Below, you will find more information on the preconditions of the standard procedure for permits issued by the Ministry of Infrastructure and Watermanegement (IenWMinistry of Infrastructure and Water Management ) for clinical research using naked DNA.
If the application of the naked DNA does not meet the preconditions of a simplified procedure, the standard procedure must be followed. In contrast to the use of naked DNA that does not contain viral sequences, applications using naked DNA that does contains viral sequences are subject to a more complicated risk assessment – because these are able to recombine with viral sequences already present in humans or animals.
Changes to the issued permit that have no consequences for the environmental risk assessment that was conducted with respect to the environmental release, can be merely notified. A specification of notifications that have no consequences for the environmental risk assessment is provided in Article 35 of the GMO Regulation 2013 (in Dutch). For an explanation of Article 35, click here.
Changes that have no significant consequences may be implemented via the adjustment procedure.