COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On March 26, 2014, 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”) gave his consent to:
(a) the supply of the product ADRENALINE-LINK 1:10,000 1mg/10mL (as acid tartrate) injection BP pre filled syringe [Aust R 210672] by Link Medical Products Pty Ltd, WARRIEWOOD, NSW;
That does not conform to the Therapeutic Goods Order No. 69—General requirements for labels for medicines (TGO 69), in that:
- The warning statements (clause 3(5)(b)(ii) relating to single use in one patient on one occasion only) are not as specified in the Order;
- Excipient quantities (clause 3(5)(b)(i)) are not included;
- A statement of the purpose or purposes for which the goods are intended is missing (clause 3(2)(m));
- The syringe labels do not include the name or registered trade mark of the sponsor or supplier or the proprietary name (clause 3(11)(c)).
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 from the date of this letter until the end of April 2014.
- The product to which this consent applies is identical in all respects to the currently approved product, and is the UK-labelled product which has been previously supplied in Australia under section 19A of the Act.
- The Dear Healthcare Provider letter supplied with the Company letter of application [TGA ref: R14/381304] explaining the circumstances behind this consent and providing information on differences between the approved Australian product information and the UK product information to be supplied with affected stock, will be supplied with the product.
Overview
The Therapeutic Goods Act 1989 was enacted by the Australian Parliament to regulate the supply of therapeutic goods in Australia, ensuring they are of acceptable quality, safety, and efficacy. This Act provides a framework for the control of therapeutic goods, including medicines, medical devices, and other related products, with the aim of protecting public health by ensuring these products meet necessary standards. In the case of the 2014 Gazette notice, the Therapeutic Goods Administration, a part of the Department of Health, exercised its authority under this Act to grant a temporary consent for the supply of a specific adrenaline injection product that did not fully comply with labelling requirements stipulated in the Therapeutic Goods Order No. 69. This consent was granted to address an immediate supply need, subject to conditions that ensure the product's quality and safety, and to inform healthcare providers of the differences from the standard approved product information.
Scope and Application
The Therapeutic Goods Act 1989, as referenced in the notice published on March 26, 2014, applies to the regulation and administration of therapeutic goods in Australia. Specifically, this notice pertains to the Therapeutic Goods Order No. 69, which sets out general requirements for labels for medicines. The Act applies to entities and individuals involved in the supply of therapeutic goods, including manufacturers, importers, and suppliers. In this instance, the consent granted applies to Link Medical Products Pty Ltd for the supply of the product ADRENALINE-LINK 1:10,000 1mg/10mL (as acid tartrate) injection BP pre-filled syringe, which does not conform to certain labelling requirements specified in TGO 69. The consent is geographically limited to Australia and is subject to specific conditions, including the timeframe of its validity and the requirement to provide additional information to healthcare providers. Any exclusions or exemptions are not explicitly stated in this notice, but the Act allows for such provisions through subordinate instruments.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) is the principal legislation governing the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood products. Sections 14 and 14A of the Act permit the Secretary, or their delegate, to give consent for the supply of goods that do not fully comply with certain regulations or standards, under specific conditions. In this case, section 14 allows for the supply of therapeutic goods that do not conform to certain labelling requirements, while section 14A provides a mechanism for the Secretary to impose conditions to mitigate any risks associated with the non-compliance.
The Act imposes certain obligations on entities involved in the supply of therapeutic goods. For example, under the Therapeutic Goods Order No. 69—General requirements for labels for medicines (TGO 69), it is mandatory for labels to include specific warning statements, excipient quantities, a statement of the intended purpose of the goods, and the name or registered trademark of the sponsor or supplier or the proprietary name. In this instance, the supplier, Link Medical Products Pty Ltd, must ensure that the product in question is supplied with the required information as per the TGO 69, in addition to any other conditions imposed by the Secretary's consent.
Breaching the provisions of the Therapeutic Goods Act 1989 can result in both civil and criminal penalties. Under section 33DA of the Act, it is an offence to supply therapeutic goods that do not comply with the Act or the regulations made under it. The maximum penalties for individuals can include fines of up to $222,200 and/or imprisonment for up to five years. For corporations, the penalties can be significantly higher, with fines potentially reaching up to $1,111,000. Additionally, the Act provides for the possibility of court-ordered confiscation of goods that are the subject of an offence, further emphasising the seriousness with which non-compliance is treated.