Quiz: Marginal Review by the Dutch Competent Authority

1 Product information of a medicinal product in the research file

In the case of an intervention study, information on the product to be administered or applied (medicinal product, medical device or nutritional product) must always be included in the submission (section D2 of the standard research file). Without this information the accredited MREC cannot form a decision on the quality and safety of the product. An investigator would like to know if he has to submit a complete Investigational Medicinal Product Dossier (IMPD) for a research with authorized medicinal products which are to be administered in accordance with the approved indication.

Are you always required to submit a complete IMPD for the review of a study with a medicinal product?

2 The review of a clinical trial with a gene therapy medicinal product

An investigator who works for a university medical center is asked to cooperate in an international multicenter research with a medicinal product. It concerns a Phase II study into the mechanism and safety of a non-authorized gene therapy product on adult patients with a malignant tumor.

You may want to use the Committee Finder tool which we explained in the previous two themes to find the answer to the question below.

To which Dutch committee and/or other organisations must the research file be submitted for review?

3 Marginal review by the Dutch Competent Authority

The review of research with a medicinal product is carried out by way of what is called a complimentary dual reviewing system. In the Netherlands, the accredited MREC carries out the medical ethical review which entails a full medical review. The competent authority carries out a marginal review. Documents may be modified or new documents submitted  during the assessment period of the reviewing MREC. If this is the case then the marginal review by the competent authority may already have been completed and a ‘no grounds for non-acceptance’ was already issued.

Does the competent authority request that all altered documents be resubmitted if a ‘no grounds for non-acceptance’ has already been issued?