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Frequently Asked Questions

The underlying pages provide answers to frequently asked questions regarding the Gene Therapy Office.

General aspects

  • Can I make changes to the clinical protocol after the Ministry of Infrastructure and Watermanagement (IenW) has issued the permit?
  • Do I have to apply for a permit for a study involving a GMO which has been approved in Europe as a medicinal product?
  • Can a sponsor submit a clinical study though the Gene Therapy Office?
  • Can I submit Part A of the application form if I have not yet finished Part B (and vice versa)?
  • Can foreign patients participate in a clinical study in the Netherlands conducted by a Dutch hospital?

Preliminary meeting

  • How long does it take to schedule the preliminary meeting after the request for such a meeting is filed?
  • Can I specify a preferred date for the preliminary meeting?
  • Can participants abroad participate in a preliminary meeting by conference call?

Part A - Biosafety aspects

  • Can I submit a single application for a multi-centre study?
  • Is it necessary to indicate a final date for the permit?
  • Can I also have biological specimens analysed by a different laboratory?
  • Am I required to include the production of the GMO itself in the permit application?
  • What else should I do for the environmental component besides submitting a permit application to the Ministry of IenW?
  • In Part A of the application form, can I include references to the literature?
  • How can I prepare an environmental risk assessment without adequate biodistribution or shedding data?

Part B - Patient-related aspects

  • What is the deadline for submitting documents to the Gene Therapy Office so they can be discussed at the next meeting of the CCMO?
  • Can I submit amendments to studies that are already being reviewed by the CCMO?
  • Which address for the competent authority¬† should I use on the EudraCT form?
  • Which address for the medical ethics review committee should I use on the EudraCT form?

 

 

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