The PQv procedure will be operated by EuFMD using the best available expertise on FAST vaccines to evaluate the suitability of vaccines for prequalification.

Applications for PQv will be submitted by applicants who may be manufacturers themselves, or who may be other companies or individuals acting on behalf of manufacturers, that undertake to provide the information and data required at the time of submission of an application for PQ and thereafter.

Evaluation of PQv applications will be carried out by a team of independent experts (the ‘Evaluation Team’) commissioned by EuFMD to prepare a report based on evaluation of the application submitted.

The operation of the procedure will be overseen by a Standing Committee of experts established by EuFMD for this purpose (the Standing Committee on Prequalification: SCPQ).

PQv is not a regulatory procedure. It is a scientific peer review process aiming to provide assurance that a vaccine complies with minimum international standards.

The PQv procedure will rely on standards and norms that have been defined by international organizations for animal health.  As a minimum, compliance will be assured with the relevant general and specific chapters of the World Organisation for Animal Health (WOAH) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (‘WOAH Terrestrial Manual’).  

The EuFMD will produce the guidance and documentation necessary for operation of the procedure on the basis of a transparent consultation process with all relevant stakeholders, including manufacturers, in line with standard EuFMD procedures.

Vaccines for which evidence is supplied of compliance with minimum international standards will be included on a list of PQv vaccines published by EuFMD.

Evaluation of fitness-for-purpose for use of a vaccine in particular epidemiological situations will not form part of the PQv procedure. The epidemiological relevance of the vaccine and the ability of the manufacturer to meet specific logistical and capacity requirements should be evaluated as part of a separate tender procedure.

When fully operational a system of fees and charges may be introduced on the basis of cost recovery to ensure the sustainability of the PQ procedure.

The EUFMD will ensure that the PQ procedure does not directly or indirectly discriminate between applicants on the basis of geography, affiliation with any industry representative organization, size of enterprise or ability to pay fees.

A phased approach will be adopted, focusing initially on establishing a list of PQ vaccines against FMD and progressively expanding to establish lists for other FAST diseases.