Registration as manufacturer, importer and distributor of active substances (APIs) for manufacturing of human medicines
Here you can find guidelines and forms to register as a manufacturer, importer or distributor of active substances intended for manufacturing of human medicines (API registration).
Active substances intended for the manufacturing of veterinary medicines are exempted from the requirement to register, because veterinary medicines are not covered by the Danish executive order on manufacture, import and distribution of active substances for manufacturing of medicinal products (the 'Danish API order' – full Danish title: 'Bekendtgørelse om fremstilling, indførsel og distribution af aktive stoffer til fremstilling af lægemidler').
A company is obliged to register pursuant to Section 50A(1) of the Danish Medicines Act. This is established in Directive 2011/62/EU of 8 June 2011 on falsified medicinal products. 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 the manufacture, import and distribution of active substances for manufacture of human medicines are laid down in the Danish API order.
Each year, registered companies must provide the Danish Medicines Agency with a list of changes that have taken place relative to the information that was provided on the registration form. Any changes that may affect the quality or the safety of the active substances being manufactured, imported or distributed must, however, be notified the immediately.
Companies that register as manufacturer, importer and distributor of active substances for manufacturing of human medicines will be inspected if the Danish Medicines Agency finds it necessary. Before the planned activities may begin, the inspection could be carried out within 60 days from the date when the Danish Medicines Agency received the registration form. Regardless of this pre-inspection, companies may be inspected later.
The inspection will be carried out according to the applicable API rules established in the Danish API order.
The fee for registration is determined by the Ministry of Health in the
For more on the payment of fees see the guidelines on registration as manufacturer, importer and distributor of active substances (APIs) for manufacturing human medicines.