Therapeutic Goods (Charges) Regulations (Amendment) (Cth)

Statutory Rules 1994

No. 223 1

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Therapeutic Goods (Charges) 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 30 June 1994.

 BILL HAYDEN

 Governor-General

By His Excellency’s Command,

ROSEMARY CROWLEY

Minister for Family Services

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1.   Commencement

1.1   These Regulations commence on 1 July 1994.

2.   Amendment

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

3.   Regulation 3 (Annual charges)

3.1   Subparagraph 3 (1) (a) (i):

Omit “$400; or”, substitute “$440; or”.

3.2   Subparagraph 3 (1) (a) (ii):

Omit “$210;”, substitute “$250; and”.

3.3   Paragraph 3 (1) (b):

Omit “$90.”, substitute “$110.”.

3.4   Subparagraph 3 (1A) (a) (i):

Omit “$400;”, substitute “$440;”.

3.5   Subparagraph 3 (1A) (a) (ii):

Omit “$210;”, substitute “$250;”.

3.6   Paragraph 3 (1A) (b):

Omit “$90.”, substitute “$110.”.

3.7   Subregulation 3 (2):

Omit the subregulation, substitute:

“(2)

For the purposes of subsection 4 (2) of the Act, the annual charge for a licence that is in force at any time during a financial year is as follows:

• (a)

  a licence for the manufacture of sterile or non-sterile therapeutic goods—$3,800;

• (b)

  a licence for the manufacture of containers in which therapeutic goods are to be packed—$3,800;

• (c)

  a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods—$1,900;

• (d)

  a licence for a single step in the manufacture of therapeutic goods—$1,900;

• (e)

  a licence for the manufacture of a sterile or non-sterile single drug—$1,900;

• (f)

  a licence for the manufacture of a sterile or non-sterile single type of therapeutic device—$1,900;

• (g)

  a licence for the manufacture of sterile or non-sterile diagnostic goods for in vitro use—$1,900;

• (h)

  a licence for the manufacture of herbal or homoeopathic preparations that are not included in a Schedule to the Poisons Standard (other than Schedule 5 or 6)—$1,600.”.

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 June 1994.

2. Statutory Rules 1990 No. 89 as amended by 1990 No. 395; 1991 Nos. 88 and 430; 1993 No. 140; 1994 No. 149.