THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On April 15 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 products:
by Boehringer Ingelheim Pty Ltd, (“the Company”);
That does not conform with paragraphs 3(2)(h) & (i) of Therapeutic Goods Order (TGO) 69, in that the batch numbers and expiry date prefixes printed on the foils do not immediately precede the respective batch number and expiry date.
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 to supply applies to the batches listed in the tables below:
AUST R | Description | Pack size | Batch | Quantity |
68052 | Micardis Tablet 40 mg | 28 | 207509 | 52,817 |
| | | 207515 | 5,168 |
| | | 208047 | 21,788 |
| | | 301589 | 25,844 |
| | | 206945 | 98,304 |
| | | 206946 | 61,825 |
| | | 206947 | 9,216 |
AUST R | Description | Pack size | Batch | Quantity |
82416 | Micardis Plus Tablets 40/12.5 mg | 28 | 207869 | 37,818 |
| | | 301663 | 39,933 |
| | | 207166A | 2,046 |
82418 | Micardis Plus Tablets 80/12.5 mg | 28 | 207889 | 9,079 |
| | | 208026 | 43,460 |
| | | 301234 | 37,172 |
| | | 301716 | 33,119 |
| | | 301715 | 56,336 |
| | | 206769 | 7,902 |
| | | 207594 | 72,303 |
| | 7 | 301686 | 15,184 |
143761 | Micardis Plus tablets 80/25 mg | 28 | 207076 | 34,311 |
| | | 207043 | 34,277 |
AUST R | Description | Pack size | Batch | Quantity |
166265 | Twynsta Tablets 40 mg + 5 mg | 28 | 205967 | 15,019 |
| | | 205541-R | 10,880 |
| | | 205538-R | 4,092 |
| | 7 | 207673 | 24,197 |
| | | 205967 | 11,648 |
166264 | Twynsta Tablets 40 mg + 10 mg | 28 | 207592 | 7,417 |
| | | 205969 | 1,900 |
| | | 206098-R | 3,807 |
166263 | Twynsta Tablets 80 mg + 10 mg | 28 | 206299 | 28,146 |
| | | 206301 | 2,108 |
| | | 206646 | 24,688 |
| | 7 | 206397 | 18,252 |
16266 | Twynsta Tablets 80 mg + 10 mg | 28 | 206031 | 6,351 |
| | | 206033 | 13,380 |
| | | 206650 | 13,310 |
| | 7 | 206032 | 4,004 |
| | | 206033 | 5,413 |
| | | 206650 | 9,568 |
AUST R | Description | Pack size | Batch | Quantity |
81525 | Spiriva Capsules 18 mcg | 30 | 262368B | 148,680 |
2. The foil labels subject to this consent to supply are identical to those provided with the submission from the Company dated March 27 2013; the batch number and expiry date prefixes printed on the foils do not immediately precede the respective batch number and expiry date, but are nonetheless present.
3. No other changes have been made to the products listed in the tables above.
4. The Dear Pharmacist letter provided with your email from the Company of February 6 2013, which sets out the circumstances surrounding this consent to supply and reminds patients to keep the blister strips with the outer carton, will be supplied with affected batches of products.
Overview
The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, is designed to regulate therapeutic goods in Australia. This Act aims to ensure the safety, quality, and efficacy of therapeutic goods, including medicines, medical devices, and blood and blood components, by controlling their manufacture, supply, and advertising. One of the Act's provisions, specifically sections 14 and 14A, allows the Secretary of the Department of Health and Ageing to give consent for the supply of therapeutic goods that do not fully comply with certain standards, subject to specific conditions. The 2013 consent under these sections facilitated the supply of specific batches of Micardis and Twynsta tablets and Spiriva capsules by Boehringer Ingelheim Pty Ltd, despite minor deviations from the Therapeutic Goods Order (TGO) 69 requirements concerning the placement of batch numbers and expiry date prefixes on the product labels. This consent was granted to address a non-compliance issue while ensuring that the overall safety and quality of the therapeutic goods were maintained.
Scope and Application
The Therapeutic Goods Act 1989 provides a framework for regulating therapeutic goods, including medicines, in Australia. Section 14 and 14A of the Act allow for the supply of certain products under specific conditions when they do not fully comply with established standards, such as the Therapeutic Goods Order (TGO) 69. In this context, the delegate of the Secretary of the Department of Health and Ageing has granted consent for Boehringer Ingelheim Pty Ltd to supply specific batches of Micardis, Micardis Plus, and Twynsta products, which do not fully conform to paragraphs 3(2)(h) and (i) of TGO 69 concerning the placement of batch numbers and expiry date prefixes on the foils. This consent applies only to the batches listed in the document and is subject to the conditions specified by the delegate. The consent allows the supply to proceed despite the non-conformity, provided that the foil labels remain identical to those submitted by the company, with no other changes made to the products. Additionally, a Dear Pharmacist letter will accompany the supplied batches to inform pharmacists of the consent circumstances and advise patients to retain the blister strips with the outer carton. This legislative application ensures that therapeutic goods can be supplied under controlled conditions when minor non-compliances occur, thereby balancing regulatory standards with the need for therapeutic goods availability.
Key Provisions
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, pertains to the regulation of therapeutic goods in Australia, ensuring their safety, efficacy, and quality. Under these sections, the delegate of the Secretary of the Department of Health and Ageing has the authority to give consent for the supply of therapeutic goods that do not fully comply with certain regulatory standards, but are deemed suitable for use. In the case of the gazetted notice C2013G00764, the delegate has given consent to the supply of several batches of pharmaceutical products by Boehringer Ingelheim Pty Ltd. These products include Micardis, Micardis Plus, Twynsta, and Spiriva, which do not conform with specific labelling requirements outlined in Therapeutic Goods Order (TGO) 69, particularly concerning the placement of batch numbers and expiry date prefixes on the product packaging (section 14(1)).
The Act imposes several obligations on the parties involved. Firstly, the Company must ensure that the consent provided by the delegate is strictly adhered to, particularly in how the products are labelled and supplied. The batch numbers and expiry date prefixes must be present on the packaging, even if not in the mandated position, and the labels must be identical to those submitted in the application. Furthermore, no other changes are to be made to the products beyond what has been specified (section 14(2)). Additionally, the Company is required to provide a Dear Pharmacist letter with each batch of the affected products, explaining the circumstances of the consent and reminding pharmacists to ensure patients retain the blister strips with the outer carton (section 14(3)).
Failure to comply with the conditions of the consent or any other requirements stipulated under the Act may result in serious consequences. While the Therapeutic Goods Act itself does not explicitly outline penalties for non-compliance in this specific context, breaches of the Act can lead to actions under other related legislation, such as the Therapeutic Goods Act 1989, the Crimes Act 1914, or state-specific health and safety laws. Penalties for such breaches can range from fines to imprisonment, depending on the severity of the non-compliance and the specific provisions of the applicable laws. Additionally, the Therapeutic Goods Administration (TGA) may take enforcement actions such as product recalls, suspension of permits, or prosecution, which can further impact the Company's operations and reputation.