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Therapeutic goods and use of human embryos or human embryonic stem cells or material derived therefrom
For products that are manufactured using a human embryo or a human embryonic stem cell, or any material sourced from a human embryo or human embryonic stem cell, there must be a statement of origin in the PI and the CMI.
In addition, where information is provided to the TGA (as part of an application for registration of a prescription medicine) that refers to the use of human embryos, human embryonic stem cells (or materials sourced from human embryos or human embryonic stem cells) in research undertaken in the development of the medicine, then the draft PI and CMI provided to the TGA should provide a statement to this effect. Subject to approval of the PI by the TGA, and following registration of the medicine, the CMI is also expected to include a similar statement in line with the PI.
A declaration concerning the use of such material must be completed and included in Module 1 of a submission.