COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On October 1, 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 Hospira Australia Pty Ltd, gave consent to the supply, of:
DBL Heparin Sodium (PORCINE MUCOUS) 35000 IU/ 35 mL injection BP vial [AUST R 16345] that does not conform with the requirements of subclause 3(1)(b)(ii) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the vial label failed to meet the 1.5 mm height requirements.
The consent is effective from October 1, 2014 until September 30, 2015.
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 those previously approved and arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current sponsor.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods in Australia, aiming to ensure that these goods meet safety, quality, and efficacy standards. The Act provides the legal framework for the regulation of therapeutic goods, including medicines, medical devices, and blood products. One of the key problems the Act addresses is the need for consistent and reliable standards in the manufacturing, distribution, and supply of therapeutic goods to protect public health. The Therapeutic Goods Administration, acting on behalf of the Department of Health, is the enforcing body of this Act. In this instance, the delegate of the Secretary has granted consent for the supply of a non-compliant product under specific conditions, illustrating the Act's role in balancing regulatory compliance with practical considerations for the therapeutic goods market. The policy objective remains to safeguard the health and safety of the Australian public by ensuring that therapeutic goods are of acceptable quality and standards.
Scope and Application
The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, ensuring that such products are safe, of high quality, and effective for their intended use. Section 14 and 14A of the Act provide the legal framework for the Therapeutic Goods Administration to issue notices allowing deviations from specific regulatory requirements under certain conditions. In this case, the Act applies to entities involved in the supply of therapeutic goods, such as pharmaceutical companies. The consent granted by the delegate of the Secretary under these sections is applicable on a national level and extends to the specific product and condition outlined in the notice. The consent given to Hospira Australia Pty Ltd for the supply of DBL Heparin Sodium injection vials that do not meet the label height requirements is effective for one year from October 1, 2014, until September 30, 2015. The consent is subject to conditions, including the use of previously approved labels and the establishment of procedures for addressing queries or complaints regarding the product. The Act’s provisions can be further extended or detailed through subordinate instruments, which may introduce additional conditions or criteria to ensure compliance with broader regulatory objectives.
Key Provisions
The Therapeutic Goods Act 1989 provides mechanisms for the regulation and control of therapeutic goods, including medicines, within Australia. Sections 14 and 14A of the Act pertain to the issuance of consents for the supply of goods that do not fully comply with certain standards. In this case, section 14(1) allows the Secretary of the Department of Health to grant consent for the supply of therapeutic goods that do not conform to certain requirements if specific conditions are met. Section 14A(1) further stipulates that such consent can be made subject to conditions that the delegate deems necessary to protect public health and safety.
The consent granted by the delegate of the Secretary, in this instance, relates to the supply of DBL Heparin Sodium (PORCINE MUCOUS) 35000 IU/ 35 mL injection BP vial [AUST R 16345]. This consent is provided due to a non-compliance issue with the label height requirements as specified in subclause 3(1)(b)(ii) of the Therapeutic Goods Order No. 69. The consent is effective from October 1, 2014, until September 30, 2015, and includes conditions that must be adhered to by the manufacturer, Hospira Australia Pty Ltd. These conditions include the use of previously approved labels and the establishment of arrangements for prompt referral of any queries or complaints concerning the products to the current sponsor.
Under the Therapeutic Goods Act 1989, entities such as Hospira Australia Pty Ltd must comply with the conditions set forth in the consent to ensure public safety. The obligation is to maintain previously approved labels for the product and to establish mechanisms for addressing any concerns or issues raised by consumers or healthcare professionals. This includes having a clear process for the referral of queries or complaints to the sponsor, who is responsible for overseeing the product's compliance and safety.
Failure to comply with the conditions outlined in the consent can lead to serious consequences. The Therapeutic Goods Act 1989 imposes penalties for non-compliance with the conditions of consent, which can include administrative and criminal sanctions. The specific penalties are not detailed in the provided text, but generally, breaches of the Act can result in substantial fines and, in severe cases, imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as any relevant case law or regulatory guidelines.