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Consultation: Revised edition of the Uniform Recall Procedure for Therapeutic Goods

27 October 2015

This consultation closed on 23 November 2015.

Invitation to comment

The TGA sought comments from interested parties on a revised edition of the Uniform Recall Procedure for Therapeutic Goods.

Consultation documents

Timetable

Documents released for consultation 26 October 2015.

Consultation closes COB 23 November 2015.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

The TGA is currently updating the procedure for recalling therapeutic goods, which defines the action to be taken by Australian health authorities, sponsors and other responsible entities when therapeutic goods are to be removed from supply or use, or subject to corrective action. The purpose of the procedure is to ensure that the action taken to recall therapeutic goods is consistent for all recall actions. This also ensures that messages regarding recall actions are communicated consistently and are well-understood across all jurisdictions, industry, wholesalers and retailers.

An overview of proposed changes is also available.

The scope of the consultation is to ensure that the Uniform Recall Procedure for Therapeutic Goods accurately describes the recall process and is well-understood by users. The Uniform Recall Procedure for Therapeutic Goods aims to:

  • define the procedure for the recall of all types of therapeutic goods
  • provide an instructional approach for conducting a recall action
  • ensure timely communication of alerts and recalls to health practitioners and consumers.

Interested stakeholders were encouraged to provide comments on the clarity and completeness of the revised Uniform Recall Procedure for Therapeutic Goods.

The views of Australian health authorities, industry, sponsors, health care professionals, consumers and the public in general will be important in ensuring that the final version of the Uniform Recall Procedure for Therapeutic Goods covers all relevant matters and deals with any issues and concerns identified in comments received.

It should be noted that the Uniform Recall Procedure for Therapeutic Goods is in a draft form to indicate that it does not represent the TGA's final views.

Submissions

Submissions may address whether the Uniform Recall Procedure for Therapeutic Goods provides adequate information for stakeholders to carry out and respond to a recall action, or other identified issues. In particular, comments are being sought on whether the procedure is comprehensive and easy to understand.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA Internet site.

A final version of the Uniform Recall Procedure for Therapeutic Goods that takes account of those comments will be published on the TGA Internet site.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification on issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available
    • help provide context about your submission (for example: to determine whether you are an individual or a director of a company or representing an interest group).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (that is, make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the coversheet).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed to the Technical and Safety Improvement Section by email recalls.consultation@tga.gov.au or by telephone to 02 6232 8103.