Send Danish package leaflet when applying for changes to product information

11 February 2015

When applying for changes to the product information, marketing authorisation holders must always send a Danish version of the package leaflet to the Danish Health and Medicines Authority, whether the medicinal product is marketed in Denmark or not (unless the medicinal product is subject to section 11 about omission of the package leaflet, cf. Executive order no. 869 of 21 July 2011, as amended, on the labelling etc. of medicinal products).

The reason is that the marketing authorisation holder may place a medicinal product on the market in Denmark in a short time (every fortnight), and that the Danish Health and Medicines Authority wants the applicable Danish version of the package leaflet to be available, regardless of the status of the medicinal product.

As regards variations under the mutual recognition procedure and the decentralised procedure (MRP/DCP), the submission time for the national version of a package leaflet appears from ”Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure”:

For purely national marketing authorisations, the package leaflet must be submitted at the time of application as well as later on in the procedure (if relevant) regardless of the type of variation.

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