From 13 March 2020, research dossiers in the field of gene therapy and medicinal products containing GMOs must be submitted directly to the relevant authority (CCMO Central Committee on Research involving Human Subjects as review committee, Ministry of Health, Welfare and Sport as competent authority or Ministry of Infrastructure and Water Management (GMO Genetically Modified Organism Office)).
The measure below, which was planned because of digitalisation, is now effective immediately because of the coronavirus outbreak.
Due to the far-reaching digitalisation of the work processes at the participating authorities, the one-stop shop function of the Gene Therapy Office has become superfluous for submission and assessment, and the forms and accompanying documents are submitted directly by the applicants to the relevant authorities without the intervention of the Gene Therapy Office.
The Gene Therapy Office will continue to function as an information point for the licensing of clinical gene therapy studies in the Netherlands. Where possible, the Gene Therapy Office will also streamline the processing of applications.
The information on the method of submission to the relevant authorities on the web pages concerned will be updated as soon as possible:
- CCMO as review committee
- Ministry of Health, Welfare and Sport as competent authority
- GMO Office (GMO Office is subject to a mandatory digital submission until further notice, see also link)