This part of the application form relates to aspects of environmental risk considered by the Ministry of IenW Ministry of Infrastructure and Water Management (Ministry of Infrastructure and Water Management) before granting a permit.
All information provided in this form and corresponding documentation comprises part of the decision to be issued, and for this reason it is, in principle, available to the public. During the procedure the information is also made available for public inspection (see database GMO Genetically Modified Organism (Genetically Modified Organism) Office). You should be aware that since the form comprises part of the permit, you must adhere to everything mentioned in the application form, for example with regard to the manner in which the research will be carried out. The application form contains questions that may not be applicable to your application. Parts that do not apply to the activities for which you are requesting permission need not be completed. Literature referred to in the application must also be submitted together with the application form.
The investigator may request that parts of the information provided remain confidential. In this case the investigator must justify in writing the reasons for wanting to keep such information confidential, and demonstrate plausibly that a lack of confidentiality would compromise the investigator’s competitive position. A public summary of such confidential information must be provided, which contains sufficient information to enable a good general understanding of the application, and which explains the risk analysis described in the application and in the decision. Confidential information should be sent together with the application in one or more separate supplements. Personal data will be treated confidentially at all times.
An application need not be limited to the concrete clinical protocol to be carried out. As long as the risk assessment is not affected, the applicant may broaden the application, for example for the inclusion of a larger number of patients, for an alternate method of administration of the GMO, or in combination with other non-GMOs if so desired. Please note: such additions and changes cannot be made once a decision has been issued.
An attempt will be made to draw up the final decision in such a way that it allows a number of clinical protocols to be executed, without this affecting the environmental risk assessment. The information provided in the application will be used for this purpose. These activities must therefore be compatible with the description of the experiment and with the risk assessment provided. Before submitting such a broad permit application, it is advisable to contact the Gene Therapy Office for an informal discussion about the possibilities.
Already issued and pending IenW licenses can be found in the public database of the GMO Office. The database may contain studies with comparable GMOs and this information can help you filling in Part A of the application form. Explanation of the database. The database is only in Dutch.