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European spongiform risk materials 18-month phase-out recommended by CPMP.

This article was originally published in The Rose Sheet

Executive Summary

EUROPEAN SPONGIFORM RISK MATERIALS 18-MONTH PHASE-OUT RECOMMENDED by the Committee on Proprietary Medicinal Products in a "provisional report" released after the group's meeting Oct. 20-23. "For products manufactured using derivatives of [specified risk materials], or other bovine-derived materials used as reagents, it would take manufacturers well into 1999 to change their production processes...to eliminate the use of such materials," the committee noted. "Hence, a substantial transition period of at least 18 months should be provided for any necessary changes." Therefore, European restrictions on use of such products should be applied prospectively after Jan. 1, and not retroactively to existing products without a suitable transition period, CPMP advised.
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