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Consultation: ARGCM Part D: Registered complementary medicines
This consultation closed on 22 July 2013
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Invitation to comment
The TGA sought comments from interested parties on the draft document Australian regulatory guidelines for complementary medicines (ARGCM) Part D: Registered complementary medicines.
The ARGCM Part D represents a revision and restructure of the current document 'ARGCM Part I: Registration of complementary medicines'. Changes to the original document include formatting, corrections and clarification of information. While the revised document does not introduce any new procedures or procedural changes, the existing ARGCM Part I contained outdated information which has been amended to reflect current regulatory practice.
Document released for consultation on 24 June 2013.
Interested parties should respond by close of business 22 July 2013.
Feedback will be released following consideration of submissions (see 'What will happen').
About the consultation
The ARGCM provides information for manufacturers, sponsors, healthcare professionals and the general public on the legal arrangements for the supply and use of complementary medicines in Australia. The current ARGCM was first published in 2001 and is comprised of Parts 1-5:
- Part I - Registration of complementary medicines
- Part II - Listed complementary medicines
- Part III - Evaluation of complementary medicine substances
- Part IV - General guidance
- Part V - Policy documents and guidelines
The TGA is currently reviewing and restructuring the ARGCM to increase the useability of the guidelines and to ensure the information provided is reflective of current regulatory requirements. The revised ARGCM has been restructured into four parts with technical information provided in Attachments.
- Part A: Provides an overview of the regulatory framework for therapeutic goods in Australia. Information is provided on: the regulation of different types of complementary medicines; active and excipient ingredients; medicine terminology; exempt medicines; practitioner products; and medicine/food interface issues.
- Part B: Provides guidance on the regulatory framework for listed 'low risk' complementary medicines.
- Part C: Provides guidance on the evaluation process for a new complementary substance to be approved for use in listed medicines.
- Part D: Provides guidance on the registration process for complementary medicines.
- Attachments: Provide technical details and requirements relevant to the procedural information provided in the main body of the document.
The TGA has undertaken a staged consultation process for the revised ARGCM. Each draft part (A, B, C and D) has been published separately on the TGA website, with a 4 week consultation period provided for each part.
ARGCM Part A: 'General Guidance' was published for consultation from 10 October to 7 November 2012.
ARGCM Part B: 'Listed medicines' was published for consultation from 21 January to 18 February 2013.
ARGCM Part C: 'Evaluation of complementary medicine substances for use in listed medicines' was published for consultation from 16 April to 14 May 2013.
ARGCM Part D: 'Registered complementary medicines' released for consultation on 24 June to 22 July 2013.
Following consideration of submissions received, all parts will be consolidated into a final document reflective of the current regulatory requirements for complementary medicines. In the future, the ARGCM will be revised as required when the proposed regulatory reforms for complementary medicines (as part of the 'TGA reforms: a blueprint for TGA's future') have been developed and implemented.
The ARGCM is being reviewed and updated in response to the Auditor-General's recommendations following the ANAO audit of TGA regulation of Complementary medicines and is part of the Complementary medicines regulatory reforms package.
Submissions might include:
- Suggested improvements, amendments, corrections and areas requiring clarification in the Draft ARGCM Part D.
- Comments on any other issues related to the review of the ARGCM.
What will happen
Submissions will be acknowledged as they are received.
At the completion of this consultation process, the TGA will collate and analyse submissions on matters that are within the scope of this review.
The TGA will finalise the ARGCM and publish as per the proposed time schedule.
Updates on progress of the review and expected timeframes will be provided on the TGA website.
If you would like to be kept informed on TGA reform consultation activities, please subscribe to the TGA-UPDATE email list.
A summary of submissions will be placed on the TGA website (at the end of the consultation process for all parts of the ARGCM). Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. 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 all parties who made a submission 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.
Any questions relating to the consultation should be directed to email@example.com, using the subject line 'ARGCM Part D consultation' or by telephone to 02 6232 8634.
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