THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On January 10 2013, the delegate of the Secretary of the Department of Health and Ageing 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 nifedipine (ADEFIN XL 60) 60 mg controlled release tablet blister pack [Aust R 91778] by Bayer Australia Ltd, Pymble NSW (“the Company”):
That does not conform with paragraphs 3(2)(h) and 3(2)(i) of Therapeutic Goods Order 69 (TGO 69), in that the batch number and expiry date prefixes are absent from the blister foil labels.
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:
- The consent applies to the foil labels of the following batches of the product only:
Batch number | Number of Units | Expiry Date |
CR 07841 | 16689 | Feb 2015 |
CR 07842 | 4110 | Feb 2015 |
CR 08235 | 16199 | June 2015 |
CR 08236 | 16462 | June 2015 |
CR 02429 | 90 | May 2014 |
CR 06592 | 8124 | May 2014 |
2. The foil labels to which this consent applies are identical to those submitted by the Company in correspondence dated November 7 2012, missing the prefixes for the batch number and the expiry date, but the actual batch number and expiry date are present.
3. No other changes have been made to the product nifedipine (ADEFIN XL 60) 60 mg controlled release tablet blister pack [Aust R 91778], and the carton labels are fully compliant with TGO 69, including paragraphs 3(2)(h) and 3(2)(i).
4. A Dear Pharmacist letter setting out the above circumstances and instructing the pharmacist to advise patients to keep the blister platforms in the outer cartons, will be supplied with the affected batches (correspondence from the Company dated January 10 2013 refers).
Overview
The Therapeutic Goods Act 1989, enacted by the Australian Parliament, serves to regulate the supply of therapeutic goods within Australia, aiming to ensure that such goods are safe, of high quality, and their benefits outweigh their risks. The Act provides a framework for the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. In certain cases, the Act allows for special provisions to be made to facilitate the supply of therapeutic goods under specific conditions, ensuring public health and safety while accommodating particular circumstances that may arise in the distribution and use of these goods. The 2013 notice regarding the supply of nifedipine (ADEFIN XL 60) 60 mg controlled release tablet blister pack by Bayer Australia Ltd exemplifies the Act's flexibility, addressing a gap where certain labelling requirements were not met but the overall safety and quality of the product were assured under specific conditions.
Scope and Application
The Therapeutic Goods Act 1989 provides a framework for the regulation of therapeutic goods in Australia. Under the authority conferred by Section 14 and 14A of the Act, the delegate of the Secretary of the Department of Health and Ageing has granted specific consents for the supply of therapeutic goods that do not fully conform to certain standards or regulations. In this instance, the consent applies to the supply of the product nifedipine (ADEFIN XL 60) 60 mg controlled release tablet blister pack by Bayer Australia Ltd. This consent is limited to specific batches where the batch number and expiry date prefixes are absent from the blister foil labels, which does not comply with paragraphs 3(2)(h) and 3(2)(i) of Therapeutic Goods Order 69 (TGO 69). The consent is conditional, applying only to the foil labels of the specified batches and requires that these labels be identical to those submitted by the company, with no other modifications to the product. Additionally, a Dear Pharmacist letter will be included with the affected batches to inform pharmacists of the situation and advise them to recommend that patients keep the blister platforms in the outer cartons.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) is the key piece of legislation governing the regulation of therapeutic goods in Australia. Section 14(1) provides that the delegate of the Secretary of the Department of Health and Ageing may consent to the supply of therapeutic goods that do not comply with the Australian therapeutic goods standards, provided that certain conditions are met. In this case, section 14A notice (a) of the Gazette details the consent given by the delegate to Bayer Australia Ltd for the supply of nifedipine (ADEFIN XL 60) 60 mg controlled release tablet blister packs that do not conform with paragraphs 3(2)(h) and 3(2)(i) of Therapeutic Goods Order 69 (TGO 69) regarding the absence of batch number and expiry date prefixes on the blister foil labels. This consent is limited to specific batches and requires the foil labels to remain identical to those submitted by the company on November 7, 2012, with no other changes made to the product.
The Act imposes certain obligations and requirements on the parties governed by it. In this instance, Bayer Australia Ltd must adhere to the conditions set out in the section 14A notice. This includes ensuring that the foil labels of the specified batches are identical to those submitted, with the actual batch numbers and expiry dates present. Furthermore, the carton labels must comply with TGO 69, including the aforementioned paragraphs 3(2)(h) and 3(2)(i). Additionally, the company must supply a Dear Pharmacist letter to inform pharmacists of the circumstances and provide instructions for advising patients to keep the blister platforms in the outer cartons.
The Therapeutic Goods Act 1989 also outlines potential offences, penalties, and consequences for breaches of the Act. While the specific consequences for non-compliance with the section 14A notice are not detailed in the Gazette, the Act generally provides for both civil and criminal penalties. Civil penalties may include fines, while criminal penalties may involve imprisonment, fines, or both, depending on the severity of the breach. The maximum penalties for breaches of the Act are set out in section 30 of the Act, with fines ranging from $2,200 to $220,000 for individuals and up to $1,100,000 for corporations, as well as potential imprisonment terms for serious offences.