Supply of AZEP NASAL SPRAY azelastine 128ug/actuation (as hydrochloride) nasal spray by Meda Pharmaceuticals Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, was introduced to regulate the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. This legislation plays a pivotal role in ensuring that therapeutic goods, including medicines, medical devices, and blood products, meet the necessary standards before they are supplied to consumers. The Act aims to protect public health by regulating the advertising, labelling, and supply of therapeutic goods, and it empowers the Therapeutic Goods Administration (TGA) to enforce compliance with these regulations. This particular legislative action involves a notice issued under sections 14 and 14A of the Therapeutic Goods Act 1989, granting consent for Meda Pharmaceuticals Pty Ltd to supply AZEP NASAL SPRAY azelastine 128ug/actuation (as hydrochloride) nasal spray, despite the product's label not fully complying with the Therapeutic Goods Order No 69. The consent, issued by Mayada Kayali, Delegate of the Secretary to the Department of Health and Ageing, allows for a six-month period during which the product can be supplied under the condition that it meets all other aspects of the standard. This decision highlights the TGA’s ability to address specific issues on a case-by-case basis while maintaining the overarching objective of safeguarding public health.

Scope and Application

The Therapeutic Goods Act 1989, as referenced in section 14 and 14A Notice, applies to entities involved in the supply of therapeutic goods within Australia. In this specific instance, the Act pertains to Meda Pharmaceuticals Pty Ltd, which is authorised to supply AZEP NASAL SPRAY azelastine 128ug/actuation (as hydrochloride) nasal spray despite a non-compliance with certain labelling standards outlined in Therapeutic Goods Order No 69. The legislation ensures that therapeutic goods meet specified standards to protect public health and safety, while also providing a framework for exceptions under the authority of a delegate. The geographic reach of this Act is national, applying across all states and territories of Australia. However, the consent provided is specific to Meda Pharmaceuticals Pty Ltd and the mentioned product for a limited period of six months, with a condition that all other aspects of the standard must be adhered to. This consent does not extend to other entities or products unless similarly authorised by the delegate under the Act.

Key Provisions

The Therapeutic Goods Act 1989 includes sections that govern the consent for the supply of therapeutic goods, which are medical products such as medicines and medical devices. Specifically, section 14 allows the Delegate of the Secretary to the Department of Health and Ageing to give consent for the supply of therapeutic goods that do not fully comply with certain standards. In this instance, section 14A of the Act provides the legal basis for such consent, with section 15(1) specifying the conditions under which such consent can be granted. Under section 14, the Delegate, in this case Mayada Kayali, has given her consent for Meda Pharmaceuticals Pty Ltd to supply AZEP NASAL SPRAY azelastine 128ug/actuation (as hydrochloride) nasal spray (AUST R 104853), despite the product's label not complying with subclause 3(2)(1) of the Therapeutic Goods Order No 69 – General requirements for medicine labels because it does not include the name and address of the current sponsor or supplier of the goods. The obligations imposed by the Act on the entities it governs include ensuring that the product complies with all other aspects of the standard and re-directing any contacts made in relation to the product to the address of the current sponsor. In this case, Meda Pharmaceuticals Pty Ltd has arranged for any contacts made in relation to the above products to the previous sponsor’s address (iNova Pharmaceuticals Australia Pty Ltd) to be re-directed to the address of the current sponsor. The consent given is for a limited period of six months from the date of the notice, which is the 7th of June 2013. Failure to comply with the conditions of the consent or the provisions of the Therapeutic Goods Act 1989 and the Therapeutic Goods Order No 69 – General requirements for medicine labels can result in civil or criminal consequences. The maximum penalties for breaches of the Act can include fines of up to $22,000 for individuals and $110,000 for corporations, as well as imprisonment for up to two years. In addition, the Therapeutic Goods Administration may take action to recall the product or take other regulatory action to protect public health and safety. It is important for entities governed by the Act to ensure that they comply with all requirements and conditions to avoid these potential consequences.