Companies' name and address changes
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:
- manufacture and wholesale distribution of medicinal products (section 39 of the Danish Medicines Act)
- retail distribution of over-the-counter and/or V-marked medicinal products sold outside pharmacies (section 39 of the Danish Medicines Act)
- retail distribution of anti-smoking products (section 39 of the Danish Medicines Act)
- retail distribution of medicinal products for production animals sold outside pharmacies (section 39 of the Danish Medicines Act)
- activities with euphoriant substances (section 5 of the Executive Order on Euphoriants)
Links to the different web pages where application forms can be found:
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.