Denmark: MAHs Advised to Revise Summary of Product Characteristics for Medicinal Products (22 January 2024)

WHO Collaborating Centre (WHOCC) updated the ATC/DDD list of 5TH Levels on 12 December 2023 and the Danish Medicines Agency (DMA) released a reminder to all related marketing authorization holders (MAHs) of medicinal products that have been authorized under the national procedure, decentralized procedure, and mutual recognition procedure, to take note on the ATC codes changes.

MAHs were advised to refer to the ATC codes for human medicinal products that will be listed in Medicine Prices on 22 January 2024. The same goes for veterinary medicinal products but this will be updated later in Medicine Prices.

MAHs were required to apply for an update of the summary of product characteristics for the medicinal products if there are changes applied to the ATC code or text of the medicinal products that have been authorized under the national procedure, decentralized procedure, and mutual recognition procedure. MAHs may refer to the Guidelines for Variations Application for the medicinal products.

Source: Danish Medicines Agency (DMA)

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