COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 21 December 2015, a delegate of the Secretary of the Department of Health, on the application of Sanofi Pasteur Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- pertussis vaccine (TRIPACEL) - acellular combined with diphtheria and tetanus toxoids (adsorbed) 0.5 mL injection vial [AUST R 63120]
that do not conform with the requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the product name is not on the label. The approved US name, Daptacel will be on the vial labels rather than the Australian registered Tripacel and the requirements of the European Pharmacopoeia, in that it is tested to United States, rather than Australian specifications, as detailed in the application letter.
AUST R | Product | Batch number |
63120 | pertussis vaccine (TRIPACEL) - acellular combined with diphtheria and tetanus toxoids (adsorbed) 0.5 mL injection vial | C5014AA expiry 29 July 2018 |
The consent is effective from 21 December 2015 until the batch number is exhausted.
The consent is subject to the following conditions:
- A ‘Dear Healthcare Professional’ letter identical to that provided to the Therapeutic Goods Administration (TGA) on 11 December 2015 will be supplied with each affected batch warning that the age indication on the US vial is incorrect;
- The vials will be repacked into the approved Australian carton together with the approved Australian Product Information leaflet at the site you have proposed in the letter dated 19 November 2015;
- The company will provide TGA with a copy of the CBER Release Certificate from the FDA relating to the above batch and
- Normal TGA lot release processes will apply to this batch except that the US lot release protocol is different from the Australian version.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the importation, supply, and other aspects of therapeutic goods in Australia, ensuring they meet quality, safety, and efficacy standards. This Act addresses the gap in regulatory oversight necessary to protect public health by providing a comprehensive legal framework for the control of therapeutic goods. The Act is administered by the Therapeutic Goods Administration (TGA), a department within the Australian Government's Department of Health. The policy objective, as indicated by this particular consent for the importation and supply of pertussis vaccine (TRIPACEL), is to ensure that therapeutic goods meet Australian standards while also accommodating exceptional circumstances that may arise, such as variations in international specifications and labelling requirements. This flexibility allows for the timely availability of necessary medical products, provided they are appropriately managed to maintain safety and efficacy.
Scope and Application
The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Commonwealth of Australia's Department of Health, applies to the regulation of therapeutic goods sold or supplied within Australia. This includes the importation, supply, and exportation of therapeutic goods, which encompasses medicines, medical devices, blood, and tissues. The Act applies to a broad range of entities, including individuals, companies, and other organisations engaged in the manufacturing, importation, or distribution of therapeutic goods. It applies nationally across the Commonwealth, states, and territories, ensuring a cohesive regulatory environment for therapeutic goods throughout Australia. The Act includes provisions that allow for certain exclusions and exemptions, often delineated in subordinate legislation or specific orders. For instance, the consent granted under sections 14 and 14A pertains to specific conditions allowing the importation and supply of a pertussis vaccine that does not conform to Australian labelling and testing standards, provided that certain conditions are met, such as the inclusion of a warning letter and adherence to Australian packaging and information standards. This demonstrates the Act’s flexibility in accommodating exceptional cases while maintaining stringent regulatory oversight.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 provide a mechanism for the Secretary of the Department of Health to consent to the importation and supply of therapeutic goods that do not strictly comply with certain requirements of the Therapeutic Goods Regulations. In this case, the consent allows for the importation and supply of a pertussis vaccine (TRIPACEL) that does not conform to the labelling and testing requirements set out in Therapeutic Goods Order No. 69 (paragraph 1). This consent was granted to Sanofi Pasteur Australia Pty Ltd on 21 December 2015, for a specific batch of the vaccine (paragraph 2). The consent is effective until the specified batch number is exhausted, and it is subject to certain conditions designed to ensure the safe and effective use of the vaccine.
The obligations imposed by this consent on Sanofi Pasteur Australia Pty Ltd include the requirement to supply a 'Dear Healthcare Professional' letter with each batch of the vaccine, warning that the age indication on the US vial is incorrect (paragraph 4(a)). Additionally, the company must repack the vials into the approved Australian carton, which includes the approved Australian Product Information leaflet (paragraph 4(b)). Sanofi Pasteur Australia Pty Ltd is also required to provide the Therapeutic Goods Administration with a copy of the CBER Release Certificate from the FDA relating to the batch in question (paragraph 4(c)). Finally, the company must adhere to normal TGA lot release processes, with the exception that the US lot release protocol differs from the Australian version (paragraph 4(d)).
Failure to comply with the conditions of the consent may result in legal consequences. While the Therapeutic Goods Act 1989 does not specify the exact penalties for non-compliance in this instance, breaches of the Act can lead to civil or criminal penalties. Civil penalties may include fines of up to $222,200 for individuals and $1,111,000 for corporations, while criminal penalties may include imprisonment for up to five years for individuals and fines of up to $5.5 million for corporations (sections 31 and 32). It is important for Sanofi Pasteur Australia Pty Ltd to adhere to the conditions of the consent to avoid any potential legal repercussions.