EU Harmonised Birth Dates

PSUR Work Sharing list, alphabetic order, Status: (118.67 kb) June 2010

PSUR Work Sharing list, alphabetic order, xls version, Status: (174.5 kb) June 2010

Synchronisation List, alphabetic order, Status: (202.54 kb) June 2010

Explanatory Note on the additional list of harmonised birth dates and PSUR data lock points for products containing the listed active substances (11.56 kb)

PSUR Worksharing - documents

Guidance Document for Marketing Authorisation Holders on Submissions under the EU PSUR synchronisation scheme (110.68 kb) 12 December 2009

PhVWP and CMD(h) Best Practice Guide for Work Sharing oncerning the Assessment of PSURs of Products for which an EU harmonised virtual Birth Date and related harmonised Data Lock Point have been agreed (188.42 kb) 12 December 2009

Questions and Answers on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures. (20.64 kb) 25 July 2008

EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures (26.46 kb) 21 August 2007

Reference safety information to be used in PSURs of generic medicinal products for which the submission date is based on an EU HBD (14.35 kb) October 2006

Harmonisation of Product Birthdates and Synchronisation of Periodic Safety Update Reports PSURs) of products authorised through national or mutual recognition procedures in the EU (29.66 kb)

- Annex 1: (23.22 kb) Towards Harmonised Birth Dates of Medicinal Products in the EU

- Annex 2: (17.26 kb) Transitional measures for submission of PSURs for nationally authorised medicinal products for human and veterinary use

February 2006

Templates:

Cover letter for the submission of PSURs under the EU PSUR synchronisation scheme:
.pdf / .doc
25 June 2008

Cover letter for the submission of the PSUR overview table to P-RMS, when specific MAH product is not authorised in P-RMS
        .pdf / .doc
25 June 2008

Overview of Marketing Authorisations for which the PSUR(s) is submitted
        .pdf / .doc
24 June 2008

P-RMS Assessment Report - template
        .pdf / .doc
12 December 2009