Danish Drug Standards
Danish Drug Standards
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 applies to 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 European Pharmacopoeia at pheur.org.
The standards in the European Pharmacopoeia 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 European Pharmacopoeia which nonetheless apply to medicinal products on the Danish market.
The Danish Drug Standards are issued pursuant to section 52 of the Danish Medicines Act.
The Danish Drug Standards in force
The latest changes to the Danish Drug Standards are available at Retsinformation.
The executive order is updated three times a year on 1 January, 1 April and 1 July. Every third year, a new main version is released at which point the previous changes become historic at Retsinformation.
The latest main version of the Danish Drug Standards is also available at Retsinformation. The latest changes are available from the right-hand menu.
The brief comments are intended as a quick guide to get an overview of the new changes in the already existing monographs of the European Pharmacopoeia as indicated in supplement 6 of the 9th edition (Ph.Eur. 9.6). The comments contain a very brief indication of the change and in special cases the background for the change.
The list of modified monographs is found in Schedule 2 of the Danish Drug Standards.
Here you can see the tables with the current status of raw materials and medicinal products in the Danish Drug Standards in 2019.0 / European Pharmacopoeia 9.6:
Danish monograph: Cannabis flower
With the entry into force of the Danish Drug Standards 2019.1, the Danish monograph for Cannabis flower has been updated with editorial changes. The updated monograph is found in the Danish Drug Standards 2019.1.
Free access to EDQM’s Standard Terms database
It is possible to access EDQM's Standard Terms database to get familiar with the applicable pharmaceutical forms, container types, routes of administration, etc.
Anyone interested can access the database subject to personal registration at EDQM’s website. The database has the advantage of always being updated and also gives access to more details than the previous tables of the Danish Drug Standards and not least to a definition of the term.