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PSUR
Cover letter for the submission of PSURs under the
EU
PSUR
synchronisation scheme
(June 2008)
[
PDF
]
Cover letter for the submission of the
PSUR
overview table to P-
RMS
, when specific
MAH
product is not authorised in P-
RMS
(June 2008)
[
PDF
]
Overview of marketing authorisations for which the
PSUR
(s) is(are) submitted
(June 2013) [
PDF
]
Concerned Member State's Comments on Lead Member State's Preliminary assessment report
(May 2016) [Word]
Template -
PSUR
Assessment Report
(March 2017)
