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ORGANISATION INTERNATIONALE DES EPIZOOTIES OIE Procedure for Validation and Certification of Diagnostic Tests. Nadia PLANTIER.
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ORGANISATION INTERNATIONALE DES EPIZOOTIESOIE Procedure for Validation and Certification of Diagnostic Tests Nadia PLANTIER
If we agree on the interest of a Certification handled by the OIE organisation, we, Diagnostic reagents producers, would prefer an harmonisation and a sole and unique European (International!!) certification. • To do so, it seems important that all authorities of the different European countries accept and validate a commune validation procedure. (Oie should sign contract with local authorities) • It is also very important that standardized control technique and reference sera are available for every diseases and every partners. It should warranty the quality of the products and the system. • The cost of Certification is very high, and as a consequence, it will limit the number of potential tests validated as well as the number of disease. • We do not understand why we should pay royalties/fees on the global revenue of the kit when OIE certification is not needed in most of countries