You are here
Fees and charges: summary from 1 July 2019
Version 1.1, July 2019
Blood, blood components and HPCs
Below are the fees and annual charges for human blood, blood components, haematopoietic progenitor cells (HPC) and human tissues not regulated as biologicals.
Manufacturing annual charges
|Therapeutic good being manufactured||Charge||Regulation|
|Blood and blood components (not HPCs) - primary manufacturing site||$163,600||Item 7(5)(f)(i)|
|Blood and blood components (not HPCs) - a fixed (non-mobile) manufacturing site||$8,050||Item 7(5)(f)(ii)|
|HPCs manufacturing site||$7,040||Item 7(5)(g)|
These charges are in the Therapeutic Goods (Charges) Regulations 2018
Only highest applicable charge is payable
|Manufacturing fees||Fee||Schedule 9 Part 2|
|Australian manufacturing sites - application fee for a manufacturing licence||$1,040||Item 8(b)|
|Blood and blood components (not HPCs) - Australian primary manufacturing site - inspection fee||$920/inspector/hour||Item 9AB|
|Blood and blood components (not HPCs) - Australian manufacturing site other than the primary site - inspection fee||$680/inspector/hour||Item 9AC|
|HPCs - Australian manufacturing site inspection fee||$680/inspector/hour||Item 9AA|
|Human tissues that are not biologicals - Australian manufacturing site - inspection fee||$680/inspector/hour||Item 9ACA|
These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
Blood plasma and technical master files
The evaluation fee for blood plasma master files and blood technical master fees depends on the number of pages.
|Pages||Fee||Schedule 9 Part 2|
These fees are in Schedule 9, Therapeutic Goods Regulations 1990
This fee applies to human blood, blood components and HPCs and human tissues not regulated as biologicals.
|Application type||Fee||Schedule 9 Part 2|
|Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard.||$480||Item 1A|
This fee in Schedule 9, Therapeutic Goods Regulations 1990