Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (CHARGES) REGULATIONS (AMENDMENT) 1994 NO. 149

STATUTORY RULES 1994 No. 149

Issued by authority of the Minister for Family Services

Therapeutic Goods (Charges) Act 1989

Therapeutic Goods (Charges) Regulations (Amendment)

The Therapeutic Goods (Charges) Act 1989 imposes an annual charge on the registration and listing of therapeutic goods and on the licensing of manufacturers of therapeutic goods.

Sections 4 and 5 of the Act enable the Governor-General to make regulations prescribing the amounts of charges. This includes

Paragraph 4(1A)

•       prescribing the annual registration or listing charge payable for the registration or listing of therapeutic goods grouped under the one registration or listing number, which is in force at any time during a financial year;

Paragraph 4(2)

•       prescribing the annual licensing charge payable in respect of a licence which is in force at any time during a financial year.

The regulations are as follows:

Subregulation 2.1 inserts a new Subregulation 3(1A) prescribing the annual charge for the registration or listing of therapeutic goods grouped under the one registration or listing number ('grouped therapeutic goods'), which is in force at any time during a financial year. This has the effect of making the charges for grouped therapeutic goods the same as the charges now payable in respect of other registrations and listings of equivalent classes of goods.

Subregulation 3.1 inserts new regulation 4A which provides that no annual charge for a licence applies to a non-profit hospital supply unit. This is in line with subsection 59(3) of the Therapeutic Goods Act 1989 which provides that no licence or inspection fees are to apply to such units.

The regulations commence on Gazettal.