(2003; 148 pages)
2.4 Dossier assessment
The dossiers will be evaluated by a team of experts appointed by the WHO in the field of pharmaceutical development, pharmaceutics, bio-equivalence and other appropriate related fields. Evaluators will be appointed in accordance with a Standard Operating Procedure (SOP) established by WHO for appointment of evaluators of product information, and will be from Regulatory Authorities. The evaluation will be done in accordance with an SOP established by WHO for assessing product files based on the WHO guidelines to ensure uniformity in evaluation.
WHO will give technical support for the evaluation of product information supplied, if required.