Applications for Clinical Trial Authorisations
The twelfth amendment to the Medicinal Products Act (The Drug Law, Arzneimittelgesetz – AMG) of 30 July 2004 was announced in the Federal Law Gazette on 5 August 2004. It came into effect on 6 August 2004. The transitional provisions, in particular relating to applications for clinical trial authorisations submitted to the competent Ethics Committee before 6 August 2004, are contained in section 138 of the Act.
Federal Gazette no. 166 dated 4 September 2006 contains a joint announcement from the Paul-Ehrlich-Institut and the Federal Institute for Drugs and Medical Devices (BfArM): the "Third Announcement on Clinical Trials of Medicinal Products on Humans". The full text of this joint announcement may be found on the BfArM website; it relates to applications to the competent higher federal authority for the authorisation of clinical trials pursuant to section 40 sub-section 1 sentence 2 of the Medicines Act (AMG) and section 7 of the ordinance supplementing section 42 sub-section 3 AMG (GCP-V), to the notification of subsequent changes during the conduct of clinical trials pursuant to section 10 as well as to the notification of the termination of a clinical trial pursuant to section 13 sub-sections 8 and 9 of this ordinance.
Please direct any questions on the procedure for clinical trials to: