Application for annual fee exemption
In exceptional circumstances, the Danish Medicines Agency may, in whole or in part, exempt a company from payment of the annual fee, cf. Danish Executive Order no. 1571 of 16 December 2013 on Fees Payable for Medicinal Products and Manufacturers of Medicinal Products, Intermediate Products and Raw Materials. Exemption is granted for a period of one year and is conditional on the marketing authorisation holder/representative having submitted an application for exemption.
The conditions for exemption are:
- the medicine concerned is of significant importance to patient treatment, and
- the medicine cannot be replaced by another product marketed in Denmark, and
- the marketing of the medicine is of no significant commercial interest to the marketing authorisation holder, and
- for veterinary medicines, the product must generally be intended for production animals.
All four conditions must be satisfied.
The Danish Medicines Agency advises that full exemption has previously been granted for human medicines with an annual turnover of less than DKK 100,000 AIP (pharmacy purchase price) and that partial exemption (half) has been granted for products with an annual turnover between DKK 100,000 and 200,000 AIP.
For veterinary medicines, full exemption has been granted for products with an annual turnover of less than DKK 50,000 AIP and partial exemption (half) for products with an annual turnover between DKK 50,000 and 100,000 AIP.
Exemption is given per pharmaceutical form and strength. This means that one pharmaceutical form/strength may be eligible for exemption from the annual fee whereas other forms and strengths from the same product family may not.
However, the Danish Medicines Agency has also granted exemption in special cases where a medicine has only been prepared for very few patients who would otherwise have no treatment options (particularly in the case of hospital products).
Application for annual fee exemption only applies to medicines listed in Medicine Prices (the Price List) and to products that have been on the Danish market for at least 12 months.
Exemption is granted for a period of one year. Please send your application for annual fee exemption no later than 16 January of the year concerned. Please state the marketing authorisation number and drug ID.