The Assessment Framework is a word document that must be fully completed. The DCRF is responsible for the review from 1 July 2016. The Keuringsraad (Inspection Board) has an administrative function receiving the submission. The procedure for submitting the request for advice with the Assessment Framework for non-WMO sponsored drug research takes place as follows.
- The Assessment Framework is completed in English or Dutch; incomplete forms will be returned.
- Please tick the box (s) of your choice for multiple choice questions
- The Assessment Framework must be sent by e-mail including all appendices to the Inspection Board for Public Promotion of Medicines (KOAG) and Inspection Board for Promotion of Health Products (KAG) (). The Inspection Board administers the application on behalf of the DCRF, provides it with a serial number, checks it for completeness and forwards it to an nWMO Advisory Committee nWMO of the applicant’s choice.
- The nWMO Advisory Committee assesses the form with the appendix (s), completes the “assessment” column, gives its final advice at the bottom of the form and sends the advice back to the Inspection Board. In the meantime, the nWMO Advisory Committee can contact the applicant directly, but in this case the Inspection Board (firstname.lastname@example.org) is always included as the CC holder.
- In the event of questions, uncertainties or insufficient substantiation, the nWMO Advisory Committee will use the form to let you know which parts still need attention in order for the research to meet the admissibility requirements.
- The Inspection Board informs the applicant of the final advice and sends the invoice to the applicant.
The Review of a new application costs € 2500 (excluding tax).