Fees and charges: summary - from 4 December 2017
Version 2.2, December 2017
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
These charges are in the Therapeutic Goods (Charges) Regulations 1990.
|Therapeutic good being manufactured||Charge||Therapeutic Goods (Charges) Regulations 1990|
|Blood and blood components (not HPCs) - primary manufacturing site||$157,300||Regulation 3(2)(j)(i)|
|Blood and blood components (not HPCs) - a fixed (non-mobile) manufacturing site||$7,740||Regulation 3(2)(j)(ii)|
|HPCs manufacturing site||$6,770||Regulation 3(2)(ja)|
Only one charge applies and that is the greatest applicable charge [regulation 3(3) Therapeutic Goods (Charges) Regulations 1990].
These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
|Manufacturing fees||Fee||Item in Schedule 9 Part 2|
|Australian manufacturing sites - application fee for a manufacturing licence||$1,000||Item 8|
|Blood and blood components (not HPCs) - Australian primary manufacturing site - inspection fee||$880/hour/inspector||Item 9AB|
|Blood and blood components (not HPCs) - Australian manufacturing site other than the primary site - inspection fee||$660/hour/inspector||Item 9AC|
|HPCs - Australian manufacturing site inspection fee||$660/hour/inspector||Item 9AA|
|Human tissues that are not biologicals - Australian manufacturing site - inspection fee||$660/hour/inspector||Item 9ACA|
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. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
|Pages||Fee||Item in Schedule 9 Part 2|
This fee in Schedule 9, Therapeutic Goods Regulations 1990 applies, to human blood, blood components and HPCs and human tissues not regulated as biologicals.
|Application type||Fee||Item in 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.||$460||Item 1A|