Fees and charges: summary - from 1 July 2018

Version 1.0, July 2018

8 June 2018

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Manufacturing medicines and OTGs

The section applies to the manufacture of:

  • all medicines
  • other listed and registered therapeutic goods (OTGs).

Annual charges: manufacturing licences

These charges are in the Therapeutic Goods (Charges) Regulations 2018.

Annual charges for manufacturing licences Charge Therapeutic Goods (Charges) Regulations 1990
Manufacturing licence charge for medicines, ingredients, components, herbal and homeopathic preparations and containers $4,590 Regulation 7(5)(a-c, e)
Manufacturing licence charge for therapeutic device (other therapeutic good) $6,380 Regulation 7(5)(d)

Only highest applicable charge is payable.

Manufacturing inspections

Australian manufacturing licences

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Fees related to Australian manufacturing licences Fee Item in Schedule 9 Part 2
Australian manufacturing sites - application fee for a manufacturing licence $770 Item 8(a)
Application for variation of a manufacturing licence $770 Item 8A
Australian manufacturing sites - inspection fee $970/hour/inspector Item 9(a)

Overseas manufacturing site inspections

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

Overseas manufacturing site inspections Fee
Overseas manufacturing sites - inspection fee $1,360/hour/inspector
Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia costs and reasonable expenses

GMP clearance fees

There is no application fee for GMP clearance. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

GMP clearance of overseas manufacturers Fee Item in Schedule 9 Part 2
GMP clearance application processing fee (per manufacturer, per site, per sponsor) $400 Item 6AA
Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor) $690 Item 6AB
Compliance verification (in lieu of an overseas GMP inspection) $2,070 Item 6ABA
Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above $1,160 Item 6AC

Issuing manufacturing certificates

Certificate Fee
Certificate of GMP compliance $180
Mutual Recognition Agreement certificate $330

Certified copy of:

  • original GMP certificate
  • certificate of GMP compliance
$70

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