You may be required to comply with this standard if you intend to manufacture blood or blood components.
This standard applies to blood and blood components other than blood and blood components that are:
- collected by a medical practitioner in the course of medical treatment and for the purposes of diagnosis of testing for, a medical condition
- manufactured by a medical practitioner for therapeutic application to a particular patient under the practitioner's care
- manufactured by a blood collection centre for a medical practitioner for therapeutic application to a particular patient under the practitioner's care.
The Therapeutic Goods Order No. 81 Standards for Blood and Blood Components, states that blood and blood components must meet the requirements of the Council of Europe document 'Guide to the preparation, use and quality assurance of blood components' 14th edition and must only be manufactured from blood that tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology.
Please note that the Agency has advised that there are various codes for medicines, medical devices and chemicals which are amended on a regular basis.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.