The Human Tissue (Quality and Safety for Human Application) Regulations 2007 No. 1523

SCHEDULE 2 Directions for securing compliance with the first, second and third Directives

Traceability and coding system

1.  Directions shall require that licence holders adopt such systems as the Authority considers appropriate to secure—

(a) in relation to traceability, compliance with the requirements of Article 8 (traceability) of the first Directive and Article 9 (traceability) of the third Directive; and

(b) in relation to the coding of information, compliance with the requirements of Article 25 (coding of information) of the first Directive and Article 10 (European coding system) of the third Directive.