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 PLANTAIN POLLEN EXTRACT plantago lanceolata 10 IR/mL injection suspension vial [AUST R 132838]
- ALUSTAL PLANTAIN POLLEN EXTRACT plantago lanceolata injection suspension vial composite pack [AUST R 132839]
that do not conform with the requirements of paragraphs 3(2)(c), (j), (k), (h), 3(5)b(i),(ii), 3(10)(a) 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;
- 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
- 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. 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 Parliament of Australia, serves to regulate therapeutic goods in the country, ensuring that products available to consumers are safe and of acceptable quality. This legislation was introduced to address the need for a cohesive regulatory framework that safeguards public health by controlling the supply, quality, efficacy, and safety of therapeutic goods. The Therapeutic Goods Administration, a department within the Commonwealth of Australia, administers the Act to ensure compliance with its provisions. In this context, the Act aims to provide a unified regulatory environment that protects consumers from the risks associated with substandard or improperly labelled therapeutic goods.
On 1 December 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 to Regulatory Concepts for the supply of certain products that did not fully comply with the labelling requirements set out in the Therapeutic Goods Order No 69. This consent was given for a limited period, from 1 December 2015 until 31 March 2016, and was subject to several conditions aimed at mitigating the risks associated with the non-compliant labelling. These conditions included the provision of additional information on the product labels and outer packaging, as well as the distribution of letters to healthcare providers to inform them about the interim labelling situation. The consent aimed to balance the need for timely access to these therapeutic goods with the imperative to protect public health and ensure that consumers receive accurate and complete information about the products they use.
Scope and Application
The Therapeutic Goods Act 1989 applies to any therapeutic goods that are manufactured, represented, or supplied in Australia. This includes a wide range of products such as medicines, medical devices, and blood products, and applies to both individuals and companies involved in the production, distribution, or sale of these goods. The Act also extends to conduct and transactions related to the goods, ensuring compliance with quality, safety, and efficacy standards. Jurisdictionally, the Act operates under the Commonwealth, but it also encompasses state and territory regulations in areas where the Commonwealth does not have exclusive power. However, certain products may be exempt under specific conditions or thresholds, such as goods for personal use or small-scale manufacturing. The Act allows for the application to be further detailed or restricted through subordinate instruments, such as regulations or orders, which provide specific guidance on compliance and enforcement.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) provide a mechanism for the Secretary of the Department of Health to consent to the supply of therapeutic goods that do not fully comply with certain legislative requirements. In this case, sections 14 and 14A permitted the Secretary to consent to the supply of ALUSTAL PLANTAIN POLLEN EXTRACT injection suspensions that did not conform to specific labelling requirements (sections 14(1) and 14A). The consent was granted for a limited period from 1 December 2015 to 31 March 2016, subject to certain conditions designed to mitigate risks associated with the non-compliance.
The obligations imposed on the parties under this consent include several assurances provided by the sponsor, Regulatory Concepts. Firstly, they must affix an additional over label to the front main panel of the outer box that includes specific information such as the product's Prescription Only Medicine signal, the AUST R number, the sponsor's name and address, and the Stallergens product code (section 14(2)). This additional labelling aims to ensure that critical information is visible and accessible to users. Secondly, the outer box must include the Australian product information, which provides detailed information about the product, including the quantity of excipients, active ingredients, and directions for use (section 14(2)). Thirdly, a "Dear Doctor" letter must be provided to advise about the interim use of the labels and the associated risks (section 14(2)). Lastly, the manufacturer's product codes must be included in the order forms to provide a second checkpoint for doctors as part of the risk mitigation procedure (section 14(2)).
Failure to comply with the conditions of the consent may result in various consequences. Although the Act does not explicitly state civil or criminal penalties for non-compliance with the consent conditions, breaches of other provisions of the Act, such as supplying non-compliant therapeutic goods, can result in significant penalties. Under section 26 of the Act, a person who contravenes certain provisions may be liable to a fine of up to $222,200 for an individual and $1,111,000 for a body corporate, depending on the severity of the breach. Additionally, section 36AA of the Act imposes penalties for false or misleading representations regarding therapeutic goods, which can include fines of up to $1,111,000 for individuals and $5,555,000 for bodies corporate. These penalties underscore the importance of adhering to the conditions set forth in the consent and the broader regulatory requirements governing the supply of therapeutic goods in Australia.