Here you will find more information of the preconditions and advantages of the simplified procedure for permits to be issued by the Ministry of Infrastructure and Water Management (IenW Ministry of Infrastructure and Water Management (Ministry of Infrastructure and Water Management)) for clinical research using naked DNA.
For permits to be issued by the Ministry of IenW, among other things for clinical research using naked DNA, an environmental risk assessment must be conducted. Under the new GMO Genetically Modified Organism (Genetically Modified Organism) Regulation 2013, the applicant may use an environmental risk assessment that is drawn up in advance by the Minister, in cases where the use of naked DNA complies with a number of preconditions.
The simplified procedure for naked DNA applies, if:
- the naked DNA does not contain any viral sequences, with the exception of a CMV promoter, an RSV promoter, an SV40 polyadenylation signal and an SV40 nuclear targeting sequence (see specifications below);
- the naked DNA does not contain any antibiotic-resistant genes that confer resistance solely to kanamycin or neomycin;
- the DNA application remains limited to tattooing or direct injection into the skin or striated muscle tissue.
The excepted viral sequences are specified below. This can also be found in the standard environmental risk assessment.
- The CMV promoter is the Human cytomegalovirus (HCMV, HHV-5) major immediate-early protein gene promoter with a sequence of a maximum length such as established in the Nucleotide Database of the US National Center for Biotechnology Information (NCBI) (Genbank Accession number M60321).
- The RSV promoter is the Rous sarcoma virus (Schmidt-Ruppin) promoter with a sequence of a maximum length such as established in the Nucleotide Database of the NCBI (Genbank Accession number J02025.1).
- The SV40 polyadenylation signal is a sequence of the Simian virus 40(SV40) with a maximum length of around 200 to 300 base pairs.
- The SV40 nuclear targeting sequence is a sequence with an average length of 100 base pairs of the Simian virus 40 (SV40).
Advantages of the simplified procedure
Short and simple application form, Part A
The application form has been greatly simplified and only requires a limited amount of information.
Standard environmental risk assessment
Under the new GMO Regulation 2013, the applicant may use an environmental risk assessment that is drawn up in advance by the Minister. See the summary of this environmental risk assessment, or download the full version.
Faster permit issuing
By using a simplified application form, which refers to the environmental risk assessment drawn up by the Minister, the permit issuing process is faster. The statutory periods of deposit for inspection, however, still apply.
Simple adjustment of the permit
Changes to the permit merely have to be notified, provided that they do not affect the standard environmental risk assessment. 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.