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Roles in recalling therapeutic goods

Uniform recall procedure for therapeutic goods, V2.2

7 February 2019

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Wholesalers and distributors and recalling goods

Cooperation from wholesalers and distributors is often essential for an effective recall. As a wholesaler, you should have a procedure for conducting a recall at a sponsor's request.

Wholesalers of medicines in schedules 2, 3, 4, and 8 should follow the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 & 8.

Your recall procedure

As a wholesaler, your recall procedure should cover:

  • the appointment of a person in charge of expediting the recall
  • a description of how the goods can be traced within the stock control system
  • quarantine arrangements for recalled goods
  • how you will handle goods in transit from the sponsor, or returns for credit from purchasers, (includes returns for credit that occur as a usual part of business where the recall was only to wholesale level)
  • record keeping, including customer lists
  • communication arrangements with the sponsor
  • the mechanism for replacing goods, if applicable.

Levels other than wholesale

For recall actions going to levels beyond you as the wholesaler, you should contact any organisations that would not be on a mailing list used by the sponsor and that you have supplied with the affected goods. Common examples include:

  • offshore pharmacies
  • exporters supplied by the wholesaler
  • clinical trials organisations
  • retailers licensed to sell pharmacy-only medicines
  • private hospitals
  • paramedic organisations
  • organisations that may include the affected goods in a new combination of goods.

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