ANNEX III附則
ANNEX III NOTIFICATION OF SERIOUS ADVERSE REACTIONS Text of image PART A Rapid notification for suspected serious adverse reactions Tissue establishment Report identification Reporting date (year/month/day) Individual affected (recipient or donor) Date and place of procurement or human application (year/month/day) Unique Donation identification number Date of suspected serious adverse reaction (year/month/day) Type of tissues and cells involved in the suspected serious adverse reaction Type of suspected serious adverse reaction(s) Text of image PART B Conclusions of serious adverse reactions investigation Tissue establishment Report identification Confirmation date (year/month/day) Date of serious adverse reaction (year/month/day) Unique donation identification number Confirmation of serious adverse reaction (Yes/No) Change of type of serious adverse reaction (Yes/No) If Yes, Specify Clinical outcome (if known) Complete recovery Minor sequelae Serious sequelae Death Outcome of the investigation and final conclusions Recommendations for preventive and corrective actions