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
Detailed guidance on advertising and promoting medicines.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Submission dates and how the submissions using the EC decision reliance procedure work.
How to change the ownership from one marketing authorisation (MA) holder to another.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How to apply for marketing authorisation via this new procedure.
How to renew marketing authorisations for products granted through different routes and at different times.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Guidance on what approved bodies are, what they do and how you can become one.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
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).