COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 17 November 2015, a delegate of the Secretary of the Department of Health, on the application of Pfizer Australia, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
Product name | ARTG number |
Centrum for Women | AUST L 200414 |
Centrum for Women 50+ | AUST L 211922 |
Centrum Specialist Cardio Plus | AUST L 224683 |
Centrum Specialist Energy Plus | AUST L 224847 |
Centrum Specialist Vision Plus | AUST L 224881 |
that do not conform with the requirements of the subclause 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the formatting of the warning statements is different to the requirements of MASS 2014, which requires some of the statements to be included at the beginning of the directions for use on the label.
The consent is effective from 17 November 2015 until 31 March 2017.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply and use of therapeutic goods in Australia, aiming to ensure their safety, quality, and efficacy. This legislation was introduced to address the need for comprehensive regulation of therapeutic goods to protect public health. The Act is administered by the Therapeutic Goods Administration, a body within the Australian Department of Health. A key policy objective of the Act is to facilitate the availability of therapeutic goods that meet appropriate standards while also protecting consumers from potentially harmful products.
In specific instances, such as the consent granted to Pfizer Australia for the supply of certain Centrum products, the Act allows for flexibility to address unique situations where products may not fully comply with labelling requirements. The consent granted under sections 14 and 14A of the Act allows for the supply of products that do not conform to certain labelling specifications for a limited period, provided it does not pose a significant risk to public health. This provision underscores the Act's balance between regulatory compliance and practical considerations in the therapeutic goods market.
Scope and Application
The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods, including medicines, medical devices, blood and blood components, tissues, and in vitro diagnostic goods. It applies to persons and entities involved in the supply, importation, and advertising of these goods within Australia. The Act covers both Commonwealth and state/territory levels, ensuring a consistent regulatory framework across the nation. The Therapeutic Goods Administration, under the Department of Health, administers the Act and has the authority to issue consents for deviations from specific regulatory requirements, as seen in the consent granted to Pfizer Australia for the supply of certain Centrum products that did not conform to particular labelling standards. This consent, issued under sections 14 and 14A of the Act, is effective from 17 November 2015 until 31 March 2017, allowing for temporary non-compliance with certain labelling requirements while ensuring the safety and efficacy of the products. The Act allows for the extension and restriction of its application through various subordinate instruments, ensuring flexibility and adaptability to new challenges and innovations in therapeutic goods.
Key Provisions
The Therapeutic Goods Act 1989 contains specific sections that govern the therapeutic goods market in Australia, and these sections include the operative provisions under sections 14 and 14A (1). These sections allow the Secretary of the Department of Health, or a delegate, to consent to certain activities that would otherwise be prohibited or restricted under the Act. In this instance, sections 14 and 14A facilitated the consent for the supply of specific Centrum products, manufactured by Pfizer Australia, which do not conform to certain labelling requirements outlined in Therapeutic Goods Order No. 69. This consent ensures that the products can be supplied under specific conditions despite not fully adhering to the labelling standards.
Under the Therapeutic Goods Act 1989, entities like Pfizer Australia must comply with stringent regulations to ensure that therapeutic goods are safe, of high quality, and effective for their intended use. The Act imposes obligations on these entities to ensure that products meet specific standards and are appropriately labelled. For the Centrum products in question, Pfizer Australia was required to apply for consent to supply the products that did not meet the labelling requirements, demonstrating their intent to comply with the Act’s broader objectives while addressing specific concerns.
Failure to comply with the Therapeutic Goods Act 1989 can result in significant consequences, both civil and criminal. The Act provides for offences and penalties where there is a breach of its provisions. For instance, supplying non-compliant therapeutic goods can result in fines and other penalties. While the specific maximum penalties are not detailed in the notice, the Act generally imposes strict penalties to ensure compliance and protect public health. The consent granted under sections 14 and 14A, therefore, serves as a temporary measure to allow for the supply of products that do not fully comply with labelling standards, under controlled conditions.
In summary, sections 14 and 14A of the Therapeutic Goods Act 1989 permit the Secretary of the Department of Health to consent to activities that would otherwise be prohibited, ensuring that therapeutic goods can be supplied under specific conditions. Pfizer Australia’s consent to supply Centrum products that do not meet certain labelling requirements is an example of how these sections are applied in practice. The Act imposes clear obligations on entities to ensure that therapeutic goods are safe and of high quality, and non-compliance can lead to significant civil and criminal consequences.