EXPLANATORY STATEMENT
SUBJECT - THERAPEUTIC GOODS (CHARGES) ACT 1989
THERAPEUTIC GOODS (CHARGES) REGULATIONS 1990 No. 89
ISSUED ON THE AUTHORITY OF THE MINISTER FOR COMMUNITY SERVICES & HEALTH
The Therapeutic Goods (Charges) Act 1989 (the Act) commences on 1 July 1990.
Section 5 of the Act provides that the Governor-General may make Regulations which are not inconsistent with the Act. The Regulations may prescribe charges relating to functions implemented by the Therapeutic Goods Act 1989.
Regulation 1 of the Regulations provides that these Regulations may be cited as the Therapeutic Goods (Charges) Regulations.
Regulation 3 prescribes annual charges for the registration or listing of goods in the Australian Register of Therapeutic Goods and the annual charges for a licence to manufacture therapeutic goods. The establishment of the Register and the licensing of manufacturers are matters dealt with in the Therapeutic Goods Act 1989.
Regulation 4 exempts from the annual registration and listing charges, goods of low volume and low value.
Regulation 5 provides for the payment of the annual charge if the exemption under Regulation 4 proves to be inappropriate.
Regulation 9 allows the Secretary to permit the label or information included in certain therapeutic goods to contain proscribed representations, if this is necessary for the appropriate use of the goods. For example, this allows the labelling of salbutamol nasal spray, which is available without a prescription, to indicate its use for the relief of the symptoms of asthma, an otherwise prohibited representation in public advertising.
Chapter 2 of the Regulations underpins self regulation of public advertising by the Therapeutic Goods Industry.
Chapter 3 of the Regulations prescribes the therapeutic goods or the classes of therapeutic goods for use in humans which are required to be included in the Australian Register of Therapeutic Goods as registered goods or listed goods under Part 3 of the Act, or which are exempted from the requirement to be registered or listed (regulations 10, 11 and 12).
Schedule 2 under Regulation 10 specifies the goods which are required to be registered. In general, drugs require registration unless listed or exempt.
Schedule 3 under Regulation 11 specifies the goods which are required to be listed. In general, therapeutic devices are required to be listed, unless registered or exempt.
Schedule 4 under Regulation 12 specifies the goods which are exempt from the operation of Part 3 of the Act.
Regulation 13 deals with the transfer of goods which are registered or listed, upon the death of the person responsible for the goods or the bankruptcy, winding up or disposal of the business of the sponsor of the goods.
Regulation 14 deals with the procedure and other requirements for transferring goods from one part of the Register to the other part. This occurs, for example, if listed goods become subject to a schedule of the Poisons standard and consequently become registrable. The regulation allows the sponsor of the goods sufficient time to provide evidence of the suitability of the goods for registration.
Regulation 15 prescribes the manner in which the registration number or the listing number, which is assigned under Section 27 of the Act, appears on the label or the packaging of therapeutic goods. This provision enables people in the supply chain, including consumers, to know that the goods are registered or listed.
Schedule 5 under Regulation 16 specifies those therapeutic devices which, if they are manufactured overseas, require the Secretary to consider the standard of their manufacture in deciding upon an application for listing. If these goods were manufactured in Australia they would be subject to the requirement to be manufactured by a licensed manufacturer.
Chapter 4 of the Regulations deals with the licensing of manufacturers.
Regulation 17 exempts therapeutic goods or classes of therapeutic goods for use in humans from the requirement to be manufactured by a licensed manufacturer. The goods are specified in Schedule 6 to the Regulation.
Regulation 18 exempts certain persons, such as trained persons dispensing therapeutic goods, from the requirement to be licensed to manufacture therapeutic goods for use in humans. The classes of persons are specified in Schedule 7 to the Regulations.
Regulations 19,20 and 21 contain requirements for licence holders and prescribe conditions upon which manufacturing licences are issued. The conditions include maintaining prescribed records of manufacture, publicly displaying the licence and notifying the Secretary of changes of key personnel involved in manufacture.
Regulation 22 deals with the transfer of the licence upon the death of the licence holder or the bankruptcy, winding up or disposal of the holder’s business. The Secretary must agree to the transfer of the licence.
Chapter 5 of the Regulations permits official samples of therapeutic goods to be taken by officers authorised by the Secretary and for the samples to be examined, tested and analysed by official analysts. The official analysts are appointed by the Secretary to investigate compliance of the goods with standards and other requirements which are established under the Act.
Regulations 23, 24 and 25 deal with, respectively, the interpretation of terms used in the Chapter, the powers and duties of officers authorised to take samples and the appointment of official analysts.
Regulation 26 prescribes the method by which official samples are taken by an authorised officer and forwarded to the official analyst so as to ensure the integrity of the sample.
Regulation 27 to 29 prescribe the procedures to be followed by an official analyst. Regulation 27 prescribes the responsibilities of the official analyst, Regulation 28 prescribes relevant tests to determine that goods are of a particular standard and Regulation 29 prescribes the procedure for reporting the findings of the official analyst.
Regulation 30 prescribes the procedure and other requirements to review the findings of an official analyst, if the findings are disputed by a person who is notified of the findings of the official analyst.
Regulation 31 prescribes the payment by the Commonwealth for official samples taken by an authorised officer.
Regulation 32 states the requirements for a person to assist and provide information to an authorised officer or an official analyst and establishes a penalty for an offence under the Regulation.
Regulation 33 requires the Secretary to issue an identity card to each authorised officer and states the responsibilities of the card holder.
Chapter 6 of the Regulations deals with the establishment of Committees created under the Act.
Regulation 34 establishes the Therapeutic Goods Committee which advises the Minister primarily on standards for the quality for goods, requirements for labelling and packaging and standards to be observed by manufacturers.
Regulation 35 establishes the Therapeutic Device Evaluation Committee which makes medical and scientific evaluations primarily of therapeutic devices and provides advice to the Minister or to the Secretary.
Regulation 36 establishes the Australian Drug Evaluation Committee which makes medical and scientific evaluations primarily of drugs and provides advice to the Minister or to the Secretary.
Regulation 37 allows the Minister or the Secretary to refer matters between committees established under Chapter 6.
Regulations 38 to 42 deals with matters relating to the administration of the Committees including tenure of office of members, responsibilities and procedures for disclosure of interests, filling vacancies and other committee rules.
Chapter 7 of the Regulations specifies the fees established under the Act. The scale of the fees is determined following advice to the Minister by an Industry-Government consultative committee which meets periodically to discuss the structure of the fees.
The fees primarily apply to applications for registration or listing of goods and for manufacturer’s licences, for the evaluation of goods for registration and experimental use in humans and for the inspection of manufacturers.
The fees are presented in Schedule 8 of Regulation 43.
Regulation 44 permits the recovery of costs where an analysis of goods has been requested, rather than instigated by the Secretary under Chapter 5.
Regulation 45 defines situations in which the Secretary may waive or reduce the fees.
Chapter 8 of the Regulations deals with a number of miscellaneous items.
Regulation 46 prescribes the information on therapeutic goods included in the Register which may be released to a person upon the request of the person.
Regulation 47 provides for the delegation of the Secretary’s powers and functions under the Regulations.
Regulation 48 provides for an appellant to request a review of a decision by the Minister and if the appellant is dissatisfied with the reviewable decision, then to request a review of that decision by the Administrative Appeals Tribunal.