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Required Advisory Statements for Medicine Labels (RASML) update 6

Consultation

7 October 2011

In response to the feedback and request by stakeholders during the consultation process for Required Advisory Statements for Medicine Labels (RASML) Update 6, the TGA provided additional background information and explanatory notes to assist stakeholders and extended the period of consultation. Due to the Easter holiday period, the TGA further extended the consultation until close of business Friday 13 May 2011.

This consultation is now closed.

Consultation documents

The RASML are being developed to:

  • provide information to help sponsors of over-the-counter (OTC) and complementary medicines to meet their obligations under therapeutic goods legislation;
  • help ensure that applications to the TGA relating to OTC and complementary medicines uniformly meet all essential regulatory requirements so that applications may be processed successfully within minimum timeframes; and
  • enhance clarity and transparency of processes leading to the Registration and Listing of OTC and complementary medicines in the Australian Register of Therapeutic Goods (ARTG).

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RASML 2008

Explanatory notes (15 April 2011)

The purpose of the explanatory notes document

To provide an extended explanation and background information to the proposed changes to the RASML statements to assist stakeholders with the RASML Update 6 Consultation.

The focus of the document is the list of ingredients included in the table of content.

Background to the explanatory notes document

Stakeholders should note that the RASML Update 5 was previously consulted and the proposed changes have been accepted. The background information for RASML Update 5 has been provided for the purpose of clarifying the amended changes in RASML Update 6.

Stakeholders should also note that the consultation document and explanatory notes for RASML 6 are only applicable to non prescription medicines only.

Invitation to comment

The Therapeutic Goods Administration (TGA) sought comments from interested parties on proposed revisions to guidelines on the Required Advisory Statements for Medicine Labels (RASML) Update 6.

Timetable

  • Initial document released for consultation on Friday 18 February 2011.
  • Explanatory notes document released for consultation on Friday 15 April 2011.
  • Interested parties to respond by close of business Friday 13 May 2011. (Initial closing date was close of business Friday 1 April 2011. On 15 April 2011, the consultation was extended until close of business Friday 13 May 2011.)
  • Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

This consultation is a component of the TGA's ongoing project to update the RASML.

These revisions provide a complete, clear and single source of information on Australian requirements for non-prescription and complementary medicines, and will replace the current RASML Update 4.

This update incorporates the RASML Update 5, which went through a public consultation in 2009 and was approved by the Therapeutic Goods Committee in 2009 but, due to related amendments in the Therapeutic Goods Act 1989, was never implemented.

To ensure consistency in our public consultation processes, the proposed changes to the RASML are being consulted on as RASML Update 6.

Once the changes to the RASML are finalised, and the legal process for it to become a legislative instrument has been completed, the final version will be published as the RASML version 1.

This consultation represents the final step in the revision process and gives interested parties the opportunity to help refine the document before it is finalised.

The TGA hopes the consultation process will assist in improving the RASML and make it clear and useful for its intended audience when published.

Content of submissions

Submissions may address any, or all, of the proposed amendments to RASML and other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the revised guideline
  • An assessment of how the revised RASML 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.

What will happen

Submissions will be acknowledged.

Submissions will be considered and the draft amended where necessary before being presented to the Therapeutic Goods Committee (TGC) for endorsement.

Feedback will be provided to respondents through the publication on the TGA's Internet site of the TGC recommendations.

Respondents should not assume however that recommendations made by the TGC will reflect the final decision of the TGA relating to any amendment to the RASML.

Confidentiality

All submissions will be placed on the TGA's website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'.

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.

More information

The TGA invited comments on the draft document from the following organisations:

  • ACCORD Australasia Limited
  • Australian Self-Medication Industry Inc. (ASMI)
  • Complementary Healthcare Council of Australia (CHC)
  • Consumers' Health Forum (CHF)
  • Generic Medicines industry Association (GMiA) of Australia
  • Medicines Australia (MA)
  • Pharmaceutical Society of Australia (PSA)
  • Pharmacy Guild of Australia

Any questions relating to submissions should be directed to the RASML Document Manager/OTC Medicines Evaluation by email to otc.medicines@tga.gov.au or by telephone to 1800 020 653.