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TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Mandatory Recalls | TGA

The new article describes the approach to be applied with respect to mandatory recalls initiated in order to avoid the customers’ exposure to healthcare products that could potentially be harmful when used for the intended purpose.

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he Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to uniform recall procedures for therapeutic goods (URPTG).

The document describes in detail the relevant procedures and also provides additional clarifications and recommendations the parties involved should follow in order to ensure compliance with the existing legal framework. The authority also reserves the right to make changes to the guidance and provision thereof, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. 

As it was mentioned before, the process of recalling therapeutic goods is a vitally important mechanism for managing risks associated with the safety, quality, performance, or efficacy of medical products. Sponsors play a central role in initiating voluntary recalls; however, under certain circumstances, TGA has the authority to mandate recalls to protect public health.

Mandatory Recalls: Legislative Framework

The Therapeutic Goods Act 1989 outlines the conditions under which mandatory recalls can be enacted. This legislation empowers a delegate of the Secretary of the Australian Department of Health and Aged Care to mandate recalls for products that pose a risk to public health. The act specifies the conditions for different categories of goods:

  • Medical Devices: Provisions under Chapter 4, Part 4-9 of the Act, addressing non-compliance with essential principles or manufacturing standards.
  • Medicines and Other Therapeutic Goods (OTGs): Addressed in Chapter 3, Part 3-2, Division 2A, focusing on compliance with applicable standards and manufacturing principles.
  • Biologicals: Specific provisions under Chapter 3, Part 3-2A, Division 8, concerning compliance with standards and manufacturing principles.

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Role of the ACCC

The Australian Competition and Consumer Commission (ACCC) also plays a role in recalling goods, especially for those therapeutic goods that are also classified as consumer goods under the Australian Consumer Law (ACL).

Coordination with the ACCC is necessary for ensuring compliance with statutory obligations related to safety recalls.

Recalls for Medical Devices, Medicines, and Biologicals

The document further highlights the key points associated with the mandatory recall procedures for different types of products. 

  • Medical Devices and In Vitro Diagnostics (IVDs): A TGA delegate can initiate recalls for devices not complying with essential principles, lacking appropriate conformity assessment, or presenting unacceptable risks concerning quality, safety, or performance.
  • Medicines and OTGs: The TGA can require recalls for products not adhering to standards, manufactured contrary to principles, or supplied illegally.
  • Biologicals: Recalls can be mandated for biologicals that do not meet applicable standards or manufacturing principles, are unfit for their intended use, or supplied illegally.

Enforcement and Penalties

In accordance with the applicable legislation, failure to comply with mandatory recall orders can result in criminal charges, civil penalties, or both, depending on the severity of the non-compliance and the associated risks to public health.

Counterfeit Goods and Tampering

The existing legal framework also has provisions to address counterfeit therapeutic goods and actual or potential tampering, requiring sponsors to take specific actions to recall affected goods and notify the public or specified classes of persons.

Notification and Publishing Requirements

According to the guidance, mandatory recalls and actions related to tampering must be notified to the TGA and published, either in the Australian Government Notices Gazette or on the TGA website, to ensure transparency and public awareness.

Conclusion

In summary, the Australian legislation on product safety and recalls provides a comprehensive framework for special actions to be taken, should it be identified that the products made available to healthcare professionals and customers in the country do not meet the applicable regulatory requirements they are subject to.

Depending on certain factors, a recall could be initiated either by a sponsor as a party primarily responsible for the product, or by the authority itself, should it be reasonably necessary to ensure public health protection by removing exposure to medicines, medical devices, or other healthcare products posing risks when used.

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