Arzneimittelinstitut

Download Aerea

Consulting in „Expedited Reporting“ of serious adverse reaction

Detailed Guidance

on the European Database of SUSARs (Eudravigilance – Clinical Trial Module), April 2003 – Final

VOLUME 9A

of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use – Final March 2007

ICH E2BM EWG

Data Elements for Transmission of ICSRs. Revised E2B Step Four Document, Version 4.4.1, FEB 2001

ICH Topic E2E

Pharmacovigilance Planning (PVP), ICH Step 4 (CPMP/ICH/5716/03), 1 DEC 2004

Volume 9 – Pharmacovigilance

Medicinal Products for Human and Veterinary Use(Attention: 323 Page’s )

ICH Topic E2A

Clinical Safety Data Management: Definitions and Standards für Expedited Reporting (CPMP/ICH/377/95) Step 5

Regulation (EC) No 540/95 of 10 March 1995

laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medical products for human or veterinary use authorized in accordance with the provisions of Council Regulations (EEC) No 2309/33