S.L. 483.4 Art. 7Notification of serious adverse events.

(1) All persons or establishments using human tissues and cells regulated by these regulations shall report any relevant information to establishments engaged in the donation, procurement, testing, processing, storage and distribution of human tissues and cells in order to facilitate traceability and ensure quality and safety control and shall have procedures in place for this purpose.

(2) It shall be the duty of -

(a) procurement organisations and tissue establishments to have procedures in place to retain the records and to notify tissue establishments without delay of any serious adverse events that occur during procurement which may influence the quality and, or safety of human tissues and cells;

(b) organisations responsible for human application of tissues and cells to have procedures in place to notify tissue establishments without delay of any serious adverse events that may influence the quality and safety of the tissues and cells;

(c) tissue establishments to provide to the organisation responsible for human application information about how that organisation should report serious adverse events to them that may influence the quality and safety of the tissues and cells.

(3) In the case of assisted reproduction, any type of gamete or embryo misidentification or mix-up shall be considered to be a serious adverse event. All persons or procurement organisations or organisations responsible for human application performing assisted reproduction shall report such events to the supplying tissue establishments for investigation and notification to the Authority.

(4) It shall be the duty of tissue establishments to -

(a) have procedures in place to communicate to the Authority without delay all relevant available information about suspected serious adverse events as referred to in sub-regulation (2)(a) and (b);

(b) have procedures in place to communicate to the Authority without delay the conclusion of the investigation to analyse the cause and the ensuing outcome.

(5) (a) It shall be the duty of the responsible person of a tissue and cell establishment to notify the Authority of the information included in the notification set out in Part A of Schedule IV.

(b) It shall be the duty of tissue establishments to:

(i) evaluate serious adverse events to identify preventable causes within the process;

(ii) notify the Authority of the conclusion of the investigation, supplying at least the information set out in Part B of Schedule IV.