Consent Given Pursuant to Sections 14 and 14A to the Supply of the Therapeutic Goods Specified by Biogen Australia

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, provides the legislative framework for regulating therapeutic goods, including medicines, in Australia. This Act was introduced to ensure that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy. In accordance with the Act, the Therapeutic Goods Administration (TGA) can grant consents for certain therapeutic goods to be supplied in Australia if they do not fully comply with specific regulatory requirements. On 9 December 2015, a delegate of the Secretary of the Department of Health granted consent to Biogen Australia Pty Ltd to supply specific batches of peginterferon beta-1a products under sections 14 and 14A of the Act. The consent was issued to allow the supply of these products with temporary label details, including an outdated sponsor address and name, to manage inventory transitions during changes in the sponsor's contact information. The consent was effective from 9 December 2015 until 24 June 2017, and was subject to specific conditions to ensure the quality and safety of the supplied products.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Commonwealth of Australia’s Department of Health, governs the supply and standards of therapeutic goods within Australia. This Act applies to a wide range of entities, including pharmaceutical companies, medical device manufacturers, and suppliers of therapeutic goods, and encompasses the conduct and transactions involving these goods. The Act’s jurisdiction extends nationally, covering the entire Commonwealth of Australia, ensuring a uniform regulatory environment for therapeutic goods across all states and territories. Under sections 14 and 14A, the Act permits specific exemptions or temporary deviations from certain regulatory requirements, such as labelling standards, under particular conditions. In this instance, the Act authorises the supply of certain batches of peginterferon beta-1a (rch) (PLEGRIDY) with non-compliant labels due to transitional changes in the sponsor’s address and name. This consent is applicable to products already in production, those warehoused domestically, and those stored overseas but intended for the Australian market. The consent is contingent on the sponsor updating the labels and product information to reflect the new address and name, ensuring compliance is restored as soon as practicable.

Key Provisions

Under sections 14 and 14A of the Therapeutic Goods Act 1989, the Secretary of the Department of Health has granted Biogen Australia Pty Ltd consent to supply specific batches of peginterferon beta-1a (rch) (PLEGRIDY) products in Australia. These products include the 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled pen titration pack, the 125 microgram/0.5 mL solution for injection pre-filled pen, the 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled syringe titration pack, and the 125 microgram/0.5 mL solution for injection pre-filled syringe. The consent allows for the continued supply of these products despite non-compliance with certain labelling requirements outlined in the Therapeutic Goods Order No 69. The consent imposes several obligations on Biogen Australia Pty Ltd. The company must ensure that the specified batches listed in Table 1, which are warehoused in Australia, already produced and labelled for Australia and held in overseas warehousing, or currently in production for Australia, continue to be supplied. The consent also requires that the sponsor's old street address and name remain on the product labels until such time as new labels with the revised sponsor address and name are approved and implemented. Furthermore, the sponsor must ensure that other valid contact information, such as telephone and postal address details, remains unchanged for these batches. The new office location must be clearly signposted within the building, and postal communications must be received at the new office. Biogen Australia Pty Ltd must submit changes to labels and product information for approval under section 9D of the Act to reflect the revised sponsor's name and address. Failure to comply with the conditions of the consent may result in legal consequences. Although the Therapeutic Goods Act 1989 does not specify maximum penalties for breaches of consent conditions, non-compliance could lead to enforcement actions, including fines, product recalls, or other regulatory sanctions. The Therapeutic Goods Administration may take action against Biogen Australia Pty Ltd if the company fails to adhere to the consent conditions, potentially leading to civil or criminal penalties.