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Use this guide to determine if your change meets any of the following categories:

· corrects an ARTG entry
· creates a separate and distinct good
· is a safety-related variation
· has the potential to impact quality, safety, or efficacy

This article describes the following steps;

For a sponsor to determine if a change is a variation to an ARTG entry and how to apply for
approval, the following processes are involved:

1. Determine if the change would have been relevant to the inclusion decision
2. Determine if the change is a correction to your ARTG entry
3. Determine the variation category
4. Determine the supporting document requirements
5. Submit your application
6. Prepare and submit your cover letter and supporting documents
7. Pay your application fee
8. TGA screening of your application
9. Pay your evaluation fee
10. TGA evaluation of your supporting documents
11. Making a decision on your application
12. Implement the change(s) if approved

 

 

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Homologous use of the goods is the use of the goods to repair, reconstruct, replace or supplement
the cells or tissues of a person (the recipient), if the goods will perform the same basic function
or functions in the recipient as the original cells or tissues performed in the person from whom
they were collected (donor).

This article describes the following points;

  • Defining basic functions of human cells and tissues
  • Examples of homologous and non-homologous uses
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Human cell and tissue (HCT) products are those that comprise, contain, or are derived from human cells and tissues.

Autologous human cell and tissue (HCT) products are those that are removed from and applied to, the same person, i.e. the donor and the recipient are the same. One group of autologous HCT products is those commonly referred to as ‘stem cell treatments.

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From March 2018, complementary medicines sponsors have the option to enter their medicine
in the Australian Register of Therapeutic Goods (ARTG) via a new pathway for listing – the
assessed listed medicines pathway.

This guideline describes the following points;

  • Part 1 – Applicant and agent details
  • Part 2 – Application category
  • Part 3 – Product details
  • Part 4 – Indication(s) details
  • Part 5 – Submission details
  • Part 6 – Fees
  • Part 7 – Certification
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