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 Concept, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- ALUSTAL AMERICAN DUST MITE EXTRACT american house dust mite 10.0 IR/mL injection suspension vial [AUST R 132679]
- ALUSTAL AMERICAN DUST MITE EXTRACT american house dust mite injection suspension vial composite pack [AUST R 132724]
that do not conform with the requirements of paragraph 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 the 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 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 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 Commonwealth of Australia Parliament, was introduced to regulate therapeutic goods in Australia, ensuring they are safe, of high quality, and performing as represented. This Act provides the legislative framework to manage the supply, advertising, and regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. Section 14 of the Act empowers the Secretary to grant consents for non-compliance with certain regulatory requirements, as was the case in the notice issued on 1 December 2015 by a delegate of the Secretary. This consent aimed to address the issue of non-compliance with specific labelling requirements for therapeutic goods supplied by Regulatory Concept. The policy objective underlying this consent was to allow for the temporary supply of these goods while mitigating any potential risks to public health and safety.
Scope and Application
The Therapeutic Goods Act 1989 applies to any therapeutic goods within Australia, which encompass a broad range of products including medicines, medical devices, blood, tissues, and therapeutic goods related to human reproduction. This Act, administered by the Therapeutic Goods Administration (TGA), regulates the importation, supply, and manufacturing of these goods to ensure their quality, safety, and efficacy. The Act applies to both individuals and entities such as pharmaceutical companies and medical device manufacturers, covering their conduct and transactions involving therapeutic goods. The Act has national jurisdiction, governing therapeutic goods throughout the Commonwealth of Australia. However, certain exclusions apply, such as to goods used solely for personal use and not for supply, and goods used for research purposes that are not intended for therapeutic use in humans. The Act’s scope can be extended or restricted through subordinate instruments, such as regulations and guidelines, which provide further detail on specific aspects of therapeutic goods regulation. For instance, the Therapeutic Goods (Advertising) Regulations 2001 elaborate on advertising requirements for therapeutic goods, ensuring that promotional materials comply with specific standards to prevent misleading or deceptive conduct.
Key Provisions
The Therapeutic Goods Act 1989, particularly sections 14 and 14A, grants authority to the Department of Health to issue consents that allow the supply of therapeutic goods that do not fully comply with certain regulatory standards. In this instance, sections 14 and 14A were invoked to permit the supply of ALUSTAL AMERICAN DUST MITE EXTRACT products that fail to meet specific labelling requirements as outlined in the Therapeutic Goods Order No 69 (subsections 3(2)(c), (j), (k), (h), 3(5)b(i), (ii), 3(10)(a), (g) and 7(1)(a)(iv)). These deficiencies include the omission of critical information such as the active ingredient name in Australian Approved Name (AAN) format, the strength of the product, directions for use, and the batch number prefix on the outer box, as well as the sponsor’s name, dosage form, and product code on the vial labels.
The Act imposes several obligations on the parties involved to mitigate the risks associated with the non-compliance of these products. Firstly, the sponsor must affix an additional over label on the front main panel of the outer box, including critical information such as the AUST R number, sponsor’s name and address, and Stallergens product code. Secondly, the outer box must contain comprehensive Australian product information, detailing quantities of excipients, active ingredients in AAN, and directions for use. Thirdly, a "Dear Doctor" letter must be provided with the product to inform physicians of the interim labelling situation. Furthermore, the alternative ingredient name must be included in the order forms, and the manufacturer’s product codes must be provided to offer an additional checkpoint for doctors.
Failure to comply with the conditions set forth in the consent can lead to various legal consequences. The Therapeutic Goods Act 1989 does not explicitly state the penalties for non-compliance in this specific context; however, breaches of the Act can generally result in both civil and criminal penalties. Civil penalties may include fines, and criminal penalties may include imprisonment, reflecting the seriousness of ensuring the safety and efficacy of therapeutic goods. The maximum penalties for breaches can vary depending on the severity and intent of the non-compliance but are intended to enforce adherence to therapeutic goods regulations and protect public health.