Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1998No. 227 1

__________________

Therapeutic Goods Regulations2 (Amendment)

I, WILLIAM PATRICK DEANE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 15 July 1998.

 WILLIAM DEANE

 Governor-General

By His Excellency’s Command,

TRISH WORTH

Parliamentary Secretary

to the Minister for Health and Family Services

for the Minister for Health and Family Services

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1.   Commencement

1.1   These Regulations commence on gazettal.

2.   Amendment

2.1   The Therapeutic Goods Regulations are amended as set out in these Regulations.

3.   Regulation 5B (Interpretation)

3.1   Definition of complementary medicine:

Omit the definition, substitute:

“complementary medicine means therapeutic goods containing 1 or more designated active ingredients, each of which has a complementary or traditional use.”.

3.2   Definition of designated active ingredient:

Omit the definition, substitute:

“designated active ingredient means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.”.

3.3   Insert the following definitions:

“complementary use, for a designated active ingredient, means use in a regimen for the prevention or alleviation of a disease or ailment, being a use that does not necessarily rely on evidence of effectiveness based on the Quality of Evidence Rating set out in Appendix A of the Guidelines for the Development and Implementation of Clinical Practice Guidelines published by the National Medical and Research Council in October 1995, as amended from time to time.

traditional use, for a designated active ingredient, means:

• (a)

  the designated active ingredient has a clearly established identity; and

• (b)

  the use is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time (for example, Chinese traditional medicine); and

• (c)

  the use accords with well-established procedures for the preparation, application and dosage for the purpose of the use.”.

4.   Regulation 6 (Advertising offences)

4.1   Paragraph 6 (1) (e):

Omit “Standard;”, substitute “Standard, except goods mentioned in Appendix H of the Standard;”.

5.   Regulation 16C (Periods within which certain evaluations must be made)

5.1   Subregulation 16C (1):

Before “Schedule 10”, insert “Part 1 of”.

6.   Regulation 16D (Periods within which certain applications must be decided)

6.1   Subregulation 16D (1):

Before “Schedule 10”, insert “Part 1 of”.

7.   Regulation 16F (Applications under subsection 32 (5) of the Act—periods within which certain decisions must be made)

7.1   Subregulation 16F (1):

Before “Schedule 10”, insert “Part 1 of”.

8.   Regulation 16G (Shorter evaluation period in certain cases)

8.1   Subregulation 16G (1):

Before “Schedule 10”, insert “Part 1 of”.

9.   Schedule 4 (Therapeutic goods required to be included in the part of the Register for listed goods)

9.1   Heading:

Omit “regulation 11”, substitute “regulations 11 and 11A”.

9.2   Part 1:

After paragraph (e) of item 3, insert:

• “(f)

  for a substance mentioned in Division 2 of Part 5—the condition mentioned in column 2 in that Division for the substance is complied with;”.

9.3   Part 2:

Insert, in the appropriate alphabetical position:

“Pyridoxal 5—phosphate

Tocopherols concentrate—mixed (high alpha type)

Tocopherols concentrate—mixed (low alpha type)”.

Note   The alphabetical position of approved names mentioned in Part 2 is determined primarily by the name regardless of prefix (for example, “d‑alpha‑Tocopherol” is positioned among names beginning with “t”, not “d”).

9.4   Part 3:

Insert, in the appropriate alphabetical position:

“Calcium phosphate—monobasic

Zinc ascorbate”.

9.5   Part 5:

After the heading to the Part, insert:

“Division 1”.

9.6   Part 5:

Add at the end:

“Rice—hydrolysed

Royal jelly

Shark cartilage

Starch—maize—high amylose

“Division 2

Interpretation

“1.

A reference in column 2 of the table to an amount of a daily dose of a substance is a reference to the amount of the substance (in all forms in which it is present in the preparation containing the substance) when the preparation is used as directed.

Column 1

Substance

Column 2

Condition

creatine

no more than 3 g of creatine per daily dose

creatine monohydrate

no more than 3 g of creatine per daily dose

creatine phosphate

no more than 3 g of creatine per daily dose

chromium nicotinate

no more than 50 mg of chromium per daily dose

chromium picolinate

no more than 50 mg of chromium per daily dose

high chromium yeast

no more than 50 mg of chromium per daily dose

cupric citrate

no more than 750 mg of copper per daily dose

high molybdenum yeast

no more than 62.5 mg of molybdenum per daily dose”.

10.   Schedule 7 (Therapeutic goods exempt from the operation of Part 4 of the Act unless supplied as pharmaceutical benefits)

10.1   Add at the end:

“20 Medicinal oxygen cylinders that have been decant filled, transfilled or cascade filled by an organisation for use on patients under the direct care of that organisation”.

11.   Schedule 10 (Drugs evaluated by the Drug Safety and Evaluation Branch of the Department)

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

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 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 SECTION 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

Item

Column 2

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

Item

Column 2

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

12.   Schedule 14 (Designated active ingredients)

12.1   Omit the Schedule, substitute:

SCHEDULE 14 Regulation 5B

DESIGNATED ACTIVE INGREDIENTS

Item	Ingredient or kind of ingredient
1	an amino acid
2	charcoal
3	a choline salt
4	an essential oil
5	plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll
6	a homeopathic preparation
7	a microorganism, whole or extracted, except a vaccine
8	a mineral including a mineral salt and a naturally occurring mineral
9	a mucopolysaccharide
10	non-human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates
11	a lipid, including an essential fatty acid or phospholipid
12	a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis
13	a sugar, polysaccharide or carbohydrate
14	a vitamin or provitamin

NOTES

1. Notified in the Commonwealth of Australia Gazette on 16 July 1998.

2. Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998).