Composition

If the composition of a medicinal product has been changed by means of an appropriate variation application, can the medicinal product be on the market simultaneously with both the old and new composition?

A medicinal product can only be on the market with one composition. A medicinal product with the old composition must be withdrawn from pharmacies and wholesalers before the product is introduced on the market with a new composition. The marketing authorisation holder must notify Fimea (notification of placing a medicinal product on the market) when the medicinal product is introduced on the market with the new composition. If justified, Fimea may grant a permission for releasing both the old and new composition to the market for a maximum of six months. The request for simultaneous marketing must be presented along with the variation application.

18 Apr 2019
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