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

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process under Article 58 evaluation and will therefore remain to be reviewed by WHO during the
streamlined prequalification evaluation.
In view of the above, a number of reviews by WHO will remain essential, namely:
− confirmation that the vaccine meets the WHO recommendations and United Nations
tender specifications;
− review of stability data to ensure it meets the needs of immunization programmes in
developing countries (particularly those with weak cold-chain systems) and to assign
a VVM category;*
− review of recommended immunization schedules to ensure compatibility with those
existing in national immunization programmes and non-interference with co-
administered vaccines;*
− review of samples, labels, inserts and packaging to suit the United Nations agency
tender requirements;*
− review of mandatory, critical and innovative product characteristics from the
programmatic point of view;*
− review of packaging for international shipment and its validation;
− if applicable, recommendation that the vaccine would be eligible for the AMC
through review of the proposed product characteristics against the target product
profile criteria.
Note: The items marked * are expected to be included in the EMA/CHMP evaluation done in
collaboration with WHO under Article 58 of Regulation (EC) No 726/2004. If such assessment
and supportive data are available, the applicant should state so and should indicate specifically
where these have been addressed in EMA/CHMP Article 58 scientific opinion documents.
Report and outcome of the assessment
Once WHO considers that the process is complete, and if the outcome is satisfactory,
WHO sends a letter to UNICEF and other United Nations agencies, advising on the compliance
of the vaccine with both the WHO recommendations and the specifications of the relevant
United Nations agency. The vaccine will then be included in the WHO list of prequalified
vaccines immediately after the letter to United Nations agencies is sent. The current list may be
consulted at:
http://www.who.int/immunization_standards/vaccine_quality/pq_suppliers/en/index.html.