You are here

Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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

Table 37: 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

Table 38: Manufacturing fees
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.

Table 39: Blood plasma and technical master files
Pages Fee Schedule 9 Part 2
1-10 $1,340 Item 9AD(a)
11-50 $11,400 Item 9AD(b)
51-100 $25,600 Item 9AD(c)
101-1000 $34,400 Item 9AD(d)
1001-3000 $53,700 Item 9AD(e)
3001-4000 $71,500 Item 9AD(f)
>4000 $87,300 Item 9AD(g)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Miscellaneous fees

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

Book pagination