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 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:

• 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)
• blood bank activities (section 6 of the Danish Act on Blood Supply)
• handling tissues and cells (sections 4 and 5 of the Danish Tissue Act)

Applications forms

Application for authorisation to manufacture and import medicines for human use

Application for authorisation to manufacture and import medicines for veterinary use

Application for marketing authorisation for parallel import of already authorised proprietary medicinal products (in Danish only)

Application for authorisation to sell medicines for production animals outside pharmacies (in Danish only)

Application for authorisation of activities with euphoriant substances.

Application for authorisation of retail sale of over-the-counter medicinal products and sale of "V" marked medicinal products in shops outside a pharmacy

Application for authorisation to sell smoking cessation medicines (in Danish only)

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.

For more information about the current processing times (case handling times).