Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1997No. 398 1

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Therapeutic Goods Regulations2(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 18 December 1997.

 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.   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 2 (Interpretation)

2.1   Definition of “active implantable therapeutic device”:

Omit the definition, substitute:

“‘active implantable therapeutic device’:

• (a)

  means an active therapeutic device designed for implantation, totally or partially, into the human body:

  • (i)

    surgically; or

  • (ii)

    by other medical intervention, into a natural orifice; and

• (b)

  includes an accessory designed for use with the device;”.

2.2   Definition of “diagnostic goods for in vitro use”:

Omit the definition, substitute:

“‘diagnostic goods for in vitro use’ means any therapeutic device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination (with other diagnostic goods for in vitro use), intended by the manufacturer to be used in vitro for the examination of specimens (including blood and tissue donations) derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state or a congenital abnormality or to determine safety and compatibility with a potential recipient;”.

3.   Regulation 15 (Application of registration or listing number to goods)

3.1   Subregulation (1):

Omit “paragraph 20 (2) (d)”, substitute “paragraph 20 (2) (a)”.

4.   Regulation 45 (Waiver or reduction of fees)

4.1   After subparagraph 45 (4A) (c) (ii), insert:

• “or (iii)

  software;”.

4.2   Paragraph 45 (9) (c):

Omit “either or both”, substitute “1 or more”.

4.3   After subparagraph 45 (9) (c) (ii), insert:

• “(iii)

  software;”.

4.4   Paragraph 45 (11) (c):

Omit “either or both”, substitute “1 or more”.

4.5   After subparagraph 45 (11) (c) (ii), insert:

• “(iii)

  software;”.

5.   Schedule 1 (Part 2 does not apply to members of an Australian branch of one of these bodies)

5.1   After item 17A, insert:

“17B International Christian Association of Natural Therapists Ltd (ICANT)”.

6.   Schedule 2 (Prohibited and required representations for the purposes of paragraphs 6 (1) (a) and (b))

6.1   Part 2, Item 1:

After “vitamin preparations” in column 3, insert “for oral ingestion”.

7.   Schedule 3 (Therapeutic goods required to be included in the part of the Register for Registered Goods)

7.1   Part 2, Item 1:

Omit the item.

7.2   Part 2, Item 5:

Omit “that are claimed to be sterilants,”, substitute “and sterilants claimed to be”.

7.3   Part 2, Item 5:

Omit “virucides”, substitute “virucides,”.

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

8.1   Item 2, paragraph (b):

After “4,” insert “5,”.

8.2   Item 7, paragraph (a):

Omit “2604:1993,”, substitute “2604:1997,”.

9.   Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)

9.1   Item 7, subparagraph (b) (iv):

Omit the subparagraph.

9.2   Item 7, paragraph (e):

Omit all the words after “therapeutic goods”, substitute:

 “except:

• (i)

  equipment specifically designed to process a patient’s blood or other tissues for re-introduction to the patient; or

• (ii)

  a bench top or portable steriliser, not permanently connected to plumbing or electrical wiring, used to sterilise medical or dental instruments; or”.

9.3   Item 8, subparagraph (g) (i):

Omit “2604:1993,”, substitute “2604:1997,”.

10.   Schedule 6 (Therapeutic devices prescribed for the purposes of paragraph 26 (1) (g) of the Act)

10.1   Item 3, subparagraphs (f) (iii) and (iv):

Omit the subparagraphs.

10.2   Item 5:

Omit the item.

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

11.1   Item 4, subparagraphs (g) (iii) and (iv):

Omit the subparagraphs.

11.2   Item 13:

Omit the item, substitute:

“13 disinfectants, except instrument grade disinfectants, that are represented to be sterilants, fungicides, sporicides, tuberculocides or virucides when used as recommended by the manufacturers on a critical medical device or a semi-critical medical device”.

11.3   Items 20, 21 and 22:

Omit the items.

12.   Schedule 8 (Persons exempt from the operation of Part 4 of the Act)

12.1   Add at the end:

“6 a person who re-labels a product to comply with the labelling requirements of the Standard for the Uniform Scheduling of Drugs and Poisons (commonly known as ‘the Poisons Standard’) the application of the new label”.

13.   Schedule 9 (Fees)

13.1   Item 2:

Add at the end:

“(h) if: (i) a person submits at the same time more than 1 application for a therapeutic device of a kind mentioned in Part 2 of Schedule 3; and (ii) the information in support of the application for each device is sufficiently common to enable simultaneous evaluation of each of the devices;
for each additional application		200”.

13.2   Item 6:

After paragraph (c), insert:

“(ca) software; 5,600”.

13.3   After item 6AB, insert:

“6AC	evaluation fee: (a) for confirmatory evaluation of overseas reports or data for an application to register a therapeutic device under section 25 of the Act; and	2,465.00
(b) if a person submits more than 1 application at the same time and the overseas reports or data in support of the application for each device are sufficiently common to enable simultaneous evaluation of the devices—for each application additional to the application mentioned in paragraph (a)	1,070.00”.

13.4   Item 7:

After paragraph (c), insert:

“(ca) software; 2,800”.

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 24 December 1997.

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 in the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 No. 162.