THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 20 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 terlipressin (GLYPRESSIN) powder for injection [Aust R 177517] by Ferring Pharmaceuticals Pty Ltd, Pymble NSW (“the Company”):
That does not conform with paragraphs 3(2)(a), 3(2)(b), 3(2)(c), 3(2)(e), 3(2)(j), 3(5)(a)(ii) and 3(5)(b)(ii) of the Therapeutic Goods Order 69, in that the product name, quantity and proportions of the active ingredients, the name and expression of the dosage form, the storage conditions and the warning about single use in one patient only are expressed differently to the approved versions on the product labels.
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 to the following batches only:
- F13034DA, expiry date 06/2014, 42 units of 5 x 1 mL
- F16534BA, expiry date 01/2015, 335 units of 5 x 1 mL
- F15998CA, expiry date 11/2014, 618 units of 5 x 1 mL
- The labels which are the subject of this consent to supply are those which have been used for the product while it has been supplied under the Special Access Scheme (copies of which were supplied by the Company in correspondence dated June 25 2012).
- No other changes have been made to the product, except for changes approved by the TGA (site of product release: Ferring International Centre SA, Switzerland).
- The Dear Healthcare Professional letter, provided by the Company in correspondence from the Company dated July 10 2012, which explains the circumstances surrounding the supply of these batches, will be supplied with the batches to which this consent applies. The letter will be accompanied by a copy of the approved Australian Product Information.
- The carton labels for the affected batches will be overstickered with the Australian sponsor address details and the Aust R number.
Overview
The Therapeutic Goods Act 1989 was enacted to provide a legal framework for regulating therapeutic goods in Australia, including medicines, medical devices, and other health-related products. The Act aims to ensure the safety, quality, and efficacy of these goods through various regulatory mechanisms, such as the requirement for authorisation and approval of therapeutic goods before they can be supplied in Australia. The Therapeutic Goods Act 1989 was introduced to address the need for a comprehensive legislative framework to regulate therapeutic goods, ensuring they meet the necessary standards for public health and safety. The Act was enacted by the Australian Parliament and is administered by the Therapeutic Goods Administration (TGA), which is responsible for implementing and enforcing the provisions of the Act. The policy objective of the Act is to protect public health by ensuring that therapeutic goods are safe, of high quality, and effective, while also facilitating access to these goods for legitimate medical needs.
Scope and Application
The Therapeutic Goods Act 1989 (the Act) applies to entities and products involved in the supply and distribution of therapeutic goods within Australia. This legislation regulates the importation, supply, and advertising of therapeutic goods, ensuring that such goods meet safety, quality, and efficacy standards. The Act applies to companies, healthcare professionals, and other entities involved in the therapeutic goods industry, encompassing a wide range of products, including medicines, medical devices, and blood products. The geographic reach of the Act is national, as it applies across all states and territories of Australia. In this specific case, the Act facilitates the conditional consent for the supply of the product terlipressin by Ferring Pharmaceuticals Pty Ltd, subject to certain labelling conditions. The consent applies to specific batches of the product and is limited to these batches only, with additional conditions that include the use of specific labels and the provision of a Dear Healthcare Professional letter along with the approved Australian Product Information.
Key Provisions
The Therapeutic Goods Act 1989, under sections 14 and 14A, allows for the delegate of the Secretary of the Department of Health and Ageing to consent to the supply of therapeutic goods that do not conform to the approved specifications set out in the Therapeutic Goods Order. In this particular instance, section 14(1) empowers the delegate to permit the supply of terlipressin (GLYPRESSIN) powder for injection by Ferring Pharmaceuticals Pty Ltd, even though the product does not meet the specific labelling requirements outlined in Therapeutic Goods Order 69. The consent is subject to specific conditions, outlined in section 15(1), which ensure the product is supplied under strict control to maintain safety and efficacy.
The obligations imposed on Ferring Pharmaceuticals Pty Ltd by this legislation are multifaceted. Firstly, the company must ensure that only the specified batches—F13034DA, F16534BA, and F15998CA—are supplied under this consent, with each batch having distinct quantities and expiry dates. The product labels must reflect the approved Australian Product Information, and the carton labels for the affected batches need to be overstickered with the Australian sponsor address details and the Aust R number. Additionally, the Dear Healthcare Professional letter, explaining the circumstances surrounding the supply, must accompany each batch, ensuring that healthcare professionals are informed about the deviations from the standard labelling.
Failure to adhere to the conditions set forth in the consent can result in significant legal consequences. While the Therapeutic Goods Act does not explicitly state offences or penalties in this context, breaches of the Act or the Therapeutic Goods Regulations can lead to severe civil and criminal penalties. For instance, supplying goods that do not comply with the Therapeutic Goods Order could be considered an offence under section 30 of the Act, which covers the prohibition of misleading or deceptive conduct. Such offences can attract penalties including substantial fines and, in severe cases, imprisonment. The exact penalties depend on the nature and extent of the non-compliance, but the overarching aim is to enforce strict adherence to the regulatory standards to protect public health.