WORKING GROUP ON PSUR SYNCHRONISATION
For any queries related to the PSUR Work Sharing and Synchronisation project, please use the following email address: P-PV-Helpdesk@ema.europa.eu
EU Harmonised Birth Dates
- Explanatory note on the additional list of harmonised birth dates and PSUR data lock points for products containing the listed active substances (latest update: July 2008)
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PSUR Worksharing - documents
- Guidance document for marketing authorisation holdesr (MAHs) on submissions under the EU PSUR synchronisation scheme
(latest update: July 2010)
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- PhVWP and CMDh Best practice guide for work sharing concering the assessment of PSURs of products for which an EU harmonised virtual birth date and related harmonised data lock point have been agreed
(latest update: July 2010)
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- Questions and Answers
on the EU synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures
(latest update: March 2011)
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- EU synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures
(latest update: August 2007)
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- Reference safety information to be used in PSURs of generic medicinal products for which the submission date is based on an EU HBD
(latest update: October 2006)
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- Harmonisation of product birthdates and synchronisation of periodic safety update reports (PSURs) of products authorised through national or mutual recognition procedures in the EU:
Letter
To all companies holding marketing authorisations for innovative medicinal products here
Annex I
Towards harmonised birth dates of medicinal products in the EU here
Annex II
Transitional measures for submission of PSURs for nationally authorised medicinal products for human and veterinary use here