Annual update for registered API companies

Please note that this website has yet to be updated regarding the regulation (EU) 2019/6 on veterinary medicinal products. We refer to the Danish website for the updated information.

Companies manufacturing, importing and/or distributing active substances (API) intended for use in the manufacturing of medicinal products for human use and covered by a marketing authorisation must register with the Danish Medicines Agency pursuant to section 50A(1) of the Consolidated Danish Medicines Act.

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 to the Danish Medicines Agency immediately pursuant to section 7 of the Danish executive order on manufacture, import and distribution of active substances for manufacture of medicinal products (in Danish).

The annual list of changes must be submitted every year before 1 March and include the following:

• A cover letter describing the change
• A list of new or removed APIs in relation to the APIs originally reported
• An updated registration form in case of changes to the activities originally reported. The form should reflect all activities currently carried out in the company.

Please send the annual list to Send an email