ANNEX V附則
ANNEX V ANNUAL NOTIFICATION FORMAT Text of image PART A Annual notification format for serious adverse reactions Reporting country Reporting date 1 January-31 December (year) Number of serious adverse reaction(s) per type of tissue and cell (or product in contact with the tissues and cells) Type of tissue/cell (or product in contact with the tissues and cells) Number of serious adverse reaction(s) Total number of tissues/cells of this type distributed (if available) 1 2 3 4 … Total Total number of tissues and cells distributed (including type of tissue and cell for which no serious adverse reactions were reported): Number of recipients affected (total number of recipients): Nature of the serious adverse reactions reported Total number of serious adverse reaction(s) Transmitted bacterial infection Transmitted viral infection HBV HCV HIV-1/2 Other (Specify) Transmitted parasitical infection Malaria Other (Specify) Transmitted malignant diseases Other disease transmissions Other serious reactions (Specify) Text of image PART B Annual notification format for serious adverse events Reporting country Reporting date 1 January-31 December (year) Total number of tissues and cells processed Total number of serious adverse events, which may have affected quality and safety of tissues and cells due to a deviation in: Specification Tissues and cells defect (specify) Equipment failure (specify) Human error (specify) Other (specify) Procurement Testing Transport Processing Storage Distribution Materials Others (specify)