Fees and charges: summary - from 1 July 2018

Version 1.0, July 2018

8 June 2018

Book pagination

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 2018.

Therapeutic good being manufactured Charge Therapeutic Goods (Charges) Regulations 2018
Blood and blood components (not HPCs) - primary manufacturing site $160,300 Regulation 7(5)(f)(i)
Blood and blood components (not HPCs) - a fixed (non-mobile) manufacturing site $7,890 Regulation 7(5)(f)(ii)
HPCs manufacturing site $6,900 Regulation 7(5)(g)

Only highest applicable charge is payable.

Manufacturing fees

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 $1,020 Item 8(b)
Blood and blood components (not HPCs) - Australian primary manufacturing site - inspection fee $900/hour/inspector Item 9AB
Blood and blood components (not HPCs) - Australian manufacturing site other than the primary site - inspection fee $670/hour/inspector Item 9AC
HPCs - Australian manufacturing site inspection fee $670/hour/inspector Item 9AA
Human tissues that are not biologicals - Australian manufacturing site - inspection fee $670/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
1-10 $1,310 Item 9AD(a)
11-50 $11,200 Item 9AD(b)
51-100 $25,100 Item 9AD(c)
101-1000 $33,700 Item 9AD(d)
1001-3000 $52,600 Item 9AD(e)
3001-4000 $70,100 Item 9AD(f)
>4000 $85,500 Item 9AD(g)

Miscellaneous fees

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. $470 Item 1A

Book pagination