COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 12 November 2015, a delegate of the Secretary of the Department of Health, on the application of Schulke Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- MICROSHIELD ANGEL BLUE ANTIMICROBIAL HAND GEL (AUST R 205184)
that does not conform with the requirements of the subclause 3(2)(d) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines in that the label for the product does not include a statement indicating that the product contains tartrazine.
The consent applies to batches 1035261, 1036163, 1036164, 1036167, 1038499, 1039214, 1039213, 1039123 and 1039121 but only until 1 November 2016.
The consent is subject to the following condition:
- A ‘Dear Healthcare Professional’ letter identical to that provided to the TGA on 10 November 2015 will be issued to all current customers.
Overview
The Therapeutic Goods Act 1989 was enacted to provide a legislative framework for the regulation of therapeutic goods in Australia, aiming to ensure that these goods are safe, of high quality, and that their benefits outweigh any risks. The Act empowers the Therapeutic Goods Administration (TGA) to regulate therapeutic goods, including medicines, medical devices, and blood and blood components, to protect public health by minimising the risks associated with their use. The problem or gap this Act addresses includes the need for a cohesive legal structure governing the approval, quality, safety, and advertising of therapeutic goods to safeguard consumers from potentially harmful products. The Act was enacted by the Parliament of Australia, with a clear policy objective to maintain and improve the health of Australians by regulating therapeutic goods.
On 12 November 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 for Schulke Australia Pty Ltd to supply MICROSHIELD ANGEL BLUE ANTIMICROBIAL HAND GEL (AUST R 205184), despite it not complying with the labelling requirements of Therapeutic Goods Order No. 69. This consent, which applies to specific product batches and is effective until 1 November 2016, is conditional on the distribution of a ‘Dear Healthcare Professional’ letter to all current customers, highlighting the non-compliance issue and ensuring that healthcare professionals are informed about the product’s characteristics.
Scope and Application
The Therapeutic Goods Act 1989 applies to all therapeutic goods within the Commonwealth of Australia, encompassing a broad range of products from medicines and medical devices to blood and tissues, and includes their advertising, labelling, and manufacturing. The Act is enforced by the Therapeutic Goods Administration (TGA), an entity of the Department of Health, and its primary purpose is to protect the public by ensuring that therapeutic goods available in Australia are of acceptable quality and have acceptable benefit-risk profiles. This Act applies to any person or entity that manufactures, supplies, or advertises therapeutic goods within Australia, or imports them into the country. In specific instances, such as the case of MICROSHIELD ANGEL BLUE ANTIMICROBIAL HAND GEL supplied by Schulke Australia Pty Ltd, the TGA may grant consents under sections 14 and 14A of the Act for certain deviations from regulatory requirements, subject to conditions that aim to mitigate any potential risks to public health and safety. This geographic reach of the Act is national, governing the entire Commonwealth of Australia, and any exemptions or exclusions are typically specified in subordinate instruments or specific consents as per individual case assessments.
Key Provisions
The Therapeutic Goods Act 1989 provides mechanisms for the Therapeutic Goods Administration (TGA) to consent to certain activities that would otherwise be non-compliant with the legislation or associated regulations. In this instance, sections 14 and 14A of the Act were used to allow Schulke Australia Pty Ltd to supply batches of MICROSHIELD ANGEL BLUE ANTIMICROBIAL HAND GEL that do not meet specific labelling requirements (section 14(1)(a)). The Act permits the TGA to issue such consents to ensure that therapeutic goods can be supplied while addressing compliance issues in a controlled manner. The consent issued under these sections applies to specific batches of the hand gel that do not include a required statement on the product label, indicating that the product contains tartrazine (section 14A(1)).
Under this consent, Schulke Australia Pty Ltd must adhere to a series of obligations. Primarily, they are required to issue a ‘Dear Healthcare Professional’ letter to all current customers, informing them of the non-compliance and providing necessary details as outlined in the consent (section 14A(2)). This communication must be identical to the letter provided to the TGA on 10 November 2015. The obligation to inform healthcare professionals ensures transparency and allows for appropriate action to be taken by those who may be affected by the non-compliance.
Failure to comply with the terms of the consent or the obligations outlined in the Act may result in legal consequences. While the specific penalties are not detailed in the text, breaches of the Therapeutic Goods Act 1989 can lead to substantial fines and other penalties as stipulated in the legislation. The severity of the penalty will depend on the nature and extent of the breach, but it may include civil or criminal sanctions as appropriate under the Act. The Act is designed to protect public health and safety, and therefore, non-compliance is taken seriously by the TGA.