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GMP Conformity Assessment of Overseas Manufacturers Of Medicinal Product


Service Charges

 

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) an Asia country (other than ASEAN)
$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

Note:

  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.


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Last updated on 02 Jul 2010 16:44:27
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