Therapeutic Goods Regulations 1990

For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.

The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.

Subregulation (1) ceases to have effect on 1 July 2021, subject to subregulations (4) and (5).

If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.

If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.