Therapeutic goods and use of human embryos or human embryonic stem cells or material derived therefrom

If a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from a human embryo or human embryonic stem cell, a statement to this effect must be included in the product’s Product Information (PI) and Consumer Medicine Information (CMI) documents.

It is no longer a requirement that a separate declaration concerning the use of such material be completed and included in Module 1 of a submission. The Declaration: Therapeutic goods and use of human embryos or human embryonic stem cells or material derived therefrom form is no longer in use. 

Instead, a declaration must now be made in Part B of Module 1.2.1: Application form to register or vary the registration of prescription medicines. Go to the form: