Feedback requested on the draft list of EU reference dates for periodic safety update reports in preparation for introduction of the new pharmacovigilance legislation
The European Medicines Agency, on behalf of the European Union (EU) medicine regulatory network, is inviting 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 Union reference date is the earliest known date of the marketing authorisation for a medicinal product containing the same active substance or the same combination of active substances.
The EURD list includes the active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding Union reference dates, frequencies for submission of PSURs and related data lock points.
The purpose of the consultation is to ensure completeness and correctness of the information before the list is adopted later this year by the Committee for Medicinal Products for Human Use (CHMP) and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, (CMDh) following consultation with the new Pharmacovigilance and Risk Assessment Committee (PRAC) from July 2012.
The consultation is open until 4 June 2012. Those submitting comments on the draft EURD list are asked to read the introductory cover note and use the Excel template submission of comments on the EURD list to provide comments. Responses should be sent to email@example.com.
The PSUR frequencies and data lock points specified in the list will override the current submission schedule and any conditions related to the frequency of submission of PSURs included in the marketing authorisation of products containing the active substance or combination of active substances.
The list is intended to optimise the management of PSURs assessment within the EU while supporting transparency. It aims to provide predictability to the various stakeholders in terms of workload related to PSURs taking into account the currently known safety profile of the active substances and combinations of active substances.