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DRAFT: Uniform Recall Procedure for Therapeutic Goods

Consultation document

27 October 2015

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Step 10 - Action by the TGA

Note: This information is part of the Consultation: Revised edition of the Uniform Recall Procedure for Therapeutic Goods

When you advise the TGA of a recall action, TGA will work with you on a case-by-case basis to address the issue as quickly as possible.

Analysing risk

The TGA will use all the information you provide to conduct its own independent assessment and decide on the appropriate recall type, class and level.

The TGA has access to experts who can help analyse the risks, especially when the nature or significance of the hazards involved is unclear.

Agreement to the recall strategy

The TGA will liaise with you on recall actions and will provide advice and assistance in relation to letters, advertisements and recall action strategies.

When the TGA reviews your recall strategy, TGA considers:

  • the proposed timeline
  • availability of alternative products and for critical products, whether future supply of stock might be affected.

If necessary, the TGA will seek advice from experts, such as clinical advisors and other technical experts.

The TGA needs to agree to:

  • the type, class and level of recall action
  • your recall strategy, including:
    • strategy close-out date
    • strategy for exported products
  • your communication strategy
  • text of all your associated written communications, such as:
    • sponsor customer letter
    • paid advertisements
    • media releases.

Sending agreement letter

The TGA will send you an agreement letter, which will:

  • specify the approved details of the recall action
  • provide instructions on contacting the ACCC, if your therapeutic goods are consumer goods
  • contain templates for your reports.

Notifying others

The TGA will notify some organisations directly and will also publish information on its website.

System for Australian Recall Actions (SARA)

The TGA publishes information about all recall actions and safety alerts undertaken in Australia in the publicly searchable database System for Australian Recall Actions (SARA). This is published on or before the second working day following agreement to the recall strategy.

The TGA may publish the agreed sponsor's customer letters in SARA. The decision to publish a sponsor's customer letter in SARA is determined on a case-by-case basis.

TGA alerts

The TGA publishes alerts on its website. The TGA will liaise with you during the preparation of an alert and will provide you with a copy of the alert before it is published. These alerts provide information and advice to consumers and health professionals.

The decision to publish a TGA alert is determined on a case-by-case basis. Recall actions subject to a TGA web alert include, but are not limited to:

  • implant hazard alerts
  • consumer level recall actions
  • recall actions for vaccines
  • any recall action that may have wider implications for public health and safety.

The TGA's alerts contain information on the recall action, including sufficient detail to define the product uniquely. The TGA gives a clear explanation of the issue without causing unnecessary alarm and state the appropriate response by the consumer and health professional.

After publication, the TGA forwards the link to appropriate organisations and professional colleges for their attention.

The TGA recall and safety alert notice

For every recall and safety alert, the TGA develops a Notice, which contains information about:

  • product identification
  • nature of the issue
  • assessment of user hazard
  • distribution of product
  • proposed action.

Some of the information (e.g., distribution details) provided with the TGA Recall Notice is confidential. As part of each Recall Notice, the recipients are advised that a Notice may contain commercially sensitive and confidential information, and safeguard this information and not to distribute it to third parties.

The TGA sends the TGA Recall Notice by email to:

For recall actions with wider health implications, the TGA will notify immediately:

  • the Commonwealth Chief Medical Officer
  • the appropriate state and territory Chief Health Officers.

The TGA will also share recall information with overseas regulatory agencies when appropriate.

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