Legal Research
Legislations
Therapeutic Goods Order No. 80A - Amendments to Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines

Therapeutic Goods Order No. 80A - Amendments to Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01920 Not in force Legislative Instrument

Select Document

EXPLANATORY STATEMENT

Subject: THERAPEUTIC GOODS ORDER NO. 80A AMENDMENTS TO THERAPEUTIC GOODS ORDER NO. 80 CHILD-RESISTANT PACKAGING REQUIREMENTS FOR MEDICINES

Therapeutic Goods Act 1989

Section 10

OUTLINE

Therapeutic Goods Order No. 80A Amendments to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines is an Order made by the delegate of the Minister for Health under section 10 of the Therapeutic Goods Act 1989 (the Act).

This Order amends Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80), which was made on 27 August 2008 and registered on the Federal Register of Legislative Instruments on 5 September 2008.

TGO 80A principally amends TGO 80 by extending the range of medicines for which child-resistant packaging (CRP) is required under TGO 80.

TGO 80A commences on 1 October 2013, allowing time for medicines already being supplied or in late development to achieve compliance with the provisions of TGO 80.

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Section 10 of the Act authorises the Minister, or the Minister's delegate, to determine standards for therapeutic goods, or to amend or revoke existing standards, after consultation with the Therapeutic Goods Committee (the TGC), a committee established under the Therapeutic Goods Regulations (the Regulations) to advise the Minister on matters relating to standards.

Unless consent is granted by the Secretary under sections 14 and 14A of the Act, therapeutic goods imported into Australia, supplied in Australia or exported from Australia must comply with any applicable standard.

TGO 80 requires that medicines containing any of the ingredients specified in that Order be supplied in original packaging that meets specified performance standards for CRP. These performance standards are also specified in TGO 80, and consist of Australian and international standards which set out requirements relating to demonstrating the effectiveness of the packaging in delaying access by children, while also allowing older persons, or those who are less able, to readily access the medicine.

Section 4 of TGO 80 explains the criteria used by the TGC when advising on requirements for CRP for a medicine containing any particular substance. These criteria include, for example, the toxicity of the relevant substances contained in a medicine, the extent and patterns of availability of medicines containing the substance in the community and the number and type of incidents reported to Poisons Information Centres involving such medicines. TGO 80 currently requires that medicines containing 398 specified substances must be packaged in CRP.

At its 35th meeting, held in October 2009, the TGC advised by resolution that stakeholder consultation should be applied in relation to medicines containing any of 23 additional substances.

TGO 80A amends TGO80 to include references to these additional substances, with the effect that medicines containing these substances will be required to be packaged in CRP.

Examples of these additional medicines include oral liquid medicines for the treatment of the symptoms of coughs and colds, and prescription medicines for the treatment of insomnia.

CONSULTATION

Those changes set out in TGO 80A which relate to the application of CRP to cough and cold products, were consulted on with stakeholders in October 2009. The other changes set out in TGO 80A were consulted on with stakeholders in February 2010.

In relation to the cough and cold related measures, these proposals were published on the TGA’s website (www.tga.gov.au), and submissions were invited. In addition, consumer organisations, health practitioner organisations and peak industry bodies were contacted directly about the proposals and consultation. A total of 17 submissions were received, which were broadly supportive of the TGA’s main proposal that oral liquid cough and cold medicines be marketed in CRP.

The consultation on the remaining measures also involved publication of the proposals on the TGA’s website, with submissions invited. Consumer organisations, injury prevention agencies, health practitioner organisations and peak industry bodies were contacted directly. A total of 16 submissions were received. Consideration of these submissions led the TGC to recommend that the concentration threshold of methyl salicylate in liquid medicines above which CRP should be required should be lowered from 25 per cent to 5 per cent, and the Minister’s delegate agreed with that recommendation in making TGO 80A.

In addition to the above, the Office of Best Practice Regulation has agreed that no Regulation Impact Statement is necessary for TGO 80A (OBPR reference 13284).

Overview

The Therapeutic Goods Order No. 80A, enacted in 2013, amends the Therapeutic Goods Order No. 80 concerning the child-resistant packaging (CRP) requirements for medicines. This legislative action was taken under the Therapeutic Goods Act 1989 by the delegate of the Minister for Health to address the identified gap in the range of medicines requiring CRP, thereby enhancing the safety of medicines for children. The Therapeutic Goods Administration (TGA) is responsible for administering this Act, which establishes and maintains a national system of controls over therapeutic goods to ensure their quality, safety, efficacy, and timely availability. The amendments to TGO 80 were made following consultations with the Therapeutic Goods Committee (TGC), which advises on matters relating to standards. The TGC recommended extending CRP requirements to include additional substances, such as those in oral liquid medicines for coughs and colds and prescription medicines for insomnia. These changes were subject to stakeholder consultation, which resulted in the TGC recommending a reduction in the concentration threshold for methyl salicylate in liquid medicines requiring CRP from 25 per cent to 5 per cent.

Scope and Application

The Therapeutic Goods Order No. 80A, amending the Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines, is an Order issued under section 10 of the Therapeutic Goods Act 1989. This legislation applies to all therapeutic goods supplied, imported into, or exported from Australia, ensuring they comply with the standards set forth in the Act. The Order specifically extends the range of medicines that require child-resistant packaging (CRP) to enhance safety, particularly in the context of medicines containing specified substances. The amendments came into effect on 1 October 2013 to provide sufficient time for compliance by existing products and those in late development stages. The scope of this Order includes a broader range of medicines, particularly targeting oral liquid medicines for coughs and colds, and prescription medicines for insomnia, thereby increasing the number of substances that mandate CRP from 398 to an extended list based on the Therapeutic Goods Committee’s advice. This legislative amendment aims to mitigate risks associated with accidental ingestion by children, thereby contributing to public health safety.

Key Provisions

Therapeutic Goods Order No. 80A, which amends Therapeutic Goods Order No. 80 (TGO 80) concerning child-resistant packaging (CRP) requirements for medicines, extends the range of medicines that must be supplied in CRP (section 1). This amendment, made under section 10 of the Therapeutic Goods Act 1989 (the Act), was introduced to ensure broader safety measures for medicines that could pose a risk if accessed by children. Specifically, TGO 80A requires additional substances to be included in the list of those necessitating CRP, thereby broadening the scope of the original TGO 80 that only required CRP for medicines containing 398 specified substances. The Order imposes obligations on manufacturers, importers, and suppliers of medicines to ensure that any medicines containing the newly specified substances are packaged in compliance with the CRP requirements. These obligations include adhering to the performance standards for CRP as outlined in TGO 80, which include criteria such as the toxicity of the substances, community availability, and incidents reported to Poisons Information Centres. Suppliers must take proactive steps to ensure that their products meet these standards, which may involve modifying their packaging processes or product formulations to achieve compliance. Failure to comply with the CRP requirements set out in TGO 80A may result in significant legal and financial consequences. While the explanatory statement does not explicitly detail the penalties for non-compliance, it is understood that contravention of the Therapeutic Goods Act 1989 and its associated Orders can lead to civil or criminal penalties, including fines and imprisonment. For instance, under the Act, supplying therapeutic goods that do not comply with the standards can result in substantial fines, and in severe cases, imprisonment for individuals responsible for the non-compliance. Additionally, businesses may face penalties such as the seizure of non-compliant products and the potential for their goods to be banned from the market. These measures underscore the importance of adhering to the CRP requirements to avoid severe repercussions.

Area of Law: Medical Law
Instrument: Order
Concepts: Definitions & Interpretation; Reporting & Disclosure Obligations; Regulatory Standards

Interactions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

Legislation content