THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On August 30 2012, 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 paroxetine (as hydrochloride hemihydrate) (Paroxetine-GA) 20 mg tablet blister pack [Aust R 199080] by Ascent Pharma Pty Ltd, South Melbourne, VIC (“the Company”):
That does not conform with paragraph 3(2)(c) of Therapeutic Goods Order 69, in that the name of the active ingredient is expressed differently to the approved version on the labels on the cartons.
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 600 and 601 of the above product and to a third batch, the batch number for which should be provided to the TGA prior to its release.
- No other changes have been made to the product paroxetine (as hydrochloride hemihydrate) (Paroxetine-GA) 20 mg tablet blister pack [Aust R 199080].
- The carton label to be used for the above batches is identical to that provided in correspondence from the Company dated August 14 2012. It includes the over-sticker as specified by the TGA.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply, import, and export of therapeutic goods in Australia, ensuring they meet safety, quality, and efficacy standards. One of the mechanisms provided by the Act is the ability for the Secretary of the Department of Health to issue notices under sections 14 and 14A, allowing for the supply of therapeutic goods that do not fully comply with certain standards, subject to specific conditions. This was introduced to address situations where therapeutic goods, while generally safe and effective, have minor non-compliance issues that can be managed through regulatory oversight. On August 30, 2012, the delegate of the Secretary provided consent for the supply of a specific batch of paroxetine tablets by Ascent Pharma Pty Ltd, conditioned on the use of a particular carton label to rectify a naming discrepancy on the active ingredient. This action is intended to ensure public health and safety by allowing the regulated use of these products under controlled conditions until full compliance can be achieved.
Scope and Application
The Therapeutic Goods Act 1989, as evidenced by the Gazette notice, applies to the regulation of therapeutic goods in Australia, including their supply, advertising, and labelling. This specific notice pertains to the supply of a particular pharmaceutical product, paroxetine (as hydrochloride hemihydrate) (Paroxetine-GA) 20 mg tablet blister pack, manufactured by Ascent Pharma Pty Ltd, a company based in South Melbourne, Victoria. The notice grants consent for the supply of specified batches of this product, which does not conform to certain labelling requirements as outlined in Therapeutic Goods Order 69. This consent is limited to batches 600 and 601 and a yet-to-be-identified third batch, which must have its batch number provided to the Therapeutic Goods Administration (TGA) prior to its release. The Act's jurisdictional reach is national, applying across all states and territories in Australia. This consent does not extend to any other batches or modifications of the product, and the carton label must remain as specified in the correspondence from the company dated August 14, 2012, including an over-sticker as mandated by the TGA.
Key Provisions
Section 14 and 14A of the Therapeutic Goods Act 1989 provide mechanisms for the delegate of the Secretary of the Department of Health and Ageing to give consent for the supply of therapeutic goods that do not conform with certain standards or specifications. In this case (section 14(a)), the delegate has consented to the supply of paroxetine (as hydrochloride hemihydrate) 20 mg tablet blister packs by Ascent Pharma Pty Ltd, but with specific conditions. The consent is limited to certain batches, specifically batches 600 and 601, with the condition that the batch number for a third batch must be provided to the Therapeutic Goods Administration (TGA) prior to its release. This consent allows the product to be supplied despite not conforming to the requirements of paragraph 3(2)(c) of Therapeutic Goods Order 69, which pertains to the labelling of the active ingredient.
The obligations imposed on the parties governed by this Act are quite specific and stringent. Ascent Pharma Pty Ltd must ensure that the carton labels for the specified batches are identical to those provided in the correspondence dated August 14, 2012, including any over-sticker as specified by the TGA. Additionally, the company must notify the TGA of the batch number for any third batch before it is released to the market. These obligations are designed to maintain the integrity and safety of the therapeutic goods supplied, ensuring that any deviations from standard requirements are tightly controlled and monitored.
Failure to comply with the conditions set forth in the consent or any other requirements of the Therapeutic Goods Act 1989 can result in significant consequences. Under the Act, breaches can lead to civil and criminal penalties. Specifically, section 32AB of the Act allows for civil penalties for non-compliance, including fines up to $22,200 for individuals and $111,000 for bodies corporate, depending on the severity and nature of the breach. Additionally, under section 32DA, criminal penalties can be imposed, with maximum penalties reaching up to $5.5 million for bodies corporate and imprisonment for up to 10 years for individuals found guilty of serious offences. These stringent penalties underscore the importance of strict adherence to the conditions and requirements outlined in the Act.