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Annual update for registered API companies

14 January 2014

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 Health and Medicines Authority pursuant to section 50A(1) of the Consolidated Danish Medicines Act

Each year, registered companies must provide the Danish Health and Medicines Authority 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 Health and Medicines Authority 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 virksomhedstilladelse@dkma.dk

Only companies that have changes to report should submit the list. Companies with no changes to report only have to send an email informing us that no changes have taken place compared to last year.

If you have any questions, please contact Company Authorisations and Distribution on +45 4488 9779 or by email to virksomhedstilladelse@dkma.dk