Manufacturers outside the EU/EEA area
When a medicinal product is manufactured at a company in a third country, i.e. outside the EU/EEA, an increased application fee and an increased annual fee are charged.
In 2018, the application/annual fee was increased to DKK 824. However, the fee is payable for maximum one strength per pharmaceutical form.
The increased annual fee has item number 3048, and the increased application fee has item number 3049.
The increased application fee is charged in connection with the application, whereas the increased annual fee is charged at the end of each year.