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Blue Box Requirements

Additional Danish labelling requirements

The Danish Medicines Agency (DKMA) has issued new requirements for the labelling and package leaflets of medicinal products1,2. Medicinal products, excluding radiopharmaceuticals, homeopathic, herbal and traditional medicines and certain vitamins and minerals, marketed in Denmark must now display the Nordic identification number on the outer label. Additional requirements have also been established for warning labels on some products. Products which may reduce the ability of the user to drive or operate machinery must now display a red warning triangle.

The DKMA also wants additional information on precautions for use to be included on the package leaflets. Additional information to...

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