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 RYE GRASS EXTRACT lolium perenne 10 IR/mL injection suspension vial
[AUST R 132843]
- ALUSTAL RYE GRASS EXTRACT lolium perenne injection suspension vial composite pack [AUST R 132844]
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.
(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, enacted by the Parliament of Australia, aims to regulate therapeutic goods including medicines, medical devices, and blood and blood components. The Act provides mechanisms for ensuring that therapeutic goods are safe and of acceptable quality. One of the key provisions of the Act is its allowance for the Therapeutic Goods Administration (TGA) to consent to deviations from certain regulatory requirements under specific conditions, as seen in the case of the consent granted for the supply of ALUSTAL RYE GRASS EXTRACT products. This consent was issued to address labelling deficiencies in the products that did not fully comply with the Therapeutic Goods Order No 69 – General requirements for labels for medicines. The consent was issued under sections 14 and 14A of the Act, ensuring that the supply of these therapeutic goods would not pose an unacceptable risk to public health and safety.
Scope and Application
The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration under the Commonwealth of Australia's Department of Health, governs the supply and regulation of therapeutic goods in Australia. Section 14 and 14A of the Act facilitate consent for the supply of goods that do not fully comply with specified standards, contingent upon certain conditions being met to ensure public safety and informed use. In this instance, a consent was granted to Regulatory Concepts for the supply of ALUSTAL RYE GRASS EXTRACT injection suspensions that do not meet all labelling requirements under the Therapeutic Goods Order No 69. This consent, which is effective from 1 December 2015 until 31 March 2016, is subject to conditions aimed at mitigating the risks associated with the non-compliance of the product labels, including the provision of additional information through over labels and letters to healthcare providers. The Act applies to entities and individuals involved in the supply of therapeutic goods within Australia, ensuring adherence to national standards and regulations to protect public health.
Key Provisions
The Therapeutic Goods Act 1989, specifically under sections 14 and 14A, provides a framework for the regulation of therapeutic goods in Australia. In this instance, section 14 allows for a delegate of the Secretary of the Department of Health to consent to the supply of therapeutic goods that do not conform to certain requirements, while section 14A enables such consent to be given under specific conditions. This consent is applicable to the supply of ALUSTAL RYE GRASS EXTRACT lolium perenne 10 IR/mL injection suspension vial [AUST R 132843] and ALUSTAL RYE GRASS EXTRACT lolium perenne injection suspension vial composite pack [AUST R 132844] from 1 December 2015 to 31 March 2016.
The obligations imposed by this consent require the sponsor to add additional over labels to the front main panel label on the box, as outlined in the application letter dated 3 November 2015. These over labels must include specific information such as the SUSMP signal headings, the AUST R number, the sponsor’s name and address, and the Stallergens product code. Furthermore, the outer box must include the Australian product information, which provides details such as the quantity of excipients, active ingredients, and directions for use. To mitigate risks associated with the use of these interim labels, the sponsor must also provide a "Dear Doctor" letter explaining the situation and include the manufacturer’s product codes in order forms.
Failure to comply with the conditions of this consent could result in civil or criminal consequences. While the Act does not specify the exact penalties for non-compliance with section 14 and 14A consents, breaches of other sections of the Therapeutic Goods Act can result in substantial penalties. For example, offences under section 26 of the Act, which pertains to the supply of therapeutic goods that do not comply with the standards, can incur a penalty of up to $504,000 for a corporation and $10,080 for an individual. Additionally, repeated or serious breaches might attract more severe penalties, including imprisonment. The precise penalties and consequences for non-compliance with this particular consent would depend on the specific breach and the discretion of the court.