Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 33C

    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.