periodic safety update reports (psurs)
This page is under revision following the new
pharmacovigilance legislation that became effective in July 2012.
For the most current information, please visit www.pharmacovigilance2012.nl .
Marketing authorisation holders must submit Periodic
Safety Update Reports (PSURs) on a regularly base. In PSURs
Marketing Authorisation Holders provide all new information to
review the safety profile of their products.
PSUR synchronisation and PSUR worksharing
In 2004 under the auspices of the Head of Medicines Agencies (HMA) the PSUR
Working group started to work out the EU-wide synchronisation of
PSUR submissions for products with the same active
For around 1800 medicinal products with the same active ingredient,
or combinations of active ingredients, a Harmonised Birth Date
(EU HBD) and accompanying Data Lock point is provided for the
compilation of PSURs.
From these 1800 medicinal products with the same active
ingredient, or combinations of active ingredients,
approximately 1200 are part of the PSUR synchronisation project and
circa 600 are included in the PSUR Worksharing project.
What’s in a PSUR?
A PSUR includes all serious and non-serious adverse
reactions, reported worldwide.
Also, PSURs should address all adverse events as reported in
literature (clinical and pharmaco-epidemiological studies etc.).
The full requirements for the contents of a PSUR are given in
chapter 1.6 of
Volume 9A of the The rules governing medicinal products in the
In its conclusion it should be indicated if the PSUR provides
a basis as to whether changes in the product information
(Summary of Product Characteristics and Patient Information
Leaflets) will be necessary.
The PSUR submission scheme to be applied is, as from the time
of granting the marketing authorisation (MA):
- a PSUR every six months for the first two years after
being placed on the market
- during the following two years a PSUR every year
- thereafter at three-yearly intervals
In case of suspicion of a specific safety issue, CBG may - at
any given time - request the authorisation holders to submit a
Next to the submission of PSURs the Marketing Authorisation Holders
is obliged to monitor the safety profile of their products on a
continuing basis and, if applicable, to apply for an update of the
product information in between.