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Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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Step 6. Drafting a communication strategy

Your first contact should be with the TGA, except for biologicals and radiopharmaceuticals.

You do not require a communication strategy if you are recalling human blood and blood components.

Follow this step to prepare your communication strategy for both recalls and non-recall actions.

Recall communication strategies

The purpose of communicating a recall

To prevent injuries by identifying, removing and /or rectifying goods that do not meet specifications.

The goal

Enable those in the supply chain to know about and comply with the recall notice.

Cooperation between everyone in the supply chain is essential for the effectiveness of the recall and for notifying everyone involved.

Do not implement your communication strategy until we agree because it may change depending on our independent and objective review of your proposal.

Contents of a communication strategy

Include:

  • A description of your intended audience within Australia and in other countries, if you have exported the goods.
  • Methods for communicating with those in the supply chain.
  • A draft copy of the sponsor's proposed customer letter, consumer recall notices, etc.

Match the communication medium to the target audience and target the relevant demographic for the recalled goods.

Include how you will manage customer enquiries including any complaints.

The minimum requirement for formal written communication is a sponsor's customer letter sent to all known recipients of the affected therapeutic goods.

Sponsor's customer letter

Go to Sponsor's customer letter for recalling therapeutic goods for guidance about:

  • how to prepare and address the letter
  • what to include
  • when and how to send the letter
  • addressing customer letters
  • an example letter.

When to send the customer letter

Send your customer letter to all intended recipients within two working days of agreement with the Australian Recall Coordinator in Step 9.

  • Do not send this letter until we agree to the content in Step 9.
  • The letter may change depending on our independent and objective assessment.

Consumer recall notices

The sponsor arranges and pays for consumer recall notices required for consumer level recalls unless they have complete and accurate distribution lists identifying all end-users.

Go to Consumer recall notices required for consumer level recalls for guidance on how to prepare your notice including:

  • Headings for notices
  • Text for notices
  • Product information
  • Communication strategy
  • When and where to publish the notices

Media release

It may be necessary to issue a media release for some Class I and Class II consumer level recalls.

Develop the text of a proposed media release, which should:

  • contain sufficient detail to define the affected goods uniquely
  • give a clear explanation of the issue without causing unnecessary alarm
  • describe the potential risks due to the issue with the goods
  • state the appropriate actions to be taken by the consumer
  • provide a phone number (preferably toll-free) for consumers to obtain further information.

Send us the draft media release in Step 7.

We may seek expert advice when we review this in Step 8.

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