Registration as a broker of medicinal products

Updated 11 August 2016

Here, please find guidelines and forms for registration as a broker of medicinal products.

Companies brokering human and veterinary medicines with a marketing authorisation must register with the Danish Medicines Agency.

Brokering means activities related to buying and selling (brokering) of medicines not involving the activities of wholesale distribution (purchase, sale, receipt, storage and supply, etc.). Thus, brokering does not include the physical handling of medicinal products, but consists of negotiating independently and on behalf of another legal or natural person.

List of companies having registered as a broker of medicinal products (Excel file)

Illustration of brokering

Brokering

Companies must register pursuant to section 41B(1) of the Danish Medicines Act, which implements article 85 of Directive 2011/62/EU of 8 June 2011 on falsified medicines. The requirement applies to brokers of medicinal products throughout the EU, but only companies with an registered address in Denmark must register with the Danish Medicines Agency.

Deadlines for registration

As from 1 January 2013, companies are required to register with the Danish Medicines Agency. Companies which started their activities before 1 January 2013 must register with the Danish Medicines Agency by 1 March 2013.

The rules applicable to brokers of medicinal products are established in the Danish executive order on distribution of medicinal products (the GDP order). These rules apply to brokers of both human and veterinary medicines.

Guidelines

Guidelines on activities subject to a section 39 authorisation or company registration

Guidelines on registration as a broker of medicinal products

Form

Form for registration as a broker of medicinal products (Word file)

Inspection

Companies having registered as a broker of medicinal products may be inspected by the Danish Medicines Agency. Inspections will be performed in pursuance of the provisions of the GDP order.

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