Supply of DIFFLAM MOUTH GEL tube by iNova Pharmaceuticals (Australia) Pty Limited

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply and standards of therapeutic goods within Australia, ensuring that these goods are safe, of high quality, and perform as claimed. This Act addresses the need for a cohesive regulatory framework to manage the diverse range of therapeutic products, including medicines, medical devices, and blood and blood components, ensuring they meet the necessary safety and efficacy standards. The Therapeutic Goods Administration (TGA), established under this Act, operates to regulate these goods and protect public health. The policy objective behind the Act is to safeguard the health and safety of Australians by ensuring that therapeutic goods available in the market are safe, of acceptable quality, and perform as represented. On 19 April 2013, Mayada Kayali, as a delegate of the Secretary to the Department of Health and Ageing, issued a consent under sections 14 and 14A of the Therapeutic Goods Act 1989, permitting iNova Pharmaceuticals (Australia) Pty Limited to supply specific batches of DIFFLAM MOUTH GEL. This consent was granted despite the tube label not fully complying with subclause 3(11)(c) of Therapeutic Goods Order No. 69, which mandates specific prefixes for batch and expiry details. The consent is conditional on the product meeting all other aspects of the standard and applies solely to the specified batch numbers, IN501301 and IN501304. This decision underscores the TGA’s role in balancing regulatory compliance with practical considerations in the pharmaceutical supply chain.

Scope and Application

The Therapeutic Goods Act 1989 (the Act) applies to a wide range of entities, including individuals and companies involved in the supply of therapeutic goods within Australia. The Act's scope encompasses the regulation of therapeutic goods, which include medicines, medical devices, blood, and tissues, ensuring their safety, quality, and efficacy. The Act applies nationally across Australia, covering both Commonwealth and state jurisdictions. Specific consents and authorisations, such as the one issued by Mayada Kayali, delegate of the Secretary to the Department of Health and Ageing, can extend or restrict the application of the Act to particular products or entities. This particular consent allows iNova Pharmaceuticals (Australia) Pty Limited to supply specific batches of DIFFLAM MOUTH GEL that do not fully comply with certain label requirements, subject to the condition that all other aspects of the product meet regulatory standards. The consent is limited to specific batch numbers and does not permit any broader deviation from the Act's requirements.

Key Provisions

Section 14 of the Therapeutic Goods Act 1989 allows the delegate of the Secretary to the Department of Health and Ageing to grant consent for the supply of therapeutic goods that do not fully comply with the standards set by the Therapeutic Goods Orders. In this case, section 14A specifies that such consent is granted to iNova Pharmaceuticals (Australia) Pty Limited for the supply of DIFFLAM MOUTH GEL (AUST R 48597). This consent is specific to the batches IN501301 and IN501304, which have tube labels that do not comply with subclause 3(11)(c) of Therapeutic Goods Order No. 69 due to the absence of required prefixes for the batch and expiry details. However, this consent is contingent on the condition that all other aspects of the standard are met. The obligations imposed by this legislation on iNova Pharmaceuticals are clear: they must ensure that the product supplied adheres to all other requirements of the Therapeutic Goods Order No. 69, while the specific non-compliance regarding the batch and expiry details on the tube label is temporarily allowed. This consent does not absolve the company from their general obligations under the Act and the relevant Orders, which include maintaining the quality, safety, and efficacy of the therapeutic goods they supply. In terms of enforcement, the Therapeutic Goods Act 1989 provides for a range of consequences for breaches of its provisions. While the specific penalties for breaches are not detailed in the consent notice itself, the Act generally allows for both civil and criminal penalties. For civil penalties, section 42AD of the Act allows for fines up to $22,200 per day for each breach, or up to $2,220,000 for a single contravention if the amount is not specified. For criminal penalties, section 42AB permits fines of up to $2,220,000 and/or imprisonment for up to five years per offence if the contravention is intentional or involves serious harm. These penalties serve as a deterrent against non-compliance and ensure the protection of public health and safety. The Act also includes provisions for the court to order the recall of non-compliant therapeutic goods, the publication of contravention notices, and the requirement to rectify the contravention. These measures are designed to mitigate any potential harm to consumers and to enforce compliance with the legislative standards. It is essential for iNova Pharmaceuticals to adhere strictly to the conditions of this consent and to the other requirements of the Act to avoid the severe consequences associated with non-compliance.