Eudralex Volume 3 GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS
Title:
Eudralex Volume 3 GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
CHMP/BWP Guideline
Content:
The quality issues, including biological safety, affecting biological active substances5 produced by the expression of one or more transgenes stably located in the genomes of higher plants constitute the scope of this guideline.