COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On May 6, 2014, 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”) gave his consent to:
(a) the supply of the product
- exenatide (BYETTA 5) 5 micrograms/20 microlitres (1.2 mL in total) solution for injection multidose cartridge [Aust R 123609]
- exenatide (BYETTA 10) 10 micrograms/40 microlitres (2.4 mL in total) solution for injection multidose cartridge [Aust R 123610]
- exenatide (BYDUREON) 2 mg powder for injection vial with diluent syringe [Aust R 175504]
by AstraZeneca Pty Ltd, NORTH RYDE, NSW (“the Company”);
That does not conform with paragraphs 3 (2) (l) of Therapeutic Goods Order No. 69—General requirements for labels for medicines (TGO 69), in that the carton label states the previous sponsor contact details.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This consent applies for 12 months from the date of this letter.
- 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 Company.
- No other changes have been made to the products:
- exenatide (BYETTA 5) 5 micrograms/20 microlitres (1.2 mL in total) solution for injection multidose cartridge [Aust R 123609]
- exenatide (BYETTA 10) 10 micrograms/40 microlitres (2.4 mL in total) solution for injection multidose cartridge [Aust R 123610]
- exenatide (BYDUREON) 2 mg powder for injection vial with diluent syringe [Aust R 175504]
Overview
The Therapeutic Goods Act 1989 was enacted to provide a legislative framework for the regulation of therapeutic goods in Australia, ensuring that these goods are of an acceptable quality, performance, and safety. The Act was introduced to address the need for a comprehensive system to control the import, export, manufacture, supply, and advertising of therapeutic goods within Australia. The enacting body for this legislation is the Parliament of the Commonwealth of Australia. The policy objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia are safe and of high quality. On May 6, 2014, the delegate of the Secretary of the Department of Health granted a specific consent under sections 14 and 14A of the Act, allowing the supply of certain exenatide products by AstraZeneca Pty Ltd, despite the products not fully complying with certain labelling requirements. This consent is subject to conditions that include the use of current labels stating previous sponsor details and the redirection of correspondence to the company, and it is effective for a period of 12 months.
Scope and Application
The Therapeutic Goods Act 1989 applies to entities involved in the supply of therapeutic goods in Australia, including medicines, medical devices, and other related products. The Act's provisions pertain to the regulation of the quality, safety, efficacy, and proper advertising of these goods. Specifically, Section 14 and 14A of the Act, as evidenced by the notice issued on May 6, 2014, concerns the consent for the supply of certain therapeutic goods by AstraZeneca Pty Ltd, a company based in North Ryde, New South Wales. This consent was granted despite the products not fully conforming with Therapeutic Goods Order No. 69, which pertains to the general requirements for labels for medicines. The notice stipulates specific conditions for this consent, such as the duration of the consent, the handling of label discrepancies, and the rerouting of correspondence to the company. This arrangement is temporary and limited to the specified products, with no other alterations made to the products themselves. The consent is subject to the broader regulatory framework established under the Therapeutic Goods Act, which is enforced by the Therapeutic Goods Administration.
Key Provisions
The Therapeutic Goods Act 1989, as amended, includes several key sections that govern the regulation of therapeutic goods in Australia. Specifically, sections 14 and 14A of the Act allow for the supply of certain therapeutic goods that do not fully conform with the Therapeutic Goods Orders, provided certain conditions are met. In this instance, section 14A(1) of the Act grants consent for the supply of specific exenatide products by AstraZeneca Pty Ltd that do not comply with paragraph 3(2)(l) of Therapeutic Goods Order No. 69, which pertains to label requirements for medicines. This consent is granted for a period of 12 months and is subject to specific conditions, ensuring that the products supplied still meet safety and efficacy standards.
The obligations imposed on the parties governed by this legislation include ensuring that all correspondence related to the products is redirected to the company, AstraZeneca Pty Ltd, and maintaining the current product specifications without any other changes. The consent granted under section 14A(1) of the Act mandates that the carton labels of the supplied products must include both the previous and current sponsor details, acting as the distributor. This ensures transparency and traceability in the supply chain while the transition from the previous sponsor to the current one is underway.
Failure to comply with the conditions specified in the consent notice or the requirements of the Therapeutic Goods Act 1989 can result in various legal consequences. Under section 26 of the Act, any person who contravenes the provisions can face civil penalties, including fines, and may also be subject to criminal prosecution. The maximum penalties for such offences can vary significantly depending on the severity and intent of the breach, but can include substantial fines and imprisonment terms for individuals and corporate entities alike. It is essential for the parties involved to adhere strictly to the conditions and requirements set forth to avoid these potential repercussions.