GMP Conformity Assessment of Overseas Manufacturers Of Therapeutic Product
|Verification of GMP Standard (GMP Evidence Evaluation)||$600 per manufacturing site|
|Quality System Dossier (QSD) Evaluation||$4500 per manufacturing site (one time payment)|
|On-site GMP audit of a manufacturer located in*:|
|(a) an ASEAN country||$18,000 per manufacturing site|
|(b) a non-ASEAN country in Asia||$20,000 per manufacturing site|
|(c) a country outside of Asia||$24,000 per manufacturing site|
Service charges varies according to the geographical location of manufacturer
- 1.Payment should be made payable to Health Sciences Authority by either cheque or GIRO
- 2.All service charges paid will not be refundable
- 3.Please refer to the Guidance Notes on GMP Conformity Assessment of an Overseas Manufacturer for further information.
- 4.The GMP conformity assessment of overseas manufacturer will be implemented with effect from 1 April 2004.