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 BERMUDA GRASS EXTRACT cynodon dactylon 10 IR/mL injection suspension vial [AUST R 132834]
- ALUSTAL BERMUDA GRASS EXTRACT cynodon dactylon injection suspension vial composite pack [AUST R 132835]
that do not conform with the requirements of paragraph 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 from1 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 included 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, was introduced to regulate therapeutic goods, including medicines, in order to protect public health by ensuring that only safe and effective goods are available. The Act establishes a framework for the regulation of therapeutic goods, including the approval of medicines, and aims to provide consumers with access to safe and effective therapeutic goods. On 1 December 2015, the Department of Health, through a delegate of the Secretary, granted consent under sections 14 and 14A of the Act for the supply of certain Bermuda Grass Extract injection suspensions that did not fully conform to the labelling requirements set out in the Therapeutic Goods Order No 69. The consent was issued to Regulatory Concepts, subject to specific conditions designed to mitigate risks associated with the non-compliant labelling, including the provision of additional over labels and a "Dear Doctor" letter to inform healthcare professionals about the interim labelling situation. This action highlights the Act's role in balancing the need for regulatory compliance with the practicalities of therapeutic goods supply.
Scope and Application
The Therapeutic Goods Act 1989, as applied in this instance, governs the regulation of therapeutic goods in Australia, including medicines, medical devices, and related substances. This Act applies to entities such as manufacturers, sponsors, and suppliers of therapeutic goods, ensuring compliance with standards that safeguard public health. The Act's jurisdiction extends across the Commonwealth of Australia, thereby encompassing all states and territories, and it mandates adherence to stringent labelling requirements for medicines. The Therapeutic Goods Administration, a division of the Department of Health, administers this legislation and can grant consents to deviations from specific regulatory requirements under certain conditions. In this case, the Therapeutic Goods Administration has permitted a temporary exception for specific labelling deficiencies in ALUSTAL BERMUDA GRASS EXTRACT cynodon dactylon injection products. This consent is valid from 1 December 2015 to 31 March 2016, contingent on several assurances, including the addition of specific information on over labels and the provision of a 'Dear Doctor' letter to mitigate potential risks. The Act's flexibility to accommodate such temporary consents underscores its comprehensive approach to maintaining therapeutic goods' safety and efficacy.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) govern the supply of therapeutic goods that do not fully comply with regulatory standards. In this case, the Act permitted the supply of ALUSTAL BERMUDA GRASS EXTRACT cynodon dactylon injection suspension vials that do not conform to specific labelling requirements. The consent granted under these sections allows the Therapeutic Goods Administration to overlook certain deficiencies in the product's labelling, provided certain conditions are met.
The Act imposes several obligations on the parties involved in the supply of these therapeutic goods. Firstly, the sponsor must ensure that an additional over label is affixed to the front main panel of the outer box, including crucial information such as the SUSMP signal headings, the AUST R number, the sponsor's name and address, and the Stallergens product code. Secondly, the outer box must also include the Australian product information, which contains 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 healthcare professionals about the use of interim labels. Lastly, the manufacturer’s product codes must be included in the order forms to serve as an additional verification point for doctors.
Failure to comply with the conditions set out in the consent may result in various legal consequences. While specific offences and penalties are not detailed in the provided text, breaches of the Therapeutic Goods Act 1989 can generally lead to civil or criminal penalties. These may include fines, imprisonment, or both, depending on the severity of the breach. The maximum penalties for contravening the Act can be substantial, reflecting the importance of ensuring that therapeutic goods meet the necessary standards for safety and efficacy.