COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 15 June 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 AbbVie Pty Ltd, gave consent to the importation and supply of
- adalimumab (rch) (HUMIRA) 10 mg solution for injection pre-filled syringe (27G)
[AUST R 238700]
that does not conform with the requirements of the clauses of 3(2)(l), 3(2)(n) and 3(5)(6)(ii) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the name of Australian sponsor of the supplier of the goods, the Australian registration number and a statement “Use in one patient on one occasion only” are not present on the carton label.
The consent is effective from 15 June 2015 until 15 June 2017.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- There will be over labelling with a sticker on all supplied cartons with the Australian sponsor name, sponsor address, AUST R number and a statement “Use in one patient on one occasion only”. Further, the Australian approved Product Information leaflet will be supplied with the carton.
- In the event of the volume increase, Australian specific label will be reinstated.
- The sponsor clearly communicates that it no longer offers a latex-free HUMIRA adalimumab (rch) 10mg solution for injection. Such communication should be directed to prescribers, pharmacists and consumers.
Overview
The Therapeutic Goods Act 1989 was enacted to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. This Act was introduced to address the need for a regulatory framework that governs the importation, supply, and monitoring of therapeutic goods, including medicines, medical devices, and blood products. The Act is administered by the Therapeutic Goods Administration (TGA), which operates under the Department of Health. The primary policy objective of this legislation is to protect public health by ensuring that therapeutic goods are safe, of acceptable quality, and perform as claimed. In the case of the Therapeutic Goods Act, the Australian Parliament established this legislative framework to provide the necessary regulatory oversight to support the safe and effective use of therapeutic goods within the Australian market.
On 15 June 2015, the delegate of the Secretary of the Department of Health issued a notice under the Therapeutic Goods Act 1989, granting consent for the importation and supply of adalimumab (rch) (HUMIRA) 10 mg solution for injection pre-filled syringe (27G) that did not conform to certain labelling requirements specified in Therapeutic Goods Order No. 69. This consent was granted in response to an application by AbbVie Pty Ltd and was subject to specific conditions to ensure the safe and effective use of the therapeutic good. The consent was effective from 15 June 2015 until 15 June 2017.
Scope and Application
The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, with Section 14 and 14A specifically concerning consent for the importation and supply of goods that do not fully comply with certain regulations. On 15 June 2015, the delegate of the Secretary of the Department of Health granted consent to AbbVie Pty Ltd for the importation and supply of adalimumab (rch) (HUMIRA) 10 mg solution for injection pre-filled syringe (27G)[AUST R 238700], which does not meet specific labelling requirements. This consent is applicable to the named entity, AbbVie Pty Ltd, and the specified therapeutic good, adalimumab (rch) (HUMIRA) 10 mg solution for injection pre-filled syringe (27G)[AUST R 238700], and is effective from 15 June 2015 until 15 June 2017. The consent is subject to specific conditions to ensure compliance, including over-labelling with necessary information and clear communication regarding the unavailability of a latex-free version of the product. The consent extends to the Commonwealth level, overseen by the Therapeutic Goods Administration under the Department of Health.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) provides a framework for regulating therapeutic goods in Australia, including medicines, medical devices, and blood products. Section 14 and 14A of the Act pertain to the importation and supply of therapeutic goods that do not conform to certain requirements, such as labelling, and allows for consent to be given under specific conditions. In this instance, Section 14(1) and 14A(1) of the Act enabled the delegate of the Secretary of the Department of Health to grant consent to AbbVie Pty Ltd for the importation and supply of adalimumab (rch) (HUMIRA) 10 mg solution for injection pre-filled syringe (27G)[AUST R 238700] that does not comply with certain labelling requirements.
The consent, detailed in Section 14(1) of the Act, is contingent upon several conditions set by the delegate, as outlined in Section 15(1). These conditions include over-labelling all supplied cartons with a sticker that includes the Australian sponsor name, sponsor address, AUST R number, and the statement "Use in one patient on one occasion only". Additionally, the Australian approved Product Information leaflet must be supplied with the carton. Should the volume of imported goods increase, the original Australian-specific label must be reinstated. Furthermore, AbbVie Pty Ltd is required to communicate clearly to prescribers, pharmacists, and consumers that it no longer offers a latex-free version of HUMIRA adalimumab (rch) 10mg solution for injection.
Entities governed by the Act, such as AbbVie Pty Ltd in this case, must ensure compliance with the conditions stipulated in the consent granted by the delegate. This involves adhering to the over-labelling requirements, supplying the necessary Product Information leaflet, and communicating changes in product offerings to relevant stakeholders. Failure to comply with these obligations may result in legal repercussions.
Under the Act, breaches of the consent conditions may lead to significant consequences. While specific offences and penalties are not outlined in the given notice, breaches of therapeutic goods regulations can generally lead to administrative penalties, including fines. The Therapeutic Goods (Administration) Regulations 1990, for example, provide for penalties up to $22,200 for individuals and $111,000 for bodies corporate for certain breaches. Additionally, ongoing non-compliance may result in the revocation of the consent or other enforcement actions, such as product recalls or market bans. These measures are designed to ensure the safety, quality, and efficacy of therapeutic goods in Australia.