EMA request feedback on the draft EU reference dates

pharmafile | April 19, 2012 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing |  Wainwright Associates; EMA; Pharmacovigilance; PV 

The European Medicines Agency has invited marketing-authorisation holders and other stakeholders to review and provide comments on the draft list of European Union reference dates (referred to as the ‘EURD list’) for periodic safety update reports (PSURs) in preparation for the introduction of the new pharmacovigilance legislation in July 2012. The purpose of the consultation is to ensure completeness and correctness of the information before the list is adopted later this year. The PSUR frequencies and data lock points specified in the list will override the current submission schedules. The purpose of generating the list to optimise the PSUR assessment process within the EU.

If you require any assistance with the preparation and submission of PSURs our team of pharmacovigilance and regulatory consultants will be pleased to discuss how we may assist you. Please contact us via email at enquiries@wainwrightassociates.co.uk or telephone +44(0)1628 530554.

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