COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 25 February 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of AstraZeneca Pty Ltd, gave consent to the importation and supply of:
- exenatide (BYDUREON ) 2mg powder for injection vial with diluent syringe [AUST R 175504]
that does not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order 69 – General requirements for labels for medicines, in that the carton label states the previous sponsor contact details.
The consent is effective from 25 February 2015 until batch number C24527 is exhausted or has expired.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels are those currently supplied which state the previous sponsor details as well as the current sponsor (as the distributor);
- Arrangements are in place to redirect all correspondence to the current sponsor (AstraZeneca); and
- No other changes have been made to the product.
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the importation, supply, and other activities related to therapeutic goods to ensure they meet safety, quality, and efficacy standards. One of the key provisions of the Act is the ability to provide consent for the importation and supply of therapeutic goods that do not conform to certain requirements, as demonstrated in the case of exenatide (BYDUREON) 2mg powder for injection vial with diluent syringe. This specific consent granted by the Therapeutic Goods Administration under Section 14 and 14A of the Act addresses a particular issue where the carton label of the product contained previous sponsor contact details instead of the current sponsor's, which did not align with the Therapeutic Goods Order 69. The policy objective in this case is to facilitate the continued supply of necessary therapeutic goods while ensuring patient safety and effective communication with the current sponsor, AstraZeneca, by imposing specific conditions on the consent.
Scope and Application
The Therapeutic Goods Act 1989, under which this notice was issued, applies to the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood. The Act provides the legal framework for the regulation of therapeutic goods, including their importation, manufacture, supply, and advertising. This particular notice pertains to the temporary consent for the importation and supply of a specific pharmaceutical product, exenatide (BYDUREON) 2mg powder for injection vial with diluent syringe, which is subject to certain conditions aimed at ensuring public safety and maintaining compliance with therapeutic goods regulations. The consent is applicable to AstraZeneca Pty Ltd as the entity responsible for the importation and supply of the specified product. Geographically, the Act operates on a Commonwealth level, governing therapeutic goods across Australia. The notice does not specify exclusions or exemptions, but it does impose conditions that the applicant must meet to ensure compliance with therapeutic goods standards. The authority to issue such consents is derived from the Therapeutic Goods Act, and the specific provisions under sections 14 and 14A allow for this temporary exemption from certain regulatory requirements to facilitate the supply of necessary therapeutic goods under controlled conditions.
Key Provisions
The Therapeutic Goods Act 1989, particularly sections 14 and 14A, provide a framework for the regulation of therapeutic goods in Australia, ensuring public health and safety. Section 14 allows the delegate of the Secretary to consent to the importation and supply of therapeutic goods that do not fully comply with specified standards, subject to certain conditions. In this instance, section 14A applies to the consent given to AstraZeneca Pty Ltd for the importation and supply of exenatide (BYDUREON) 2mg powder for injection vial with diluent syringe [AUST R 175504]. This consent is specifically tailored to address a non-conformity with the labelling requirements outlined in paragraph 3(2)(l) of Therapeutic Goods Order 69, which pertains to the general requirements for labels for medicines.
The obligations imposed by this consent on AstraZeneca Pty Ltd include ensuring that the labels supplied with the product indicate both the previous and current sponsor details, thereby maintaining transparency and continuity in communication. Furthermore, AstraZeneca must establish arrangements to redirect all correspondence to the current sponsor, ensuring that any queries or issues regarding the product are appropriately managed. Additionally, AstraZeneca must not make any other changes to the product beyond what is explicitly permitted under the consent. These conditions are designed to mitigate any potential risks associated with the non-conforming label while allowing for the continued supply of the therapeutic good.
Failure to comply with the conditions stipulated in the consent may result in significant legal and financial consequences. Under the Therapeutic Goods Act, breaches of the conditions can lead to enforcement actions, including the potential revocation of the consent, which could halt the supply of the therapeutic good. Furthermore, such non-compliance could be viewed as a violation of the Act, potentially leading to criminal charges, fines, and civil penalties. The specific penalties for breaches of the Therapeutic Goods Act are not detailed in the consent but could include substantial fines for corporations and imprisonment for individuals, depending on the severity of the breach and the discretion of the court. These potential consequences underscore the importance of adhering to the conditions set forth in the consent and the broader regulatory requirements under the Act.