Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (CHARGES) AMENDMENT REGULATIONS 2000 (NO. 1) 2000 NO. 71

EXPLANATORY STATEMENT

STATUTORY RULES 2000 No. 71

Issued by authority of the Parliamentary Secretary to the Minister for Health and Aged Care

Therapeutic Goods (Charges) Act 1989

Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 1)

The object of the Therapeutic Goods Act 1989 is to establish and maintain a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or are exported from Australia. Under that Act therapeutic goods, unless they have been exempted from this requirement, are required to be registered or listed in the Australian Register of Therapeutic Goods (the Register) before they may be manufactured, supplied, imported or exported for use in humans.

Section 3 of the Therapeutic Goods (Charges) Act 1989 (the Act) states that the Therapeutic Goods Act 1989 is incorporated, and is to be read as one, with the Act.

Subsection 4(1) of the Act provides that annual charges as are prescribed are payable for maintaining registration and listings of therapeutic goods in the Register. Subsection 4(1A) of the Act provides that where more than one therapeutic good is "grouped" and each of the "grouped" therapeutic goods is covered by the same registration or listing number, then an annual charge as prescribed will apply for maintaining all the registered or listed therapeutic goods covered under the same grouping. A single annual charge has been prescribed for this purpose.

Section 5 of the Act enables the Governor-General to prescribe the level of charges that are payable for maintaining goods in the Register or for maintaining grouped therapeutic goods in the Register.

The regulations increase the annual charges that are payable, in order to meet the government's requirement that the Therapeutic Goods Administration operate on a full costrecovery basis. Industry has been extensively consulted on the increases, which are linked to the recovery of operating costs.

Details of the amending Regulations are set out in the Attachment.

The Regulations commence on 1 July 2000.

ATTACHMENT

Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 1)

Regulation 1 states that the title of these regulations is the Therapeutic Goods (Charges) Amendment Regulations 2000 (No. 1).

Regulation 2 provides that these regulations commence on 1 July 2000.

Regulation 3 provides that these regulations amend the Therapeutic Goods (Charges) Regulations 1990 as provided in Schedule 1.

SCHEDULE 1 - AMENDMENTS

Item 1 replaces the definition for "Poisons Standard" to align it with the definition for "current Poisons Standard" set out in the Therapeutic Goods Act 1989.

Item 2 increases the annual charges for maintaining registrations of drugs that are principally prescription only medicines, or controlled drugs, from $750 to $950. Controlled drugs are those listed in Schedule 8 of the Poisons Standard, being drugs that attract restrictions on their manufacture, supply, distribution, possession and use in order to reduce abuse, misuse and physical or psychological dependence. Examples of controlled drugs include cocaine, methadone, pethidine and morphine.

Item 3 increases the annual charges for maintaining registrable medicines, other than prescription only medicines or controlled drugs, from $455 to $465.

Item 4 increases the annual charges for maintaining listings of listable medicines from $270 to $350.

Item 5 increases the annual charges for maintaining registrations of medicines (being mainly prescription only medicines or controlled drugs) that have been grouped, pursuant to section 16 of the Therapeutic Goods Act 1989, from $750 to $950. The effect of "grouping" is to enable the sponsor of each of the goods covered by a "grouping" to use the same registration number for all grouped goods, and to pay only one annual charge for all goods grouped. But for "grouping" pursuant to section 16 of the Therapeutic Goods Act 1989, the- sponsor would be required to use different registration numbers for each product being supplied, and to pay a separate annual charge for each product included in the Register.

Item 6 increases the annual charges for maintaining registrations of grouped registered medicines, other than grouped prescription only medicines or grouped controlled drugs, from $455 to $465.

Item 7 increases the annual charges for maintaining listings of grouped listable medicines, from $270 to $350.


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