CHAPTER II

OBLIGATIONS ON MEMBER STATES' AUTHORITIES

Notification of serious adverse events and reactions
Article 11
1
Member States shall ensure that there is a system in place 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.
2
All persons or establishments using human tissues and cells regulated by this Directive 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.
3
The responsible person referred to in Article 17 shall ensure that the competent authority or authorities is or are notified of any serious adverse events and reactions referred to in paragraph 1 and is or are provided with a report analysing the cause and the ensuing outcome.
4
The procedure for notifying serious adverse events and reactions shall be established by the Commission, in accordance with the procedure referred to in Article 29(2).
5
Each tissue establishment shall ensure that an accurate, rapid and verifiable procedure is in place which will enable it to recall from distribution any product which may be related to an adverse event or reaction.