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Consultation: Permitted (coded) indications for listed medicines

14 January 2013

This consultation closed on Friday 15 March 2013.

The TGA sought comments from interested parties on proposed reforms relating to 'Permitted (coded) indications' for listed medicines.

Consultation documents

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Consultation: Permitted (coded) indications for listed medicines

Attachment 1: List of permitted indications

Attachment 2: List of indications that will not be permissible

Timetable

Document released for consultation on Monday 14 January 2013.

Interested parties responded by close of business Friday 15 March 2013.

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

About the consultation

Currently, when listing a medicine on the ARTG via the Electronic Lodgement Facility (ELF), sponsors may either select indications from a coded list or use a free text field to describe indications in their own words. Unlimited use of the free text field has resulted in a large number of inappropriate indications and other statements being entered on the ARTG.

The TGA proposes to remove the free-text option and require sponsors to select indications from a list of permitted indications only. Attachment 1 to the consultation paper provides a draft list of permitted indications. Following the current consultation process, the list will be expanded and restructured to ensure that it is sufficiently comprehensive and only includes indications that are consistent with the low risk profile intended for listed medicines.

The TGA recognises that the proposed changes will affect sponsors of listed medicines, including listed complementary medicines and listed sunscreens. Consumers who use listed medicines may also be affected.

In order to understand the possible impacts of the proposed changes for consumers and sponsors, the purpose of the current consultation is to:

  • identify issues that might be faced by these different stakeholder groups as a result of the change; and
  • use feedback received to help devise appropriate mechanisms to implement the changes.

Background

The reforms proposed in this paper are part of the TGA reforms: A blueprint for TGA's future ("the Blueprint") and include a number of recommendations from the Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines ("the Auditor-General's Report") and the Informal Working Group Examining Complementary Medicines Regulation (the Complementary Medicines Working Group).

The reform package for complementary medicines that the TGA is progressing is aimed at improving community confidence in the safety and quality of listed medicines.

Content of submissions

Submissions might include:

  • Answers to the specific questions raised in the consultation paper.
  • Comments on any other issues related to the proposed reforms relating to Permitted (coded) indications for listed medicines.

What will happen

Submissions will be acknowledged as they are received.

Feedback received from stakeholder groups as part of this consultation will be used to determine an appropriate strategy to implement the changes in a way that achieves the outcome with the least possible inconvenience.

At the completion of this consultation process, the TGA will collate and analyse submissions on matters that are within the scope of this review.

Updates on progress of the review and expected timeframes will be provided on Reform timeframe and progress.

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 ocm@tga.gov.au, using the subject line 'Permitted (coded) indications consultation' or by telephone to 02 6232 8634.

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