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 |
Part 2 -- Evaluation of complementary medicines by the Complementary and OTC Medicines Branch
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 |
Part 3 -- Evaluation of non - prescription and other medicines by the Complementary and OTC Medicines Branch
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 |