During the informal preliminary consultation the draft application will be discussed by each assessment body.

The draft application (Part A of the application form) will be assessed by several members of COGEMNetherlands Commission on Genetic Modification  (Netherlands Commission on Genetic Modification) and by assessment staff of the GMOGenetically Modified Organism  Office. In practice this means that the application form will be gone through step by step to highlight any parts containing insufficient information for a full risk assessment or where anything is unclear. The investigator is not obliged to respond straight away, but can take these points into consideration when preparing the official submission. All documents submitted by the investigator for the preliminary meeting will be kept confidential. When the official submission takes place, the fact that a preliminary assessment has taken place does not mean that the file no longer needs to be assessed or that no other questions will be asked that did not come up during the preliminary meeting.

The CCMOCentral Committee on Research involving Human Subjects  (Central Committee on Research involving Human Subjects) does not consider a preliminary meeting to be a preliminary assessment of the draft research file (Part B of the application form and other documentation). The preliminary meeting with several members of the CCMO is intended to give investigators in the preliminary stages of compiling their research file an opportunity to exchange ideas on relevant topics, such as data from preclinical animal studies, research design, vectors used, production methods, quality control, validation of safety tests and systematic risk assessment. The meeting also gives submitting parties a chance to have their questions answered and to discuss any bottlenecks prior to official submission of the file. 

Read more