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Consultation: Reforms to the generic medicine market authorisation process

Invitation to comment

7 February 2019

This consultation closed on 21 March 2019.

Invitation to comment

The TGA sought comments from interested parties on proposed improvements to the generic medicine authorisation process.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Thursday, 7 February 2019.

Interested parties should respond by close of business Thursday, 21 March 2019.

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

About the consultation

Proposed reforms

This consultation focuses on reforms to the market authorisation process for generic medicines. It explores ideas and opportunities to improve the supply of generic medicines in Australia.

Proposals include ways to reduce regulatory burden, make the application process easier, support international work sharing and options to encourage applications for generic medicines of special interest.

This consultation looks specifically at generic prescription medicines. In the future many of these ideas could be extended to processes for prescription medicines generally and those for non-prescription medicines.

Generic medicines and the market authorisation process

A generic medicine is an additional brand of an existing prescription medicine. It contains the same active component as the existing medicine but may have differences in formulation.

We evaluate the safety, quality and efficacy of all prescription medicines intended for supply in Australia. If approved, the medicine is entered on the Australian Register of Therapeutic Goods (ARTG) and can be sold. This review and decision process is known as 'market authorisation'.

Content of submissions

Submissions may address any, or all, of the questions posed in the consultation document, or any other issues relating to the generic medicine market authorisation process.

Enquiries

Any questions relating to submissions should be directed to the by email to generic.medicines.reform@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.

Impacted parties will be further consulted prior to implementation of the proposed reforms. This may include additional public consultation.

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.