Source: https://www.legislation.gov.au/Details/F1998B00210
Timestamp: 2019-12-06 03:41:28
Document Index: 282509001

Matched Legal Cases: ['art 1', 'art 1', 'art 5', 'art 2', 'art 2', 'art 3', 'art 5', 'art 5', 'art 4', 'ART 1', 'ART 2', 'ART 3']

Details: F1998B00210
- F1998B00210
SR 1998 No. 227 Regulations as made
Gazetted 16 Jul 1998
Statutory Rules 1998 No. 2271
Dated 15 July 1998.
3. Regulation 5B (Interpretation)
3.1 Definition of complementary medicine:
“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:
“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):
7. Regulation 16F (Applications under subsection 32 (5) of the Act—periods within which certain decisions must be made)
7.1 Subregulation 16F (1):
8. Regulation 16G (Shorter evaluation period in certain cases)
8.1 Subregulation 16G (1):
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:
“Calcium phosphate—monobasic
Zinc ascorbate”.
9.5 Part 5:
After the heading to the Part, insert:
“Division 1”.
9.6 Part 5:
“Rice—hydrolysed
Starch—maize—high amylose
“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.
no more than 3 g of creatine per daily dose
no more than 50 mg of chromium per daily dose
no more than 750 mg of copper per daily dose
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)
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:
16D (1), 16F (1) and 16G (1)
Therapeutic goods FOR EVALUATION
PART 1—EVALUATION BY THE DRUG SAFETY AND EVALUATION BRANCH OF THE DEPARTMENT
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
an allergen, except an allergen for skin patch testing on unbroken skin
a biotechnology drug
a radio contrast agent, except barium sulphate preparation for radiological use
a radiopharmaceutical
a dialysis solution
an irrigation solution
a special dosage form, such as a transdermal system or osmotic pump
an injectable drug dosage form
a blood product, unless coated on a therapeutic device
therapeutic goods referred for evaluation to the Drug Safety and Evaluation Branch of the Therapeutic Goods Administration within the Department
an excipient in therapeutic goods mentioned in this Part
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:
an excipient in complementary medicine
therapeutic goods referred for evaluation to the Complementary Medicines Section of the Therapeutic Goods Administration within the Department
PART 3—EVALUATION BY SOTCDES
a sunscreen preparation
all other therapeutic goods, except a therapeutic device, not mentioned in another Part of this Schedule
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:
Ingredient or kind of ingredient
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).