COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On May 20 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”), by application of Aspen Pharmacare Australia Pty Ltd, gave consent to:
The importation and supply of testosterone esters [SUSTANON 250] 250 mg in 1 ml injection ampoule [AUST R 14521] that does not conform with the requirements of the paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the labels state the previous sponsor contact details.
The consent is effective from May 20, 2014 until May 20, 2015.
The delegate of the Secretary has, 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;
- Arrangements are in place to redirect all correspondence to the current sponsor (Aspen); and
- No other changes have been made.
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate therapeutic goods and ensure their safety, efficacy, and quality. In 2014, a specific notice was issued under sections 14 and 14A of this Act by the delegate of the Secretary of the Department of Health, to address a particular concern regarding the non-conformity of product labels. This notice granted consent for the importation and supply of testosterone esters (SUSTANON 250) by Aspen Pharmacare Australia Pty Ltd, subject to certain conditions to ensure compliance with the Act and to maintain the integrity of the therapeutic goods regulation. The policy objective here is to facilitate the continued availability of necessary therapeutic goods while ensuring that appropriate regulatory standards are met.
This legislative action underscores the flexibility within the Therapeutic Goods Act 1989 to address specific regulatory challenges while maintaining the overarching goal of protecting public health by ensuring that therapeutic goods are safe and of high quality. The notice issued highlights the Act's capacity to adapt to particular circumstances where non-conformity issues arise, allowing for the resolution of such issues without compromising the regulatory framework.
Scope and Application
The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Department of Health, governs the regulation of therapeutic goods in Australia. This legislation applies to all therapeutic goods, including medicines, medical devices, and blood products, and it is applicable to any person or entity involved in the supply, importation, and manufacture of these goods within Australia. The Act encompasses a wide range of industries including pharmaceuticals, medical devices, and blood products, ensuring that these goods meet safety, quality, and efficacy standards. The geographic reach of the Act is national, applying uniformly across all states and territories of Australia. While the Act generally applies to all therapeutic goods, there are specific exclusions such as certain types of cosmetics and industrial goods that fall outside its scope. The Act also allows for the issuance of consents and exemptions under specific conditions, as demonstrated in the case of the consent provided to Aspen Pharmacare Australia Pty Ltd for the importation and supply of Sustanon 250 that does not conform with certain labelling requirements. This consent, which is effective from May 20, 2014, until May 20, 2015, is subject to specific conditions to ensure compliance with overall regulatory standards.
Key Provisions
The Therapeutic Goods Act 1989 provides a framework for regulating therapeutic goods in Australia. Under sections 14 and 14A, the Secretary of the Department of Health can grant consent for the importation and supply of goods that do not fully comply with the Act or its associated orders, provided that certain conditions are met. In this instance, Aspen Pharmacare Australia Pty Ltd received consent for the importation and supply of testosterone esters [SUSTANON 250] 250 mg in 1 ml injection ampoule [AUST R 14521]. The consent is effective from May 20, 2014, until May 20, 2015, and allows for the continuation of the supply of this specific product despite it not meeting the labelling requirements stipulated in Therapeutic Goods Order No. 69.
The consent granted to Aspen Pharmacare Australia Pty Ltd imposes several obligations on the company. Firstly, the labels of the product must remain as they are, continuing to display the previous sponsor's contact details. Secondly, Aspen must ensure that all correspondence related to the product is redirected to the current sponsor, which is Aspen itself. Additionally, no other changes to the product or its packaging can be made during the period of consent.
Failure to comply with the conditions outlined in the consent could result in various legal consequences. Under the Therapeutic Goods Act 1989, non-compliance may lead to enforcement actions by the Therapeutic Goods Administration (TGA). Offences related to the supply of non-compliant therapeutic goods can be subject to both civil and criminal penalties. For example, under section 34HA of the Act, a corporation can be fined up to $2,100,000 for knowingly supplying therapeutic goods that do not comply with the Act or its associated orders. Individual officers or employees responsible for the offence may also face penalties, including fines and imprisonment, depending on the severity and intent behind the breach. These provisions underscore the importance of adhering to the terms and conditions set forth in the consent to avoid legal repercussions.