Fees for retail distributors of medicines

Updated 04 May 2022

Companies applying for an authorisation to sell OTC medicines or smoking cessation products must pay a fee to the Danish Medicines Agency.

The different fees are listed below.

Fees from 1 January to 30 april 2022

Authorisation Application fee Annual fee
Retail sale of OTC medicines* DKK 950 DKK 950
Retail sale of smoking cessation products Calculated individually based on the time spent by the DKMA (per commenced half hour) and hourly rate: DKK 910 None

* Including HV marked products.

Fees from 1 May 2022

Link to the executive order on fees for medicinal products and companies, etc. (No. 531 of 29 April 2022 - in danish only)

Application fee

The Danish Medicines Agency charges an application fee upon receipt of an application. The application fee/annual fee is usually adjusted on 1 January every year.

The application fee for new applications is not refunded when the retail authorisation has been granted.

Fee for change of address

When a shop moves to a new address, an administration fee equivalent to the application fee is charged. If a shop is authorised to sell OTC medicines outside pharmacies, the relevant fee listed above is charged if the shop moves to a new address.

Annual fee

An annual fee is charged as long as the authorisation is valid. The annual fee covers the expenses for supervision of companies or shops as well as administration. The annual fee is typically charged in February/March.

Note!

The annual fee is charged whether the authorisation is used or not.

See the fees that were applicable from 1 January 2022 to 30 April 2022

 

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