Facility registration - human cells, tissues, cell and tissue-based products
The TGA requests facilities and individuals engaged in or responsible for the retrieval/collection, processing, storage, labelling and packaging, product testing or release for supply of human tissue and cell based products for therapeutic purposes, or for the screening of cell or tissue donors, in Australia, to provide the TGA with current information relating to the facility/individual and its activities by completing and returning the attached form.
The TGA first requested Facility Registration for Human Cells, Tissues, Cellular and Tissue-Based Products in 2003, and the information collected at that time was used to inform the TGA of organisations with whom it should consult and of activities to be considered during the development of the HCT framework. During the intervening period, more organisations will have become aware of their potential obligations on introduction of the framework, others will have restructured at a management/production level and some may have ceased operation.
Definition for Human cells, tissues and cellular and tissue-based products:
Articles containing or consisting of, or derived from, human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient, other than as an ingredient of a product regulated as a medicine under the Therapeutic Goods Act 1989.
Facility, activity & product form
How to access a pdf or zipped rtf document
The pdf form below can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.