COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 1 July 2015, a delegate of the Secretary of the Department of Health, on the application of AbbVie Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- VIEKIRA PAK RBV composite therapy packs [AUST R 224636, 224637, 224638, 234434 and 234442]
that do not conform with the requirements of the paragraphs 3(2)(a), 3(2)(l) & 3(5)(b) (j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicine, in that the product name differs from that agreed, and which appears on the carton labels, the sponsor's address (and website and phone number) are not those of the Australian sponsor and the storage condition is not described as permitted by clause 7 of Therapeutic Goods 0rder 69 and that the storage conditions differs from that assigned to the products.
The consent is effective from 1 July 2015 until 31 December 2015 (for a period of 6 months).
The consent is subject to the following conditions:
- The 'daily wallet' labels to which this consent applies are those provided with
the responses to S31-PM-2014-01438-I-2 (date March 2015).
2. A 'Dear Healthcare Provider/Pharmacist' letter identical to that provided to the Therapeutic Goods Administration on 30 June 2015 will be supplied only to Healthcare providers that have patients enrolled in sponsor's VIEKIRA PAK supply program.
3. No other changes have been made.
Overview
The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, was introduced to regulate the importation, supply, and other dealings with therapeutic goods in Australia, aiming to ensure their safety, quality, and efficacy. A notable instance of this Act's application is evident in the consent granted under sections 14 and 14A for the importation and supply of VIEKIRA PAK RBV composite therapy packs by AbbVie Pty Ltd, effective from 1 July 2015 until 31 December 2015. This consent, issued by a delegate of the Secretary of the Department of Health, allowed for the supply of products that did not fully conform to certain labelling requirements stipulated in the Therapeutic Goods Order No. 69, including discrepancies in product name, sponsor details, and storage conditions. The consent was subject to specific conditions to mitigate potential risks, such as the provision of a 'Dear Healthcare Provider/Pharmacist' letter to relevant healthcare providers. This case exemplifies the Act's role in balancing regulatory compliance with public health needs, ensuring that therapeutic goods meet essential standards while facilitating access to necessary treatments.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, covering a broad range of products including medicines, medical devices, and blood. The Act applies to all persons and entities involved in the supply of therapeutic goods, encompassing manufacturers, importers, sponsors, and healthcare professionals. The legislation is enforced by the Therapeutic Goods Administration, which operates at the Commonwealth level. While the Act generally governs all therapeutic goods within Australia, specific exclusions and exemptions are detailed in the Therapeutic Goods Regulations 1990 and subsequent orders. For instance, certain products may be exempt under specific conditions, such as for research or personal use. Additionally, the Act allows for the issuance of consents under sections 14 and 14A for products that do not fully comply with regulatory standards, subject to certain conditions that aim to mitigate any potential risks to public health and safety. These conditions are tailored to the particular circumstances of the non-compliant products and are documented in the specific consent granted by the Secretary of the Department of Health.
Key Provisions
The Therapeutic Goods Act 1989, specifically under sections 14 and 14A, provides a mechanism for consent to be granted in cases where certain therapeutic goods do not fully comply with established regulatory standards. In this instance, AbbVie Pty Ltd has applied for and received consent to import and supply VIEKIRA PAK RBV composite therapy packs, identified by Australian Register of Therapeutic Goods (ARTG) numbers 224636, 224637, 224638, 234434 and 234442. This consent was issued on 1 July 2015 and is effective until 31 December 2015, covering a period of six months. The consent permits the importation and supply of these products despite their non-compliance with certain labelling requirements stipulated in the Therapeutic Goods Order No. 69, such as discrepancies in product names, sponsor details, and storage conditions.
The Therapeutic Goods Act 1989 imposes several obligations and requirements on the entities it governs. In this case, AbbVie Pty Ltd must adhere to the conditions set forth in the consent granted. For instance, the 'daily wallet' labels accompanying the VIEKIRA PAK RBV composite therapy packs must match those provided in response to S31-PM-2014-01438-I-2 dated March 2015. Furthermore, a 'Dear Healthcare Provider/Pharmacist' letter, identical to the one submitted to the Therapeutic Goods Administration on 30 June 2015, must be distributed exclusively to healthcare providers who have patients enrolled in the sponsor's VIEKIRA PAK supply program. These conditions ensure that the therapeutic goods are accompanied by appropriate informational materials and that only eligible healthcare providers receive specific communications.
Failure to comply with the conditions of the consent, or any other requirements set out in the Therapeutic Goods Act 1989, may result in legal consequences. While specific offences and penalties are not detailed in the provided text, breaches of the Act can generally lead to civil or criminal penalties. The Therapeutic Goods Act 1989 allows for enforcement actions which may include fines, prosecution, and other measures designed to ensure compliance with therapeutic goods regulations. The severity of penalties can vary depending on the nature and extent of the breach, with maximum penalties potentially reaching significant monetary fines and/or imprisonment for serious or repeated violations.