Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 10

Therapeutic goods for evaluation

Note:   See regulations   16C, 16D, 16F, 16G and 45.

Part   1 -- Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch

 

 

Column 1
Item

Column 2
Product

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
Item

Column 2
Product

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
Item

Column 2
Product

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



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