Danish Drug Standards
A pharmaceutical company must ensure that its medicinal product and the raw materials 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 edqm.eu.
The standards in the European Pharmacopoeia come into force in Denmark by means of the executive order "Danish Drug Standards" (Danske Lægemiddelstandarder), which is published by the Danish Medicines Agency. The “Danish Drug Standards” is only available in Danish.
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
Every three years in January, a new updated main version of the executive order “the Danish Drug Standards” is issued. Between these triennial issues, the main version is updated three times a year on the first day of January, April and July by way of eight consecutive executive orders to amend the executive order “the Danish Drug Standards”.
When a new main version of the Danish Drug Standards is issued, all versions of “executive order to amend the executive order on the Danish Drug Standards” published after the issue of the latest main version are marked as obsolete on Retsinformation.
The latest main version of the Danish Drug Standards is available at Retsinformation with the subsequent amendments available from the left-hand menu. The legal basis is made up of the latest main version of the Danish Drug Standards and the subsequent versions of the “Executive order to amend the executive order on the Danish Drug Standards” published after the issue of the current main version of the Danish Drug Standards.
From 2020, the naming of the executive orders to amend the executive order on the Danish Drug Standards was changed. The names of these amending executive orders will now be based on the year of publication of the main version of the Danish Drug Standards (2020.1 to 2020.8) instead of the year of the publication of the individual executive orders. The new naming convention is to make it easier to identify the direct connection between the executive orders to amend the Danish Drug Standards and the supplement volumes to the European Pharmacopoeia.
From the List of raw materials and finished products section below, you can find a table of all monographs in the Danish Drug Standards. This table was previously divided into raw materials, finished products and medicinal products in the Danish Drug Standards. The table is from the current main version of the Danish Drug Standards, which will be regularly updated as subsequent versions of “Executive order to amend the executive order on the Danish Drug Standards” are published.
Comments to the texts in Ph. Eur. 11.4
General monographs – Important notice
Comments concerning revised texts published in Supplement 11.4
The list of modified monographs in Ph. Eur. since the last update can be found in appendix 2 in the Danish Drug Standards and in the subsequent versions of the “Executive order to amend the executive order on the Danish Drug Standards”.
List of raw materials and finished products
This table represent the current status of raw materials and finished products in the Danish Drug Standards 2023.4 / Ph. Eur 11.4:
Raw materials and finished products in the Danish Drug Standards 2023.4
Table of isotonic solutions
In the Danish Drug Standards 2023.2, the table of isotonic solutions is deleted from the executive order published in Retsinformation. Instead, the table can be found in the pdf-file below.
Danish monograph: Cannabis flower
The Danish monograph for Cannabis flower was updated with the entry into force of the Danish Drug Standards 2020.0.
In the Danish Drug Standards 2020.3, the monograph for Cannabis flower has been updated with small corrections and clarification of the wording with no impacts on the interpretation of the monograph. The repeated first section has been deleted, and the formulas have been moved into place and corrected.
In the Danish Drug Standards 2020.6, the monograph for Cannabis flower has been updated with small corrections and clarification of the wording with no impacts on the interpretation of the monograph. The possibility to use a blender for the pulverisation of the herb is added. The paragraph for foreign matter has been rephrased. The method for loss on drying has been harmonised with Ph. Eur. (2.2.32). In the quantitative test, a step of filtration has been removed and the formula for the structure of Δ8-THC has been corrected.
In the Danish Drug Standards 2023.0, no changes have been made to the monograph for Cannabis flower.
In the Danish Drug Standards 2023.2, the Danish monograph on Cannabis flower can be found in appendix 8. No changes have been made to the monograph in this publication.
Free access to EDQM’s Standard Terms database
It is possible to access the EDQM's Standard Terms database to get familiar with the applicable terms for pharmaceutical forms, container types, routes of administration, etc.
Anyone interested can access the database subject to personal registration at the website of the EDQM. The database is always up to date 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. Please find the document “Introduction and guidance for use” on the Standard Terms-website for more information.