Order No. 1 of 2001 allow the AUST R number of the existing product to be retained for the new product, if the new product replaces the existing product. Only the name—not the nonproprietary name of the drug substance—can be changed under this application type. The details of the product, including indications and sponsor, must remain the same. Required information Proposed replacement trade name. Revised labels. Information on use or non-use of human embryos or human embryonic stem cells, or other material sourced from human embryos or human embryonic stem cells, in the manufacture of the product (this is a requirement under regulation 9B of the ). A copy of the PI must be provided. Where the proposed change would involve approval of a new PI, a marked-up copy should also be provided, as outlined in of this document. 5.4 Summary of variations s. 23 Figure 5.1 shows a flowchart of the processes for making a decision under s. 23. ARTG = Australian Register of Therapeutic Goods; Cat 3 = Category 3 application; PI = product information; SAR = self-assessable request; TGA = Therapeutic Goods Administration; wd = working days Figure 5.1 Process for applications under s. 23 of the Therapeutic Goods Act 1989 Part 6 Changes that do not require prior approval
Order No. 1 of 2001 allow the AUST R number of the existing product to be retained for the new product, if the new product replaces the existing product. Only the name—not the nonproprietary name of the drug substance—can be changed under this application type. The details of the product, including indications and sponsor, must remain the same. Required information Proposed replacement trade name. Revised labels. Information on use or non-use of human embryos or human embryonic stem cells, or other material sourced from human embryos or human embryonic stem cells, in the manufacture of the product (this is a requirement under regulation 9B of the ). A copy of the PI must be provided. Where the proposed change would involve approval of a new PI, a marked-up copy should also be provided, as outlined in of this document. 5.4 Summary of variations s. 23 Figure 5.1 shows a flowchart of the processes for making a decision under s. 23. ARTG = Australian Register of Therapeutic Goods; Cat 3 = Category 3 application; PI = product information; SAR = self-assessable request; TGA = Therapeutic Goods Administration; wd = working days Figure 5.1 Process for applications under s. 23 of the Therapeutic Goods Act 1989 Part 6 Changes that do not require prior approval
consult-pm-minor-variations-121210-dr-chemical_0.docx