Periodic safety update reports are pharmacovigilance documents intended to provide a safety update resulting in an evaluation of the impact of the reports on the risk-benefit balance of a medicinal product. The list overrules the 'standard' PSUR submission cycle and any conditions related to the frequency of PSUR submission included in a marketing authorisation.ĮMA updates the EURD list every month, following adoption by the Committee for Medicinal Products for Human Use ( CHMP) and Coordination Group for Mutual Recognition and Decentralised Procedures - Human ( CMDh), after consultation with the Pharmacovigilance Risk Assessment Committee ( PRAC).Īny amendment to the EURD list becomes effective six months after its publication.įor more information on the EURD list and answers to frequently-asked-questions, see the following document: The EURD list is a legally binding document and MAHs are legally responsible for complying with its requirements.
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