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Guidance on using non-investigational medicinal products in a clinical trial.
Approach to MHRA’s assessment of applications for medicines that use alternative methods to replace animals in science
Urgent and clinically significant safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
List of words and phrases that will cause a veterinary product to be medicinal by presentation either through use or contextual use.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
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