COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On September 25, 2013, 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 hydralazine hydrochloride (APRESOLINE) 20 mg powder for injection ampoule [Aust R 43190]
by Link Medical Products Pty Ltd, WARRIEWOOD, NSW (“the Company”);
That do not conform with paragraphs 3(2)(g), (j) & 3(11)(c) of Therapeutic Goods Order 69, in that the ampoule label does not contain the batch number prefix and the Australian sponsor’s details. The carton labels do not include; the appropriate warning statement(s), the correct storage conditions and, the Australian Approved Name for glucose.
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 only to batch number 132005;
- The cartons will be over-stickered with the AUST R number and the Australian sponsor’s details;
- A ‘Dear Pharmacist’ letter, provided with the email dated September 24, 2013, advising healthcare practitioners to disregard the stated storage temperature on the carton and to disregard the carton leaflet will be provided with each order of the affected batch;
- A copy of the Australian approved Product Information document will accompany each ‘Dear Pharmacist’ letter; and
- No other changes have been made to the product, hydralazine hydrochloride (APRESOLINE) 20mg powder for injection ampoule [Aust R 43190].
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring they meet safety, quality, and efficacy standards. This Act provides the legal framework for the Therapeutic Goods Administration (TGA) to control the import, manufacture, and distribution of therapeutic goods, including medicines, medical devices, and blood products. It addresses the need for a cohesive and comprehensive regulatory system to protect public health by overseeing the therapeutic goods lifecycle. The Act was enacted by the Australian Parliament and its policy objective is to safeguard public health by regulating therapeutic goods to ensure they are of acceptable quality, safety, and efficacy. This particular consent issued by the delegate of the Secretary for the Department of Health under the Act allows for the supply of a specific batch of hydralazine hydrochloride (APRESOLINE) 20 mg powder for injection ampoule, despite its non-compliance with certain labelling requirements, subject to specific conditions designed to mitigate any potential risks to public health.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, ensuring that such products are safe, of acceptable quality, and their benefits outweigh any risks. The Act applies to the supply and advertising of therapeutic goods, including medicines, medical devices, and blood and blood components, and is administered by the Therapeutic Goods Administration, which is part of the Commonwealth Department of Health. The Act’s reach encompasses the entire Australian jurisdiction, including all states and territories. It applies to both individuals and entities involved in the supply of therapeutic goods, including manufacturers, importers, sponsors, and suppliers. The Act also extends its application through various regulations and orders, which may provide further detail on specific aspects of therapeutic goods regulation. While the Act generally applies comprehensively, there are certain exclusions and exemptions, such as those related to research and clinical trials under specific conditions. Additionally, the Act may impose certain thresholds that determine the level of regulation applicable to different categories of therapeutic goods.
Key Provisions
The main operative sections of this consent relate to the supply of hydralazine hydrochloride (APRESOLINE) 20 mg powder for injection ampoules, which are supplied by Link Medical Products Pty Ltd. The Act permits the supply of this product under specific conditions due to its non-compliance with certain labelling requirements (sections 3(2)(g), (j), and 3(11)(c) of Therapeutic Goods Order 69). This consent applies solely to batch number 132005 and includes several conditions to mitigate the risks associated with the labelling issues.
Under these conditions, the cartons of the product will be over-stickered with the AUST R number and the Australian sponsor’s details. A ‘Dear Pharmacist’ letter will accompany each order, advising healthcare practitioners to disregard the stated storage temperature on the carton and to disregard the carton leaflet. Additionally, a copy of the Australian approved Product Information document will be provided with each ‘Dear Pharmacist’ letter. These steps are taken to ensure that healthcare professionals are informed of the discrepancies and can take appropriate action.
The obligations imposed by this Act require the company to address the labelling deficiencies by over-sticker the cartons with the correct information and to include the ‘Dear Pharmacist’ letter and the Product Information document with each order. These steps are essential to inform healthcare practitioners about the issues with the product and to prevent potential harm from the incorrect information.
There are no explicit offences, penalties, or civil/criminal consequences mentioned in the consent for failure to comply with these conditions. However, non-compliance with the Therapeutic Goods Act 1989 generally can lead to severe penalties, including fines and imprisonment. The Therapeutic Goods Regulations 2008 outline specific penalties, with fines up to $1,650,000 for corporations and $330,000 for individuals for serious or repeated breaches. Therefore, it is crucial for Link Medical Products Pty Ltd to adhere to the conditions of this consent to avoid potential legal repercussions.