NLClinicalTrialsIMP object

General Act(s) on Medical/Clinical Research in Humans
Transposition of (CT) Directive 2001/20/EC

Grand Ducal Regulation of 30th May 2005 on clinical trials of drugs for human use ("Modified RGD 30 May 2005") / RGD du 30 mai 2005 relatif à l'application de bonnes pratiques cliniques dans la conduite d'essais cliniques de médicaments à usage humain

Other national legal texts are also applicable in the context of clinical trials and other types of studies:

(1) Hospital Act of 28th August 1998 (fr)/ Code de la Santé - 11 Hôpitaux - A - Dispositions Générales
Article 25 states that no trial, study or experimentation can be done on a human being with the aim of furthering knowledge in the fields of biological and medical sciences if the project has not firstly been submitted to the approval of a research ethics committee
(2) Medical Deontology Code (fr), approved by the Ministerial Decree of 1st March 2013/ Arrêté ministériel du 1er mars 2013 approuvant le Code de déontologie médicale (2005);
Chapter 5 (Art 76-79) on human experimentation, in particular, states that any study protocol, whether it is done in a hospital context or not must have been authorized. The trial can only start after the delivery of a positive opinion from the research ethics committee and after the implicit or explicit approval of the health Minister, in agreement with the legal and regulatory requirements that are to be applied in the matter.

NB: Modified RGD 30 May 2005 does not apply to non-interventional trials!