Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1994

No. 364 1

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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 25 October 1994.

 BILL HAYDEN

 Governor-General

By His Excellency’s Command,

A. THEOPHANOUS

Parliamentary Secretary to the Minister

for Human Services and Health for the

Minister for 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   Insert the following definition:

“ ‘quarter’ means a period of 3 months commencing on 1 January, 1 April, 1 July or 1 October in a year;”.

3.   Regulation 9A (Information about certain therapeutic goods to be supplied)

3.1   Subregulation 9A (1):

Omit the subregulation, substitute:

“(1)

The sponsor of therapeutic goods that are:

• (a)

  specified in Schedule 10; and

• (b)

  approved for registration on or after 1 January 1993;

must not supply the goods unless the sponsor supplies with the goods written information about the goods that meets the requirements for a patient information document set out in Schedule 12.

Penalty:  $1,000.”.

4.   Regulation 29 (Certificate of official analyst)

4.1   Subregulation 29 (1):

Omit “, a certificate signed by him or her”, substitute “a certificate signed by the analyst”.

4.2   Subregulation 29 (2):

Omit “him or her,”, substitute “the analyst,”.

5.   Regulation 45 (Waiver or reduction of fees)

5.1   Subparagraph 45 (5) (f) (ii):

Omit “3”, substitute “2”.

5.2   Subregulations 45 (6) and (7):

Omit the subregulations, substitute:

“(6)

If there are no more than 2 applications for evaluation in addition to the principal application, the evaluation fees set out in item 4 of Schedule 9 for each application other than the principal application are reduced to zero.

“(7)

Where subregulation (6) does not apply, those fees for the applications for evaluation (other than the principal application) are reduced to a total of:

• (a)

  for 3 applications—$2,000; or

• (b)

  for 4 applications—$3,500; or

• (c)

  for 5 applications—$4,500; or

• (d)

  for 6 applications—$5,000; or

• (e)

  for more than 6 applications—the amount of:

  • (i)

    $5,000; and

  • (ii)

    $500 for each application in excess of 6.”.

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

6.1   Item 8:

Omit the item.

6.2   After item 9A, insert:

“9B Australian Federation of Homoeopaths (WA) Inc.”.

6.3   After item 17, insert:

“17A International Association of Trichologists”.

6.4   After item 26, insert:

“26A The Alumni Association of Natural Medicine Practitioners Inc.”.

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

7.1   Part 1, paragraph 3 (a):

Omit “Schedule 4.”, substitute “Schedule 4; or”.

8.   Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions)

8.1   Add at the end:

“5

Therapeutic goods, other than goods referred to in item 3, that are: (a) manufactured by a person: (i) under a contract between the person and a private hospital; and (ii) in accordance with a formulation specified by the private hospital; and (iii) for use by, or in connection with, a patient of the private hospital; or (b) manufactured by a person: (i) under a contract between the person and a public hospital in a State or Territory; and (ii) in accordance with a formulation specified by the public hospital; and (iii) for use by, or in connection with, a patient of a public hospital in the same State or Territory; or

(a) there are no listed goods or registered goods that, in all relevant respects, are substantially similar to the goods; and (b) the person: (i) manufactures the goods at premises in Australia; and (ii) holds a licence, required by the Act, that  authorises the manufacture, or a step in the manufacture, of the goods at those premises; and (c) the person notifies the Secretary, in accordance with a form approved by the Secretary and within 15 days of the end of a quarter, of:

(c) manufactured by a person: (i) under a contract between the person and a public institution; and (ii) in accordance with a formulation specified by the public institution; and (iii) for use by, or in connection with, a patient of the public institution

(i) the goods manufactured under the contract during that quarter; and (ii) the private hospital, public hospital or public institution that entered the contract”.

9.   Schedule 9 (Fees)

9.1   Item 14A:

Omit “conduct”, substitute “sponsor”.

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 1 November 1994.

2. Statutory Rules 1990 No. 88 as amended by 1990 No. 394; 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150 and 222.