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
How to create a model of how your digital health product works and choose measures for your evaluation.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Things to consider when buying and using products.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
The rules about product labelling - including special rules for retailers and manufacturers in different business sectors (like food, jewellery and toys)
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
The guide, toolkit and further information for GB authorities with responsibility for consumer product safety.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
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).