New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017

03 July 2017

On 1 July 2017, a new executive order on fees payable for medicinal products, pharmaceutical companies and clinical trials became effective. The new fees involve changes in a number of areas.

Changes in relation to marketing authorisations and variations etc.

In connection with applications for marketing authorisations and variations etc., the new executive order entails a number of changes to the size of fees and the way in which they are calculated. Changes will be made to:

  • Applications for new marketing authorisations and extensions
  • Applications for renewal of marketing authorisations
  • Applications for variations
  • Applications for parallel import
  • Mutual recognition of Danish marketing authorisations (MRP/RUP)

See our guidelines on the collection of fees for applications for marketing authorisations, variations etc.

New obligation to inform us if the number of employees exceeds 500 at one location

In future, pharmaceutical companies holding the below authorisation or registration from the Danish Medicines Agency will be charged an additional fee for all locations with more than 500 employees:

  • Authorisation to manufacture and import medicinal products and intermediate products
  • Registration to manufacture active substances
  • Authorisation to conduct toxicological and pharmacological trials (GLP)

The additional fee will be charged if the company employs more than 500 employees at one location on the application date (application fee) or at 1 January (annual fee). The additional fee will only be charged once per location, even though there is more than one authorisation/registration at the location.

Obligation to inform us if the number of employees exceeds 500

In future, companies have an obligation to inform us if they have more than 500 employees at one location. This is laid down in section 14 of the updated executive order on fees payable for medicinal products and pharmaceutical companies etc.:

Section 14 When the size of a fee, see annex 3, depends on the number of employees at a location, the company applying for or holding an authorisation or registration must inform the Danish Medicines Agency if the number of employees exceeds 500.

Information in relation to fees for 2017

Companies with more than 500 employees at one or more locations that hold one of the mentioned authorisations/registrations must inform us about this no later than 15 August 2017 by email to virksomhedstilladelse@dkma.dk

Changed rules for application fees and annual fees in case of several company authorisations

In future, pharmaceutical companies holding more than one company authorisation must pay a full fee for all authorisations, except for the simultaneous manufacture of medicinal products/intermediate products and active substances. This is laid down in section 13 of the updated executive order on fees payable for medicinal products and pharmaceutical companies etc.:

Section 13 If a company holds several authorisations, a full annual fee will be charged for each authorisation, but see subsection 2.

(2) If a company holds an authorisation to manufacture and import medicinal products and intermediate products and is registered as a manufacturer of active substances intended for the manufacture of medicinal products, the company must pay a full annual fee for the authorisation to manufacture and import medicinal products and intermediate products and a half annual fee to be registered as a manufacturer of active substances.

The new rules for payment of a full fee apply to both the application fee and the annual fee.

Collection of application and annual fees

The new executive orders apply to applications that we receive after 30 June 2017. Applications received before 1 July 2017 are subject to the fees applicable at the time of receipt.

As the new rules on fees take effect in the middle of a financial year, we have not yet charged the annual fees payable by Danish pharmaceutical companies for 2017. In the third quarter of 2017, we will charge annual fees as follows:

  • A half fee for the first half of 2017 – previous rate
  • A half fee for the second half of 2017 – new rate

Links

Danish executive order on fees payable for medicinal products and pharmaceutical companies etc. (Retsinformation.dk) (in Danish)

Danish executive order on fees for clinical trials of medicinal products (Retsinformation.dk) (in Danish)

Did you get answers to your questions?

Please tell us how we can improve our website?