COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 29 June 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Biogen Australia Pty Ltd, gave consent to the supply of
- peginterferon beta-1a (rch) (PLEGRIDY) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled syringe TITRATION PACK [AUST R 214198]
- peginterferon beta-1a (rch) (PLEGRIDY) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled pen TITRATION PACK [AUST R 214200]
- peginterferon beta-1a (rch) (PLEGRIDY) 125 microgram/0.5 mL solution for injection pre-filled syringe [AUST R 214199]
- peginterferon beta-1a (rch) (PLEGRIDY) 125 microgram/0.5 mL solution for injection pre-filled pen [AUST R 214197]
that do not conform with the requirements of paragraph 3 (2)(1) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the product labels include the old sponsor name Biogen Idec Australia Pty Ltd until such time as labels with the revised sponsor name Biogen Australia Pty Ltd are approved by the TGA and implemented into the supply chain.
The consent is effective from the 29 June 2015 until 24 June 2017.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- This consent applies to only batches that are warehoused in Australia, those already produced, labelled and packed for Australia and held in overseas warehousing, or those currently in production for Australia.
- The only change to labels to which this consent applies is the change in the company name from Biogen Idec Australia Pty Ltd to Biogen Australia Pty Ltd. Existing sponsor contact information, such as telephone and address details, remain the same.
- That labels to which this consent applies are those previously approved and arrangements for redirection is in place for electronic contact information such as email address.
- Assurance that sponsor will notify the change in sponsor name for ARTG entries within three months of the sponsor name change in accordance with the Regulations 10A and 10F of the Therapeutic Goods Regulations 1990, and will submit changes to labels and Product Information for approval under section 9D of the Act to reflect the revised sponsor name.
Overview
The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the supply of therapeutic goods, including medicines, medical devices, and blood and blood components, within Australia. This Act addresses the need for ensuring the safety, quality, and efficacy of therapeutic goods through regulation and oversight by the Therapeutic Goods Administration (TGA). The Act was designed to fill the gap by providing a legal framework to control the manufacturing, importation, advertising, and distribution of therapeutic goods, aiming to protect public health. The 2015 notice under Section 14 and 14A of the Act, issued on behalf of the Secretary of the Department of Health, highlights the administrative flexibility in managing specific therapeutic goods, in this case, allowing the supply of peginterferon beta-1a products with temporarily non-compliant labelling due to a change in the sponsor's name, subject to certain conditions to ensure compliance and consumer safety.
Scope and Application
The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA), governs the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood and blood components. Under the Act, the Secretary of the Department of Health can provide consent for deviations from specified requirements, such as labelling standards, to ensure the safe and effective use of therapeutic goods. In this instance, the consent granted under sections 14 and 14A of the Act pertains specifically to the temporary use of outdated sponsor names on the labels of peginterferon beta-1a products supplied by Biogen Australia Pty Ltd. This consent applies to batches of the specified products that are either warehoused in Australia, already produced and packaged for distribution in Australia but held overseas, or currently in production for Australia. The consent does not extend to any other products or changes beyond the specified sponsor name alteration. It is effective from 29 June 2015 until 24 June 2017 and is subject to specific conditions, including the requirement that the sponsor update the Australian Register of Therapeutic Goods with the new company name within three months of the change and submit revised labels and product information for TGA approval.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 allow the delegate of the Secretary of the Department of Health to consent to certain variations in the supply of therapeutic goods. In this case, the delegate consented to the supply of peginterferon beta-1a products under specific conditions, primarily due to a change in the sponsor name from Biogen Idec Australia Pty Ltd to Biogen Australia Pty Ltd. The consent (paragraphs 1 and 2) allows for the temporary supply of products with outdated labels bearing the old sponsor name until the new labels are approved by the Therapeutic Goods Administration (TGA) and implemented.
The obligations imposed by this consent are detailed and specific. Firstly, the consent applies only to batches warehoused in Australia, those already produced and labelled for Australia and held overseas, or those currently in production for Australia (paragraph 3). Secondly, the only change permitted to the labels is the modification of the sponsor name. Other sponsor contact information, such as telephone and address details, must remain unchanged (paragraph 4). Moreover, the sponsor must ensure that electronic contact information is redirected appropriately (paragraph 5). Lastly, the sponsor is required to notify the change in sponsor name for the Australian Register of Therapeutic Goods (ARTG) entries within three months of the change, in accordance with Regulations 10A and 10F of the Therapeutic Goods Regulations 1990 (paragraph 6). The sponsor must also submit changes to labels and Product Information for approval under section 9D of the Act (paragraph 7).
Failure to comply with the conditions set out in the consent could result in serious consequences. While the Therapeutic Goods Act 1989 does not explicitly state penalties for breaching this specific consent, general provisions in the Act apply. Under the Act, breaches can lead to both civil and criminal penalties. Civil penalties can include fines, and in severe cases, criminal penalties may include imprisonment. The specific penalties depend on the severity and nature of the breach but can be substantial, reflecting the importance of ensuring the safety and efficacy of therapeutic goods in Australia. It is therefore crucial for the sponsor to adhere strictly to the terms of the consent to avoid any legal repercussions.