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 HOUSE DUST MITES EXTRACT european house dust mite and american house dust mite 10.0 IR/ mL injection suspension vial [AUST R 132680]
- ALUSTAL HOUSE DUST MITES EXTRACT european house dust mite and american house dust mite injection suspension vial composite pack [AUST R 132725]
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.
(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 products, 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 products 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, provides a legislative framework for the regulation of therapeutic goods, including medicines, in Australia. This Act was introduced to address the need for a comprehensive regulatory system that ensures the safety, quality, and efficacy of therapeutic goods available to the public. Within this Act, the Therapeutic Goods Administration (TGA) has the authority to oversee the supply and standards of these goods. The specific notice under sections 14 and 14A of the Act, issued on 1 December 2015, grants consent for the supply of certain house dust mite extract products that do not fully comply with labelling requirements, contingent on specified conditions to mitigate associated risks. These conditions include the addition of necessary information on over labels and the distribution of risk-mitigating communications to healthcare professionals.
Scope and Application
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, applies to the regulation of therapeutic goods in Australia, ensuring that such goods meet safety, quality, and efficacy standards. This legislation is enforced by the Therapeutic Goods Administration, a division of the Department of Health, and applies to all therapeutic goods supplied in Australia, including medicines, medical devices, and blood and blood components. The Act covers a wide range of entities, including manufacturers, importers, sponsors, and suppliers, and governs their conduct in the supply of therapeutic goods within Australia. The legislation also extends its reach through subordinate instruments, which may provide further details on the application and enforcement of the Act. Notably, the Act includes specific exclusions and exemptions, such as for therapeutic goods used for personal or domestic purposes, and may apply thresholds that determine the level of regulation required for certain goods. This Act thus provides a comprehensive framework for the regulation of therapeutic goods in Australia, ensuring that they are safe and of high quality for public use.
Key Provisions
The Therapeutic Goods Act 1989, as amended, includes sections 14 and 14A that allow for specific consents to be given for therapeutic goods that do not fully comply with certain regulatory requirements. In this instance, sections 14 and 14A have been invoked to permit the supply of specific house dust mite extract products that do not meet the labelling requirements outlined in the Therapeutic Goods Order No 69 (paragraphs 3(2)(c), (j), (k), (h), 3(5)b(i), (ii), 3(10)(a), (g) and 7(1)(a)(iv)). These products, ALUSTAL HOUSE DUST MITES EXTRACT european house dust mite and american house dust mite, are supplied in two forms: 10.0 IR/mL injection suspension vial and a composite pack. The consent provided by the Therapeutic Goods Administration (TGA) allows for these products to be supplied without full compliance with certain labelling requirements, such as the absence of active ingredient names as per the Australian Approved Name (AAN), strength in terms of IR/mL or IC/mL, directions for use, and the word ‘Refrigerate’ as part of the storage condition, among others.
Under the Therapeutic Goods Act 1989, the obligations imposed on the parties governed by this consent include several key measures to mitigate the risks associated with the non-compliance of the product labelling. Firstly, the sponsor must affix additional over labels to the front main panel of the outer box. These labels 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. Secondly, the outer box must include the Australian product information, which contains other important details such as the quantity of excipients, active ingredients as per the AAN, and directions for use. Additionally, a "Dear Doctor" letter must be provided with the products, detailing the situation regarding the interim labels. To further mitigate risks, the alternative ingredient name must be included in the order forms for the products, and the manufacturer's product codes must also be included in the order forms.
Failure to comply with the conditions of the consent granted under sections 14 and 14A of the Therapeutic Goods Act 1989 may result in both civil and criminal consequences. The specific penalties for breaches of the Therapeutic Goods Act 1989 can vary widely depending on the nature and severity of the breach. Civil penalties may include fines, while criminal penalties could include imprisonment, depending on the severity of the breach and whether it was intentional or negligent. The exact penalties are not specified in the consent but would be determined in accordance with the general provisions of the Therapeutic Goods Act 1989 and any other applicable legislation. It is crucial for the sponsor to adhere to the outlined conditions to avoid legal repercussions.