Fees for retail distributors of medicines
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 31 December 2019
|Authorisation||Application fee||Annual fee|
|Retail sale of OTC medicines*||DKK 913||DKK 913|
|Retail sale of smoking cessation products||Calculated individually based on the time spent by the DKMA (per commenced half hour) and hourly rate: DKK 900||None|
* Including HV marked products.
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.
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.
The annual fee is charged whether the authorisation is used or not.