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The Minister of Health, Welfare and Sport (VWS) 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). This declaration is issued after the necessary documents have been submitted (these are the same documents that must be submitted to the CCMO) and if a search of the EudraVigilance Clinical Trial database managed by the EMA (European Medicines Agency) has not found any suspected unexpected serious adverse reactions (SUSARs) 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)

Details and contact person


Ministry of Health, Welfare and Sport
   Attn. Competent Authority, c/o Medicines Evaluation Board

Postal address

PO Box 8275, 3503 RG Utrecht, The Netherlands

Visiting address

Graadt van Roggenweg 500, Utrecht, The Netherlands

Telephone no.

+31 (0)88 224 8000



Contact person

Dr. R.M. (Martijn) van der Plas (info-bi@cbg-meb.nl)


Contact Information

Gene Therapy Office
Coordinator: Dr. D.A. Bleijs

PO Box:
PO Box 1
Intern Postvak 1
3720 BA Bilthoven
The Netherlands

Intern Postvak 1
Antonie van Leeuwenhoeklaan 9
3721 MA Bilthoven
The Netherlands

Tel: +31 30 274 7569
Fax: +31 30 274 4401
Internet: www.loketgentherapie.nl
Email: contact@loketgentherapie.nl

GMO Office, Dr. D.A. Bleijs
+31 30 274 2793
CCMO, Dr K.R.J. Vanmolkot
+31 70 340 6700