Working Group on PSUR synchronisation
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
PSUR Worksharing - documents
Guidance Document for Marketing Authorisation Holders on Submissions under the EU PSUR synchronisation scheme
(110.68 kb)
12 December 2009
- 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 2008Overview of Marketing Authorisations for which the PSUR(s) is submitted
.pdf / .doc
24 June 2008P-RMS Assessment Report - template
.pdf / .doc
12 December 2009
