S.L. 483.6 Art. 11Reporting system and management of serious adverse events and reactions. S.L. 483.01

(1) Procurement organisations and transplant centres shall establish and maintain a system to report, investigate, register and transmit relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.

(2) Procurement organisations and transplant centres shall have an operating procedure in place for the management of serious adverse events and reactions.

(3) In particular, and with regard to sub-regulations (1) and (2), procurement organisations and transplant centres shall ensure that operating procedures are in place for the notification, in due time, of:

(a) any serious adverse event and reaction to the Licensing Authority and to the concerned procurement organisation or transplantation centre;

(b) the management measures with regard to serious adverse events and reactions to the Authority.

(4) Where organs are exchanged between Member States, the procurement organisations and transplant centres shall ensure that serious adverse events and reactions are reported in conformity with the procedures established by the European Commission pursuant to Article 29 of Directive 2010/53/EU.

(5) Procurement organisations shall, where relevant, ensure the interconnection between the reporting system referred to in sub-regulation (1) and the notification system established in accordance with regulation 8 of the Tissues and Cells (Quality and Safety) Regulations.