How is the risk management plan (hereinafter – RMP) provided during the registration of a medicinal product in Ukraine?

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Information on the risk management system is provided as part of the registration dossier materials in accordance with Annexes 1 and 5 to the Procedure for the expert evaluation of registration materials for medicinal products, approved by MoH order No. 460 of 23.07.2015.

Regulatory references: http://zakon5.rada.gov.ua/laws/show/z1210-15

How is the risk management plan (hereinafter – RMP) provided during the registration of a medicinal product in Ukraine?

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