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

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WHO/BS/10.2155
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Appendix 4 Prequalification procedure for vaccines evaluated by
EMA under Article 58 of Regulation (EC) No 726/2004
Background
WHO provides a service to UNICEF and other United Nations agencies that purchase vaccines,
to determine the acceptability, in principle, of vaccines from different sources for supply to these
agencies.
The purpose of the prequalification assessment is to verify that the vaccines meet the
specifications of the relevant United Nations agency, and are produced and overseen in
accordance with the principles and specifications recommended by WHO for good
manufacturing practice (GMP), and for good clinical practice (GCP). This is to ensure that
vaccines used in national immunization services in different countries are safe and effective for
the target population at the recommended schedules, and that they meet particular operational
specifications for packaging and presentation.
For vaccines (and all medicines) manufactured by European manufacturers (or at least those with
a legal presence in the European Community) intended for exclusive use in markets outside the
European Community, the European Medicines Agency (EMA) established a mechanism
(Article 58 of Regulation (EC) No 726/2004) whereby the EMA may give a scientific opinion, in
the context of cooperation with the WHO.
WHO recognizes that the evaluation by EMA under Article 58 is conducted according to the
principles applied by the prequalification process in terms of assurance of quality, safety and
efficacy for the intended population (i.e. developing countries). WHO provides input at different
stages of the process, including the determination of eligibility of the product for evaluation
under Article 58 and involvement in the assessment of the dossier. Therefore, in order to align
the EMA evaluation under Article 58 and the WHO evaluation for prequalification purposes, a
simplified procedure has been developed.
Application process to WHO
The applicant must submit the following: