Statutory Rules 1992 No. 891
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Therapeutic Goods Regulations 2 (Amendment)
I, THE 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 7 April 1992.
BILL HAYDEN
Governor-General
By His Excellency’s Command,
PETER STAPLES
Minister of State for Aged, Family
and Health Services
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1. Amendment
1.1 The Therapeutic Goods Regulations are amended as set out in these Regulations.
[NOTE: These Regulations commence on gazettal: see Acts Interpretation Act 1901,
s. 48]
2. Regulation 3 (State or Territory laws that continue to apply)
2.1 Subparagraph 3 (1) (c) (i):
Omit the subparagraph, substitute:
“(i) the Drugs Standard Adopting Act 1976;
(ia) the Health Act 1937-1991;”.
3. Regulation 11 (Listed goods)
3.1 Add at the end:
“(2) For the purposes of items 11 and 12 in that Part, ‘kit’ means a package that contains or includes a group of therapeutic goods, being a group that:
(a) is for supply to a consumer by the sponsor of the therapeutic goods as a single unit; and
(b) is the subject of an order under subsection 16 (2) of the Act; and
(c) consists, wholly or in part, of items of therapeutic goods, each of which is, or is included in a class of therapeutic goods that is:
(i) included in the Register; or
(ii) exempt from the operation of Part 3 of the Act; and
(d) does not consist of or contain:
(i) therapeutic goods; or
(ii) a combination of therapeutic goods;
declared by the Secretary for the purposes of this subregulation to be unsuitable for inclusion in a kit.”.
4. Regulation 12 (Exempt goods)
4.1 After subregulation 12 (1), insert:
“(1AA)For the purposes of item 7 in Schedule 5, a device or part of a device:
(a) is powered if the whole or part of the energy applied to it comes from a source other than the application of human energy; and
(b) is non-powered if paragraph (a) does not apply.”.
5. Regulation 16 (Listing of Therapeutic Goods)
5.1 Add at the end:
“(2) For the purposes of paragraph 26 (1) (k) of the Act, the criteria stated in Part 2 of Schedule 11 are prescribed for therapeutic goods of the kinds stated in Part 1 of that Schedule.”.
6. Regulation 22 (Transfer of licences)
6.1 Subregulations 22 (5) and (6):
Omit the subregulations, substitute:
“(5) When a person notifies the Secretary of an event referred to in paragraph (1) (b), (2) (b), (3) (b), (4) (d) or (4a) (a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
“(6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1) (b), (2) (b), (3) (b), (4) (d) or (4a) (a) or (b) as if it were an application for a licence.”.
6.2 Subregulation 22 (8):
Omit “(4) (b)”, substitute “(4) (d)”.
7. Schedule 3 (Therapeutic goods required to be included in the Part of the Register for registered goods)
7.1 Item 3, paragraph (g):
After “devices” (first occurring), insert “that are, or that have components,”.
8. Schedule 1 (Part 2 does not apply to members of an Australian Branch of one of these bodies)
8.1 Add at the end:
“23 Society of Chinese Medicine and Acupuncture (Vic) Inc.
24 Naturopathic Practitioners Association Inc.”.
9. Schedule 4 (Therapeutic goods required to be included in the Part of the Register for listed goods)
9.1 Add at the end of Part 1:
“11 kits (to be known as ‘device kits’) consisting:
(a) solely of therapeutic devices; or
(b) partly of therapeutic devices and partly of drugs
12 kits (to be known as ‘drug kits’) consisting solely of drugs”.
9.2 Item 3 in Part 1:
After paragraph (d), insert:
“and (e) the herbal substance is present in therapeutic goods included in the Register for supply in Australia;”.
10. Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)
10.1 Item 7, paragraphs (a) to (l) (inclusive):
Add “or” at the end of each paragraph.
10.2 Item 7, paragraph (a):
Omit “component;”, substitute:
“component, other than:
(i) components for artificial limbs; or
(ii) programmers for implantable electronic devices; or
(iii) components of implantable devices that are assembled in the body;”.
10.3 Item 7, subparagraph (b) (v):
Omit the subparagraph.
10.4 Item 7, paragraph (d):
After “supplied”, insert “in whole or in part”.
10.5 Item 7, paragraph (e):
After “used”, insert “in diagnosis or”.
10.6 Item 7, subparagraph (j) (ii):
Omit the subparagraph, substitute:
“(j) surgeon’s gloves, patient examination gloves and other protective gloves for the prevention of contact with blood, other body fluids or body tissue”.
10.7 Item 7, subparagraph (j) (iii):
After “radiation”, insert “shields and radiation”.
10.8 Item 7, paragraph (k):
Add at the end “except telemetry equipment and other patient monitoring equipment that directly monitors a physiological process”.
10.9 Item 7, paragraph (l):
Omit “than syringes”, substitute:
“than:
(i) syringes; or
(ii) bags designed to contain blood or blood components; or
(iii) patient drainage bags; or
(iv) parental solution administration bags;”.
10.10 Item 7:
Add at the end:
“; and
(n) non-sterile, non-powered therapeutic devices that are medicine measures, droppers or non-absorbent applicators, medicine spoons;
(o) non-powered orthoses or splints that do not exert traction;
(p) non-powered hot or cold packs”.
10.11 Item 8, paragraph (f):
Add at the end “other than disinfectants for use with contact lenses”.
11. Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions)
11.1 Item 1, Column 2, paragraph (a)
Omit “regis-tration”, substitute “registration”.
11.2 Item 2, paragraph (a):
Omit “Labora-tories”, substitute “Laboratories”.
11.3 Item 3, paragraph (a):
Omit “he or she”, substitute “the sponsor”.
12. Schedule 6 (Therapeutic devices prescribed for the purposes of paragraph 26 (1) (g) of the Act)
12.1 Item 3, paragraph (c):
Omit the paragraph, substitute:
“(c) bandages, dressings, adhesive tapes and similar products (other than casting materials), required to be sterile and to be supplied in accordance with criteria prescribed under paragraph 26 (1) (k) of the Act; or”.
13. Schedule 7 (Therapeutic goods exempt from the operation of Part 4 of the Act unless supplied as pharmaceutical benefits)
13.1 Add at the end:
“17 bulk, liquified medical gases
18 human blood and components prepared by a blood donation centre from human blood, other than plasma for supply by a manufacturer to another manufacturer for the manufacture of blood components”.
14. Schedule 8 (Persons exempt from the operation of Part 4 of the Act)
14.1 Item 6:
Omit the item.
15. Schedule 9 (Fees)
15.1 Add at the end:
“15 fee, including deposit, for an The amount, including a
application under subsection deposit, that would be
61 (6) of the Act payable under the Freedom of Information
Act 1982 and the
Freedom of Information
(Fees and Charges)
Regulations for a request if the application
were a request under section 15 of that Act”.
16. Schedule 10
16. Add at the end:
“14 injectable drug dosage forms
15 blood products, unless coated on a therapeutic device”.
17. New Schedule 11
17.1 After Schedule 10, add:
SCHEDULE 11 Subregulation 16 (2)
CRITERIA PRESCRIBED UNDER PARAGRAPH 26 (1) (k) OF THE ACT
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PART 1
Column 1 Column 2
Item Kind of goods
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1 Primary dressings, for wounds, burns or broken skin, that are:
(a) plain dressings; or
(b) adhesive dressings; or
(c) “combine” dressings; or
(d) impregnated dressings; or
(e) gauzes; or
(f) wound closures
SCHEDULE 11—continued
other than dressings that are:
(g) adhesive dressing strips, or combine dressings, supplied in bulk length for multiple use; or
(h) plain gauze or other absorbent dressing pieces that are supplied in bulk packs not individually wrapped
2 Surgical absorbents, for use in surgical procedures or for introduction into body cavities to absorb blood or secretions, that are:
(a) gauzes; or
(b) sponges; or
(c) swabs; or
(d) x-ray detectable gauzes; or
(e) x-ray detectable sponges
3 Goods supplied as sterile, and labelled “sterile”, that are:
(a) absorbents; or
(b) adhesive tapes
(c) bandages; or
(d) dressings; or
(e) gauzes; or
(f) stockinets; or
(g) undercast padding
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PART 2
Column 1 Column 2
Item Criteria
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1 Unless item 2 applies—the goods must be sterile
2 In the case of non-sterile goods supplied in bulk otherwise than to consumers—the goods must comply with quality and safety criteria approved by the Secretary for the purposes of this item
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NOTES
1. Notified in the Commonwealth of Australia Gazette on 14 April 1992.
2. Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 No. 19.