COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 25 February 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of AstraZeneca Pty Ltd, gave consent to the importation and supply of
- dapagliflozin (as propanediol monohydrate) (FORXIGA) 10 mg film coated tablets blister pack [AUST R 180147]
that does not conform with the requirements of paragraph 3(2)(l), of the Therapeutic Goods Order 69 – General requirements for labels for medicines in that the carton label states the previous sponsor contact details.
The consent is effective from the 25 February 2015 until batch number is 4C86509 (sample Pack) is exhausted or is expired.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels are those currently supplied which state the previous sponsor details as well as the current sponsor (as the distributor);
- Arrangements are in place to redirect all correspondence to the current sponsor (AstraZeneca); and
- No other changes have been made to the product.
Overview
The Therapeutic Goods Act 1989, enacted by the Australian Parliament, addresses various issues related to the regulation of therapeutic goods, including medicines, medical devices, and blood products. This Act was introduced to ensure that therapeutic goods available in Australia meet safety, quality, and efficacy standards. On 25 February 2015, the delegate of the Secretary of the Department of Health granted AstraZeneca Pty Ltd consent to import and supply dapagliflozin (FORXIGA) 10 mg film-coated tablets under specific conditions, as the product did not conform to certain labelling requirements. This consent acknowledges the existing carton labels with outdated sponsor contact details while ensuring that all correspondence is redirected to the current sponsor and that no other changes are made to the product. The policy objective is to maintain the integrity of therapeutic goods supply while allowing for necessary adjustments under strict oversight.
Scope and Application
The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration within the Department of Health, governs the regulation of therapeutic goods in Australia. Specifically, Section 14 and 14A of the Act pertain to the importation and supply of therapeutic goods, including medicines, and allows for the granting of consents for goods that do not fully conform with specific regulatory requirements. In the case of the dapagliflozin product supplied by AstraZeneca Pty Ltd, the Act provides the framework through which consent was granted for the importation and supply of the product despite its non-compliance with certain labelling requirements. This consent is tightly regulated and applies solely to the specified product batch, ensuring that the therapeutic goods market remains safeguarded while allowing for specific exceptions where necessary. The consent issued under the Act is subject to conditions ensuring that the product labels include both the previous and current sponsor details, all correspondence is redirected to the current sponsor, and no other changes have been made to the product. This ensures that while the product may not fully comply with certain labelling standards, its introduction into the market is tightly controlled and monitored.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood. In particular, Section 14 and Section 14A of the Act allow the delegate of the Secretary of the Department of Health to grant consent for the importation and supply of therapeutic goods that do not fully comply with the Therapeutic Goods Order (TGO). In this case, AstraZeneca Pty Ltd applied for consent to import and supply dapagliflozin (as propanediol monohydrate) (FORXIGA) 10 mg film-coated tablets blister packs, which do not meet the labelling requirements specified in TGO 69 – General requirements for labels for medicines. The carton label states the previous sponsor's contact details rather than the current sponsor's details, which is a deviation from the labelling requirements.
The Act imposes specific obligations on the parties governed by it. In this instance, AstraZeneca must ensure that the labels of the supplied product include both the previous and current sponsor details, as well as redirecting all correspondence to the current sponsor. Furthermore, AstraZeneca must ensure that no other changes have been made to the product. These obligations are necessary to maintain the integrity of the therapeutic goods regulation and to ensure the safety, quality, and efficacy of the products supplied.
Breaches of the Act or TGOs can result in various penalties and consequences. Under Section 34 of the Act, it is an offence to import or supply therapeutic goods that do not comply with the Act or TGOs, and penalties can include fines, imprisonment, or both. For example, under Section 34(1) of the Act, an individual can be fined up to 500 penalty units (approximately AUD 78,000) or imprisoned for up to two years, or both, for an offence involving therapeutic goods that are dangerous to health. Similarly, under Section 34(2) of the Act, a body corporate can be fined up to 5,000 penalty units (approximately AUD 780,000) or more for an offence involving therapeutic goods that are dangerous to health. These penalties serve as a deterrent to non-compliance and ensure that the regulation of therapeutic goods in Australia remains robust and effective.
In addition to criminal penalties, the Act provides for civil penalties for breaches of the Act or TGOs. For example, under Section 125 of the Act, a person who contravenes a TGO can be issued with a civil penalty notice by the Therapeutic Goods Administration (TGA). The maximum penalty for an individual is 50 penalty units (approximately AUD 7,800), and for a body corporate, it is 250 penalty units (approximately AUD 39,000). Furthermore, under Section 126 of the Act, a court can order a person who has contravened a TGO to pay compensation to any person who has suffered loss or damage as a result of the contravention. These civil penalties provide an additional deterrent to non-compliance and can help to ensure that the regulation of therapeutic goods in Australia remains effective.
In conclusion, the Therapeutic Goods Act 1989 and the Therapeutic Goods Order 69 – General requirements for labels for medicines provide a comprehensive regulatory framework for the importation and supply of therapeutic goods in Australia. The Act and TGOs impose specific obligations on parties governed by them, including AstraZeneca in this case, and breaches of the Act or TGOs can result in criminal and civil penalties. The consent granted by the delegate of the Secretary of the Department of Health for the importation and supply of dapagliflozin (as propanediol monohydrate) (FORXIGA) 10 mg film-coated tablets blister packs, which do not meet the labelling requirements specified in TGO 69, is subject to specific conditions to ensure that the integrity of the therapeutic goods regulation is maintained.