You are here

Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

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 $166,800 Item 7(5)(f)(i)
Blood and blood components (not HPCs) - a fixed (non-mobile) manufacturing site $8,210 Item 7(5)(f)(ii)
HPCs manufacturing site $7,180 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 $1,060 Item 8(b)
Blood and blood components (not HPCs) - Australian primary manufacturing site - inspection fee $940/inspector/hour Item 9AB
Blood and blood components (not HPCs) - Australian manufacturing site other than the primary site - inspection fee $690/inspector/hour Item 9AC
HPCs - Australian manufacturing site inspection fee $690/inspector/hour Item 9AA
Human tissues that are not biologicals - Australian manufacturing site - inspection fee $690/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 $1,370 Item 9AD(a)
11-50 $11,600 Item 9AD(b)
51-100 $26,100 Item 9AD(c)
101-1000 $35,100 Item 9AD(d)
1001-3000 $54,700 Item 9AD(e)
3001-4000 $72,900 Item 9AD(f)
>4000 $89,000 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.

Table 40: Miscellaneous fees
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 where the application relates to a single entry in the register. $490 Item 1A(a)
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 where the application relates to two or more entries in the register.

$490 for the first entry

plus $100 for each additional entry

Item 1A(b)

This fee in Schedule 9, Therapeutic Goods Regulations 1990

Book pagination