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 THREE GRASSES 10 IR/mL injection suspension vial [AUST R 132845]
- ALUSTAL EXTRACT OF THREE GRASSES injection suspension vial composite pack
[AUST R 132846]
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 and
- 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, enacted by the Australian Parliament, addresses the regulation of therapeutic goods in Australia, ensuring that such goods are of acceptable quality and their benefits outweigh any risks. The Act empowers the Therapeutic Goods Administration (TGA) to regulate therapeutic goods, including medicines, medical devices, and blood and blood components, with the aim of protecting public health and safety. In a specific case, on 1 December 2015, the Department of Health, via a delegate of the Secretary, granted a consent under sections 14 and 14A of the Act for the supply of specific grass extract injection suspensions that did not fully comply with labelling requirements. The consent was subject to conditions aimed at mitigating risks to public health, including the addition of specific information to the product labels and providing additional communication to healthcare professionals about the use of interim labels. This action underscores the TGA's role in balancing regulatory compliance with the availability of therapeutic goods that meet public health needs.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods, including medicines, in Australia. This legislation provides the legal framework for the control of therapeutic goods to ensure that they meet safety, quality, and efficacy standards. The Act applies to a wide range of entities, including sponsors, manufacturers, importers, and suppliers of therapeutic goods. It also governs the conduct and transactions related to the supply and advertising of therapeutic goods. The Act’s jurisdiction extends across the Commonwealth of Australia, with additional state and territory legislation providing further regulation. Specific exclusions and exemptions may apply, such as for research or clinical trials under certain conditions, but these are typically detailed in subordinate instruments or specific orders. The Therapeutic Goods Act 1989 allows for the issuance of consents and notices to accommodate particular circumstances, as illustrated by the consent granted for the supply of ALUSTAL EXTRACT OF THREE GRASSES injection suspension vial, which allows for certain label deficiencies to be overlooked under strict conditions to manage the risk associated with these non-compliant labels.
Key Provisions
The Therapeutic Goods Act 1989, under sections 14 and 14A, allows for a delegate of the Secretary of the Department of Health to consent to the supply of therapeutic goods that do not fully comply with the requirements of certain Therapeutic Goods Orders. In this instance, sections 14 and 14A of the Act were applied to the supply of ALUSTAL EXTRACT OF THREE GRASSES 10 IR/mL injection suspension vials and composite packs, which do not meet several label requirements specified in the Therapeutic Goods Order No 69 – General requirements for labels for medicines. Despite these non-conformities, the delegate consented to the supply of these products on certain conditions, primarily focusing on risk mitigation and additional information provision.
The Act imposes specific obligations on the parties involved, particularly the sponsor, to ensure that the therapeutic goods are supplied with the necessary information to mitigate any potential risks to consumers. For the ALUSTAL products, the sponsor must add an over label to the front main panel of the outer box. This over label must include specific information such as the SUSMP signal headings, PRESCRIPTION ONLY MEDICINES and KEEP OUT OF REACH OF CHILDREN, the AUST R number, the sponsor’s name and address, and the Stallergens product code. Additionally, the outer box must contain Australian product information, which includes details such as the quantity of excipients, the active ingredients as per the Australia Approved Name, and directions for use. The sponsor is also required to provide a "Dear Doctor" letter with the product, explaining the situation with the interim labels and the alternative ingredient name included in the order forms.
Failure to comply with the conditions outlined in the consent, or with the Therapeutic Goods Act 1989 and the Therapeutic Goods Order No 69, can result in significant legal consequences. Although the specific penalties are not detailed in the given text, under the Act, breaches of therapeutic goods regulations can lead to both civil and criminal penalties. Civil penalties can include fines, while criminal penalties can include imprisonment, depending on the severity and intent of the breach. The Act is designed to ensure that therapeutic goods supplied in Australia meet the necessary standards for safety, quality, and efficacy, thereby protecting public health.