If your company changes name or address, be aware that the company's authorisations must be renewed by the Danish Health and Medicines Authority.
An authorisation granted by the Danish Health and Medicines Authority may in many cases be linked to
- the registered address of your company and
- the registered name of your company.
It is therefore necessary – and your company is obliged to – prior to any change to 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 Health and Medicines Authority. 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 for manufacture and wholesale distribution of medicinal products (section 39 of the Danish Medicines Act)
- Authorisations for retail distribution of over-the-counter and/or V-marked medicinal products sold outside pharmacies (section 39 of the Danish Medicines Act)
- Authorisations for retail distribution of anti-smoking products (section 39 of the Danish Medicines Act)
- Authorisations for retail distribution of medicinal products for production animals sold outside pharmacies ( section 39 of the Danish Medicines Act )
- Authorisations related to euphoriants (section 5 of the Executive Order on Euphoriants)
- Authorisations for blood bank activities (section 6 of the Danish Act on Blood Supply)
- Authorisations for handling tissues and cells (sections 4 and 5 of the Danish Tissue Act)
The box to the right provides links to different application forms to be used if your company needs to have an authorisation renewed.
Changes to marketing and manufacturing authorisations (variation applications)
Be aware that prior to any change of company address or company name, your company must submit a variation application (type I A) to the Danish Health and Medicines Authority 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 in the box to the right.
Processing times for applications
The Danish Health and Medicines Authority has either 14, 30 or 90 days to process your submitted application. Be aware that the timelines for review vary between the different types of applications. The Danish Health and Medicines Authority endeavours to process all submitted applications as quickly as possible.
Refer to the box to the right for more information about the current processing times (case handling times).
