You are here

Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

Book pagination

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 $4,680 Item 7(5)(a), Item 7(5)(b), Item 7(5)(c) and Item 7(5)(e)
Manufacturing licence charge for therapeutic device (other therapeutic good) $6,510 Item 7(5)(d)

These charges are in the Therapeutic Goods (Charges) Regulations 2018
Only highest applicable charge is payable

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 $790 Item 8(a)
Application for variation of a manufacturing licence $790 Item 8A
Australian manufacturing sites - inspection fee $990/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 $1,390/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.

GMP clearance of overseas manufacturers Fee Schedule 9 Part 2
GMP clearance application processing fee (per manufacturer, per site, per sponsor) $650 Item 6AA
Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor) $700 Item 6AB
Compliance verification (in lieu of an overseas GMP inspection) $2,480 Item 6ABA
Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above $1,180 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 $340

Certified copy of:

  • original GMP certificate
  • certificate of GMP compliance
$70

Book pagination