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 Danish Drug Standards in force
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 national 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 most recent main version of the DLS is available on Retsinformation. Amendments to the main version can be found in the menu on the left-hand side. The legal basis consists of the latest main version of DLS together with all subsequent amendments to DLS published since the release of the current main version of DLS.
Updates
From 2025, the Ph. Eur. is available exclusively online. The website is updated three times a year, with texts that become legally binding on 1 January, 1 April, and 1 July. DLS is updated on the same dates to implement the new issue of Ph. Eur. into Danish legislation.
Updates to texts and monographs in Ph. Eur. are subject to public consultation via Pharmeuropa. By creating a user account on Pharmeuropa, you can set up notifications to receive alerts about consultations on relevant legislation. Comments on proposed changes must be submitted to the Pharmacopoeia Secretariat Send an email.
In case of major changes to DLS, the draft is submitted for consultation via høringsportalen.
Comments to the texts in Ph. Eur. 12.1
Comments concerning revised texts published in Issue 12.1
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
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.
Table with the current status of raw materials and finished products in the Danish Drug Standards 2026.1 / Ph. Eur. 12.1:
Raw materials and finished products in the Danish Drug Standards 2026.1
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.
Previous Amendments to DLS
Further information on major changes to the Danish Pharmaceutical Standards (DLS) can be found in the categories below. All current and previous editions of DLS are available on Retsinformation.
Naming of DLS
From 2026, the naming convention for DLS will be updated to align with the new naming system of the European Pharmacopoeia (Ph. Eur.). As Ph. Eur. will change its version number annually, DLS will also adopt an annual year-based versioning system. This means that the three releases of DLS in 2026 will be named 2026.1, 2026.2, and 2026.3.
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 was in 2020-2025 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 was 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.
Danish monograph on Cannabis flower
The Danish monograph for Cannabis flower is omitted with the implementation of Danish Drug Standards 2023.5 (DLS 2023.5) because of the new monograph for Cannabis flower in Ph. Eur. 11.5. Therefore, the Cannabis flower monograph from Ph. Eur. is the official quality standard according to Danish legislation as of 1st July 2024.
The Danish Cannabis flower monograph has been applicable from DLS 2018.1 (1st April 2018) to DLS 2023.5 (1st July 2024). The monograph has been updated regularly (DLS 2020.0, DLS 2020.3 and DLS 2020.6) with minor changes and clarification of wording.
With the removal of the Danish monograph for Cannabis flower, there are no additional monographs to Ph. Eur. in the Danish legislation.
The list of standard terms (table 6.2.1 in DLS) are applicable to both approved medicinal products and products containing medicinal cannabis. An additional list of terms applicable for only medicinal cannabis can be found in the Danish Drug Standards Appendix 8 (table 8.1). Appendix 8 has been amended in DLS 2023.5 due to the omission of the Danish Cannabis flower monograph, but there are no changes to table 8.1.
List of raw materials and finished products
The table List of raw materials and finished products was previously divided into raw materials, finished products and medicinal products in the Danish Drug Standards. These tables have now been consolidated, and the list covers all monographs, except for monographs on homeopathic raw materials and medicinal products.
Table of isotonic solutions
In the Danish Drug Standards 2023.2, the table of isotonic solutions was deleted from the executive order published in Retsinformation. Instead, the table can be found in the 5th edition of the book "Almen Farmaci" (ISBN: 9788759344149).
Storage conditions
Previously, information about storage conditions has been stated on this website.
Storage conditions for medicinal products for human use can be found in: Guideline on declaration of storage conditions: A: in the product information of medicinal products, B: for active substances (CHMP/QWP/609/96/Rev 2)
For labelling and text in the summary of product characteristics for medicinal products, please refer to the Executive Order bekendtgørelse om mærkning m.m. af lægemidler til mennesker (in Danish) with associated amending executive orders, vejledning til bekendtgørelse om mærkning m.m. af lægemidler til mennesker (in Danish) and the applicable QRD template (Quality Review of Documents).