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

Applications for PQv are 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 is carried out by a team of independent experts commissioned by EuFMD to prepare a report based on evaluation of the application submitted.

The operation of the procedure is overseen by a Standing Committee of experts established by EuFMD for this purpose (SCPQ).

PQv is not a regulatory procedure. It is a scientific evaluation process aiming to provide assurance that a vaccine complies with the minimum international standards of the World Organisation for Animal Health. National regulatory authorities are responsible for approving vaccines for use on their territory and the information included on the PQV list may be useful in reaching decisions on approval for use.

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 Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.  

The EuFMD had published 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 are included on a list of PQv vaccines published by EuFMD.

Evaluation of fitness-for-purpose for use of a vaccine in particular epidemiological situations is not 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.

At a future stage of development, it is envisaged that 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 ensures that the PQv 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 is being followed to implement prequalification, focusing initially on establishing a list of PQv against FMD and progressively expanding to establish lists for other FAST diseases.