Document ID: chunk:federal_register_of_legislation:F2022C01065:reg:37a
Version: federal_register_of_legislation:F2022C01065
Segment Type: reg
Provision Reference: reg 37A
Character Range: 301902–303319

37A  Alternative conditions—listed semi‑synthetic, fermentation‑derived active ingredients
 (1) This section applies to listed semi‑synthetic, fermentation‑derived active ingredients (the goods).
 (2) For paragraph 12(1)(b), alternative conditions for bringing or importing the goods into Australian territory are:
 (a) the goods are intended for human therapeutic use or veterinary therapeutic use; and
 (b) the goods have been manufactured without the use of materials of terrestrial animal or avian origin (including the culture media used during fermentation of the goods); and
 (c) the goods do not contain any plant material (other than highly processed and purified plant extracts or oils) and are not on an animal or grain based carrier; and
 (d) the goods are derived from a fermentation process that used culture media that was sterilised before use; and
 (e) the goods were manufactured to be compliant with:
 (i) the relevant monograph from at least one of the following published standards: United States Pharmacopeia, European Pharmacopoeia, British Pharmacopoeia; or
 (ii) the specifications approved by the Australian Pesticides and Veterinary Medicines Authority (within the meaning of the Agricultural and Veterinary Chemicals (Administration) Act 1992); and
 (f) the goods are accompanied by a declaration by the manufacturer of the goods stating the matters referred to in paragraphs (b) to (e).