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Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Guidance on using non-investigational medicinal products in a clinical trial.
Information on comparator products used in studies supporting abridged marketing authorisation application.
The review of the safety of isotretinoin has concluded.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Criteria applied by the VMD for accepting and agreeing the invented name of veterinary medicinal products.
Find out how to apply VAT zero rating for the supply of those plants and seeds that are used to grow food for human consumption.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
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