Consultation: Options for the implementation of a claimer for efficacy assessed non-prescription medicines

10 May 2018

This consultation closed on 21 June 2018.

The TGA sought comments from interested parties on the use of a claimer for efficacy assessed non-prescription medicines to address the Government-agreed Recommendation 45 from the Review of Medicines and Medical Devices Regulation.

Consultation documents

How to access a pdf or Word document

Timetable

Documents released for consultation on Thursday, 10 May 2018.

Interested parties should respond by close of business Thursday, 21 June 2018.

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

About the consultation

The purpose of this consultation is to provide an opportunity for consumers, health professionals and industry to comment on proposed changes to improve the transparency of medicine labelling. These changes are intended to help consumers make more informed healthcare decisions when self-selecting medicines.

In our February 2017 consultation paper, Reforms to the framework for complementary medicines: Assessment Pathway, we consulted on a proposal to allow sponsors to claim (‘the claimer’) that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA. This was supported by the majority of respondents.

Through further targeted consultation with industry and consumer representative groups, we have now refined options for the claimer and options for its implementation. In this consultation we are seeking feedback:

  • the types of medicines that should be allowed to carry a claimer
  • options to implement the claimer as a visual identifier and/or label statement
  • how the claimer can be used on medicine labels.

We will also conduct consumer focus group testing on the options presented in this paper to confirm whether our potential options will achieve the objectives of the recommendation.

Content of submissions

Submissions may address any, or all, of the proposals in the consultation document or other identified issues. Submissions might include, for example, suggested improvements or an assessment of how the proposed change will impact on you.

Enquiries

Any questions relating to submissions should be directed to the Reform Coordination and Support Section by email to or by telephone to our information line on 1800 020 653 (TGA information line, managed by the Regulatory Assistance Section).

What will happen

All electronic or paper based submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

The outcomes of the online survey will be de-identified and summarised prior to publication on the TGA website.

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

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • Seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.