On this page you find some important thematic documents for download (.pdf):

Directive 2001/83/EC relating to medicinal products for human use, amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC, and 2004/27/EC

Directive 2005/61/EC

Directive 2005/62/EC

ICH Harmonised Tripartite Guideline - Clinical Safety Data Management: Periodic Safety Update Reports for marketed Drugs E2C

ICH Harmonised Tripartite Guideline (ADDENDUM TO ICH E2C) - Clinical Safety Data Management: Periodic Safety Update Reports for marketed Drugs E2C

ICH E2D Post Approval Safety Data Management

Kroth E. Pharmakovigilanz. Pharm Ind 2005; 67(12):1432-1436

EudraLex. Volume 9 – Pharmacovigilance. Volume 9A of The Rules Governing Medicinal Products in the European Union. - Guidelines on Pharmacovigilance for Medicinal Products for Human use (Version September 2008)

CEU Harmonised Birth Dates, related Data Lock Points, allocated P-RMSs, alphabetic order, dated 25 July 2008

Additional list of EU HBDs and DLPs, alphabetic order, dated 15 July 2008

Heads of Medicines Agencies - Working Group on PSUR synchronisation