S.L. 483.4 Art. 6Notification of serious adverse reactions.

(1) The Authority shall ensure that:

(a) procurement organisations have procedures in place to retain the records of tissues and cells procured and to notify tissue establishments without delay of any serious adverse reactions in the living donor which may influence the quality and safety of tissues and cells;

(b) organisations responsible for human application of tissues and cells have procedures in place to retain the records of tissues and cells applied and to notify tissue establishments without delay of any serious adverse reactions observed during and after clinical application which may be linked to the quality and safety of tissues and cells;

(c) tissue establishments that distribute tissue and cells for human application provide information to the organisation responsible for human application of tissues and cells about how that organisation should report serious adverse reactions as referred to in paragraph (b).

(2) The Authority shall ensure that tissue establishments have procedures in place to communicate to it without delay:

(a) all relevant available information about suspected serious adverse reactions as referred to in sub-regulation (1)(a) and (b); and

(b) the conclusion of the investigation to analyse the cause and the ensuing outcome.

(3) It shall be the duty of the responsible person of a tissue establishment to notify the Authority of the -

(a) information included in the notification set out in Part A of Schedule III;

(b) actions taken with respect to other implicated tissues and cells that have been distributed for human applications;

(c) conclusion of the investigation, supplying at least the information set out in Part B of Schedule III.