COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 1 July 2015, a delegate of the Secretary of the Department of Health, on the application of AbbVie Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- VIEKIRA PAK paritaprevir/ritonavir/ombitasvir 75 mg/50 mg/12.5 mg tablets and dasabuvir (as sodium salt) 250 mg tablets composite pack blister pack [AUST R 224612]
that do not conform with the requirements of the paragraphs 3(2)(a), 3(2)(I) & 3(5)(b)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicine, in that the product name differs from that agreed, and which appears on the carton labels, the sponsor's address (and website and phone number) are not those of the Australian sponsor and the storage condition is not described as permitted by clause 7 of TG0 69 and that the storage conditions differs from that assigned to the products.
The consent is effective from 1 July 2015 until 31 December 2015 (for a period of 6 months).
The consent is subject to the following conditions:
- The 'daily wallet' labels to which this consent applies are those provided with
the response to S31-PM-2014-01436-1-2 (dated March 2015).
2. A 'Dear Healthcare Provider/Pharmacist' letter identical to that provided to the
Therapeutic Goods Administration on 30 June 2015 will be supplied only to Healthcare Providers that have patients enrolled in sponsor's VIEKIRA PAK supply program.
3. No other changes have been made.
Overview
The Therapeutic Goods Act 1989 was enacted to ensure that therapeutic goods available in Australia meet standards that protect public health. This legislation provides the legal framework for the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. The Act aims to facilitate access to therapeutic goods that are safe, of high quality, and effective, while also ensuring that such goods are available in a timely manner. The Therapeutic Goods Administration (TGA), which is part of the Department of Health, is responsible for administering the Act. The policy objective behind the Act is to safeguard public health by ensuring that therapeutic goods meet appropriate standards and are subject to rigorous oversight throughout their lifecycle, from development through to post-market surveillance. The consent granted under sections 14 and 14A of the Act addresses specific non-conformities in the labelling and storage conditions of imported medicines, allowing for their temporary use under strict conditions to ensure patient safety and public health.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a wide range of products including medicines, medical devices, and blood and blood components. This Act provides the legal framework under which the Therapeutic Goods Administration (TGA) operates, ensuring that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy. The legislation applies to various entities including manufacturers, importers, and suppliers of therapeutic goods, and governs their conduct and transactions. Geographically, the Act applies on a national level, regulating the therapeutic goods market across the Commonwealth of Australia. However, certain aspects of the Act may be subject to state or territory legislation, particularly in relation to the supply of certain therapeutic goods. The Act does not specify any particular exclusions or exemptions, but the application of its provisions may be influenced by subordinate instruments or regulations that provide further detail or establish specific thresholds and conditions for compliance.
In the specific case of the consent granted under sections 14 and 14A of the Therapeutic Goods Act 1989, the application pertains to the importation and supply of VIEKIRA PAK by AbbVie Pty Ltd. This consent allows for the temporary importation and supply of the product despite it not fully conforming to certain labelling requirements. The consent is strictly time-bound, effective from 1 July 2015 to 31 December 2015, and is subject to specific conditions designed to mitigate any potential risks to consumers. These conditions include the provision of specific 'daily wallet' labels and a 'Dear Healthcare Provider/Pharmacist' letter to ensure healthcare providers are fully informed about the product’s characteristics and storage conditions.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 allow for the consent of the Secretary of the Department of Health to the importation and supply of therapeutic goods that do not conform to certain labelling requirements, provided certain conditions are met. In this case, AbbVie Pty Ltd applied for and received consent to import and supply VIEKIRA PAK, a combination of paritaprevir/ritonavir/ombitasvir and dasabuvir tablets, that do not meet the specifications outlined in paragraphs 3(2)(a), 3(2)(I) and 3(5)(b)(j) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines. The consent is valid for six months, from 1 July 2015 until 31 December 2015, and is subject to specific conditions, including the use of particular 'daily wallet' labels and the provision of a 'Dear Healthcare Provider/Pharmacist' letter to healthcare providers with patients enrolled in the sponsor's VIEKIRA PAK supply program.
The Therapeutic Goods Act 1989 imposes several obligations on the parties it governs. AbbVie Pty Ltd must ensure that the VIEKIRA PAK supplied under this consent meets all other requirements of the Act and the Therapeutic Goods Regulations 1990. They must also adhere to the conditions of the consent, such as using the specified 'daily wallet' labels and providing the 'Dear Healthcare Provider/Pharmacist' letter to eligible healthcare providers. Furthermore, the sponsor must ensure that the product is only supplied to healthcare providers with patients enrolled in the VIEKIRA PAK supply program, and that no other changes are made to the product or its labelling.
Failure to comply with the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, or the conditions of a consent granted under sections 14 or 14A may result in civil or criminal penalties. Under section 36 of the Act, a person who contravenes certain provisions of the Act or the Regulations is liable to a penalty of up to $222,200 for a corporation and $44,440 for an individual. Additionally, under section 37, a person who is found guilty of an offence against the Act or the Regulations is liable to imprisonment for up to two years, or both. The maximum penalties for offences under the Act or the Regulations may be higher if the offence is committed by a corporation, or if the offence involves a therapeutic good that is likely to cause death or serious injury.
In summary, sections 14 and 14A of the Therapeutic Goods Act 1989 provide a mechanism for the Secretary of the Department of Health to consent to the importation and supply of therapeutic goods that do not conform to certain labelling requirements, provided specific conditions are met. AbbVie Pty Ltd has been granted consent to import and supply VIEKIRA PAK that does not meet the labelling requirements outlined in Therapeutic Goods Order No. 69, subject to certain conditions. Failure to comply with the Act, the Regulations, or the conditions of a consent may result in civil or criminal penalties, including substantial fines and imprisonment.