The Human Tissue (Quality and Safety for Human Application) Regulations 2007

Procurement and use of tissue or cells

6.  Directions shall specify the requirements to be met by all licence holders authorised to procure tissue or cells to secure compliance with the requirements (including as to staff training, written agreements with staff, standard operating procedures, and appropriate facilities and equipment) laid down in Article 2 (requirements for the procurement of human tissues and cells) of the second Directive.

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.

8.  In giving directions for the purposes of paragraph 7, the Authority shall, in particular, impose a requirement on designated individuals to ensure that records are retained, and the Authority and tissue establishments are notified without delay, of any serious adverse event and any serious adverse reaction.