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Pharmacovigilance system requirements
How to use a combination of quantitative and qualitative data to evaluate your digital health product.
The guide, toolkit and further information for GB authorities with responsibility for consumer product safety.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
How a marketing authorisation holder should report a defect with a veterinary medicine.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
Things to consider when buying and using products.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Find out which standards and regulations apply to your product and how to make sure you follow the right procedures.
Resources to help anyone developing or running a digital health product to conduct an evaluation.
Your purchasing strategy must show you’ve considered commercial and technology aspects, and contractual limitations.
The rules about product labelling - including special rules for retailers and manufacturers in different business sectors (like food, jewellery and toys)
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
How to assess household and non-household packaging from 2024 onwards if you’re a UK organisation affected by extended producer responsibility (EPR) for packaging.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How to use a cost benefit analysis to evaluate your digital health product.
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