COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 23 November 2015, a delegate of the Secretary of the Department of Health, on the application of Sanofi Aventis Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- HEXAXIM Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) (DTPa-hepB-IPV-Hib) [AUST R 215536]
that do not conform with the requirements of the Therapeutic Goods Order No 69 General requirements for labels for medicines in that the syringe label does not comply with:
• Subparagraph 3(1)(b)(ii) in letter height of not less than 1.5 millimetres
• Paragraph 3(2)(c) the quantity or proportion of all active ingredients in the goods in accordance with clause 4
and the carton label does not comply with:
• Subparagraph 3(5)(b)(i) the name and quantity of each excipient in the goods because the syringes are labelled with the Standard International syringe label for Hexaxim and space limitations on the approved Australian carton label preclude complete compliance with Subparagraph 3(5)(b)(i).
The consent is effective from 23 November 2015 until 28 February 2017.
I consent under those sections to the importation and supply in Australia of 300 doses of batch L0119-2 with expiry 28 February 2017.
The consent is subject to the following conditions:
- A ‘Dear Healthcare Professional’ letter identical to that provided to the Therapeutic Goods Administration on 27 October 2015 will be supplied.
- The product will be supplied with labels identical to those supplied to the Therapeutic Goods Administration with the application dated 27 October 2015.
- The consent only applies to 300 doses of batch L0119-2 with expiry 28 February 2017 of the product.
Overview
The Therapeutic Goods Act 1989 (the Act) was enacted to regulate therapeutic goods in Australia, ensuring that the quality, efficacy, and safety of such goods are maintained for the public. One of the key mechanisms within the Act is the ability to grant consents for the supply of therapeutic goods that do not fully comply with certain regulatory standards under specific circumstances. The Therapeutic Goods Administration, acting on behalf of the Department of Health, exercises this power to balance the need for stringent regulatory compliance with the practicalities of the therapeutic goods market. In the case of the consent granted to Sanofi Aventis Australia Pty Ltd, the primary objective was to facilitate the supply of a specific vaccine, Hexaxim, under exceptional conditions due to labelling constraints, ensuring that the product remains available to the Australian market without compromising safety standards. This consent was issued to address the specific issue of non-compliance with certain labelling requirements, allowing for a limited supply of the vaccine to meet immediate medical needs while maintaining overall regulatory integrity.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components, within the Commonwealth of Australia. This legislation sets out the legal framework for the evaluation, approval, and monitoring of therapeutic goods to ensure their safety, quality, and efficacy. Under sections 14 and 14A, the Act allows for specific consents to be granted for the supply of therapeutic goods that do not fully comply with certain regulatory requirements, provided that such deviations do not pose an unacceptable risk to health and safety. This particular consent relates to the supply of a specific batch of HEXAXIM vaccine, which has labelling issues that prevent complete adherence to certain labelling standards. The consent is narrowly tailored to 300 doses of the specified batch and includes conditions to mitigate any risks, such as the provision of an explanatory letter to healthcare professionals and the use of specific labelling provided to the Therapeutic Goods Administration. The consent is effective for a limited period, highlighting the temporary and controlled nature of such approvals.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) provides a framework for the regulation of therapeutic goods in Australia. In this case, sections 14 and 14A of the Act allow for consent to be given for the supply of therapeutic goods that do not fully comply with certain requirements of the Therapeutic Goods Order No 69. Specifically, the consent permits the importation and supply of a specific batch of the Hexaxim vaccine, which does not meet the labelling requirements due to limitations on space for listing excipients on the carton label and the letter height on the syringe label.
The obligations under this consent include the provision of a ‘Dear Healthcare Professional’ letter and the supply of the product with labels that match those provided to the Therapeutic Goods Administration. These obligations are designed to ensure that healthcare professionals are informed about the non-compliance and the specific details of the product being supplied. The consent applies strictly to 300 doses of batch L0119-2 with an expiry date of 28 February 2017.
Failure to comply with the terms and conditions of this consent may result in legal consequences. Under the Act, breaches can lead to civil or criminal penalties. The specific penalties for non-compliance with the Act are not detailed in the provided text, but generally, the Act allows for fines and, in some cases, imprisonment. The Therapeutic Goods Act 1989 is a robust piece of legislation intended to protect public health by ensuring that only therapeutic goods that meet safety, quality, and efficacy standards are supplied in Australia. This consent mechanism allows for some flexibility in exceptional circumstances while maintaining stringent oversight.