Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 16

Note:   See regulation   2.

1A   Class 1 biologicals

    For the purposes of the definition of Class 1 biological in regulation   2, a biological is a Class 1 biological if:

  (a)   it is a faecal microbiota transplant product; and

  (b)   it is not advertised to consumers; and

  (c)   it is to be collected under the supervision or direction, or in accordance with the requirements, of a medical practitioner registered, in a State or internal Territory, as a medical practitioner; and

  (d)   each later step in the manufacture of it is to be carried out in a hospital by, or under the supervision or direction of, the practitioner (unless the step relates to the storage or testing of the biological, in which case it may instead be carried out by a person under a contract with the hospital in a State or internal Territory); and

  (e)   it is for use in a recipient who is a patient of the hospital with the recipient being under the clinical care of the practitioner.

1   Class 4 biologicals

    For the purposes of the definition of Class 4 biological in regulation   2, the following biologicals are Class 4 biologicals:

  (a)   biologicals that comprise or contain:

  (i)   live animal cells; or

  (ii)   live animal tissues; or

  (iii)   live animal organs;

  (b)   biologicals to which both of the following paragraphs apply:

  (i)   the biologicals comprise, contain or are derived from human cells or human tissues that have been modified to artificially introduce a function or functions of the cells or tissues;

  (ii)   the artificially introduced function or functions were not intrinsic to the cells or tissues when they were collected from the donor;

  (c)   pluripotent stem cells;

  (d)   biologicals derived from pluripotent stem cells.