The new directive on falsified medicinal products was implemented into Danish law on 1 January 2013 after a consultation process. Under the new rules, companies which broker medicinal products and companies which manufacture, import or distribute active substances in Denmark must register their activities with the Danish Health and Medicines Authority.
To do so, companies must fill out a registration form, which we have placed on our website together with guidelines for completion. Likewise, the general information on our website about company authorisations has been updated.
Brokering of medicinal products
Brokering of medicinal products means any form of activities of buying and selling human medicines – except for wholesale distribution. Brokering does not include the physical handling of medicinal products, but consists of negotiating independently and on behalf of another legal or natural person.
As from 1 January 2013, brokering activities require registration. Companies which already carried out brokering activities before 1 January 2013 must register by 1 March 2013. Only companies based in Denmark are to register in Denmark.
Guidelines on registration as a broker of medicinal products
Registration as a broker of medicinal products (registration form)
Manufacture, import or distribution of active substances intended for medicinal products
After 1 January 2013, companies are required to register the manufacture, import or distribution of active substances for human medicines in Denmark. Companies that already performed these activities before 1 January must register by 1 March 2013.
Guidelines on registration as manufacturer, importer and distributor of active substances (API) for manufacturing of human medicines
Registration as manufacturer, importer and distributor of active substances for manufacturing of human medicines (registration form)
Update of information about company authorisations
As a result of the new types of activities, our guidelines on company authorisations have also been updated.
Guidelines on requirements and deadlines for applications for company authorisations
Guidelines on activities subject to a section 39 authorisation or company registration