TGA product recalls

Sponsors responsibility for TGA product recalls

In an era where health and well-being are paramount, the pharmaceutical industry plays a pivotal role in ensuring the safety of consumers. However, the reality is that pharmaceutical TGA recalls can and do occur, posing challenges to sponsors.

In this Blog, we shed light on how PharmOut can provide support and expertise preventing these critical situations, or if they do arise, how to respond.

Key Services Offered by PharmOut:

  1. Risk Assessment and Mitigation: Conduct thorough risk assessments to identify potential issues, allowing companies to implement preventive measures and mitigate risks before they escalate.
  2. Regulatory Compliance: Staying abreast of ever-evolving regulatory requirements is crucial. PharmOut provides expert guidance to ensure that pharmaceutical companies comply with the latest regulations, reducing the likelihood of recalls.
  3. Quality Management Systems: PharmOut assists in the development and implementation of robust quality management systems, fostering a culture of continuous improvement and adherence to industry best practices.
  4. Recall Planning and Execution: In the unfortunate event of a recall, PharmOut helps companies develop comprehensive recall plans and supports the execution process, minimizing disruptions and ensuring swift and effective resolution.

Understanding Pharmaceutical Recalls

Pharmaceutical recalls are instances where a company withdraws a drug from the market due to safety concerns or defects that could potentially harm consumers. These recalls can be initiated by regulatory agencies, or sponsors. The reasons for recalls vary, ranging from contamination issues to packaging errors, and the impact can be widespread, affecting patients, healthcare providers, and the pharmaceutical industry as a whole.

In Australia, sponsors are required to comply with the requirements of the Uniform Recall Procedure for Therapeutic Goods (URPTG), June 2022 when implementing a product recall. 

The High Stakes of Pharmaceutical Recalls

The consequences of pharmaceutical recalls are far-reaching, encompassing not only the financial implications for sponsors but also the potential harm to patients who rely on these medications for their health. Effective management of recalls is essential to mitigate risks, protect public health, and uphold the reputation of the pharmaceutical industry.

PharmOut’s Expertise: A Guiding Light in Challenging Times

In the face of a pharmaceutical recalls, having a trusted partner with extensive experience in regulatory compliance and quality assurance becomes indispensable. PharmOut, with its proven track record in the pharmaceutical and healthcare industries, stands out as a reliable ally for sponsors navigating the complexities of recalls.

PharmOut has the templates, the knowledge and the expertise to implement a recall quickly and effectively.  We will work with you and liaise directly with the TGA to minimise the disruption to your business.

Manufacturers of pharmaceuticals are required to comply with, Clause 8.30 of the PIC/C Code of Good Manufacturing Practice for Medicinal Products which states that the effectiveness of the arrangements in place for recalls should be periodically evaluated to confirm that they remain robust and fit for purpose.  Colloquially, these checks are referred to as a ‘mock recall’ by manufacturers and are generally conducted annually. 

There is no requirement for sponsors to conduct mock recalls.  However, as a sponsor, how confident are you that you would be able to efficiently and effectively remove marketed product from the distribution chain? PharmOut can provide you with a level of confidence and assurance that the arrangements you have in place for managing recalls would be effective by conducting a mock recall for you.


Pharmaceutical recalls are complex challenges that demand a strategic and well-coordinated response. PharmOut’s commitment to quality, compliance, and client success positions it as a valuable partner for pharmaceutical companies aiming to navigate recalls seamlessly. By leveraging PharmOut’s expertise, the pharmaceutical industry can proactively address challenges, uphold public trust, and most importantly, safeguard the health and well-being of patients worldwide.

Further reading can be found here – Uniform Recall Procedure for Therapeutic Goods (URPTG) V2.3, Updated June 2022