Danish Drug Standards

Updated 26 September 2018

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 may concern the strength of the medicinal product, how fast it is dissolved, its purity, labelling, etc.

The Danish Medicines Agency takes part in the development of standards for the quality of medicinal products, which apply 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. Read more about the EDQM and the Ph. Eur. at pheur.org

The standards in the Ph. Eur. come into force in Denmark by means of the executive order “Danish Drug Standards”, which is published by the Danish Medicines Agency.

The Danish Drug Standards also contain standards that are not described in the Ph. Eur. but which apply to the Danish market.

The Danish Drug Standards are published three times a year and are updated in amending executive orders three times a year, simultaneously with the publication of new supplementary volumes to the Ph. Eur.

The Danish Drug Standards are available in Danish only: Danske Lægemiddelstandarder

Comments

General monographs in Ph.Eur. 9.5

General notices to the Ph. Eur. Supplement 9.5

Brief comments to Ph. Eur. monographs as amended in DLS 2018.2 / European Pharmacopoeia 9.5

Free access to the EDQM’s Standard Terms database

The EDQM’s Standard Terms database is always updated and contains terms and definitions to describe applicable pharmaceutical forms, containers, routes of administration etc.

To access the database you need to register and create an account at the EDQM’s website

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.