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 EUROPEAN DUST MITE EXTRACT european house dust mite 10.0 IR/ mL injection suspension vial [AUST R 132678]
- ALUSTAL EUROPEAN DUST MITE EXTRACT european house dust mite injection suspension vial composite pack [AUST R 132723]
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 It is present using 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 Excipient ingredients and
- The word ‘Refrigerate’ as part of the storage condition
- The batch number prefix
(ii) generic vial labels do not include the following
- Sponsor 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 with 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 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 Australia 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 label 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 ingredient name 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 was enacted to provide for the regulation of therapeutic goods in Australia, ensuring they are safe, of high quality, and effective. This Act was introduced to address the need for a comprehensive regulatory framework governing the manufacturing, supply, and advertising of therapeutic goods, including medicines, medical devices, and blood products. The Therapeutic Goods Administration, established under this Act, is responsible for regulating these goods to protect public health. The policy objective of the Act is to safeguard the health and safety of Australians by ensuring that therapeutic goods are of acceptable quality, performance, and safety. Through mechanisms such as consents and approvals, the Act allows the administration to manage the supply of goods that may not fully conform to certain standards, provided that appropriate safeguards are in place.
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 for the supply of specific European dust mite extract products that did not conform to certain labelling requirements. This consent was issued by the Therapeutic Goods Administration and was effective until 31 March 2016. The consent was granted subject to several conditions designed to mitigate the risks associated with the non-compliance of the product labels, including the provision of additional over labels on the product boxes, inclusion of Australia product information, and distribution of a "Dear Doctor" letter to inform healthcare professionals about the temporary nature of the labels. These measures were intended to ensure that the therapeutic benefits of the products were not compromised while addressing the deficiencies in the labelling.
Scope and Application
The Therapeutic Goods Act 1989 applies to therapeutic goods, their labelling, and advertising within Australia. The Act establishes the Therapeutic Goods Administration (TGA) and regulates the manufacture, supply, and importation of therapeutic goods, which include medicines, medical devices, blood, and tissues. The Act applies to individuals and entities involved in the supply chain of therapeutic goods, including manufacturers, importers, sponsors, and suppliers. The consent granted under sections 14 and 14A of the Act pertains to the specific product ALUSTAL EUROPEAN DUST MITE EXTRACT, which does not conform to certain labelling requirements. The consent is granted for a limited period and is subject to conditions aimed at mitigating the risks associated with the non-compliance. The consent does not alter the scope of the Act but provides an exception for the specified product and conditions. The Act extends its application through various subsidiary legislation, such as regulations and codes, which provide further detail on specific aspects of the therapeutic goods regulatory framework.
Key Provisions
Under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), a delegate of the Secretary of the Department of Health granted consent to Regulatory Concepts for the supply of two specific dust mite extract products, ALUSTAL EUROPEAN DUST MITE EXTRACT, which do not conform to certain labelling requirements specified in the Therapeutic Goods Order No 69 (section 14(1)). The consent is limited to the period from 1 December 2015 until 31 March 2016 and is subject to certain conditions aimed at mitigating the risks associated with the non-compliance of the product labels. These conditions include the provision of additional over labels on the product boxes, inclusion of the Australia product information, and the dissemination of a "Dear Doctor" letter to inform medical practitioners of the labelling situation (section 14A(2)).
The Act imposes specific obligations on the parties involved, primarily focusing on ensuring that the therapeutic goods supplied meet the required standards. Regulatory Concepts, as the applicant, must adhere to the conditions set forth in the consent. These conditions necessitate the addition of specific information to the over labels, such as the AUST R number, sponsor details, product code, and the inclusion of a "Dear Doctor" letter. Furthermore, the consent requires the sponsor to ensure that the outer box includes the Australia product information, which details the quantity of excipients, active ingredients, and directions for use (section 14A(2)).
Failure to comply with the conditions of the consent or with the labelling requirements could result in legal consequences. The Therapeutic Goods Act 1989 provides for both civil and criminal penalties for breaches of the Act and its regulations. For instance, supplying therapeutic goods that do not comply with the standards set out in the Act can result in significant fines and potential imprisonment. Specifically, section 32DA of the Act outlines that a person who contravenes a provision of the Act can be fined up to $1,215,000 for a corporation and $243,000 for an individual, or imprisonment for up to five years, or both. These penalties reflect the seriousness with which the Act treats non-compliance and the potential public health risks associated with supplying non-compliant therapeutic goods.
The Act also provides for the imposition of administrative penalties for breaches of the regulations. For example, section 15 of the Act allows for the imposition of a penalty of up to $22,200 for an individual and $111,000 for a corporation for each day of non-compliance. Additionally, the Act empowers the Therapeutic Goods Administration to issue infringement notices for certain minor or technical breaches, with penalties not exceeding $1,650 for an individual and $8,250 for a corporation. These provisions ensure that there are clear disincentives for non-compliance and that the Therapeutic Goods Administration has the tools necessary to enforce the Act effectively.