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Consultation: TGA - enhancing sanctions and penalties in the Therapeutic Goods Act 1989

30 October 2017

This consultation closed on 31 May 2017.

The TGA sought comments from interested parties on the consultation paper proposing enhancing sanctions and penalties in the Therapeutic Goods Act 1989 (the Act).

Consultation documents

How to access a pdf or Word document

Timetable

Documents released for consultation on Wednesday, 3 May 2017.

Interested parties responded by close of business Wednesday, 31 May 2017.

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

About the consultation

Sought stakeholder's views on proposed legislative reforms to ensure the Act provides for an effective layered approach to compliance and enforcement. The proposed amendments will provide us with an expanded suite of possible regulatory actions to address the severity of a compliance breach. The ultimate objective is to ensure that regulatory actions are proportionate with the risk that the therapeutic goods pose and to address any potential health and safety issues to the Australian public.

Background

Some of the proposed amendments directly relate to the Government's response to the Expert Panel's Review such as the introduction of substantiation notices and public warnings in relation to advertising non-compliance. Other amendments from the Review will enhance sanctions and penalties and introduce the ability to seek an injunction to rapidly address serious cases of non-compliant advertising of therapeutic goods.

Other proposed amendments intend to give further clarification to the 2006 amendments with changes to strict liability offences and the infringement notice regime that are consistent with contemporary Government policy.

All these measures will align the Act with regulatory provisions comparable to other Commonwealth regulators ensuring that we will have the right tools to effectively address non-compliance with appropriate and effective risk-based graduated responses in a timely manner.

Content of submissions

The consultation paper includes a 'questions' box at the end of each section, with prompts for stakeholders to consider. Submissions may address any, or all, of the proposed amendments to the Therapeutic Goods Act 1989 or other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • An assessment of how the proposed change will impact on you.
  • 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. This is important - the TGA is required to quantify the regulatory impact (burden and/or savings) of any proposed changes.

Enquiries

Any questions relating to submissions should be directed by email to info@tga.gov.au or by telephone to 1800 020 653.

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 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 review.