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Companies' name and address changes

Updated 08 April 2016

If your company changes name or address, be aware that the company's authorisations must be renewed by the Danish Medicines Agency.

An authorisation granted by the Danish Medicines Agency may in many cases be linked to

  • the registered address of your company and
  • the registered name of your company.

Your company must therefore apply for authorisation under the new address or the company name. 

Your company must apply for an authorisation renewal for each license granted by the Danish Medicines Agency. 

In other words, your company cannot submit a general notification concerning the change of address or company name.

Changes to authorisation for distribution and handling of medicinal products

You company must apply for authorisation renewals in respect of the following authorisations:

Applications forms

Links to the different web pages where application forms can be found:

Authorisation to distribute medicines outside pharmacies

Authorisation to manufacture and import medicines and intermediates

Authorisation for wholesale distribution of medicines

Authorisation of activities with euphoriant substances

Changes to marketing and manufacturing authorisations (variation applications)

In connection with any change of company address or company name, your company must submit a variation application (type I A) to the Danish Medicines Agency in the following situations:

  • Your company holds a marketing authorisation
  • Your company represents a marketing authorisation holder
  • Your company is a parallel distributor of a medicinal product
  • Your company is a manufacturer of the active substance of a medicinal product
  • The manufacturer of your company's finished medicinal product changes address.

Find more information about variation applications.

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