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

Procurement and use of tissue or cells

7.  Directions shall be given—

(a) for the purpose of securing that procurement organisations comply with the requirements of the Annex to the first Directive (information to be provided on the donation of tissue or cells), and

(b) for the purpose of securing that procurement organisations and organisations responsible for human application of tissue or cells comply with the requirements of Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.