The IenW Ministry of Infrastructure and Water Management (Ministry of Infrastructure and Water Management ) Ministry of Infrastructure and Water Management permit procedure takes maximal 120 days.
For gene therapy research, a permit application must be submitted to the Ministry of Infrastructure and Water Management (IenW, c/o GMO Genetically Modified Organism (Genetically Modified Organism ) Genetically Modified Organism Office) (1). When submitting a permit application to the GMO Office, applicants must realise that the scope of a permit is in the first instance determined by the ‘breadth’ of the application. Efforts will be made to draw up the final decision in such a way that, if applicable, multiple clinical protocols can be executed under the permit. The information provided in the application will be used for this purpose. Before submitting such a broader permit application, it is advisable to contact the GMO Office for an informal discussion on the possibilities.
The procedure period starts as soon as the application has been received. A confirmation of receipt is also sent. The procedure is halted if there is a request for additional information, and continued as soon as this additional information has been received.
A draft decision must have been drawn up within seven weeks (3). It is initiated by the Ministry of IenW (4) and then made available for perusal together with the public part of the file (5). When the draft decision and research file are made available for perusal, a notification is published and the applicants are informed in writing. The notification is published in a number of relevant national and regional daily newspapers. Thereafter, for a period of six weeks, third parties can lodge objections to the proposed permit to be granted (6). COGEM Netherlands Commission on Genetic Modification (Netherlands Commission on Genetic Modification ) Netherlands Commission on Genetic Modification (Netherlands Commission on Genetic Modification) will also advise on the application during this period. After the deadline for perusal has expired, the objections and the COGEM advice received are incorporated into the decision (7).
Apart from requiring a permit from the Ministry of IenW, the proposed work must also be reported to the other Member States of the European Union. For this purpose the GMO Office will send the investigator the SNIF Summary Notification Information Format (Summary Notification Information Format ) Summary Notification Information Format (Summary Notification Information Format) form. After the investigator has filled in the SNIF form and returned it to the GMOOffice, the GMO Office will forward it to the European Commission after which it will be published on the Internet.
The decision must be signed by the Ministry of IenW (8) no later than week 17. Notification of this decision is then sent to the investigator before being published in national and regional daily newspapers (9). The decision takes effect as soon as the perusal deadline of six weeks has passed. If any objections to the permit are lodged, the Council of State informs the investigator and the Ministry of IenW.
After the permit comes into effect, a description of the proposed work must be submitted before said work can be started. Since this description must be in accordance with the provisions of the permit, individual clinical protocols do not require approval from the Ministry of IenW.
Stroomschema van de beoordelingsprocedure van IenW
A simplified procedure of up to 56 days for specific categories of GMOs. Currently, 2 categories are eligible for this simplified procedure:
- genetically modified viral vectors derived from Adeno-associated dependoparvovirus A or B (AAV Adeno-Associated Virus (Adeno-Associated Virus )) without harmful sequences;
- human cells genetically modified with viral vectors derived from murine gamma retroviruses or human immunodeficiency virus (HIV), provided there is no risk of replication competent virus formation and where residual infectious retroviral or lentiviral particles are absent in the final product.
For this procedure, standardized environmental risk assessment is applicable as well as fixed conditions that are laid down by law in the GMO Genetically Modified Organism (Genetically Modified Organism ) Regulation 2013. For this reason a full public consultation procedure as applies to the regular permit procedure is no longer necessary. This results in a shorter procedural period a a maximum of 56 days. If the application meets a number of additional criteria, the maximum term can be further shortened to a maximum of 28 days.
All other (categories of) GMOs that do not meet these requirements the standard procedure with a maximum term of 120 days applies.
In case of applications for multicenter studies each legal entity is required to apply for a permit. If such applications from separate legal entities are not submitted simultaneously, but sequentially, they will be processed more quickly provided the intended activtiies are described exactly identical as the initial main application. The permit procedure for copy applications has been shortened to a maximum of 28 days.
Finally special procedural aspects may apply in case of studies with medical products that consist of plasmids or so-called 'naked DNA'.