Regulation 15 Amendment of the Schedule to the principal Regulations
Original text. Later amendments are not shown.
In the Schedule to the principal Regulations, after Part 5 (quality and safety requirements for blood and blood components) insert the following Parts—
“PART 6
RECORD OF DATA ON TRACEABILITY
A. BY BLOOD ESTABLISHMENTS
1.
Blood establishment identification
2.
Blood donor identification
3.
Blood unit identification
4.
Individual blood component identification
5.
Date of collection (year/month/day)
6.
Facilities to which blood units or blood components are distributed, or subsequent disposition.
B. BY FACILITIES
1.
Blood component supplier identification
2.
Issued blood component identification
3.
Transfused recipient identification
4.
For blood units not transfused, confirmation of subsequent disposition
5.
Date of transfusion or disposition (year/month/day)
6.
Lot number of the component, if relevant.
PART 7
NOTIFICATION OF SERIOUS ADVERSE REACTIONS
SECTION A
Rapid notification format for suspected serious adverse reactions
SECTION B
Serious adverse reactions – imputability levels
SECTION C
Confirmation format for serious adverse reactions
SECTION D
Annual notification format for serious adverse reactions
PART 8
NOTIFICATION OF SERIOUS ADVERSE EVENTS
SECTION A
Rapid Notification Format for Serious Adverse Events
SECTION B
Confirmation Format for Serious Adverse Events
SECTION C
Annual Notification Format for Serious Adverse Events”.
