Notice On The Fee For Clinical Trials

Original Language Title: Bekendtgørelse om gebyr for kliniske forsøg

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Notice on the fee for clinical trials

Under section 103, paragraph 1, of the lov nr. 1180 of 12. December 2005 on medicinal products, as amended by Act No. 534 by 17. June 2008 and Act No. 1258 by 18. December 2012 shall be determined: § 1. To cover part of the National Board of Health's cost of processing of applications for approval and monitoring of clinical trials, the applicant shall pay a fee of us $7,226. for each application for approval of a clinical trial.

(2). To cover part of the National Board of Health's costs in processing applications for change in one of the National Board of Health approved the experimental protocol, the applicant shall pay a fee of us $1,639. for each application.

(3). Include an application under paragraph 2 more changes to the Protocol are paid only one fee.

§ 2. The National Board of health shall notify the procedure for payment of fees pursuant to this order. Fee shall be paid to the health protection agency not later than 1 month after order.

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

(2). At the same time repealed Executive Order No. 1233 of 14. December 2011 on the fee for the clinical trials.

The Ministry of health and prevention, 20. December 2012 Astrid Krag/Nina Moss