COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On August 14 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 Gilead Sciences Pty Ltd gave consent to the importation and supply, of:
sofosbuvir (SOVALDI) 400 mg tablet bottle [AUST R 211019] that does not conform with the requirements of paragraph 3(2)(g) and 3(2)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that :
- the warning statement (signal heading) ‘Prescription only medicine, Keep out of reach of children’, required by clause 3(2)(g), is not in the approved form;
- the registered storage condition, ‘store below 30°C’, required by clause 3(2)(j), is absent.
The consent is effective from August 14, 2014 until March 31, 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- Further to the Company email assurance dated August 13, 2014 [TRIM reference R14/965623], users of the product under Gileads ‘compassionate access program’ will be informed to refer to the Australian consumer medicine information document, instead of the UK version supplied with the product to which this consent applies. For the very small number of private patients, this information will be communicated to their prescribing physician along with a copy of the Australian consumer information document; and
- The labels to which this consent applies are those used for the UK market. They will be overstickered with the Australian sponsor’s address details and the AUST R number.
Overview
The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament of Australia, was introduced to regulate therapeutic goods in the country, ensuring their safety, quality, and efficacy. This legislation provides a legal framework for the regulation of therapeutic goods, including medicines, medical devices, and other related products. The Act aims to protect public health by controlling the importation, supply, and advertising of therapeutic goods within Australia. The Therapeutic Goods Administration (TGA), a department within the Australian Government’s Department of Health, is responsible for administering the Act. In 2014, a notice was issued under the Act to allow the importation and supply of sofosbuvir (SOVALDI) 400 mg tablets by Gilead Sciences Pty Ltd, despite the product not fully conforming to certain labelling requirements. This consent was granted to address specific circumstances, such as the need for a compassionate access program, and was subject to conditions to ensure consumer safety and accurate information dissemination.
Scope and Application
The Therapeutic Goods Act 1989, as amended and applied in this specific instance, facilitates the importation and supply of therapeutic goods that may not fully conform to certain regulatory standards under specific conditions. In this case, Gilead Sciences Pty Ltd was granted consent to import and supply sofosbuvir (SOVALDI) 400 mg tablets which do not meet the labelling requirements outlined in the Therapeutic Goods Order No. 69. This consent is narrowly focused on the therapeutic good in question and applies only to the specified product in the context of Gilead's compassionate access program. The consent is effective from August 14, 2014, until March 31, 2015, and is subject to specific conditions that address the deficiencies in labelling, including the requirement for users to refer to the Australian consumer medicine information document and the oversticker of UK market labels with Australian-specific details. The jurisdictional reach of this Act is national, as it falls under the purview of the Commonwealth of Australia's Therapeutic Goods Administration.
Key Provisions
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, outline the process by which consent can be granted for the importation and supply of therapeutic goods that do not conform to certain regulatory requirements. In this instance, Gilead Sciences Pty Ltd has received consent to import and supply sofosbuvir (SOVALDI) 400 mg tablets under specific conditions. The consent acknowledges that the product does not meet the labelling requirements stipulated in the Therapeutic Goods Order No. 69 (paragraphs 3(2)(g) and 3(2)(j)) as the warning statement is not in the approved form, and the storage condition is absent. The consent is effective from August 14, 2014, to March 31, 2015.
The obligations imposed by this consent on Gilead Sciences Pty Ltd include ensuring that users of the product under their ‘compassionate access program’ are directed to the Australian consumer medicine information document, rather than the UK version. Additionally, for private patients, Gilead must communicate this information to their prescribing physician along with a copy of the Australian consumer information document. Furthermore, the labels intended for the UK market must be overstickered with the Australian sponsor’s address details and the AUST R number. These conditions are intended to ensure that consumers in Australia are provided with accurate and compliant information regarding the use and storage of the medication.
Failure to comply with the conditions set out in the consent may result in legal consequences. Under subsection 15(1) of the Therapeutic Goods Act 1989, breaches of the conditions can lead to enforcement actions by the Therapeutic Goods Administration (TGA). The penalties for non-compliance can include fines and other civil or criminal sanctions, depending on the severity of the breach. The maximum penalties for contravening the Act can be substantial, reflecting the importance of adhering to the regulatory framework designed to protect public health and safety. Gilead Sciences Pty Ltd, as the entity granted consent, bears the responsibility to ensure compliance with these conditions to avoid any adverse legal repercussions.