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Consultation: Remaking Therapeutic Goods Order No. 78

17 December 2018

This consultation closes on 8 February 2019.

Invitation to comment

The TGA is seeking comments from interested parties on the proposed remaking of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules and reintroducing pills into the remade Order.

Consultation documents

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Supporting documents

Draft: Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019

Draft: Guidance for TGO 101: Standard for tablets, capsules and pills

Timetable

Document released for consultation on Monday, 17 December 2018.

Interested parties should respond by close of business Friday 8 February 2019.

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

About the consultation

Therapeutic Goods Order No. 78 Standard for Tablets and Capsules (TGO 78) is the minimum quality standard for medicines that are tablets or capsules.

In accordance with the Legislative Instruments Act 2003, TGO 78 is due to sunset on 1 April 2019.

Initial consultation with peak industry bodies has confirmed that the Order needs to be remade to provide continuing clarity on specific requirements needed to maintain quality standards for tablets and capsules.

Although TGO 78 continues to operate largely effectively and efficiently, further efficiencies could be achieved by increased international harmonisation and improving clarity.

Content of submissions

Submissions may address any, or all, of the proposed amendments to the remaking Therapeutic Goods Order No. 78 - Standard for tablets and capsules and reintroducing pills into the remade Order or other identified issues.

In addition, submissions might include:

  • The suitability of the requirements specified in the Standard.
  • The exclusion of unapproved goods from the application of the Order.
  • The usefulness of the proposed guidance document.
  • Suggested improvements to either document.
  • Whether or not you support the proposal. If you do not support the proposal, you may make suggestions for an alternative acceptable to you.
  • An assessment of how the proposal will positively and adversely 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.

How to submit

Complete the online consultation submission form to upload your submission in either pdf or word format.

Consultation submission form

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

Scientific Operations Management Section
Scientific Evaluation Branch
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 Scientific Operations Management Section by email to tgo78.remake@tga.gov.au.

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.