Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products - Scientific guideline

This document provides standard texts for warning statements on transmissible agents to be included in summary of product characteristics and package leaflets for plasma-derived medicinal products.

Keywords: Warning statements, plasma derived medicinal products, immunoglobulins, albumin, summary of product characteristics (SmPC), package leaflet

Current effective version

Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products

Adopted Reference Number: EMA/CHMP/BWP/360642/2010 Summary:

This guideline provides standard texts for warning statements on transmissible agents to be included in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products. The original guideline (CPMP/BPWG/BWP/561/03) was aopted by CHMP in October 2003 and came into operation in May 2004. This revision affects only the introduction, where an update related to vCJD and an addition concerning albumin as excipient are now included.

Document history - Revision 1

Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products

Adopted Reference Number: EMA/CHMP/BWP/360642/2010 Summary:

This guideline provides standard texts for warning statements on transmissible agents to be included in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products. The original guideline (CPMP/BPWG/BWP/561/03) was aopted by CHMP in October 2003 and came into operation in May 2004. This revision affects only the introduction, where an update related to vCJD and an addition concerning albumin as excipient are now included.

Overview of comments received on 'Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products' (EMA/CHMP/BWP/360642/2010 rev. ...

Adopted Reference Number: EMA/CHMP/BWP/552050/2011

Draft guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products

Draft: consultation closed Consultation dates: 17/02/2011 to 30/04/2011 Reference Number: EMA/CHMP/BWP/360642/2010

Document history - First version

Note for guidance on the warning on transmissible agents in Summary of Product Characteristics (SPCs) and package leaflets for plasma–derived medicinal products (CPMP/BPWG/BWP/561/03)

Adopted Reference Number: CPMP/BPWG/BWP/561/03 Legal effective date: 30/04/2004