Fees and charges: summary - from 1 July 2017

Version 2.0, June 2017

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28 June 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].

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 $1,000 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
1-10 $1,290 Item 9AD(a)
11-50 $11,000 Item 9AD(b)
51-100 $24,600 Item 9AD(c)
101-1000 $33,100 Item 9AD(d)
1001-3000 $51,600 Item 9AD(e)
3001-4000 $68,800 Item 9AD(f)
>4000 $83,900 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. $460 Item 1A

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