Fees payable for medicinal products and companies
The fees payable for medicinal products and companies are laid down in Executive Order no. 1571 of 16 December 2013 on Fees Payable for Medicinal Products, etc
Fees mentioned in sections 11 and 20 have been adjusted at 1 January 2016 by the rate for the general price and wage index fixed by the Danish Ministry of Finance. Please find the applicable fees in Schedule 1
The Danish Medicines Agency sends out invoices payable within one month.
Increased fee applicable to the manufacture of medicines outside the EU/EEA
When a medicinal product is manufactured at a company in a third country, outside the EU/EEA, an increased application fee and an increased annual fee are charged.
In 2016, the increased application fee/annual fee is DKK 7,242. However, the fee is payable for maximum one strength per pharmaceutical form.
The increased annual fee has item number 30368, and the increased fee has item number 30369.
The increased application fee is charged currently, whereas the increased annual fee is charged at the end of each year.