Research with a medicinal product: extra review competent authority

Only amendments and relevant notifications of research with a medicinal product subject to the Dutch WMO Act need to undergo an extra, marginal review alongside the review by the reviewing committee (MREC or CCMO).

The extra review is carried out by the competent authority. This is known as a dual reviewing system. Furthermore, the CCMO is responsible as competent authority for entering data into the European EudraCT database.