Exposure drafts: Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017

Consultation

31 August 2017

This consultation closed at 9am on 5 September 2017

Invitation to comment

The TGA sought comments from interested parties on the exposure draft Bills amending the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989.

Consultation documents

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Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

Therapeutic Goods (Charges) Amendment Bill 2017

Timetable

Document released for consultation on 31 August 2017.

Interested parties should respond by 9am on 5 September 2017.

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

About the consultation

The draft Bills are being released to seek your concise submissions on 'show stopper' issues with the clarity, readability and complexity of the draft Bills; the explanatory memorandums are intended to assist you in navigating the Bills. A summary of proposed regulations to support the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 is also included to assist you with a view of the overall legislative package. Your feedback will be used to assess and improve the Bills so that you and the broader public are able to access, read and understand the laws that apply to them.

The final Bills are anticipated to be introduced to Parliament on 13 September 2017.

In order to allow the Bills to be introduced in the Spring 2017 sittings of Parliament, only a short period of time is available for consultation on the Bills.

Updating the regulatory framework for medicines and medical devices in Australia allows Australia to remain in a position to continue to support the availability of high quality, safe and efficacious products in a timely way to the community.

Background

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 (the Bill) and the Therapeutic Goods (Charges) Amendment Bill 2017 (the Charges Bill) are part of the legislative response to the Expert Panel Review Medicines and Medical Devices Regulation.

The Bill builds on recent amendments to the Act to support the continued implementation of the Australian Government Response to the Review of Medicines and Medical Devices Regulation. The amendments will primarily:

  • establish a scheme for the provisional approval of promising new medicines
  • streamline and simplify the framework for advertising therapeutic goods to the public
  • enhance the regulation of complementary medicines; and
  • strengthen monitoring and compliance provisions.

The Charges Bill will enable annual charges to be levied for Australian conformity assessment bodies and for provisionally registered goods.

The Bills are scheduled to be introduced into Parliament in September 2017, and we are seeking your views prior to their introduction.

Submissions

Submissions may address any, or all, of the provisions of the draft Bills, in particular their clarity, complexity and readability.

Enquiries

Any questions relating to submissions should be directed to the Legal and Regulatory Policy Officer by email to info@tga.gov.au or by telephone to 02 6232 8159.

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.

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 privacy is available on our website.