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Consultation: Mechanisms to maintain the currency of approved Product Information (PI) and Consumer Medicine Information (CMI)

13 May 2013

This consultation closed on 13 June 2013.

The TGA sought comments around issues relating to the preparation, approval and maintenance of PI and CMI by consulting with interested parties on mechanisms which may be used to maintain the currency of these documents. This consultation also seeks advice on how the community can be assured documents uploaded into the Australian Register of Therapeutic Goods (ARTG) and the PI / CMI search facility are current.

Consultation documents

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Timetable

Document released for consultation on 13 May 2013.

Interested parties responded by close of business 13 June 2013.

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

About the consultation

The TGA is reviewing the issues relating to the preparation, approval and maintenance of PI and CMI and mechanisms which may be used to maintain the currency of these documents.

The purpose of this consultation is to seek views from interested parties on the currency of the PI and CMI documents.

The TGA will also hold consultation workshops in May with peak bodies representing consumers, health professionals, the therapeutic products industry and providers of therapeutic product information. Workshop outcomes will be published on the TGA website.

Background

In 2010, the TGA undertook a review of the way it communicates its regulatory processes and decisions, with the aim of improving its transparency. One of the recommendations of the review was that the TGA consider processes and regulatory changes that would help ensure that CMI and PI reflect current circumstances. The Panel considered that the TGA, in the first instance, needs to explore a mechanism to maintain the currency of CMIs and PIs, including consideration of links to other information providers.

Submissions

See: Submissions received

Submissions may address any issues relating to maintaining the currency of PI and CMI. In particular, the TGA invites comment about:

  • the "Questions for Consideration" raised in this paper;
  • the possible further options to maintain PI and CMI;
  • the possible options to address Recommendation TR17;
  • whether or not you support any of these options;
  • whether there are other possible options you wish to raise; and
  • how any or all of these options will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

Organisations represented at the stakeholder workshops are not expected to also provide a written submission. See: Summary of outcomes for consultation workshops

What will happen

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

Content of submissions will inform the further development of a model for a new-to-market risk communication scheme and the evaluation of its feasibility, including impacts on the regulated industry.

The TGA's evaluation report will be provided to Government by June 2014.

If you would like to be kept informed on TGA reform consultation activities, please subscribe to the TGA-UPDATE email list.

Confidentiality

All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Enquiries

Any questions relating to the consultation should be directed to complianceconsultation@tga.gov.au, or by telephone to 02 6232 8660.

If you would like to be kept informed about TGA activities, please subscribe to one of the TGA's email lists.