This is the application form for the dossier containing the necessary information about a diagnostic kit to be submitted to WOAH for certification of “fitness for purpose”.
1. General Information
Before filling in the form and submitting an application, applicants should read “Standard Operating Procedure (SOP) for WOAH Registration of Diagnostic Kits: Guide and Administrative Forms”.
The chapter 1.1.6., “Principles and methods of validation of diagnostic assays for infectious diseases” of the WOAH Manual of Diagnostic Tests and Vaccines for Terrestrial Animals should be also read (available on the WOAH website at : https://www.woah.org/en/international-standard-setting/terrestrial-manual/access-online/). It deals with principles of validation and therefore could be helpful when filling in this dossier.
2. Application form (2023)
3. The applicant shall send the completed application form and the applicable fee to WOAH:
WOAH procedure for validation and certification of the diagnostic assays
12, rue de Prony