This section of the site provides advice and guidance on the regulatory arrangements that apply to advanced therapy medicinal products (ATMPs) and answers to frequently asked questions.
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Advanced therapy medicinal products advice form
Companies, researchers and others who wish to get advice from the MHRA on the regulatory classification of a product that may come into the ATMP category should complete this advice form. For this kind of product, this form will replace existing arrangements for those who want to get regulatory classification advice.
Advanced therapy medicinal products advice form