Changes to documents during the primary submission

The submitting party often makes or has to make changes to certain documents before the reviewing committee (MREC or CCMO) can reach a positive decision. In the case of research with a medicinal product, the competent authority (CCMO or Ministry of Health, Welfare and Sport) may have already issued a 'No grounds for non-acceptance' as the review by the reviewing committee and the competent authority can occur simultaneously.

If the competent authority has already issued a 'No grounds for non-acceptance', then you do not have to send any updated documents to the competent authority which are deemed necessary for the primary submission to an accredited MREC or CCMO. There is one exception: documents concerning a change to the medication used in the study. This is because the competent authority always performs a search of the expected effects of the product in the EMA EudraVigilance database before it issues a ‘No grounds for non-acceptance’. A change to the medication can influence the expected effects, and therefore to the already issued No grounds for non-acceptance.