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 provides advice for Retailers and Producers of e-cigarette / vape products.
Guidance on what approved bodies are, what they do and how you can become one.
This advice has been written by the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) at the request of the Medicines and Healthcare products Regulatory Agency (MHRA – UK regulator). It is in the …
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
How test manufacturers or distributors can apply for approval of their tests to sell on the UK market.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Guidance for importers of unlicensed human medicines on meeting the requirements of the TSE (Transmissible Spongiform Encephalopathies) guidelines.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
Guidance for healthcare professionals on effectively decontaminating endoscopes.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
Industry must notify the MHRA if they will not be using these flexibilities
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).