NLClinicalTrialsIMP object

Transposition of (CT) Directive 2001/20/EC
Transposition of (GCP) Directive 2005/28/EC

Medical Research Involving Human Subjects Act -Unoffical english translation: WMO (en)/ Wet medischwetenschappelijk onderzoek met mensen- WMO (Dutch) Transposition of Directive 2001/20/EC and 2005/28/EC, came into operation on 1 March 2006 Minor chang

Regulation for scientific research with medicinal products:
covering the implementing rules for scientific research with medicinal products

Insurance:
Insurance Decree (Verzekeringsbesluit)
The adapted Decree came into force as of the 1th of July 2015 and applies to reserach issued a positive decision by an accredited MREC or the CCMO after the 1st of July 2015.

) CCMO External Review Directive 2012 (RET 2012)
The RET 2012 applies to all multicentre research that falls under the Medical Research Involving Human Subjects Act (WMO), whether it is research with a medicinal product or not.
NB! Update not available in English yet

WMO: Minor changes implemented in 2012 have not yet been translated to English.
NB! A recent amendment to WMO on reporting requirements of serious adverse events (SAEs) will come into force on October 1, 2015 (published in the Government Gazette in Dutch)