COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 1 December 2015, a delegate of the Secretary of the Department of Health, on the application of Regulatory Concepts, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- ALUSTAL EXTRACT OF TWELVE GRASSES 10 IR/mL injection suspension vial [AUST R 132849]
- ALUSTAL EXTRACT OF TWELVE GRASSES injection suspension vial composite pack [AUST R 132850]
that do not conform with the requirements of paragraphs 3(2)(c), (j), (k), (h), 3(5)b(i),(ii), 3(10)(a),(g) and 7(1)(a)(iv) of the Therapeutic Goods order No 69 – General requirements for labels for medicines, in that:
(i) generic outer box with affixed over labels provided do not include the following:
- Active ingredient name as per the AAN (noting that labels contains the scientific name which is recognised by physicians)
- Strength in terms of IR/mL or IC/mL (although this is included on the vial labels inside the box)
- Direction for use
- The statement “Single patient use only” although there is a statement that states: NPP: NAMED Patient Product
- Quantities of Excipients
- The word ‘Refrigerate’ as part of the storage condition
- The batch number prefix
(ii) generic vial labels do not include the following:
- Sponsor’s name or logo
- Active ingredient name as per AAN (noting that labels contains the scientific name which is recognised by physicians)
- Dosage form (suspension)
The consent is effective from 1 December 2015 until 31 March 2016.
The consent is subject to the following conditions:
- An assurance that sponsor will add an additional over label to the front main panel label on the box as contained in the application letter dated 3 November 2015. These extra over labels will include the following information:
- SUSMP signal headings: PRESCRIPTION ONLY MEDICINES and KEEP OUT OF REACH OF CHILDREN in sans serif, bold capital letters not less than 1.5 mm in height
- The AUST R number for the specific product
- Sponsor’s name and address
- Stallergens product code such as 3I51 or 3I5M. The numbers relate to the specific allergen while the ‘I’ and the ‘M’ identify the initiation or maintenance packs.
2. An assurance that the outer box will also include the Australian product information which does include other important information such as the quantity of excipient, active ingredients as per the Australia Approved Name and Directions for use.
3. An assurance to mitigate the risks posed by the use of these generic labels by providing with the product a “Dear Doctor “ letter advising about the situation with regards to the use of these interim labels.
4. The alternative ingredient name will be included in the order forms for the product so as to mitigate the risk that the ingredients names on the generic labels were not Australian Approved Names.
5. An assurance that the manufacturer’s product codes are also included in the order forms and so provide a second check point for the doctor as part of the risk mitigation procedure.
Overview
The Therapeutic Goods Act 1989 was enacted to provide a legislative framework for the regulation of therapeutic goods in Australia, addressing the need for ensuring the safety, quality, and efficacy of such goods. This Act was passed by the Parliament of Australia and its primary policy objective is to protect public health by regulating the supply, advertising, and development of therapeutic goods. In December 2015, a consent was granted under sections 14 and 14A of this Act, allowing the supply of certain grass pollen extract products that did not fully conform to the labelling requirements set out in the Therapeutic Goods Order No 69. This consent was issued by a delegate of the Secretary of the Department of Health in response to an application by Regulatory Concepts, and it was effective from 1 December 2015 until 31 March 2016. The consent included specific conditions to mitigate the risks associated with the non-compliance of the product labels, such as the provision of additional over labels and a "Dear Doctor" letter to inform healthcare professionals about the labelling situation.
Scope and Application
The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, ensuring that these products are safe, of acceptable quality, and properly represented. The Act applies to all therapeutic goods, including medicines, medical devices, and blood and blood components, which are intended for use in humans or animals. It encompasses entities such as manufacturers, importers, and sponsors who are responsible for the therapeutic goods, ensuring compliance with the standards set by the Therapeutic Goods Administration (TGA). The Act's jurisdictional reach is national, applying across the Commonwealth of Australia and extending to territories and external affairs. Certain exclusions and exemptions apply, such as for goods used for research purposes or in clinical trials under specific conditions. The Act also allows for the application of subordinate instruments to extend or restrict its application, ensuring flexibility in regulatory measures. In this specific instance, the consent granted under sections 14 and 14A allows for certain deviations in labelling for ALUSTAL EXTRACT OF TWELVE GRASSES injection suspension vials, subject to strict conditions aimed at mitigating risks and ensuring patient safety.
Key Provisions
Under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), a delegate of the Secretary of the Department of Health has permitted the supply of ALUSTAL EXTRACT OF TWELVE GRASSES injection suspension vials and composite packs, which do not fully comply with the labelling requirements specified in Therapeutic Goods Order No 69. This consent, effective from 1 December 2015 until 31 March 2016, allows for the supply of the specified products despite certain deficiencies in their labelling. The consent is granted subject to several conditions to ensure patient safety and compliance with regulatory standards. For instance, the outer box must include an additional over label with crucial information such as the SUSMP signal headings, the AUST R number, the sponsor’s name and address, and the Stallergens product code.
The obligations imposed by this Act on the parties involved include ensuring that the product labels are as complete and informative as possible within the permitted timeframe. The sponsor must affix an over label on the front main panel of the outer box, which includes specific headings, the AUST R number, the sponsor’s name and address, and the product code. Additionally, the outer box must incorporate the Australian product information, which encompasses details such as the quantity of excipients, active ingredients as per the Australia Approved Name, and directions for use. The sponsor is also required to issue a “Dear Doctor” letter to inform healthcare providers about the interim labelling situation and to include the alternative ingredient name in the order forms to mitigate any confusion regarding the ingredient names on the generic labels.
Failure to comply with the conditions outlined in the consent may result in various consequences. Under the Act, there may be enforcement actions taken for non-compliance, which could include fines or other penalties. Although specific penalties are not detailed in the text, breaches of the Therapeutic Goods Act 1989 can lead to substantial financial penalties and other legal repercussions. The Act empowers the Therapeutic Goods Administration to take appropriate measures to ensure that therapeutic goods meet the necessary safety, quality, and efficacy standards. Non-compliance not only risks these penalties but also undermines public trust in the healthcare system by potentially compromising patient safety.