Fees for clinical trials

Updated 01 January 2019

Executive order on fees for clinical trials

Fees applicable from 1 January 2019

Clinical trials with medicinal products in development stage phase I along with clinical trials that are conducted predominantly without influence from the pharmaceutical industry (non-commercial trials), will no longer be subject to DKMA application fees from 1 July 2018.

Please note that ‘without influence from the pharmaceutical industry’ means clinical trials initiated by researchers, where no pharmaceutical company has any impact on the design, planning and conduct of the clinical trial nor has any influence on the registration and publication of data.

If a commercial sponsor/applicant submits an IMPD, the fee under section ‘B’ (please see below) is applicable. The applicant needs to justify in the cover letter of the submitted application if the applicant deems that the fee under section ‘A’ is applicable.

   

Item number

Fee 
A. Application for authorisation of a clinical trial of a medicinal product, for which a marketing authorisation has been issued in an EU country or an ICH country (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use): 3201  DKK 23,639
  Application for amendment of a clinical trial (substantial amendment) authorised by the Danish Medicines Agency. Fee per application: 3205  DKK 4,896
B.

Application for authorisation of a clinical trial - documentation for the manufacture and quality of the investigational medicinal product is submitted in the form of an Investigational Medicinal Product Dossier (IMPD):

If the below conditions are met, the fee is the same as for marketed medicinal products (A):

  1. The submitted IMPD is very simplified.
  2. The investigational medicinal product is a modification of a medicinal product for which a marketing authorisation has been issued.
  3. The modification only concerns the package, labelling, form or appearance of the medicinal product.
3202  DKK 46,933
C. Application assessed under the European Voluntary Harmonisation Procedure (VHP) with the Danish Medicines Agency acting as Reference Member State:  3203  DKK 85,491
  If the Danish Medicines Agency acts as Concerned Member State: 3204  DKK 52,331
  Application for amendment of a clinical trial (substantial amendment) authorised by the Danish Medicines Agency via VHP. Fee per application:  3206  DKK 6,784
D. Annual fee for clinical trials: The annual fee is payable per year started and until national completion, however, not for the first year after authorisation of the trial. The annual fee only applies to trials for which we have received an application after 30 June 2017:  3207  DKK 13,194

The fees clinical trials are annually adjusted according to the price index (2019: 0,9%) and are laid down in the Danish executive order no. 980 of 28 June 2018 on fees for clinical trials of medicinal products (in Danish).

Payment

All fees must be paid to the Danish Medicines Agency no later than one month after receipt of the invoice. Please state the invoice details in the cover letter to the application. If the invoices must include specific information, for example references like PO number or contact person, please indicate this in the invoice details. Likewise, you should state the EAN number if the invoice is to be sent electronically (primarily public institutions).

Companies that apply via our DKMAnet extranet do not have to state the invoice details as this information is integrated in the application on DKMAnet.

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