The preliminary meeting is an informal meeting that takes place before the application is officially submitted.

Do not be hesitant to approach the Gene Therapy Office or the bodies involved for information beforehand. The preliminary meeting page contains details of the contact people at the Gene Therapy Office and at each of the bodies concerned, including their telephone numbers, email addresses and website addresses. Should you require the texts of the legislation and regulations in question, the Dutch versions can be found by entering the appropriate search criteria at http://www.overheid.nl/, option ‘Wet- en regelgeving’.

You may also make use of the opportunity offered to engage in preliminary discussions with all the bodies involved. This can provide very useful information for the investigator before a definitive application is submitted. Any questions submitted in writing by the investigator to the Gene Therapy Office prior to the preliminary meeting can be dealt with during the preliminary meeting.

Read more