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
This is a work sharing model for the co-ordinated assessment of a generic application that has been filed with multiple Access Consortium agencies.
How to apply for an exceptional use authorisation to place medical devices on the UK market.
Apply for and maintain registrations for the brokering of human medicines.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Information for patients, healthcare professionals and developers of new medicines
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
A list of herbal ingredients which are banned or restricted for unlicensed medicines.
Guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates.
Guidelines to help mitigate and manage medicine shortages.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
This publication clarifies which regulatory guidelines should be followed, and which apply, in the development of phage therapeutic products.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Information and recommendations for manufacturers on the preparation and presentation of a post market surveillance report (PMSR).
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
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).