The deadline by which the Minister of VWSMinistry of Health, Welfare and Sport ’s decision is announced to the applicant is 44 days.
A declaration of no objection is issued by the Ministry of Health, Welfare and Sport (VWS). It is applied for through the central Gene Therapy Office. The documents to be submitted with the application are the same as the documents that must be submitted to the CCMOCentral Committee on Research involving Human Subjects . After the research file is received, the applicant may receive a request for any missing data. The deadline by which the Minister of VWS’s decision is announced to the applicant is 44 days after the request for a declaration of no objection was submitted. The 44-day assessment period starts as soon as all the necessary documentation has been received.
If, after receiving the necessary information, the Minister of VWS has not found any suspected unexpected serious adverse reactions (SUSARsSuspected Unexpected Serious Adverse Reactions ) in the EMAEuropean Medicines Agency EudraVigilance database that would present an unacceptable risk for human subjects, a written declaration of no objection is issued. This is done by means of an email announcement that the ToetsingOnline web portal sends out automatically to the applicant (and to the CCMO).
Diagram of the Minister of VWS’s gene therapy assessment procedure.