New Danish Fees Include Extra Payment For Firms With Over 500 Employees Per Site
Executive Summary
Denmark’s new fees for medicinal product, manufacturing and clinical trials authorizations, which came into force on July 1, involve changes in a number of areas, including an extra payment for companies with more than 500 staff at any one site.
Drug makers that have manufacturing authorizations in Denmark or permission to conduct toxicological and pharmacological trials have until Aug. 15 to tell the Danish medicines regulator if they employ over 500 people at any one location, as they will be charged an additional payment under new fees for pharma that came into force on July 1.
The new rules, introduced via two executive orders, also involve changes to the fees payable for medicinal product authorizations, variations, parallel imports and clinical trials. The amounts payable to Denmark’s medicines agency, the DKMA, are laid out in the executive orders (both in Danish): Danish executive order on fees payable for medicinal products and pharmaceutical companies, etc; and Executive order on fees for clinical trials of medicinal products.
The additional fee for companies with more than 500 employees at one location applies to companies that hold the following authorizations or registrations from the DKMA:
- authorization to manufacture and import medicinal products and intermediate products;
- registration to manufacture active substances; or
- authorization to conduct toxicological and pharmacological trials (GLP).
These companies will be charged an additional fee for all locations with more than 500 employees, the DKMA said. The new fee will be charged if the company employs more than 500 people at one location on the application date (application fee) or on Jan. 1 (annual fee). The additional fee will only be charged once per location, even if there is more than one authorization/registration at the location.
There are also new rules for application fees and annual fees in cases where there are several company authorizations. Pharmaceutical companies holding more than one company authorization must pay a full fee for all authorizations, except for the simultaneous manufacture of medicinal products/intermediate products and active substances.
“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 DKMA clarifies.
Changes For Marketing Authorizations, Variations
Regarding applications for marketing authorizations 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. The changes concern applications for:
- new marketing authorizations and extensions;
- renewal of marketing authorizations;
- variations;
- parallel imports; and
- mutual recognition of Danish marketing authorizations (mutual recognition procedure/repeat-use procedure).
Regarding marketing authorization applications, there is an additional fee for complex assessments of new submissions. The fee has been fixed for the assessment of a new marketing application based on a standard evaluation in relation to the documentation on quality, safety and efficacy that is typically submitted according to the type of application, explains a guidance document on the new fees. However, the standard fee does not cover an assessment of bioequivalence data or any additional assessments of a non-clinical, clinical or veterinary clinical nature, the guidance document says. In such cases, an additional fee will be charged.
The application fee for new marketing authorizations covers all strengths and pharmaceutical forms in the procedure, regardless of the application procedure, the guidance document adds. Subsequent applications for an extension of the authorization, e.g., with new pharmaceutical forms or strengths (extensions), are subject to a separate fee.
Annual Fees
The new executive orders apply to applications received by the DKMA after June 30, 2017. Applications received before July 1 are subject to the fees applicable at the time of receipt.
The DKMA notes that because the new rules on fees take effect in the middle of a financial year, it has not yet charged the annual fees payable by Danish pharmaceutical companies for 2017. In the third quarter of 2017, it will charge the following annual fees:
- a half fee for the first half of 2017 – previous rate; and
- a half fee for the second half of 2017 – new rate.
From the editors of Scrip Regulatory Affairs.