Consent given pursuant to Sections14 and 14A for the supply of therapeutic goods specified - GlaxoSmithKline Australia

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the provision of therapeutic goods in Australia, ensuring that these goods are safe, of acceptable quality, and that appropriate information is provided to consumers. This legislation was introduced to address the gap in the regulation of therapeutic goods, which included medicines, medical devices, and other health-related products, to protect public health and safety. The Act is administered by the Therapeutic Goods Administration (TGA), an agency of the Department of Health within the Australian Government, and its policy objective is to ensure that therapeutic goods available in Australia meet safety, quality, and efficacy standards. Through the Act, the TGA is empowered to control the supply and advertising of therapeutic goods, enforce compliance with standards, and take action against non-compliance, thereby safeguarding the health and wellbeing of the Australian population.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, with Section 14 and 14A addressing consent for the supply of goods that do not fully conform to legislative requirements. This legislation applies to entities involved in the supply of therapeutic goods, including pharmaceutical companies like GlaxoSmithKline Australia. The Act’s scope extends to ensuring that therapeutic goods meet safety, quality, and efficacy standards, and it applies nationally across the Commonwealth of Australia. The application of the Act is not limited to specific industries but encompasses all entities involved in the supply of therapeutic goods. In this instance, the Therapeutic Goods Administration granted consent for the supply of specific batches of Boostrix vaccine, which did not conform to certain labelling requirements, under strict conditions to ensure that the therapeutic standards are maintained despite the non-conformance. This consent is effective until 30 November 2016, highlighting the time-bound nature of such regulatory allowances.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) permit the Secretary of the Department of Health to grant consent for the supply of therapeutic goods that do not fully conform to certain regulatory requirements. In this instance, Section 14 consent was given for the supply of Boostrix 0.5mL injection pre-filled syringes (AUST R 158363) that do not comply with the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, specifically Clause 3(1)(b)(ii), Clause 3(2)(j), Clause 3(5)(b)(i), and Clause 3(5)(b)(ii). This consent is limited to the export packs of the product, as detailed in the application from GlaxoSmithKline Australia. The consent applies to the specific batches AC37B164BE and AC37B164BG, which expire on 30 November 2016, and includes a total of 20,000 doses. The consent granted under Section 14 of the Act imposes several obligations on the parties involved. Firstly, the supply of the product must be strictly limited to the general export packs as provided to the Therapeutic Goods Administration (TGA). To ensure compliance, the cartons must be over-stickered with a sticker containing the Australian Sponsor's details and the Australian Register of Therapeutic Goods (ARTG) number. Additionally, the package insert in the export pack must be removed, and the current Australian Product Information and Consumer Medicines Information must be inserted into each carton. It is also mandatory to maintain approved storage conditions during the transfer of the package insert. Lastly, the batches must comply with all other conditions of registration applicable to the product. Failure to comply with the conditions outlined in the consent may lead to legal consequences. Under Section 15(1) of the Act, the delegate of the Secretary made the consent subject to these conditions to ensure the therapeutic goods are supplied safely and effectively. Breach of these conditions could result in both civil and criminal penalties. Civil penalties can include fines and other civil remedies as stipulated in the Act. Criminal penalties might include fines up to $220,000 for individuals and $1,100,000 for bodies corporate, reflecting the severity of non-compliance with therapeutic goods regulations. Additionally, non-compliance could lead to product recalls, suspension of supply permissions, and potential legal action against the parties involved.