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Application for variation to a marketing authorisationhumanveterinaryNATIONAL Authorization IN MRP Variation procedure number(s) 1: ....................EU AUTHORISATIONNATIONAL AUTHORISATIONReference
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National authorisation in mrpvariation is a process where a member state grants approval for a variation to a Marketing Authorisation of a medicinal product.
Marketing Authorisation Holders (MAHs) are required to file national authorisation in mrpvariation.
National authorisation in mrpvariation can be filled out by submitting the necessary forms and documentation to the relevant regulatory authority.
The purpose of national authorisation in mrpvariation is to ensure that variations to Marketing Authorisations of medicinal products meet the regulatory requirements of the member state.
Information such as the proposed variation, supporting data, and any potential impact on the quality, safety, or efficacy of the medicinal product must be reported on national authorisation in mrpvariation.
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