S.L. 483.1 Art. 8Notification of serious adverse events and reactions.

An establishment shall:

(a) establish and maintain a system to report, investigate, register and transmit information about serious adverse events and reactions which may influence the quality and safety of tissues and cells and which may be attributed to the procurement, testing, processing, storage and distribution of tissues and cells, as well as any serious adverse reaction observed during or after clinical application which may be linked to the quality and safety of tissues and cells;

(b) 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

(c) ensure that an accurate, rapid and verifiable procedure is in place which will enable such establishment to recall from distribution any product which may be related to an adverse event or reaction.