Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1996 NO. 9

STATUTORY RULES 1996 No. 9

Issued by Authority of the Minister for Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

Sections 17, 18, and 63 of the Act enables the Governor-General to make regulations prescribing matters necessary or convenient to be prescribed for carrying out or giving effect to the Act. These include:

Paragraph 17(4) (a) and Sub-section 18(1)

*       prescribing the classes of therapeutic goods which are to be included in the Australian Register of Therapeutic Goods (the Register) either as registered goods or listed goods, and exempting certain goods from the requirement to be included in the Register;

Paragraph 63(2)(c)

*       prescribing requirements for the advertising of therapeutic goods.

A number of amendments have become necessary to clarify the operation of some of the existing provisions in the Regulations, to address a shortage of a critical drug (Anti-D Immunoglobulin) required for supply in Australia, or to restrict the advertisement of therapeutic goods that have not been approved for supply to the general public. A more detailed description of the nature of and reasons for these changes is set out in the Attachment.

The regulations will:

(a)       extend the period of exemption during which Anti-D Immunoglobulin RhaGAM may be imported into Australia and supplied here without the requirement for those goods to be included in the Register (Regulation 3);

(b)       adopt the recommendation of the Medicines Evaluation Committee that therapeutic goods containing ferrous lactate as its therapeutically active ingredient qualify for listing (rather than registration) in the Register (Regulation 4.2);

(c)       correct an anomaly in the description for one of the classes of goods exempted from the requirement to be included in the Register (Regulation 4.1);

(d)       remove the item exempting Japanese Encephalitis Vaccine from the requirement to be included in the Register. This product has now been included in the Register, so the exemption is obsolete (Regulation 6);

(e)       clarify the description of an item of exemption in Schedule 5 to enable samples of therapeutic goods to be manufactured, imported, exported and supplied without the need for registration or listing where the goods are not for commercial supply and are not used in clinical trials (Regulation 5.1);

(f)       adopt the recommendation of the National Co-ordinating Committee on Therapeutic Goods to exempt Radiopharmaceutical Cold Kits from the need to be included in the Register (Regulation 5.2); and

(g)       establish an offence to advertise unapproved goods that may only be be obtained by individuals for restricted use under the "Personal Imports Scheme" (Regulation 2).

Further details of the amendments are set out in the Attachment.

The Regulations commence on the date of Gazettal.

ATTACHMENT

Regulation 1 provides that the Therapeutic Goods Regulations are to be amended as set out in the amending Regulations.

Regulation 2 introduces a new advertising offence to assist in preventing abuse of the of the Personal Importation Scheme.

Under the Therapeutic Goods Act 1989 (the Act), subject to certain exemptions, therapeutic goods must be included in the Australian Register of Therapeutic Goods ("the Register") before they may be imported into, exported from, manufactured or supplied in Australia. The goods are required to be included in the Register either as "registered goods" or "listed goods". Registrable goods are goods that require a higher level of scrutiny before marketing approval is granted for their supply to the general community. Examples of registrable goods include prescription drugs and certain implantable devices. Listable goods require less rigorous assessment before being released for general marketing. Such goods include many over-the-counter drugs, vitamins and most medical devices.

Under the Personal Import Scheme, individuals are permitted to import, for their own use or for the use of their immediate family, up to three months supply of unapproved therapeutic goods (goods that have not been included in the Register), providing these goods are not prohibited imports and are not injectables containing material of human or animal origin. Products imported in this way cannot be sold.

Investigations have discovered that abuses of the personal imports scheme are occurring. One form of abuse occurs when large seminars around Australia are hosted where potential distributors are advised that although unapproved products cannot be marketed in Australia, customers can order them direct under the personal importation scheme from overseas sources based in, for example, New Zealand. To prevent this abuse of the personal import scheme, it is necessary to create an offence for advertising unapproved products. Accordingly, the proposed amendment would prohibit any advertising of therapeutic goods that are imported under the Personal Import Scheme.

Regulation 3 extends the current period of exemption to allow for the importation and supply in Australia of Anti-D Immunoglobulin that has not been included in the Register

The current exemption was inserted to enable CSL Limited to immediately import the product into Australia for a period of one year, without the need for them to register or list the imported product, a process that could take over a year. This action was to overcome an acute shortage of the product expected to be overcome by the end of February 1996.

However, this date is premature. The acute shortage of the product is not expected to diminish until around 31 August 1996.

Regulation 4 makes two changes to Schedule 4 of the Regulations. This Schedule contains a list of therapeutic goods required to be included in the part of the Register for listed goods.

Regulation 4.1 clarifies that preparations containing as their therapeutically active ingredients only vitamins, minerals, herbal substances etc. are to be listed in the Register when they fulfil certain criteria. The criterion set out under paragraph 3(a) should in fact be 2 separate criteria. At present, the paragraph states the criterion to be that "the preparation is not included in a Schedule to the Poisons Standard, or is not of a kind required to be sterile". Upon review, it is considered that both conditions under that paragraph should apply, and should not be read as alternative conditions. The proposed amendment will make this clear.

Regulation 4.2 inserts an additional item - products containing ferrous lactate as an active ingredient - in the list of goods that may be included in the Register as listable goods.

Following consideration of a submission from a pharmaceutical company, the Medicines Evaluation Committee has recommended that such goods should be eligible for "listing" in the Register instead of the present requirement for "registration" which attracts a more intensive product evaluation and higher costs to the product sponsor. Ferrous lactate is a source of mineral iron and is used similarly to a number of other iron salts which when included as an ingredient of therapeutic goods are already accepted as "listable" products.

The Medicines Evaluation Committee is an expert committee engaged under the terms of a Commonwealth - State arrangement to advise the Therapeutic Goods Administration on the regulation of non-prescription drug products.

Regulation 5 makes two changes to Schedule 5 of the Regulations. This Schedule contains a list of goods that are exempted from the requirement to be included in the Register before they may be marketed.

Regulation 5.1 corrects an anomaly. At present an exemption applies to therapeutic goods supplied in Australia solely for analysis or testing purposes. This exemption enables industry to engage in product development and the like before applications to market are lodged. The proposed amendment would overcome the anomaly that it is lawful to supply the sample for the specified reasons, however unlawful to import, manufacture or export the sample. Unless this amendment is made, the present prohibition effectively prevents the supply of the product, thus defeating the intended effect of this exemption.

Regulation 5.2 adopts the recommendation of the National Coordinating Committee on Therapeutic Goods to exempt radiopharmaceutical cold kits from the requirement to be included in the Register where they are manufactured by, and supplied to patients in, a hospital.

The recommendation was made following representations from the ANZ Society of Nuclear Medicine. Hospitals need to produce, ahead of their use by individual patients, sterile vials of reagents called cold kits which have a radio-isotope added before administration to the patient. To enable hospitals to manufacture these cold kits for their patients expeditiously, the proposed amendment will insert the necessary exemption under Schedule 5.

Regulation 6 removes an exemption from Schedule 5A. This Schedule contains a list of goods exempted from the requirement to be included in the Register before they may be lawfully marketed. The exemption applying to Japanese Encephalitis Vaccine is no longer required, as the vaccine is now a registered product available for general supply.