THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On September 10 2012 the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the following products by AbbVie, Botany, NSW (“the Company”):
- paricalcitol (Zemplar Capsule) 2 micrograms capsule blister pack [Aust R 121762]
- ritonavir (Norvir) 100 mg tablets bottle [Aust R 158301]
- lopinavir 200 mg and ritonavir 50 mg (Kaletra Tablets) tablets bottle [Aust R 121055]
- lopinavir 100 mg and ritonavir 25 mg (Kaletra Tablets) tablets bottle [Aust R 140509]
- (Kaletra) oral solution bottle [Aust R 78627]
- Calcitriol (Calcijex) 1 microgram/1 mL injection ampoule [Aust R 54452]
That do not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the previous name of the sponsor (Abbot) is listed on the labels on the cartons and containers instead of the new sponsor name (AbbVie).
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- The consent to supply applies for a period of two years from September 10 2012.
- The labels to be used are identical to those provided by the Company in correspondence dated September 6 2012.
- No other changes have been made to the products listed above.
- Details of the process in place to ensure continuous customer contact with the Company are as described in correspondence from the Company dated August 1 2012.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply and importation of therapeutic goods in Australia, addressing the need for a comprehensive framework to ensure the safety, quality, and efficacy of these goods. This Act was designed to provide a unified approach to the regulation of therapeutic goods, encompassing medicines, medical devices, and blood and blood components, thereby filling the gap left by previous fragmented regulations. Enacted by the Commonwealth Parliament, the Act aims to protect public health by ensuring that therapeutic goods meet specific standards and are appropriately advertised and labelled. This legislative initiative was crucial in establishing a coherent and enforceable framework to manage the therapeutic goods sector in Australia, reflecting the policy objective of safeguarding consumers through stringent regulatory oversight.
Scope and Application
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, applies to the regulation of therapeutic goods, including medicines, in Australia. This Act provides the legislative framework under which the Therapeutic Goods Administration (TGA) operates, ensuring that therapeutic goods available in Australia meet safety, quality, and efficacy standards. The Act applies to various entities, including pharmaceutical companies like AbbVie, which are involved in the manufacture, supply, and labelling of therapeutic goods. The geographic reach of the Act is national, as it governs the regulation of therapeutic goods across all states and territories in Australia. This particular notice given by the delegate of the Secretary of the Department of Health and Ageing extends to the supply of certain therapeutic goods by AbbVie that do not conform to specified labelling standards under Therapeutic Goods Order (TGO) 69. The notice includes specific conditions for the supply of these products, such as the use of labels provided by AbbVie and the maintenance of customer contact details as stipulated in the company's correspondence. The consent granted under this notice is subject to these conditions and applies for a period of two years from the date of issuance.
Key Provisions
Under the Therapeutic Goods Act 1989, specifically sections 14 and 14A, the delegate of the Secretary of the Department of Health and Ageing has granted consent for AbbVie, Botany, NSW, to supply a range of therapeutic goods that do not conform to certain labelling standards. This consent allows AbbVie to supply specific products, including paricalcitrol, ritonavir, lopinavir and ritonavir in various forms, and calcitriol, despite the labels bearing the previous sponsor name "Abbott" instead of the current sponsor name "AbbVie" (section 14(1)). This consent is subject to certain conditions, including the use of labels provided by the company as of September 6, 2012, and the maintenance of a process for continuous customer contact as outlined in correspondence from August 1, 2012 (section 14(1)).
The Act imposes several obligations on AbbVie in relation to the supply of these therapeutic goods. Firstly, the consent is time-limited, applying only for a period of two years from the date of issuance, September 10, 2012. Secondly, AbbVie must use the labels provided in their correspondence dated September 6, 2012, and ensure that these labels are identical to those approved. Additionally, AbbVie must adhere to the process for continuous customer contact as detailed in their correspondence from August 1, 2012, to maintain communication with customers regarding the supplied products.
Failure to comply with the conditions set out in the consent may result in legal consequences. Although the Therapeutic Goods Act 1989 does not explicitly state the penalties for non-compliance in this specific context, general provisions of the Act provide for potential civil and criminal penalties. For instance, supplying non-compliant therapeutic goods can result in civil penalties, including fines, and criminal penalties, including imprisonment, if the non-compliance is deemed serious enough to warrant such consequences. The exact penalties would be determined based on the nature and extent of the non-compliance.