The European Commission for the Control of Foot-and-Mouth Disease (EuFMD)

Prequalification Veterinary Medicines

Background and rationale

Governmental and non-governmental organizations seek to procure veterinary medicines as part of programs to control or eradicate diseases in animals. The range of veterinary medicinal products needed to control diseases in animals is extremely wide, ranging from pharmaceutical medicines, such as antiparasitics through to highly specialized vaccines.

International organizations and agencies procuring veterinary medicinal products usually have in place systems to assure the quality of vendors of veterinary medicines either through quality assurance schemes or through evaluation as part of tender procedures. There are currently no internationally recognized schemes to provide an independent assurance of the quality of veterinary medicines that are provided by vendors.  

Prequalification (PQ) is a system for assuring the quality of veterinary medicines to international standards in advance of need giving confidence to organizations procuring such medicines on their pharmaceutical quality, safety, effectiveness and the manufacturing standards for their production. Procuring organizations would therefore benefit from the establishment of a science based, independent and sustainable system for PQ of veterinary medicines. PQ allows organizations that procure through tenders to obtain products that are included on a list of approved products. A PQ system can also be integrated within a system for vendor qualification by requiring and verifying that vendors only procure medicines that have been pre-qualified. 

The 44th General Session of the European Commission for the Control of Foot-and-Mouth Disease (EuFMD), in April 2021, endorsed the establishment of a prequalification system for vaccines (PQv) against FAST diseases following consultation with stakeholders. 

In parallel to continuing the development of the PQv system the FAO undertook a joint project with the USAID Bureau of Humanitarian Affairs (BHA) to explore options for widening the scope of the PQ project to conduct a feasibility study on a PQ system for veterinary (pharmaceutical) medicines (PQm). 

A first draft feasibility study report on the Development of a sustainable system for prequalification of veterinary medicines has now been finalized in co-operation with partner organizations and an advisory group with specific expertise regarding technical requirements and standards for veterinary medicines and is being published for wider consultation.

The feasibility study will be finalized considering comments received by end of August 2022. 

This webpage will be updated as the PQm project progresses.