Faecal microbiota transplant products—Part 3‑3 of the Act
71 Faecal microbiota transplant products—Part 3‑3 of the Act
For the purposes of this regulation, a biological is a transitional biological if it is:
a faecal microbiota transplant product; and
a biological other than a Class 1 biological.
Exemption
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
Subregulation (2) ceases to have effect on 1 July 2021, subject to subregulation (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those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.
This Act’s bill:Explanatory statement
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