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 FIVE GRASSES 10 IR/mL injection suspension vial [AUST R 132847]
- ALUSTAL EXTRACT OF FIVE GRASSES injection suspension vial composite pack [AUST R 132848]
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 vials inside the box)
- Direction for use
- The statement “Single patient use only” but 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 (it is present using the scientific name which is recognised by the 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. 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 PI which does include other important information such as the quantity of excipient ingredients, 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 to regulate the provision of therapeutic goods in Australia, including medicines, medical devices, and blood and blood components, was amended in 2015 to allow for the supply of therapeutic goods that do not fully comply with labelling requirements under certain conditions. This was introduced to address the need for flexibility in exceptional circumstances, such as the supply of therapeutic goods with minor labelling deficiencies that do not significantly impact their safety or efficacy. The Department of Health, through its delegate, granted consent under sections 14 and 14A of the Act to the supply of ALUSTAL EXTRACT OF FIVE GRASSES 10 IR/mL injection suspension vials, which did not fully conform to labelling requirements. The policy objective of this consent was to ensure patient safety and proper information dissemination while allowing the continuation of essential medical treatments under strict conditions that mitigate any potential risks arising from the labelling deficiencies.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. Section 14 of the Act allows for the consent to supply therapeutic goods that do not fully comply with specific labelling requirements, provided certain conditions are met to mitigate any potential risks. In this instance, the Act applies to Regulatory Concepts, the sponsor of the therapeutic goods in question, and the therapeutic goods themselves, which are allergen extracts supplied in non-compliant packaging. The consent granted under the Act is effective from 1 December 2015 until 31 March 2016, and is subject to conditions designed to ensure patient safety and compliance with regulatory standards. These include the provision of additional over labels on the product packaging, inclusion of the Australian Product Information leaflet, and communication with healthcare professionals to mitigate risks associated with the non-compliant labelling. The Act's scope is national, covering the entire Commonwealth of Australia, and is enforced by the Therapeutic Goods Administration, an agency of the Department of Health.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) includes specific provisions regarding the labelling and supply of therapeutic goods. In this instance, sections 14 and 14A pertain to the supply of therapeutic goods that do not fully comply with the labelling requirements specified in the Therapeutic Goods Order No 69. Specifically, the consent granted under these sections allows for the supply of two types of ALUSTAL EXTRACT OF FIVE GRASSES products, which do not conform to several labelling requirements outlined in the order (sections 14(1)(a) and (b), 14A(1)(a) and (b)).
The obligations imposed by the Act in this case include the requirement for the sponsor to provide additional over labels on the product boxes. These over labels must include critical information such as the SUSMP signal headings, PRESCRIPTION ONLY MEDICINES and KEEP OUT OF REACH OF CHILDREN, in bold, capital letters. They must also include the AUST R number, the sponsor's name and address, and the Stallergens product code. Furthermore, the outer box must contain the Australian Product Information (PI), which includes details such as the quantity of excipient ingredients, active ingredients as per the Australian Approved Name, and directions for use. The sponsor must also issue a "Dear Doctor" letter to advise healthcare professionals about the interim labels and include the alternative ingredient names on order forms to prevent confusion.
Failure to comply with the conditions set out in the consent may result in various consequences. Under the Therapeutic Goods Act 1989, breaches of the labelling requirements can be considered an offence. The maximum penalties for contravening the Act include fines and imprisonment. Specifically, for corporations, the maximum penalty can be significant, often reaching into the thousands of Australian dollars, while for individuals, the penalties can also be substantial, including fines of up to $22,000 and/or imprisonment for up to 12 months. Additionally, civil and criminal consequences can include product recalls, injunctions, and further regulatory action to ensure compliance with the Act.