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Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

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Manufacturing medicines and OTGs

The section applies to the manufacture of:

Annual charges for manufacturing licences

Manufacturing licences have an annual charge.

Table 25: Annual charges for manufacturing licences
Annual charges for manufacturing licences Charge Regulations
Manufacturing licence charge for medicines, ingredients, components, herbal and homeopathic preparations and containers $4,770 Item 7(5)(a), Item 7(5)(b), Item 7(5)(c) and Item 7(5)(e)

This charge is in the Therapeutic Goods (Charges) Regulations 2018

Manufacturing inspections

Australian manufacturing licences

Applications for Australian manufacturing licences have application, variation and inspection fees.

Table 26: Australian manufacturing licences
Fees related to Australian manufacturing licences Fee Schedule 9 Part 2
Australian manufacturing sites - application fee for a manufacturing licence $810 Item 8(a)
Variation application for a manufacturing licence $810 Item 8A
Australian manufacturing sites - inspection fee $1,010 /hour/inspector Item 9(a)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Overseas manufacturing site inspections

There is no application fee for GMP certification of overseas manufacturing sites.

Table 27: Overseas manufacturing site inspections
Overseas manufacturing site inspections Fee Schedule 9 Part 2
Overseas manufacturing sites - inspection fee $1420 /hour/inspector Item 9(b)
Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia Costs and reasonable expenses

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

GMP clearance fees

There is no application fee for GMP clearance. See GMP clearance guidance for information on this process.

Table 28: GMP clearance fees
GMP clearance of overseas manufacturers Fee Schedule 9 Part 2
GMP clearance application processing fee (per manufacturer, per site, per sponsor) $660 Item 6AA
Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor) $710 Item 6AB
Compliance verification (in lieu of an overseas GMP inspection) $2,530 Item 6ABA
Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above $1,200 Item 6AC

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Issuing manufacturing certificates

There are fees for issuing manufacturing certificates.

Table 29: Issuing manufacturing certificates
Certificate Fee
Certificate of GMP compliance $180
Mutual Recognition Agreement certificate $350

Certified copy of:

  • original GMP certificate
  • certificate of GMP compliance
$70

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