Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:33c
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 33C
Character Range: 311524–312467

33C  Report on release of nonconforming biological
  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:
 (a) within 6 months after the release—a report that includes the following information:
 (i) date of release;
 (ii) product identification details;
 (iii) name and address of transplant centre or medical practitioner to whom the nonconforming biological was released;
 (iv) initials, gender and date of birth of patient;
 (v) any adverse events relating to the use of the nonconforming biological; and
 (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:
 (i) the decision making process leading to the supply; and
 (ii) any adverse events related to the supply.

Part 6—Committees

Division 1A—Advisory Committee on Medicines