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 substance.
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 European Union.

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 PSUR.

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.