regulations and their implementation in Northern Ireland
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Guidance for industry on flexible approaches we are taking on good distribution practices.
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).