COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 11 December 2015, a delegate of the Secretary of the Department of Health, on the application of Generic Health Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- PHARMACY ACTION ANTI-INFLAMMATORY PAIN RELIEF GEL diclofenac sodium 10mg/g tube [AUST R 93539] – batches 41037, 29606, 42136; and
- PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule blister pack [AUST R 191154] – batch 450471
that do not conform to the requirements of paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine, in that the product labels do not include all of the new warning statements that will be required by the legislative instrument made by the Minister under subsection 3(5A) of the Act from 12 December 2015.
The consent applies to the nominated batches but only until 31 December 2016.
The consent is subject to the following conditions:
- the labels to which this consent applies are those previously approved by the TGA for these products, copies of which were provided with the request.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply, importation, and advertising of therapeutic goods in Australia, ensuring their quality, efficacy, and safety. The Act addresses the need for a comprehensive framework governing the therapeutic goods industry, providing mechanisms for the regulation and control of these goods to protect public health. Administered by the Therapeutic Goods Administration, the Act aims to maintain and enhance the quality, safety, and efficacy of therapeutic goods through rigorous oversight and compliance measures. On 11 December 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Act to Generic Health Pty Ltd for the importation and supply of specific batches of anti-inflammatory pain relief gel and diarrhoea relief capsules, which did not fully comply with the labelling requirements set out in Therapeutic Goods Order No. 69. This consent, applicable only until 31 December 2016, was subject to conditions ensuring the use of previously approved labels and underscores the Act’s objective to balance regulatory compliance with the timely availability of necessary therapeutic products.
Scope and Application
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, pertains to the regulation and control of therapeutic goods in Australia, encompassing various substances, including pharmaceuticals and medical devices. This legislation applies to entities involved in the manufacture, importation, supply, and advertising of therapeutic goods, ensuring they meet safety, quality, and efficacy standards. The Act operates on a national level, regulating goods across the Commonwealth, states, and territories to ensure uniformity in standards and practices. However, certain exclusions and exemptions may apply, particularly to goods for personal use or those intended for export, as outlined in the Therapeutic Goods Regulations 1990. Additionally, subordinate instruments may extend or restrict the application of the Act, providing further clarification on specific conditions and exceptions. In the case of the notice issued on 11 December 2015, a delegate of the Secretary consented to the importation and supply of specific batches of diclofenac sodium gel and loperamide hydrochloride capsules that do not conform to new labelling requirements, effective until 31 December 2016, subject to certain conditions to ensure public safety.
Key Provisions
Under sections 14 and 14A of the Therapeutic Goods Act 1989, the delegate of the Secretary of the Department of Health has granted Generic Health Pty Ltd consent to import and supply certain batches of two pharmaceutical products that do not fully comply with the label requirements as stipulated in the Therapeutic Goods Order No. 69 (paragraph 3(2)(g)). Specifically, the consent pertains to the importation and supply of "PHARMACY ACTION ANTI-INFLAMMATORY PAIN RELIEF GEL diclofenac sodium 10mg/g tube" in batches 41037, 29606, and 42136, and "PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule blister pack" in batch 450471. These products lack certain new warning statements that will be mandatory as per a legislative instrument made under subsection 3(5A) of the Act from 12 December 2015. This consent is valid for the specified batches and is limited to a period ending on 31 December 2016.
The Act imposes several obligations on the parties involved. Generic Health Pty Ltd must ensure that the product labels used for the specified batches are the same as those previously approved by the Therapeutic Goods Administration (TGA). The company is required to adhere to these approved labels, which were provided with the application. This consent allows for a temporary deviation from the forthcoming regulatory requirements but mandates the use of pre-approved labels that were compliant with the existing standards at the time of their approval.
Failure to comply with the conditions of the consent or the requirements of the Therapeutic Goods Act 1989 could result in legal consequences. Although the specific penalties are not detailed in the provided excerpt, breaches of the Act can generally lead to both civil and criminal penalties. Civil penalties may include fines, while criminal penalties could result in imprisonment or substantial fines, depending on the severity and intent of the breach. It is crucial for Generic Health Pty Ltd to adhere strictly to the terms of the consent to avoid any legal repercussions.