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Renewals and variation applications

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After a marketing authorisation has been granted, the holder of a marketing authorisation or registration is obliged to actively maintain the marketing authorisation or registration.

The holder of a marketing authorisation for a medicinal product or traditional herbal medicinal product must notify the authority of all changes that will affect the marketing authorisation documentation of the produ ...

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Text edited by: Finnish Medicines Agency Fimea
Updated: 18/3/2021