Draft a recall action strategy, which you will submit to the TGA at Step 9.

You need the TGA's agreement with your recall strategy. You may negotiate with the TGA while you draft the strategy, or the TGA can liaise with you after you have submitted your strategy.

In Step 7: Objectives of a recall action | Overview of a recall strategy | Preparing your recall strategy

Objectives of a recall action

Your recall strategy needs to assure the TGA that the risks arising from the product deficiency will be effectively mitigated by:

• stopping the distribution, sale and use of the affected products as soon as possible
• effectively and efficiently removing from the market place or correcting any product that is potentially unsafe
• preventing further distribution of unsafe products
• informing the relevant authorities of the issue
• informing the product users of the issue
• analysis of root cause and implementation of CAPAs to prevent re-occurrence of issue.

Overview of a recall strategy

Your recall strategy should address:

• consumer, patient and health professional safety
• the quality of the product
• the nature of the deficiency in the product
• the number of complaints (including the number of known injuries or incidents)
• distribution networks
• exported products
• recovery procedures
• resources for field corrections and availability of alternative products
• the factors that may affect the duration of the recall action.

Preparing your recall strategy

Include in your recall strategy the following information:

• an explanation of the issue, including the potential hazard associated with the deficient product and your assessment of the risk posed by the product
• the proposed type, classification and level for the recall as described in Step 6
• the number of units supplied, relevant dates and their distribution within the supply chain including PBS supply for medicines if applicable
• details of any known injuries or incidents associated with the product
• details of the life cycle of the product
• information about the manner in which the recalled product will be collected and disposed, destroyed or rectified:
  • disposal must be in accordance with relevant Commonwealth, state and territory requirements
• strategy for exported products
• an expected close-out date
• action you have taken to identify and correct the cause of the hazard, including the outcome of any root cause analysis or the time period in which such analysis will occur
• contact details of:
  • the sponsor of the product
  • other entities in the supply chain to whom the recalling sponsor has supplied the product
  • international recipients of products.

You will also need a communication strategy, as described in Step 8.