COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 28 July 2015, a delegate of the Secretary of the Department of Health, on the application of Australian Red Cross Blood Service, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- Blood and blood components
that do not conform with the age limit of 65 years for regular donors and 60 years for new donors required by the Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components, 14th Edition, as specified in Therapeutic Goods Order No. 81 Standards for Blood and Blood Components, in that blood and blood component can be collected from donors that are over the age of 60 years and less than 81 years (exclusive) without medical review.
The consent is effective from 28 July 2015 until Friday 28 July 2020.
The consent is subject to the following conditions:
- There is no evidence to support the exclusion of older donors.
- Annual medical review is not necessary as selection of blood donors is based on skilled in-person interview.