European Medicines Agency Consultation: Draft guideline on the warning on transmissible agents SmPCs and package leaflets for plasma-derived medicinal products

The European Medicines Agency has recently published a draft guideline providing 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 adopted 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.

The document is available for consultation on the following webpage:

Comments related to this draft guideline should be provided using this template The completed comments form should be sent to

Please note that the deadline for comments for this draft guideline is 30 April 2011.

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