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 OLIVE TREE EXTRACT olea europaea 10 IR/mL injection suspension vial
[AUST R 132840]
- ALUSTAL OLIVE TREE EXTRACT olea europaea injection suspension vial composite pack [AUST R 132841]
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 was enacted to provide a regulatory framework for the control of therapeutic goods in Australia, addressing the need for a comprehensive legislative instrument to govern the safety, quality, and efficacy of therapeutic products. The Act was introduced by the Australian Parliament to fill the gap in regulation concerning the provision and oversight of therapeutic goods, including medicines, medical devices, and other health-related products. The primary policy objective of the Act is to ensure that therapeutic goods available to the public meet necessary standards for safety, quality, and efficacy, thereby protecting public health. The Therapeutic Goods Administration (TGA), operating under the Department of Health, is responsible for the administration and enforcement of the Act.
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 specific AlustaL Olive Tree Extract products that did not fully comply with certain labelling requirements stipulated in Therapeutic Goods Order No 69. This consent, which was effective until 31 March 2016, was granted subject to conditions designed to mitigate potential risks, including the provision of additional over labels on the product boxes and the distribution of a "Dear Doctor" letter to inform medical practitioners about the interim labelling situation. These measures were implemented to ensure that despite the non-conformity, the therapeutic goods supplied would still meet the essential safety and informational requirements for consumers and healthcare providers.
Scope and Application
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, applies to the supply of therapeutic goods within Australia, and this particular consent granted by a delegate of the Secretary of the Department of Health pertains to the supply of ALUSTAL Olive Tree Extract injection suspension vials that do not fully comply with certain labelling requirements. The consent allows for the supply of these non-compliant products under specified conditions to address the deficiencies in the labelling, such as the omission of certain mandatory information like the strength in terms of IR/mL, directions for use, and storage conditions. The consent applies to Regulatory Concepts and their products, and it is effective for a limited period from 1 December 2015 until 31 March 2016. The consent is conditional upon the provision of additional over labels, inclusion of Australian product information, and risk mitigation measures including a "Dear Doctor" letter to inform medical practitioners about the interim labelling situation. This Act and its subordinate instruments extend to the entire Commonwealth of Australia, governing the regulation of therapeutic goods across the nation.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 provide the framework for the Secretary of the Department of Health to consent to the supply of therapeutic goods that do not fully comply with certain regulatory requirements. In this instance, the consent granted under these sections pertains to the supply of ALUSTAL OLIVE TREE EXTRACT products, specifically the olea europaea 10 IR/mL injection suspension vial and the injection suspension vial composite pack, which do not meet some labelling requirements specified in the Therapeutic Goods Order No 69 (paragraphs 3(2)(c), (j), (k), (h), 3(5)b(i), (ii), 3(10)(a) and 7(1)(a)(iv)). These deficiencies include the absence of certain information on the outer box and vial labels, such as the strength in terms of IR/mL or IC/mL, directions for use, a "Single patient use only" statement, quantities of excipients, the word "Refrigerate" as part of the storage condition, the batch number prefix, the sponsor’s name or logo, the dosage form (suspension), and other critical details.
The consent granted under sections 14 and 14A imposes several obligations on the parties involved. Firstly, the sponsor must affix additional over labels on the front main panel of the product boxes, ensuring these labels include 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. Secondly, the outer box must include the Australian product information, which encompasses other essential details such as the quantity of excipients, active ingredients, and directions for use. Thirdly, a "Dear Doctor" letter must be provided with the product to inform medical practitioners about the interim use of these labels and to mitigate any risks associated with such use. Lastly, the manufacturer’s product codes must be included in the order forms to serve as an additional checkpoint for doctors.
Failure to comply with the terms and conditions of this consent can result in various legal and administrative consequences. Although the Therapeutic Goods Act 1989 does not explicitly state the specific penalties for breaches of consent granted under sections 14 and 14A, general provisions within the Act allow for significant penalties for non-compliance with therapeutic goods regulations. These penalties can include fines, imprisonment, or both, depending on the severity and intent behind the breach. For instance, under section 33 of the Act, a person who contravenes certain sections can face fines up to $1.1 million for a corporation and $220,000 for an individual, along with potential imprisonment for up to five years. These consequences underscore the importance of adhering to the prescribed conditions to avoid legal repercussions.