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Danish Drug Standards

Updated 02 July 2012

A pharmaceutical company must ensure that its medicinal product and the substances used in the manufacturing process at least meet the requirements subject to which the medicinal product was authorised. These requirements could concern the strength of the medicinal product, how fast it is dissolved, its purity, labelling, etc.

The Danish Health and Medicines Authority takes part in the development of standards for the quality of medicinal products, which applies to all medicines on the European market. These standards are published in the European Pharmacopoeia (Ph. Eur.), which is prepared and published by the European Directorate for the Quality of Medicines & Healthcare (EDQM) in Strasbourg. You can read more about the EDQM and the Ph. Eur. at www.Pheur.org.

The standards in the European Pharmacopoeia come into force in Denmark by means of the executive order "Danish Drug Standards" (Danish title: Bekendtgørelse om Danske Lægemiddelstandarder), which is published by the Danish Health and Medicines Authority. The Danish Drug Standards also contain standards not described in the Ph. Eur. but which apply to the Danish market nonetheless.

The Danish Drug Standards are published three times a year in a complete version. They are available in Danish only: Danske Lægemiddelstandarder