The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials.
This first part describes the general and specific elements constituting the dossier for the submission of an animal health in vitro diagnostic reagent, in the above-described framework, to the control and approval by a control organization. Its purpose is to provide the applicant submitting an animal disease in vitro diagnostic reagent to control with the general input for the preparation of the control application file. It describes the optimal administrative and technical information regarding the applicant and the reagent required for the application file for initial control and for a batch-to-batch control respectively. It specifies, in particular, the validation parameters of the method using the reagent (objectives, methodology, criteria and results) according to international standards.
NOTE This document does not cover the step in which the user verifies a reagent (refer to section 3.1 for definition).