Supply of products by Aspen Pharmacare Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the quality, efficacy, and safety of therapeutic goods, including medicines, in Australia. This Act was introduced to address the need for a comprehensive legislative framework that ensures the therapeutic goods available to the public are of acceptable standards and properly labelled. The Parliament of Australia enacted this legislation to provide a unified system for the regulation of therapeutic goods, thus safeguarding public health by controlling the supply and distribution of these products. The policy objective underlying the Act is to ensure that therapeutic goods available in Australia meet the necessary safety, quality, and efficacy standards, thereby protecting consumers from potential harm. On 12 September 2013, the delegate of the Secretary of the Department of Health granted consent for the supply of specific insulin products by Aspen Pharmacare Australia Pty Ltd, despite the products not conforming to the Therapeutic Goods Order (TGO) 69 concerning packaging and labelling. This consent was issued under subsection 14 and 14A of the Therapeutic Goods Act 1989, subject to conditions aimed at ensuring compliance with Australian standards, including the requirement to use Australian-approved packaging and labelling, and to include appropriate Australian identifiers on the product cartons. These measures were put in place to maintain the integrity of the Australian regulatory system and to ensure that consumers receive products that adhere to local safety and quality benchmarks.

Scope and Application

The Therapeutic Goods Act 1989 applies to any therapeutic goods that are supplied within Australia, and this includes products such as insulin injection vials supplied by entities like Aspen Pharmacare Australia Pty Ltd. The Act encompasses the regulation of therapeutic goods through various measures, including the approval of products and their packaging and labelling. In the specific context of the notice issued on September 12, 2013, the Act allows for the supply of insulin products by Aspen Pharmacare Australia Pty Ltd, despite these products not conforming to the Therapeutic Goods Order (TGO) 69 due to the use of UK packaging and labelling. The consent granted by the delegate of the Secretary of the Department of Health is subject to certain conditions, ensuring that the supplied products align more closely with Australian standards while still allowing for the supply of UK packaged products under specified conditions and limitations. The Act thus extends its reach to ensure that any therapeutic goods supplied within Australia meet certain quality and safety standards, with particular attention to labelling and packaging to protect public health.

Key Provisions

The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia. In particular, sections 14 and 14A of the Act allow for the supply of therapeutic goods that do not comply with certain standards, subject to certain conditions. On September 12, 2013, the delegate of the Secretary of the Department of Health gave consent for the supply of two insulin products by Aspen Pharmacare Australia Pty Ltd, which do not conform with the Therapeutic Goods Order (TGO) 69, in that they are supplied with UK packaging and labelling (subsection 15(1) of the Act). The consent given by the delegate is subject to several conditions. Firstly, the product must be supplied in UK approved packaging and labelling, as detailed in the Company's letter. Secondly, the product must be identical to that which is currently registered in Australia, apart from the labelling and packaging. The carton label main panel must also be stickered with the appropriate Australian registration numbers and Aspen Pharmacare's contact details, covering the "Wockhardt" logo. For the packaging of insulin (HYPURIN ISOPHANE) injection [Aust R 27803], the statement "subcutaneous/intramuscular" on the UK packaging must be over stickered with "subcutaneous" to be consistent with the approved Australian packaging. Where the packs are not sealed, the UK pack insert will be replaced with the Australian CMI. Where the packs are sealed, the Australian CMI will be attached to the carton, and instructions will be provided to indicate that the Australian CMI replaces the UK pack insert. If the supply of the product is greater than 200 units in a month, the product must be supplied in Australian approved labelling and packaging. The Act imposes obligations and requirements on the parties or entities it governs. Aspen Pharmacare Australia Pty Ltd, as the supplier of the products, must comply with the conditions set out in the consent given by the delegate of the Secretary of the Department of Health. This includes ensuring that the products are supplied in UK approved packaging and labelling, with the appropriate Australian registration numbers and contact details stickered on the carton label main panel. The company must also ensure that the products are identical to that which is currently registered in Australia, apart from the labelling and packaging. If the supply of the product is greater than 200 units in a month, the product must be supplied in Australian approved labelling and packaging. Failure to comply with the conditions set out in the consent given by the delegate of the Secretary of the Department of Health may result in offences, penalties, or civil/criminal consequences. The Act provides for a range of penalties for breaches of its provisions, including fines and imprisonment. The maximum penalties for offences under the Act depend on the nature and severity of the offence. For example, supplying a therapeutic good that does not comply with the standards set out in the Act may result in a fine of up to $1.65 million for a corporation, or imprisonment for up to five years, or both. It is important for parties or entities governed by the Act to comply with its provisions to avoid any potential legal consequences.