Extra review competent authority

Amendments and relevant notifications  of ongoing research with a medicinal product subject to WMO (under outdated legislation) that has not as yet been submitted in CTS, must undergo an extra review alongside the medical ethical review. This review is carried out by the competent authority. See also Research with a medicinal product: extra review competent authority for practical information on the marginal review. This extra review for WMO research with a medicinal product will ba carried out until  31 January 2025. After this date, all research with a medicinal preduct is subject to CTR. 

The same set of documents are to be submitted to the reviewing committee and the competent authority.