Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 71

Faecal microbiota transplant products--Part 3 - 3 of the Act

  (1)   For the purposes of this regulation, a biological is a transitional biological if it is:

  (a)   a faecal microbiota transplant product; and

  (b)   a biological other than a Class 1 biological.

Exemption

  (2)   For the purposes of subsection   34(1) of the Act, transitional biologicals are exempt from the operation of Part   3 - 3 of the Act.

When exemption ceases

  (3)   Subregulation (2) ceases to have effect on 1   July 2021, subject to subregulation   (4).

  (4)   If, on or before 30   June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation   (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1   July 2021.


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