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Consultation: TGA guidance on release for supply for medicines manufacturers

Related information

3 June 2013

This consultation closed on 6 September 2013

The TGA sought comments from interested parties on proposed draft TGA guidance on release for supply for medicines manufacturers - Part 1.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Monday, 3 June 2013.

Interested parties responded by close of business Friday, 6 September 2013.

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

About the consultation

  • In consultation with industry, the TGA is in the process of drafting guidance on release for supply.
  • This guidance will consist of two parts: Part 1 will describe the general requirements and responsibilities relating to release for supply and Part 2 will outline specific considerations on how the general requirements in Part 1 can be met for specific areas of manufacture, for example for complementary medicines or sunscreens, or for different supply chains.
  • A drafting group has been set up for this purpose with representatives from TGA, industry associations and the TGA Technical Working Groups (TWGs).
  • The drafting group has completed its Part 1, and is ready to commence drafting Part 2.
  • This consultation calls for suggested improvements to Part 1, as well as for suggested topics to be addressed in Part 2.

Submissions

See: Submissions received

Submissions might include:

  • Suggested improvements to all or any of the numbered paragraphs in Part 1.
  • Suggested topics to be addressed in Part 2.

What will happen

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA's Internet site.

All submissions will be conveyed to the drafting group. All suggested improvements to Part 1 and suggested topics to be addressed in Part 2 will be considered by the drafting group.

The drafting group will commence drafting Part 2 once this consultation is completed. Throughout this drafting process, interested parties may wish to provide comments to their industry association's representative in the drafting group. To do so, members of industry associations should contact their association who can direct them to their association’s representative in the drafting group.

Confidentiality

All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Enquiries

Any questions relating to submissions should be directed to the OMQ Quality & Technical Manager by email to gmp@tga.gov.au or by telephone to 02 6221 6880.

More information

Additionally, or as an alternative to making a submission to this consultation, interested industry may wish to provide comments to their industry association's representative in the drafting group. To do so, members of industry associations should contact their associations who can direct them to their association's representative in the drafting group.