COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 9 December 2015, a delegate of the Secretary of the Department of Health, on the application of Biogen Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- natalizumab (TYSABRI) 300 mg/15 mL concentrate for infusion vial [AUST R 112372]
that do not conform with the requirements of paragraph 3(2)(l)of the Therapeutic Goods Order No 69 – General requirements for labels for medicines, in that the sponsor’s old street address (for all batches given in Table 1) will be on the product labels until such time as labels with the revised sponsor address are approved by the Therapeutic Goods Administration and implemented in the supply chain.
Table 1: List of batches with sponsor’s old street address (Suite 1, Level 5, 123 Epping Road North Ryde) and old name (Biogen Idec Australia Pty Ltd) on the labels:
ARTG Number | Product | Batch Number(s) |
112372 | natalizumab (TYSABRI) 300 mg/15 mL concentrate for infusion vial | 150549A 150321A 150965A |
The consent is effective from 9 December 2015 until 24 June 2017.
The consent is subject to the following conditions:
- This consent applies to those 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.
- Other sponsor’s valid contact information such as telephone and postal address details will remain the same.
- The new office location is clearly signposted within the building and postal communications are being received at the new office.
- The sponsor will submit changes to labels and product information for approval under section 9D of the Act to reflect the revised sponsor’s name and address.
Overview
The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament of Australia, was introduced to regulate the supply, quality, and safety of therapeutic goods, including medicines, within the country. One of its key objectives is to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. In addressing a specific issue with the labelling of certain batches of the medicine natalizumab (TYSABRI), the Therapeutic Goods Administration, as a delegate of the Secretary of the Department of Health, provided consent under sections 14 and 14A of the Act. This consent allowed for the temporary use of product labels that did not conform to the specified labelling requirements, due to the outdated sponsor’s address still being printed on the labels. The consent was granted to Biogen Australia Pty Ltd, permitting the continued supply of affected batches until updated labels could be approved and implemented. This action was taken to facilitate a smooth transition while ensuring patient safety and compliance with regulatory standards.
Scope and Application
The Therapeutic Goods Act 1989 provides the legal framework for regulating therapeutic goods in Australia, including medicines, medical devices, and blood and blood components. Under sections 14 and 14A of the Act, a delegate of the Secretary of the Department of Health has the authority to consent to certain deviations from the regulatory requirements, subject to specific conditions. In this instance, the delegate granted consent to Biogen Australia Pty Ltd for the supply of natalizumab (TYSABRI) vials with product labels that do not conform to the Therapeutic Goods Order No 69 due to the inclusion of an old sponsor address. This consent applies to batches of the product that are either warehoused in Australia, already produced and labelled for Australia but held overseas, or currently in production for the Australian market. The consent is effective from 9 December 2015 until 24 June 2017 and is contingent upon the sponsor maintaining other valid contact information, ensuring the new office location is clearly signposted, and submitting changes to labels and product information for approval to reflect the revised sponsor name and address.
Key Provisions
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provides a framework for the Therapeutic Goods Administration (TGA) to grant consents for the supply of therapeutic goods that do not fully comply with certain legislative requirements. In this case, under section 14, a delegate of the Secretary of the Department of Health has consented to the supply of natalizumab (TYSABRI) 300 mg/15 mL concentrate for infusion vial [AUST R 112372], which does not conform to the labelling requirements stipulated in the Therapeutic Goods Order No 69. The consent allows for the continued supply of these specific batches, bearing the sponsor’s old street address, until the labels are updated and approved by the TGA.
Under section 14A of the Act, the consent granted to Biogen Australia Pty Ltd is conditional and must adhere to certain terms. These conditions include the application to batches that are warehoused in Australia, those produced, labelled, and packed for Australia but held overseas, or those in production for Australia. Additionally, the consent ensures that all other sponsor contact information remains valid, and the new office location is clearly signposted and receiving postal communications. The sponsor is also required to submit changes to labels and product information under section 9D of the Act to reflect the revised sponsor’s name and address.
The Therapeutic Goods Act 1989 imposes several obligations and requirements on entities involved in the supply of therapeutic goods. Firstly, sponsors must ensure that all products supplied comply with the legislative and regulatory requirements unless a consent has been granted under sections 14 and 14A. In this instance, Biogen Australia Pty Ltd must ensure that all other sponsor contact information remains accurate and that the new office location is clearly identified. Furthermore, the sponsor must submit all changes to labels and product information for TGA approval. These obligations are critical to maintaining the integrity of the therapeutic goods supply chain and ensuring consumer safety.
Breach of the provisions of the Therapeutic Goods Act 1989 can result in both civil and criminal consequences. Under section 90 of the Act, a person who contravenes certain provisions may be liable to a fine of up to $222,200 for an individual or $1,111,100 for a body corporate. Additionally, under section 92, a person who causes or permits a contravention may be liable for a penalty of up to $1,111,100 for an individual or $5,555,500 for a body corporate. These penalties underscore the importance of compliance with the Act’s provisions to avoid severe repercussions.