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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.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Information on comparator products used in studies supporting abridged marketing authorisation application.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
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