Procedure for assessing the acceptability, in principle, of vaccines ...

collaborative effort. Special attention should be given to authorities from countries
where English is not the mother tongue. In such cases, engagement in this exercise
would imply additional workload for the NRA in making its reports available in
English. Specificities of the collaboration (nature and extent) should be defined on a
case-by-case basis and should be reflected in the agreement.
Vaccines that are produced for export-only purposes require special consideration and
are not eligible for evaluation through the streamlined procedure described in section
4.2. In these cases, the report of the assessment is performed in accordance with the
standard prequalification procedure (see section 3).
4.3 Vaccines with positive scientific opinion issued by the European
Medicines Agency
WHO is involved at different stages in the process of evaluation of vaccines by the
EMA/CHMP under Article 58 (Regulation EC No. 726/2004). In this context, the
EMA/CHMP issues a scientific opinion based on evidence of quality, safety and
efficacy and taking into consideration the benefit−risk assessment for the intended
population, which is consistent with WHO's focus on developing countries.
All vaccine applications submitted for evaluation under Article 58, and intended for
immediate prequalification after a positive scientific opinion, will be assessed through
a streamlined procedure (see Appendix 4) in such a way that the time elapsed between
the positive scientific opinion and prequalification will be minimized.
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