Note: See regulations 16C, 16D, 16F, 16G and 45.
Column 1 | Column 2 |
1 | therapeutic goods (except therapeutic goods mentioned in another Part of this Schedule), that: (a) contain a substance mentioned in Schedule 4, 8 or 9 to the Poisons Standard; or (b) contain a substance not mentioned in any of those Schedules but which meets the criteria for mention in any of those Schedules |
2 | a medical gas |
3 | a vaccine |
4 | an allergen, except an allergen for skin patch testing on unbroken skin |
5 | a biotechnology medicine |
6 | an immunoglobulin |
7 | a radio contrast agent, except barium sulphate preparation for radiological use |
8 | a radiopharmaceutical |
9 | a dialysis solution, except a haemodialysis solution |
11 | a special dosage form, such as a transdermal system or osmotic pump |
12 | an injectable medicine dosage form |
13 | a blood product |
14 | therapeutic goods referred to the Prescription Medicines Authorisation Branch of the Therapeutic Goods Administration within the Department for the purpose of evaluation as a prescription medicine |
15 | an excipient in therapeutic goods mentioned in this Part |
The following therapeutic goods, if the sponsor has satisfied the Secretary that the goods do not meet the criteria for mention in Schedule 4, 8 or 9 of the Poisons Standard:
Column 1 | Column 2 |
1 | a complementary medicine |
2 | an excipient in complementary medicine |
3 | therapeutic goods referred for evaluation to the Complementary and OTC Medicines Branch of the Therapeutic Goods Administration within the Department |
The following therapeutic goods, if the sponsor has satisfied the Secretary that the goods do not meet the criteria for mention in Schedule 4, 8 or 9 of the Poisons Standard:
Column
1 | Column 2 |
1 | an antiseptic |
2 | a sunscreen preparation |
3 | all other therapeutic goods not mentioned in another Part of this Schedule |
4 | an excipient in therapeutic goods mentioned in this Part |
5 | therapeutic goods referred to the Complementary and OTC Medicines Branch of the Therapeutic Goods Administration within the Department for the purpose of evaluation as a non - prescription medicine |