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:
- saxagliptin (as hydrochloride)( ONGLYZA) 5 mg film coated tablet blister pack
[AUST R 157907]
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 25 February 2015 until batch number 4A84016 (sample pack) is exhausted or has 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 to regulate the importation, supply, and other activities related to therapeutic goods in Australia, was introduced to ensure that therapeutic goods available in the Australian market are of an acceptable standard and quality. This Act, administered by the Therapeutic Goods Administration under the auspices of the Department of Health, aims to protect public health by ensuring that only safe and effective therapeutic goods are available. In addressing the specific instance noted in the 2015 Gazette, the Act's provision for consent to import and supply goods that do not fully comply with certain regulatory standards reflects a policy objective to balance regulatory rigour with practical considerations, ensuring that minor non-conformities do not impede access to necessary therapeutic goods. The consent granted to AstraZeneca Pty Ltd for the importation and supply of saxagliptin (ONGLYZA) 5 mg film coated tablet blister pack, despite a label non-conformance, exemplifies this approach by allowing for temporary supply under specific conditions that safeguard public health.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood and blood components. It encompasses a broad range of entities, including manufacturers, importers, suppliers, and distributors of these goods. The Act's application extends to the entire Commonwealth of Australia, ensuring a cohesive national regulatory framework. The legislation allows for exceptions and exemptions through the issuance of consents, as evidenced by the notice regarding the importation and supply of saxagliptin (ONGLYZA) 5 mg film-coated tablet blister packs by AstraZeneca Pty Ltd. This particular consent is limited to specific conditions, such as maintaining the existing label details and redirecting correspondence to the current sponsor, and is in effect until the specified batch is exhausted. The scope of the Act can be further refined through subordinate instruments, which may include regulations and orders that provide additional detail or extend the application of the primary legislation.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) governs the importation and supply of therapeutic goods in Australia, and under sections 14 and 14A, the Secretary of the Department of Health can give consent for certain therapeutic goods that do not conform to specific regulatory requirements to be imported and supplied. In this instance, the Secretary's delegate granted consent to AstraZeneca Pty Ltd for the importation and supply of saxagliptin (as hydrochloride) 5 mg film coated tablet blister packs (ONGLYZA) [AUST R 157907]. These products do not meet the requirements of paragraph 3(2)(l) of Therapeutic Goods Order 69 – General requirements for labels for medicines, as the carton label contains the previous sponsor's contact details rather than the current sponsor's details. The consent is effective from 25 February 2015 until batch number 4A84016 (sample pack) is exhausted or has expired.
In granting this consent, the Secretary's delegate imposed certain conditions to ensure the continued safety and efficacy of the therapeutic goods. Firstly, the labels supplied must include both the previous sponsor's details and the current sponsor's details (AstraZeneca, as the distributor). Secondly, arrangements must be in place to redirect all correspondence to the current sponsor, AstraZeneca. Lastly, no other changes should be made to the product. These conditions ensure that the therapeutic goods are supplied with accurate and up-to-date information, and that the current sponsor can be easily contacted by consumers and healthcare professionals.
Failure to comply with the conditions of the consent, or any other requirements under the Act, may result in various consequences, including civil or criminal penalties. Under the Act, offences and penalties can be imposed for breaches of the legislation, such as supplying therapeutic goods that do not comply with the relevant requirements. The maximum penalties for these offences can vary depending on the nature and severity of the breach. In some cases, individuals or entities found guilty of an offence under the Act may face fines, imprisonment, or both. Additionally, the Therapeutic Goods Administration (TGA) may take enforcement action, such as issuing warnings, seizing non-compliant goods, or prosecuting offenders in court. It is crucial for parties governed by the Act to be aware of their obligations and to ensure compliance with the legislation to avoid any potential consequences.