Wholesale distribution of certain substances
Here you will find guidelines and forms for applying for authorisation to wholesale distribute certain substances within the EEA (wholese distribution authorisation). The Danish Medicines Agency issues wholesale distribution authorisations in accordance with Section 39 of the Danish Medicines Act.
Certain substances are a term for substances that have anabolic, anti-infectious, antiparasitic, anti-inflammatory, hormonal, euphoric or psychotropic properties that may be used in animals.
The wholesale distribution and import of certain substances requires an authorisation. The requirement also applies to products containing one or more of those substances as a constituent.
Guidelines
Guidelines on activities subject to a section 39 authorisation or company registration
Guidelines on requirements and deadlines for applications for company authorisations
Form
Legislation
Wholesale distribution of certain substances and requirements for authorisation are laid down in Section 93 of the Danish Medicines Act.Companies authorised to wholesale distribute certain substances
List of companies (in Danish only)
Submission of Wholesale Distributor Authorisations (WDA) to EudraGMDP
We submit Danish WDAs to the EMA’s EudraGMDP database as they are issued. This means that Danish WDAs are publicly available at EudraGMDP and authorisations can be verified in the database.
You can read more about EudraGMDP on the EMA’s website under EudraGMDP database.
Information on Rules for activities with certain substances can be found here