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How to ensure the products you make or import comply with the law and are safe for consumers to use.
How to use an interrupted time series to evaluate your digital health product.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
How to make sure that your products are properly checked for conformity and your technical documents are managed correctly.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How we are building national capacity for product safety.
Check what you need to do to sell cosmetic products in Great Britain.
Guidance on choosing evaluation study types and methods.
How a marketing authorisation holder should report a defect with a veterinary medicine.
Product security factsheet accompanying the Product Security and Telecommunications Infrastructure Bill, outlining the problems the Bill will address and how.
What you need to do to comply with regulations on manufactured goods you place on the Northern Ireland market.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Ensuring you get what you pay for.
Guidance for suppliers and dealers.
Why it's important to evaluate digital health products that have been developed rapidly and how to choose evaluation methods in these circumstances.
Lists of standards that businesses can use to show their products, services or processes comply with essential requirements of legislation.
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