Consultation: Options for the future regulation of 'low risk' products

31 March 2017

This consultation closes on 12 May 2017.

Invitation to comment

The TGA is seeking comments from interested parties on the options for the future regulation of 'low risk' products.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Friday, 31 March 2017.

Interested parties should respond by close of business Friday, 12 May 2017.

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

About the consultation

The Therapeutic Goods Administration (TGA) is seeking comments on proposed options for future regulation of 'low risk products', noting that decisions on significant changes to the regulatory framework would be made by government.

We are specifically looking for feedback on the potential regulatory options for low risk products that are discussed in the consultation document, including which (if any) might be most appropriate and why. The options presented in the paper represent a range of possible regulatory directions for the identified 'low risk' products.

Background

In March 2015, the Expert Review of Medicines and Medical Devices Regulation (MMDR) made three recommendations to conduct further reviews of the regulation of 'low risk' products in Australia. This approach was supported by Government in its broader consideration of MMDR implementation.

The attached public consultation paper contains a range of options for the future regulation of 'low risk' therapeutic goods (including maintenance of the status quo). This is in line with the MMDR recommendations as follows:

Recommendation Fourteen: The Panel recommends that the Australian Government undertake a review of the range of products currently listed in the Australian Register of Therapeutic Goods (ARTG) (not including complementary medicines) and subject to regulation under the medicines framework, with a view to ensuring that products that might best be regulated under other regulatory frameworks, without undermining public health and safety, are removed from the auspices of the Act; and goods remaining under the auspices of the Act are subject to regulatory requirements that are commensurate with the risk posed by the regulated products.

Recommendation Twenty-Three: The Panel recommends that the Australian Government undertake a review of the range of products currently classified as Class I medical devices, with a view to reclassifying products as consumer goods in circumstances where the product poses little or no risk to consumers should it not perform as specified or malfunctions.

Recommendation Forty-Eight: The Panel recommends that the Australian Government undertakes a review of the range of complementary medicinal products, currently listed in the ARTG and subject to regulation under the medicines framework, with a view to ensuring that products that might best be regulated under other regulatory frameworks, without undermining public health and safety, are removed from the auspices of the Act.

Content of submissions

Submissions may address any, or all, of the Options for the future regulation of 'low risk' products.

In addition, submissions might include:

  • Suggested improvements
  • An assessment of how the options will impact on you.

How to respond

Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.

Consultation submission form

Alternatively, hardcopy submissions with a printed coversheet may be mailed to:

Regulatory Reforms Team
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

How to access a Word document

Enquiries

Any questions relating to submissions should be directed to the Regulatory Reforms Team by email to .

What will happen

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

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

Following analysis of public responses, specific proposals for regulatory reforms will be developed and public consultation on these specific proposals is expected in late 2017.

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.

More information

Further information on the Government's response to the MMDR recommendations is available at Medicines and Medical Devices Regulation review.