COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On July 29 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 AbbVie Pty Ltd, gave consent to:
the importation and supply, of
AUST R No. | Product Name. |
76815 | levobupivacaine (as hydrochloride)(CHIROCAINE) 25 mg/10 mL injection ampoule |
76862 | levobupivacaine (as hydrochloride)(CHIROCAINE) 50 mg/10 mL injection ampoule |
76864 | levobupivacaine (as hydrochloride)(CHIROCAINE) 75 mg/10 mL injection ampoule |
94481 | levobupivacaine hydrochloride (CHIROCAINE) 125 mg/200 mL solution for injection bag |
94482 | levobupivacaine hydrochloride (CHIROCAINE) 250 mg/200 mL solution for injection bag |
133452 | levodopa/carbidopa (DUODOPA) 20 mg/mL and 5 mg/mL intestinal gel PVC bag |
29656 | isoflurane (FORTHANE) 1 mL/mL inhalation bottle |
140509 | lopinavir (KALETRA) 100 mg and ritonavir 25 mg tablets bottle |
121055 | lopinavir (KALETRA) 200 mg and ritonavir 50 mg tablets bottle |
78627 | KALETRA oral solution bottle |
114303 | leuprorelin acetate (LUCRIN DEPOT 3 – MONTH) 22.5 mg powder for injection prefilled dual-chamber syringe |
114304 | leuprorelin acetate (LUCRIN DEPOT 4-MONTH) 30 mg powder for injection prefilled dual-chamber syringe |
114302 | leuprorelin acetate (LUCRIN DEPOT) 7.5 mg powder for injection prefilled dual-chamber syringe |
29658 | leuprorelin acetate (LUCRIN) 5 mg/mL injection multidose vial |
158301 | ritonavir (NORVIR) 100 mg tablet bottle |
55004 | ritonavir (NORVIR) 600 mg/7.5 mL oral liquid bottle |
51919 | sevoflurane (SEVORANE) anaesthetic inhalation bottle |
121762 | paricalcitol (ZEMPLAR) 2 micrograms capsule blister pack |
that does not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the sponsor’s old address (AbbVie Pty Ltd, 32-34 Lord St Botany NSW 2019) is used instead of the sponsor’s new address as of September 1, 2014 (AbbVie Pty Ltd, 241 O’Riordan St Mascot NSW 2020) on the labels.
The consent is effective from July 29, 2014 until September 1, 2016 for the products listed in the table above.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels for use are those previously approved bearing the details of the sponsor’s old address.
- Details of the process in place to ensure continuous customer contact with your Company as the sponsor are as described in the letter.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods in Australia, ensuring they meet safety, quality, and efficacy standards. The Act was introduced to address the need for a comprehensive regulatory framework governing the manufacturing, supply, and advertising of therapeutic goods, including medicines, medical devices, and blood products. Enacted by the Parliament of Australia, the Act aims to protect public health by controlling the quality and safety of therapeutic goods available in the market. On July 29, 2014, the delegate of the Secretary of the Department of Health granted consent to AbbVie Pty Ltd for the importation and supply of several medicinal products, despite the labels not conforming to the Therapeutic Goods Order No. 69, which specifies requirements for medicine labels. The consent was issued to allow the transition period for updating the labels with the sponsor's new address, ensuring that the products remain available while maintaining regulatory compliance.
Scope and Application
The Therapeutic Goods Act 1989, as amended, applies to the regulation of therapeutic goods in Australia, including their importation, supply, and advertising. In the context of this particular consent notice, the Act applies to AbbVie Pty Ltd, which is a manufacturer or sponsor of the listed therapeutic goods. The Act ensures that therapeutic goods meet specified standards for quality, safety, and efficacy. The consent granted under the Act allows AbbVie Pty Ltd to import and supply certain products that do not conform to the labelling requirements specified in the Therapeutic Goods Order No. 69. The consent is geographically limited to Australia and is in effect from July 29, 2014, until September 1, 2016. This consent does not exempt AbbVie Pty Ltd from other compliance requirements under the Act and is subject to conditions that ensure the continuity of customer contact and adherence to other regulatory standards. The scope of the Act can be further extended or restricted through subordinate instruments, which may include regulations and orders that provide detailed implementation and enforcement mechanisms.
Key Provisions
The Therapeutic Goods Act 1989, in particular sections 14 and 14A, provides the framework under which the delegate of the Secretary of the Department of Health can consent to certain activities that would otherwise be prohibited. In this instance, section 14(1) allows for the granting of consent for the importation and supply of therapeutic goods that do not meet certain legislative requirements. Here, the delegate has allowed AbbVie Pty Ltd to import and supply a list of therapeutic goods that do not comply with the label requirements specified in Therapeutic Goods Order No. 69 (subsection 14A(1)). Specifically, the labels for these goods bear the old address of AbbVie Pty Ltd rather than the new address that has been in effect since September 1, 2014 (subsection 14A(2)(a)).
The obligations imposed by this consent require AbbVie Pty Ltd to ensure that the labels for the listed products are those that were previously approved and bear the sponsor’s old address. Furthermore, AbbVie must maintain a process that ensures continuous customer contact as described in a letter accompanying the consent (subsection 15(1)). This includes the responsibility of ensuring that any customers who received products with the old address are informed of the new address and any relevant changes in the supply chain or contact information.
Failure to comply with the conditions of this consent could result in legal repercussions. Under the Therapeutic Goods Act 1989, non-compliance could lead to offences that may incur civil or criminal penalties. Specifically, section 31(1) of the Act stipulates that a person who contravenes the Act or any regulations or orders made under it is liable to a penalty. The maximum penalties for such offences can be substantial, with fines that may extend to thousands of Australian dollars for individuals and corporations, as well as potential imprisonment terms for serious offences. These penalties underscore the importance of adhering to the legislative requirements and the conditions set forth in the consent.