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

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WHO/BS/10.2155
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1) An application letter is to be sent to the Coordinator, Quality, Safety and Standards,
Department of Immunization, Vaccines and Biologicals (WHO/IVB/QSS) at WHO with a copy
to the vaccines prequalification manager and the EMA, with details of country and sites of
manufacture and presentations offered.
Note: Application letters can be sent at any time after the submission of the dossier to the EMA.
Manufacturers are encouraged to advise WHO as early as possible of their intention to submit a
specific vaccine application to facilitate planning.
2) A statement that the applicant acknowledges and agrees to the fact that the EMA will share
the report of the CHMP evaluators, inspection reports (manufacturing facilities and clinical trial
sites) and test results, if available, with the WHO prequalification team, as well as mutual
immediate notification of quality or safety concerns of the product.
3) An electronic copy of the dossier submitted to the EMA for evaluation under Article 58.
4) Technical information relevant to United Nations specifications, including information
relevant to the programmatic suitability of the vaccine.
5) Notification about the official medical control laboratory (OMCL) selected for any testing
required by the EMA for evaluation under Article 58 or for prequalification by WHO.
6) Fees (see section 14).
The evaluation process
WHO will base the evaluation on the following:
− the EMA Article 58 scientific opinion and its annexed assessment report from
EMA/CHMP;
− a certificate of analysis of consistency lots by a qualified (OMCL) laboratory;
− reports from relevant inspections (GMP, GCP and good laboratory practice [GCP])
jointly agreed by WHO and the EMA and performed during the EMA/CHMP
evaluation procedure for Article 58 scientific opinion.
Although the EMA/CHMP procedure under Article 58 of Regulation (EC) No 726/2004 is done
by rapporteur/co-rapporteur in collaboration with WHO and its experts/expert groups, with the
evaluation ensuring that the clinical data provided by the applicant is relevant to the United
Nations target population at the intended schedules, other programmatic aspects reflected in the
tender specifications of the United Nations purchasing agencies will not be part of the review