Division 1.1 General criteria

Vaccines must comply with the standards set out in the chapter on Newcastle disease in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE).

Vaccines must be registered by the competent authorities of the third country or territory of origin concerned before being allowed to be distributed and used. For such registration, the competent authorities of the third country or territory of origin concerned must rely on a complete file submitted by the applicant containing data on the efficacy and innocuity of the vaccine. In the case of imported vaccines, the competent authorities of the third country or territory of origin may rely on data checked by the competent authorities of the country where the vaccine is produced, insofar as these checks have been carried out in conformity with OIE standards.

In addition to the requirements set out in points (a) and (b), imports or the production and distribution of the vaccines must be controlled by the competent authorities of the third country or territory of origin concerned.

Before distribution of the vaccines is allowed, each batch of vaccines must be tested on innocuity, in particular regarding attenuation or inactivation and freedom from extraneous agents, and on efficacy. The testing is performed under the control of the competent authorities of the third country or territory of origin.