THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On March 1 2013, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product paracetamol (PARACETAMOL IV PFIZER) 10 mg/ mL solution for infusion 100mL PVC bag [Aust R 1932132], by Pfizer Australia, West Ryde, NSW (“the Company”);
That do not conform with paragraphs 3(5)(b)(i) of Therapeutic Goods Order (TGO) 69, in that the units for the quantity of excipients are expressed incorrectly.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- The consent applies only to batches P121001, P121002, P121003, P 121004, P121005, P 131001, P131002, P131003, P131004, P131005, P131006 and P131007 of the product paracetamol (PARACETAMOL IV PFIZER) 10 mg/ mL solution for infusion 100mL PVC bag [Aust R 1932132].
- The labels for use are identical to those submitted with the Company’s application.
- No other changes have been made to the product, paracetamol (PARACETAMOL IV PFIZER) 10 mg/ mL solution for infusion 100mL PVC bag [Aust R 1932132].
Overview
The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for the quality, safety, efficacy and timely access of therapeutic goods in Australia. The Act establishes a system for the regulation of therapeutic goods, including medicines, medical devices, blood and tissues, through a combination of regulatory activities by the Therapeutic Goods Administration (TGA) and industry compliance. On March 1, 2013, the delegate of the Secretary of the Department of Health and Ageing provided consent under section 14 and 14A of the Act for the supply of specific batches of the product paracetamol (PARACETAMOL IV PFIZER) 10 mg/ mL solution for infusion 100mL PVC bag [Aust R 1932132], which did not conform with the Therapeutic Goods Order (TGO) 69 due to incorrect expression of the units for the quantity of excipients. The consent is subject to certain conditions, including the requirement that the labels for use must be identical to those submitted with the Company’s application and no other changes have been made to the product. This consent demonstrates the ongoing commitment of the Therapeutic Goods Administration to ensuring that therapeutic goods available in Australia meet the necessary standards of quality, safety and efficacy.
Scope and Application
The Therapeutic Goods Act 1989, specifically as amended by the Gazette on March 1, 2013, pertains to the regulation of therapeutic goods within Australia, ensuring their safety and efficacy. In this instance, the Act's Section 14 and 14A notice grants consent for the supply of a particular product, paracetamol (PARacetamol IV PFIZER) 10 mg/mL solution for infusion 100mL PVC bag, manufactured by Pfizer Australia. This consent is limited to certain batches that do not conform to the Therapeutic Goods Order (TGO) 69 concerning the expression of units for the quantity of excipients. The consent is subject to specific conditions, including the requirement that the labels for use remain unchanged from those submitted with the company’s application and that no other modifications be made to the product. The Act's application here is narrowly focused on these specific batches and conditions, illustrating its role in regulating therapeutic goods with precision.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) includes specific provisions, such as sections 14 and 14A, which pertain to the regulation of therapeutic goods. Section 14 allows the delegate of the Secretary of the Department of Health and Ageing to give consent for the supply of goods that do not conform with certain standards. In this instance, the delegate has consented to the supply of certain batches of the product paracetamol (PARACETAMOL IV PFIZER) 10 mg/mL solution for infusion 100mL PVC bag [Aust R 1932132], manufactured by Pfizer Australia, which do not meet the specified units for the quantity of excipients as outlined in TGO 69 (paragraph 3(5)(b)(i)). This consent is specifically for batches P121001 through P131007.
Under the Act, the obligations imposed on the parties involved are stringent. Pfizer Australia, as the supplier of the therapeutic goods, must ensure that the product supplied conforms to the standards specified in TGO 69. Given the consent, they must ensure that the labels for the specified batches remain identical to those submitted with their application and that no other changes are made to the product. The delegate's consent is also conditional on compliance with these terms, ensuring that the therapeutic goods supplied are safe and appropriately labelled.
Failure to comply with the conditions stipulated in the consent can result in significant legal and financial consequences. Under the Act, breaches of the conditions can lead to various offences. These may include civil penalties, such as fines, and criminal penalties, including imprisonment, depending on the severity and intent of the breach. The exact penalties are not specified in the text but are generally determined by the courts based on the nature and impact of the non-compliance. It is crucial for Pfizer Australia to adhere strictly to the terms of the consent to avoid these potential repercussions.