Commonwealth Numbered Regulations

1995 No. 33 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 3

3.1 Add at the end:

"6 Anti-D immunoglobulin

   (a)  the product must be imported by Commonwealth Serum Laboratories
        Limited ("CSL") from Orthodiagnostic Systems Inc. ("OSI") in the
        United States of America; and

   (b)  supply of the product in Australia must be by, or on behalf of, CSL;
        and

   (c)  when supplied to the patient, the product must have with it:

        (i)    a copy of the Patient Information that includes an explanation
               of the conditions under which its importation was permitted;
               and

        (ii)   a copy of the Product Information, applicable to the product,
               that is published by OSI and approved by the United States Food
               and Drug Administration; and

   (d)  the patient must give to the treating medical practitioner, in
        writing, adequately informed consent to the administration of the
        product; and

   (e)  the treating medical practitioner must retain the written consent of
        the patient".