Table I.

Precautionary operational measures to be adopted.

Case	Plasma-derived medicinal productsa	Communication
1. Variant CJD	Recall from the market	Yes
2. “Classical TSE”b in which the clinical picture does not yet enable a diagnosis of variant CJD to be excluded	Quarantine (Ban of use)	Yes
3. “Classical TSE” in which the diagnosis of variant CJD cannot be definitively excludedc	Continuation of the quarantine (ban of use)	No
4. “Classical TSE” in which the diagnosis of variant CJD has been excluded	Lifting the quarantine	Yes

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^aGiven its production process, albumin is considered one of the plasma derivatives with the lowest risk. In the event of albumin used as an excipient, its possible recall should be carefully evaluated case by case because a single lot of albumin can be used to produce various lots of medicinal products and efforts should be made to avoid an automatic quarantine/recall from having repercussions on entire stocks of a product and creating major shortages on the market. In this regard, it is worth noting that, as a precautionary measure, albumin used as an excipient should not come from countries in which cases of variant CJD have been reported.;

^bThe simplified term “classical” TSE indicates the sporadic, iatrogenic and genetic forms of CJD and other genetic TSE;

^cIt would be useful that donors with a diagnosis of “classical” TSE in whom the diagnosis of variant CJD could not be excluded undergo post-mortem studies (i.e., neuropathological and/or immunochemical analyses).