Operation of the Standing Committee on Prequalification of Vaccines against FAST diseases
The SCPQv is established by the EuFMD in line with Article VII of its constitution and operates according to the rules of procedure for such committees.
The committee may invite additional experts who are not members of the SCPQv to meetings as observers or to provide specialist advice, subject to the agreement of the Chairperson. The lead experts from the scientific evaluation teams that are responsible for preparing the evaluation reports on applications for PQv will be invited to participate in meetings where these reports are considered.
Regular meetings of the committee will be organized at least twice a year, either in-person or remotely.
The meetings of the committee will focus on the following standard items:
- Prequalification of vaccines
- Adoption of guidelines and PQv procedures;
- Consideration of reports from expert evaluation teams on recommendations to include, maintain, exclude or remove vaccines from the list;
- Appeals from applicants on decisions on listing in line with approved procedures;
- Issues related to the PQv procedure referred to the committee from the secretariat, evaluations teams, committee members or applicants;
- Review of the current list of PQv vaccines.
- Vaccine Security
- General topics on assuring the quality and supply of FAST vaccines;
- AESOPS (assured emergency supply options);
- Liaison with partner and other international organizations on development of PQv and related procedures, particularly FAO, WOAH, EU and non-member countries.
- Stakeholder liaison
- Regular opportunity for exchange with stakeholders, particularly the veterinary vaccine industry.
The EuFMD secretariat will consult with relevant stakeholders in an open and transparent manner before proposing documents to the committee for adoption (e.g. on technical requirements and procedures relating to PQv). The outcome of the PQv procedure will take the form of a vaccine’s inclusion or maintenance on the list, or its exclusion or removal. A summary report will be included for vaccines for which a positive decision is made on listing.
All information supplied to the committee by applicants in relation to PQv applications will be treated as commercially confidential information (CCI) and managed accordingly. Members, observers and invited experts will operate according to an agreed code of conduct to ensure that CCI is respected. Distribution of documents containing CCI will be limited to members and experts directly involved in decisions on listing who will be required to confirm in writing that they will apply all necessary procedures to respect CCI.
Procedures will be put in place to ensure that members, observers and invited experts do not have conflicts of interest (COI) in relation to matters under consideration by the committee. Individuals or the secretariat will identify any potential for COI, in advance of the meeting whenever possible, and will bring them to the attention of the Chairperson who will put in place appropriate measures by excluding or limiting the contribution of individuals with potential COI from involvement on particular topics of items of the agenda.