Commonwealth Numbered Regulations

THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1998 No. 227 - REG 11

11.1 Omit the Schedule, substitute:
                           SCHEDULE 10        Subregulations 16C (1),

16D (1), 16F (1) and 16G (1)
THERAPEUTIC GOODS FOR EVALUATION
PART 1-EVALUATION BY THE DRUG SAFETY AND EVALUATION
BRANCH OF THE DEPARTMENT Column 1 Column 2
Item      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 drug

 6        an immunoglobulin

 7        a radio contrast agent, except barium sulphate preparation 
for radiological use
 8        a radiopharmaceutical

 9        a dialysis solution

10        an irrigation solution

11        a special dosage form, such as a transdermal system or 
osmotic pump
12        an injectable drug dosage form

13        a blood product, unless coated on a therapeutic device

14        therapeutic goods referred for evaluation to the Drug Safety 
and Evaluation Branch of the Therapeutic Goods Administration within the
Department
15        an excipient in therapeutic goods mentioned in this Part

16        a therapeutic device that depends upon the release of a 
substance for some or all of its action
PART 2-EVALUATION BY THE COMPLEMENTARY MEDICINES
REGON OF 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
Item       Product
1          a complementary medicine
2          an excipient in complementary medicine
3          therapeutic goods referred for evaluation to the 
Complementary Medicines Section of the Therapeutic Goods Administration within
the Department
PART 3-EVALUATION BY SOTCDES 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
Item       Product
1          an antiseptic
2          a sunscreen preparation
3          all other therapeutic goods, except a therapeutic device, 
not mentioned in another Part of this Schedule
4          an excipient in therapeutic goods mentioned in this Part

5          therapeutic goods referred for evaluation to the Scheduling 
and Over-the-counter Drug Evaluation Section of the Therapeutic Goods
Administration within the Department