Approximately twenty years ago, the regulation of Substances of Human Origin (“SHO”) in Europe was reshaped by the introduction of the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC) (together the “BTC Directives”). Although EU directives are legislative acts, they are not directly binding on Member States and merely set out a goal that all EU countries must achieve. It is up to the particular Member State to determine...
October 25, 2022
5 min read