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Submission of the official application

You can submit all applications simultaneously, but it is preferable to submit for each assessment body separately.

You do not have to wait until you are ready to submit all applications simultaneously. If your application for the Ministry of IenW is ready earlier, it may be more expedient for you to apply for this permit on the basis of the GMO Decree in advance of the other applications. Because the IenW permit procedure is subject to statutory time periods for public perusal, it has the longest applicable total procedure (120 days). This is followed, in decreasing order of length, by CCMO (90 days) and by VWS (44 days). In terms of content, it is possible to apply for the IenW permit separately from the other authorisations because the research protocol is not part of the IenW application.

In Part A of the application form you are not allowed to make reference to Part B or to the CCMO research file. Nor are you allowed to include, or make reference to, any confidential information.

The assessment procedures describe the way in which the procedures have been coordinated. More details on the procedure per body are also provided. As regards the coordination between the different bodies, we recommend that investigators explicitly grant permission for consultation and for the exchange of data between the bodies with regard to his or her application. Such formal permission is included in the application form.

There is no fees associated with the submission of an application and further procedures by the assessment bodies.

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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