AUSTRALIA: TGA updates the Uniform Recall Procedure

The Uniform Recall Procedure for Therapeutic Goods (URPTG) is updated by Australian Therapeutic Goods Administration (TGA). The aim of this procedure is to assist Sponsors in leading recall and non-recall actions using systematic standard procedures, thereby promoting an effective and efficient response from Sponsors to problems which may result in a risk to security and public health.

TGA updates the Uniform Recall Procedure

Among the most meaningful changes to 2.0 version, the following need to be mentioned:

  • recall: in case of emergency, TGA will directly contact the concerned professional operators (doctors), while in case of non-emergency, the Sponsor will be responsible for contacting them; furthermore, the report to TGA will be released through the TGA Business Services portal;
  • recall and non-recall: it is specified that withdrawal of time-expired products does not fall under the scope of a recall, but changes in the instructions for use may be able to, since they may imply the correction of a defective device;
  • non-recall Communications of Sponsors: it will not be possible to use terms such as “voluntary” or “voluntarily” within these communications, as they may make it unclear to users whether they are required to perform the stated actions, and letter templates are provided, also in tabular form, because they are more usable and easier to comprehend.

Since the process as defined by URPTG is in progress and subject to a continuous updating, further amendments and adjustments are foreseeable, in such a way as to make the Application for recall procedures by Manufacturers and Sponsors clearer and more standard.