The Minister of Health, Welfare and Sport (VWS Ministry of Health, Welfare and Sport ) is responsible for issuing a declaration of no objection regarding the proposed gene therapy research.

The Minister of VWS decides this on the basis of the Medical Research Involving Human Subjects Act (WMO Medical Research Involving Human Subjects Act ). This declaration is issued after the necessary documents have been submitted (these are the same documents that must be submitted to the CCMO Central Committee on Research involving Human Subjects ) and if a search of the EudraVigilance Clinical Trial database managed by the EMA European Medicines Agency  (European Medicines Agency) has not found any suspected unexpected serious adverse reactions (SUSARs Suspected Unexpected Serious Adverse Reactions ) of the investigational medicinal product that would present unacceptable risks for human subjects. As of 1 March 2012, the Ministry of VWS has delegated its tasks to the Medicines Evaluation Board (MEB Medicines Evaluation Board ).