COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On April 4 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 Phebra Pty Ltd gave consent to the importation and supply, of
SYNTOMETRINE 1mL injection ampoule [AUST R 13396] that does not conform with the requirements of the paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the details of the previous sponsor Novartis Australia appear on the label instead of those of the current sponsor.
The consent is effective from April 4, 2014 until October 31, 2014.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are as supplied with the Company letter. They are those used by Novartis in the New Zealand market, and comply in all other respects with TGO 69. The carton labels are overstickered with the Australian sponsor (Phebra) address and the AUST R number.
- Arrangements are in place for the prompt referral of all queries or complaints concerning the product to Phebra.
- The Dear Healthcare Provider letter supplied with the Company letter (our reference R14/416272) will be supplied with the product, and to the chief medical officers of State and Territory Health Departments as well as to Directors of pharmacy in all Australian hospital pharmacies. A copy should also be sent to the Royal Australian and New Zealand College of Obstetrics & Gynaecology. The letter sets out the circumstances behind this consent to supply and requests users to discard the New Zealand product information supplied with the product, and to refer to the approved Australian product information.
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, aims to regulate the importation, supply, and standardisation of therapeutic goods within the country. This legislation was introduced to address the need for a comprehensive regulatory framework that ensures the safety, quality, and efficacy of therapeutic goods available to consumers. The Therapeutic Goods Administration, a department under the Commonwealth of Australia, is responsible for administering the Act. In specific cases where there may be gaps or unique circumstances, such as with the importation and supply of therapeutic goods that do not fully conform to established standards, the Act allows for the issuance of consents under certain conditions to ensure public health and safety are maintained. These consents are issued with specific conditions to mitigate any risks associated with the non-conformance, ensuring that the therapeutic goods continue to meet acceptable standards of quality and safety.
Scope and Application
The Therapeutic Goods Act 1989, as applied in the Therapeutic Goods Order No. 69, pertains to the regulation of therapeutic goods in Australia, encompassing medicines, medical devices, and other related products. Under Section 14 and 14A of this Act, specific consents can be granted for certain therapeutic goods that do not strictly comply with the regulatory standards, provided that adequate justification and conditions are met. In the case of Phebra Pty Ltd’s consent to import and supply Syntometrine 1mL injection ampoule, the Act applies to the entities involved in the manufacturing and supply of the therapeutic goods. This consent allows for the temporary importation and supply of Syntometrine injection ampoules with labels that do not meet the full requirements of TGO 69, provided certain conditions are met to ensure the safety and efficacy of the product. The consent is applicable throughout Australia and is effective until October 31, 2014. This demonstrates the Act's flexibility to accommodate specific situations while maintaining stringent oversight of therapeutic goods in the national market.
Key Provisions
The Therapeutic Goods Act 1989 (the "Act") includes sections 14 and 14A which allow the Secretary of the Department of Health to consent to the importation and supply of therapeutic goods that do not fully comply with certain regulatory requirements, provided it is in the public interest. In this instance, section 14 consent was given for the importation and supply of SYNTOMETRINE 1mL injection ampoule [AUST R 13396] by Phebra Pty Ltd, which does not fully comply with the labelling requirements under Therapeutic Goods Order No. 69 (section 14(1)). The consent is valid from April 4, 2014 until October 31, 2014.
The Act imposes several obligations on the parties involved. Firstly, Phebra Pty Ltd must ensure that the labels for the product comply with all aspects of TGO 69 except for the requirement to include the current sponsor's details. Instead, the labels must be overstickered with the address of the current sponsor, Phebra, and the AUST R number. Secondly, arrangements must be in place to promptly address any queries or complaints regarding the product, directing them to Phebra. Additionally, a Dear Healthcare Provider letter (reference R14/416272) must be supplied with the product, and to the chief medical officers of State and Territory Health Departments, Directors of pharmacy in all Australian hospital pharmacies, and the Royal Australian and New Zealand College of Obstetrics & Gynaecology. This letter should explain the circumstances of the consent and request users to discard any New Zealand product information supplied with the product and refer to the approved Australian product information.
Failure to comply with the conditions of the consent may result in various consequences. While the Act does not explicitly outline specific offences or penalties for breach of the consent conditions, non-compliance with the Therapeutic Goods Act or related regulations can lead to enforcement actions such as fines, product recalls, or legal proceedings. The maximum penalties for breaches of the Therapeutic Goods Act can be substantial, including fines of up to $1.1 million for corporations and $220,000 for individuals, as well as potential imprisonment. The Therapeutic Goods Administration also has the authority to issue public warnings or require corrective actions to mitigate any risks to public health and safety.