[e-drug] Importation approval fees

[Martin Auton <mauton@iname.com>]

E-drug: Importation approval fees
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The United Nations Interim Joint Administration in Kosovo 
(UNMIK) is in the process of establishing a pharmaceutical regulatory 
office to re-establish some control of the pharmaceutical sector in Kosovo 
with respect to importation and sale of drugs. This will involve on 
establishment of regulations based on the WHO Technical specifications for 
import approval, wholesaling and retailing of pharmaceuticals. Initially 
the system will be not very sophisticated, as the capacities of 
implementation and enforcement are not high.

The WHO Humanitarian Assistance Office in Kosovo has a significant 
pharmaceutical project to advise UNMIK on pharmaceutical management and 
policy issues.

It has been proposed that the importation approval should be subject to a 
2% fee for administration (pharmaceuticals are exempt from customs duties). 
We would very much like to hear of examples and experiences from other 
countries concerning the types and level of fees collected for importation 
approvals at drug regulatory offices - the advantages and disadvantages of 
a % fee vs. a fixed (administration) fee.


Martin Auton
Pharmaceutical Adviser
World Health Organisation
Humanitarian Assistance Office
Pristina, Kosovo
e-mail: mauton@iname.com
tel: + 381(0)38 549 216/8
Fax: + 381 (0)38 549 217

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