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Additional Information

Research with a medicinal product must undergo an extra, marginal review carried out by the CA (CCMO or Ministry of Health, Welfare and Sport) alongside the review by the reviewing committee (dual reviewing system). Both reviews can take place simultaneously.

The Ministry of Health, Welfare and Sport published a comprehensive folder providing detailed guidance on how to conduct clinical reseach with medicines in the Netherlands in compliance with the regulatory requirements:
Clinical Research with medicinal products in the Netherlands - Instruction Manual.

National Portal: ToetsingOnline is an internet portal for the submission, review, registration and publication of medical research involving human subjects. The portal is only used for clinical research which falls under the scope of the WMO (en).