Uniform recall procedure for therapeutic goods (URPTG), 2004 edition

2004 edition

Book pagination

12 April 2017

I. Responsibilities of Australian recall co-ordinator

In connection with recall of therapeutic goods, using the Procedure, the responsibilities of the Australian Recall Co-ordinator are:

  1. A list of current recall co-ordinators for sponsor companies is to be maintained.
  2. The Uniform Recall Procedure for Therapeutic Goods is to be maintained for currency and available on the TGA Website for downloading free of charge.
  3. Copies of the Uniform Recall Procedure for Therapeutic Goods are to be available to all sponsors of therapeutic goods and others on request.
  4. The Australian Recall Co-ordinator will advise the sponsor immediately of problem reports with therapeutic goods which may necessitate recall. All available information is to be provided in order to facilitate investigation by the sponsor.
  5. Where there may be a hazard to the user, expert advice on the classification and level of recalls may be sought by the Australian Recall Co-ordinator.
  6. The Australian Recall Co-ordinator will liaise with the sponsor on recall and provide advice and assistance in relation to letters, advertisements and recall strategies. Sponsors will be informed of actions being taken by the Australian Recall Co-ordinator in advising third parties.
  7. Where applicable, the Australian Recall Co-ordinator will liaise with State and Territory Recall Co-ordinators in assessing the strategy for recall.
  8. In patient or consumer level recalls, where the consumer hazard warrants, the Australian Recall Co-ordinator will liaise with experts within the Therapeutic Goods Administration and with the sponsor to prepare a statement for immediate use by the media (including the major ethnic media). These statements are intended to bring the problem to consumers' attention as quickly as possible as there may be a delay of several days in publication of paid advertisements.
  9. Where necessary, the co-ordinator is to liaise with officers of the ACCC on safety-related recall actions.
  10. The Australian Recall Co-ordinator will forward for each recall a report in writing (by facsimile and/or email) to the relevant parties listed in Appendix V. Such reports will include identification of the goods for which recall action is being taken, the nature of the problem, an assessment of consumer hazard, the distribution of the goods and the action proposed. For urgent recall action, notification is to be by telephone with confirmation in writing.
  11. Where therapeutic goods have been exported to other countries, and are subject to safety related recall, the Co-ordinator will liaise with the sponsor in order to determine:
  12. the sponsor's recall strategy for the exported goods; and
    1. the form of the TGA advice of the recall to the authorities in the other countries.

      The Australian Recall Co-ordinator will forward copies of sponsors' final recall reports and related papers to the Australian Competition and Consumer Commission, Product Safety Policy Section where the recall is safety-related.

      The Australian Recall Co-ordinator will maintain detailed records of individual recalls and a register in which summaries of recalls are entered.

      The Australian Recall Co-ordinator will prepare summarised reports of all recalls for review at meetings of the National Co-ordinating Committee on Therapeutic Goods.

      The Australian Recall Co-ordinator may accompany personnel from the ACCC, Product Safety Policy Section, on audits of sponsors' records of safety-related recalls.

      The Australian Recall Co-ordinator is responsible for the preparation of safety-related recall summaries for publication in the Bulletin of Australian Recalls and Cancellations published by the Therapeutic Goods Administration.

Book pagination