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Cost recovery implementation statement: Blood, blood components and biologicals (human cell and tissue therapies), From 1 July 2015

Version 1.0, July 2015

2 July 2015

Book pagination

Attachments

1. Schedule of fees and charges from 1 July 2015

Schedule of fees and charges from 1 July 2015 - Evaluation fees for blood
Evaluation fees - per submission for blood, blood components and human tissues Pages Fee $
Page Counts - Blood Plasma Master File and Blood Technical Master File 1 - 10 1,235
11 - 50 10,600
51 - 100 23,700
101 - 1000 31,900
1001 - 3000 49,700
3001 - 4000 66,200
> 4000 80,700
Schedule of fees and charges from 1 July 2015 - GMP inspections
Good manufacturing practice (GMP) inspections Hourly rate per inspector
GMP inspection of primary site of Manufacturers of Blood and Blood Components except Haematopoietic Progenitor Cells $850
GMP inspection of site other than primary site of Manufacturers of Blood and Blood Components except Haematopoietic Progenitor Cells $630
GMP inspection of Manufacturers of Haematopoietic Progenitor Cells $630
GMP Audit of Manufacturers of Human Tissues $630
Schedule of fees and charges from 1 July 2015 - Application and notification fees for human cell and tissue
Application and notification fees for human cell and tissue therapy products Fee $
Application for manufacturing licence 1,025
Application for variation 1,025
Application for inclusion of a Class 1,2,3,4 biological 1,025
Notification Fee for a biological (CTN) 320
Schedule of fees and charges from 1 July 2015 - Evaluation fees for human cell and tissue therapy products
Evaluation fees for human cell and tissue therapy products Fee $
Evaluation of dossier for a Class 2 biological 68,200
Evaluation of dossier for a Class 3 biological 136,300
Evaluation of dossier for a Class 4 biological 221,600
Variation Class 2 biological 6,255
Minor Variation Class 3 and 4 16,400
Major Variation Class 3 and 4 32,400
Evaluation of an ingredient/component 22,100
Evaluation Clinical Trial Exemption 24,600
Schedule of fees and charges from 1 July 2015 - human cell and tissue therapy products
Inspection fees for human cell and tissue therapy products Fee $
Domestic initial manufacturing inspection 20,300
Domestic subsequent manufacturing inspection 15,400
Overseas initial manufacturing inspection 20,300
Overseas subsequent manufacturing inspection 15,400
Inspection Fee - in addition to initial or subsequent inspection fee outside Australia 630
Schedule of fees and charges from 1 July 2015 - Anual charges
Annual charges Fee $
Primary site of manufacturers of blood and blood components except haematopoietic progenitor cells 151,300
Additional fixed site (non-mobile) of manufacturers of blood and blood components except haematopoietic progenitor cells 7,445
Manufacturing premises of haematopoietic progenitor cells 6,515
Single step and single human tissue of manufacturers of human tissues 6,515
Two or more steps of manufacturers of human tissues 12,700
Annual charge for Class 1 biological 630
Annual charge for Class 2,3,4 biological 6,255

Book pagination