A list of relevant national and international regulations and guidelines pertaining to PSUR submission and writing has been provided below.

Addendum to ICH E2C: Clinical Safety Data Management – Periodic Safety Update Reports for Marketed Drugs; Version February 2003

Clinical Safety Data Management – Periodic Safety Update Reports for Marketed Drugs; Version November 1996

Clinical Safety Data Management – Periodic Safety Update Reports for Marketed Drugs; Version November 2005

4. Bekanntmachung zur Anzeige von Nebenwirkungen und Arzneimittelmissbrauch nach §63b Abs. 1 bis 8 des Arzneimittelgesetzes; Version 29 April 2005

5. Bekanntmachung zur Anzeige von Nebenwirkungen und Arzneimittelmissbrauch nach §63b Abs. 1 bis 8 des Arzneimittelgesetzes; Version 5. Dezember 2007

VOLUME 9A of the Rules Governing Medicinal Products in the European Union 9 – Guidelines on Pharmacovigilance for Medicinal Products for Human Use; final Version March 2007

Harmonisierte EU Birth Dates

Please note:

To open PDF-files and to activate links contained in them, you must use the PDF-Reader! This program will allow you to open, print, and search PDF-files.