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This page includes information on periodic safety update reports (psurs), psur submission requirements, psur single assessment procedures (psusas) and the european union reference dates (eurd) list. Any changes to the psur submission frequency, the submission date and the psur submission requirement for medicinal products referred to in articles 10(1), 10a, 14 or 16a of directive 2001/83/ec as stated in the eurd list come into force 6 months after its publication. List of european union reference dates (eurd) and frequency of submission of periodic safety update reports (psurs)
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The psur frequency and related data lock points for a given active substance or combination of active substances in the eurd list take effect six months after the publication date and overrule the submission schedule described in article 107c (2) of directive 2010/84/eu, and any conditions related to the frequency of submission of psur included. Introduction this best practice guide sets out the arrangements for introducing new substances and combinations into the list of european union reference dates (eurds) and frequency of submission of psurs (eurd list) following a mrp/dcp procedure for a new marketing authorisation (ma) and setting the initial psur data lock point (dlp) and submission frequency A psur has not been previously been submitted in eu
All data since launch of the product until the dlp mentioned in the eurd list
It is acknowledged that the reporting period for the first psur will cover a longer period than the one indicated by the psur frequency. Procedure management department list of union reference dates and frequency of submission of periodic safety update reports (psurs) related information Introductory cover note to the list of european union reference dates and frequency of submission of psurs including requirements for psurs submission The european union reference dates (eurd) list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding eu reference dates, frequencies for submission of periodic safety update reports and related data lock points
More information is available under. Colour indicates blue recently added active ingredients & active ingredient combinations yellow psur frequency and dlp updated orange psur frequency updated green dlp updated chan Eu reference dates lis notes active substances and combinations of active substances psur submission frequency dlp publication date (18f) fludeoxyglucose
