Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (CHARGES) REGULATIONS (AMENDMENT) 1992 NO. 88

EXPLANATORY STATEMENT

STATUTORY RULES 1992 No. 88

Issued by authority of the Minister for Aged, Family and Health Services

Therapeutic Goods (Charges) Act 1989

Therapeutic Goods (Charges) Regulations (Amendment)

The Therapeutic Goods (charges) Act 1989 imposes an annual charge for the registration and listing of therapeutic goods in the Australian Register of Therapeutic Goods, and an annual charge for licences to manufacture therapeutic goods.

Section 5 of that Act empowers the Governor-General to make regulations prescribing the amounts of those charges.

Background

The amending Regulations:

(a)       amend the Therapeutic Goods (Charges) Regulations to correct an anomaly in the annual amount being charged for manufacturers, licences covering the manufacture of single therapeutic goods, and

(b)       substitute the words "device" and "feel" with terminology that is more appropriate for the Regulations.

Regulation 2 amends subparagraph 3(2)(b)(iii) of the Charges Regulations to remove the present anomaly whereby an annual licence charge of $1500 is payable for the manufacture of a single sterile product, whereas a charge of $3000 applies for the manufacture of a single non-sterile product. The effect of the amendment will be that the same annual charge of $1500 will be payable by a manufacturer for a licence to manufacture a single therapeutic product, whether or not that product is sterile. Also, the reference to "device" in subparagraph 3(2)(b)(iii) has been amended to correctly refer to "therapeutic device", which is defined in the Therapeutic Goods Act 1989.

Regulation 3 substitutes the word "fee" in paragraphs 4(2)(a) and (b) with the word "charge", in line with the correct terminology used in the Regulations.


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