A Periodic Safety Update Report (PSUR) is intended to provide an update of the worldwide safety experience of a medicinal product to Competent Authorities at defined time points post-authorisation. At these times, Marketing Authorisation Holders are expected to provide succinct summary information together with a critical evaluation of the risk-benefit balance of the product in the light of new or changing information. This evaluation should ascertain whether further investigations need to be carried out and whether changes should be made to the marketing authorisation and/or product information.
A Periodic Safety Update Report (PSUR) is intended to provide an update of the worldwide safety experience of a medicinal product to Competent Authorities at defined time points post-authorisation. At these times, Marketing Authorisation Holders are expected to provide succinct summary information together with a critical evaluation of the risk-benefit balance of the product in the light of new or changing information. This evaluation should ascertain whether further investigations need to be carried out and whether changes should be made to the marketing authorisation and/or product information. If the Marketing Authorisation Holder considers, on the basis of the data included in the PSUR, that amendment of the Summary of Product Characteristics (SPC) is necessary, a variation application should be submitted with the PSUR, or where this is not possible, a timetable for submission should be proposed at the time of PSUR submission.
Once a medicinal product is authorised in the EU, even if it is not marketed, the Marketing Authorisation Holder is required to submit PSURs. The submission of PSUR is described in Volume 9A of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use. PSURs should also be submitted upon request of a Competent Authority at any time after granting of the marketing authorisation.
Volume 9A started to be in effect on 30 October 2005 and replaces the earlier version Volume 9. One difference between the two versions is that submission of PSURs at a lower frequency than once every three years is not possible. As a consequence the transition rules have been implemented in Code of Statutes, LVFS 2006:4.
There is an agreement among the European Commission and the national Competent Authorities that for all medicinal products authorised through national or Mutual Recognition Procedure/ Decentralised Procedure (MRP/DCP) PSURs have to be submitted no later than 30 October 2008 i.e. no later than three years after the date of the revised legislation. In terms of data lock point (DLP) for PSURs it means that DLP should be no later than 30 August 2008, taking into account that MAH need 60 days to compile a PSUR.
So generally a PSUR should be submitted to the Medical Products Agency:
For products having a marketing authorisation (MA) with an expiry date no later than 30 April 2009 the next PSUR should be submitted with the renewal application no later than 30 October 2008 (taking into account the requirement that application should be submitted six month before expiry of the current MA). Thereafter PSURs should be submitted every three years, unless other requirements have been made.
For products having a MA with an expiry date after 30 April 2009 the next PSUR should be submitted no later than 30 October 2008. Thereafter PSURs should be submitted every three years, unless other requirements have been made.
If uncertainty about your medicinal products, you can contact the Medical Products Agency for discussion and advice. The MAH are requested to adopt these rules when planning for submission of PSURs.
Please note; If applicable the DLP for the PSUR could preferably be harmonised with the date for the active substance decided in PSUR Work Sharing (WS). The dates are published at Heads of Medicines Agencies homepage.