Notice On The Fee For Clinical Trials

Original Language Title: Bekendtgørelse om gebyr for kliniske forsøg

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Completion of a clinical trial fee ;

In accordance with section 103 (1). 1, in Law No 1. 1180 of 12. In December 2005 on medicinal products, as amended by law no. 534 of 17. June 2008 and Law No 1258 of 18. December 2012 :

§ 1. The applicant shall pay a fee of 7.226 DKK for partial coverage of the costs incurred by the Health Service. for each application for the approval of a clinical trial.

Paragraph 2. Partial coverage of the health management costs when processing requests for a change in one of the Health Services approved test protocol shall pay a fee of 1.639 kr. for each application.

Paragraph 3. Includes an application in accordance with paragraph 1. 2 more amendments to the test protocol shall be subject to one fee alone.

§ 2. The Board of Health shall notify the procedure for the payment of fees pursuant to this notice. Fees shall be paid to the Board of Health at least one month after claims.

§ 3. The announcement shall enter into force on 1. January 2013.

Paragraph 2. At the same time, notice No 1233 of 14. December 2011 on fee for clinical trials.

The Ministry of Health and Prevention, the 20th. December 2012

Astrid Krag

/ Nina Moss