COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 26 May 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 Takeda Pharmaceuticals Australia Pty Ltd, gave consent to the supply of
- brentuximab vedotin (rch) (ADCETRIS) 50 mg powder for injection vial [AUST R 203372]
that does not conform with the requirements of subsections 3(2)(j), 3(2)(k), 3(2)(l) and 3(5)(c), of the Therapeutic Goods Order No 69 – General requirements for labels for medicines (TGO 69), in that storage conditions, direction for use, the name, the address of the Sponsor and the following text is included on the outer carton but omitted on the vial label.
“For intravenous use after reconstitution and dilution, Don’t administer the reconstituted solution undiluted. Refer to the enclosed package.”
The consent is effective from 26 May 2015 until 31 May 2017.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- That ADCETRIS vial will be supplied in a sealed tamper evidence outer carton that contains all the information required to meet TGO 69 requirements and to support the safe and effective use of ADCETRIS.
2. That additional text as the storage conditions, direction for use, the name, the address of the sponsor and the following text will be included on the outer carton to make it clear to the reader.
3. That product information will be included as pack insert, as required for all injectable medicines.
“For intravenous use after reconstitution and dilution, don’t administers the reconstituted solution undiluted. Refer to the enclosed package.”
4. That labels to which this consent applies are those previously approved and arrangements are in place for the prompt referral of any queries or complaints concerning the product.
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the quality, safety, efficacy, and timely availability of therapeutic goods, including medicines, medical devices, and blood products. This Act provides the legal framework for the Therapeutic Goods Administration (TGA) to control the therapeutic goods market. In addressing potential gaps or problems in the regulation of therapeutic goods, the Act seeks to ensure that all products available in Australia meet the required standards and are safe for consumers. The Act empowers the TGA to issue consents and impose conditions to ensure compliance with the regulatory standards, as exemplified by the consent given for the supply of brentuximab vedotin (rch) (ADCETRIS) under sections 14 and 14A. This legislative framework is designed to safeguard public health by ensuring that therapeutic goods meet stringent requirements before they are made available to the public.
Scope and Application
The Therapeutic Goods Act 1989, under sections 14 and 14A, applies to pharmaceutical entities seeking to supply therapeutic goods that do not conform to specified regulatory requirements, including labelling standards as set out in the Therapeutic Goods Order No 69. This particular application concerns Takeda Pharmaceuticals Australia Pty Ltd and its product ADCETRIS, a medicine that has been granted a specific consent to supply despite not meeting certain labelling requirements. The consent granted by the delegate of the Secretary of the Department of Health allows for the supply of ADCETRIS with specific conditions to ensure that the deficiencies are addressed through alternative labelling solutions. This consent is effective from 26 May 2015 until 31 May 2017, and it encompasses the requirement that the product be supplied in a tamper-evident outer carton containing all necessary information, including storage conditions, directions for use, the name and address of the sponsor, and explicit warnings against administering the reconstituted solution undiluted. The consent also mandates that product information, including the aforementioned warnings, be included in the pack insert. The application of this Act is within the Commonwealth jurisdiction, impacting pharmaceutical entities and their products across Australia.
Key Provisions
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, pertain to the consent given by the delegate of the Secretary of the Department of Health for the supply of certain therapeutic goods. In this case, the consent was given to Takeda Pharmaceuticals Australia Pty Ltd for the supply of brentuximab vedotin (rch) (ADCETRIS) 50 mg powder for injection vial (AUST R 203372), which does not fully comply with the requirements of TGO 69. The consent permits the supply of this medicine under specific conditions designed to ensure that the required information is adequately communicated to users (subsection 14(1)).
The conditions imposed on Takeda Pharmaceuticals Australia Pty Ltd under this consent include ensuring that the ADCETRIS vial is supplied in a sealed tamper-evident outer carton that contains all necessary information to meet TGO 69 requirements. This outer carton must include clear details about storage conditions, directions for use, the name and address of the sponsor, and a specific warning: “For intravenous use after reconstitution and dilution, don’t administer the reconstituted solution undiluted. Refer to the enclosed package.” Additionally, the product information must be included as a pack insert, as mandated for all injectable medicines. These obligations are critical to ensuring that healthcare providers and patients have all the information they need to use the medication safely and effectively (subsection 14A(2)).
Failure to comply with the conditions outlined in the consent could result in legal repercussions. The Therapeutic Goods Act 1989 sets out various offences and penalties for breaches. While the specific penalties are not detailed in the Gazette extract, breaches of the Act can lead to substantial fines, imprisonment, or both, depending on the severity of the offence. The maximum penalties for offences under the Act can be significant, reflecting the importance of adhering to the regulations designed to protect public health and safety. The Act also allows for civil and criminal proceedings to be taken against those who fail to comply with its provisions, underscoring the seriousness with which non-compliance is treated.