Therapeutic Goods Act 1989

Therapeutic Goods Order Number 54B

AMENDMENT TO THE STANDARD FOR DISINFECTANTS AND STERILANTS (TGO 54)

I, Clive Morris, delegate of the Minister for Health and Aged Care, for the purposes of the exercise of the Minister’s powers under section 10 of the Therapeutic Goods Act 1989 and acting under subsection 10(1), hereby DETERMINE that the matters specified in this Order shall constitute an amendment to the Therapeutic Goods Order No. 54, the Standard for Composition, Packaging, Labelling and Performance of Disinfectants and Sterilants.

Therapeutic Goods Order No. 54 is amended as follows:

Clause 5 – Standards for Packaging and Labelling of Disinfectants and Sterilants

(a)          Delete from the heading “Clause 5” and replace with “Clause 4”.

(b)          Delete from paragraph 5(4)(a) “subparagraphs 5(5)(a)(i), (ii) and (iii)” and replace with “subparagraphs 4(4)(a)(i), (ii) and (iii)”.

(c)          Delete from paragraph 5(4)(e) “the Upper Case (Capital) letter B surrounded by a circle” and replace with “             .”

(d)          Delete from subparagraph 5(4)(h)(ii) “subclauses 5(8) and 5(9)” and replace with “subclauses 4(7) and 4(8)”

(e)          Delete from subparagraph 5(4)(h)(iii) “subclause 5(10)” and replace with “subclause 4(9)”.

(f)           Delete from subclauses 5(5) and 5(6) “paragraphs 5(5)(h) and (i)” and replace with “subparagraphs 4(4)(h)(i)”.

(g)          Delete from subclause 5(7) “paragraphs 5(5)(h) and (ii)” and replace with “subparagraphs 4(4)(h)(ii)”.

(h)          Delete from subclause 5(8) “Paragraphs 5(5)(h)(ii) and (iii)” and replace with “Subparagraphs 4(4)(h)(ii) and (iii)”.

(i)            Delete from subclauses 5(9) and (10) “paragraphs 5(5)(h)(iii)’ and replace with “subparagraph 4(4)(h)(iii)”.

(j)            Delete from subclause 5(11) “paragraphs 5(5)(a)” and replace with “paragraphs 4(4)(a)”.

(k)          Delete from subclause 5(12) “subclause 5(5)” and replace with “subclause 4(4)”.

(l)            Add after subclause 4(12):

“(13) Despite subclause 4(12) the batch and expiry particulars required by paragraphs 4(4)(e) and 4(4)(f) may be embossed on a label attached to or appearing on the container or any primary pack containing a disinfectant or sterilant.”

(m)        Delete from subclause 5(13) “(13)” and replace with “(14)”.

(n)          Delete from subclause 5(13) “subclause 5(5)” and replace with “paragraph 4(4)(a)”.

(o)          Delete subclause 5(14).

Commencement Dates

This Order shall commence to operate from the date it is gazetted in the Commonwealth Gazette.

Dated this 23RD    day of September 1999.

Clive Morris A/G

Delegate of the Minister for Health and Aged Care