Review of changes to, or a request for renewal of the marketing authorization of an innovator FPP or multisource (generic) FPP, that received approval from a stringent regulatory authority (SRA), before application for prequalification, are the responsibility of that SRA. Nevertheless, WHO should be notified of any changes approved by that SRA and that would alter information contained in the Quality Information Summary of the FPP Approved by the Reference SRA (QIS-SRA), the product information (Summary of Product Characteristics, Patient Information Leafelt, Labelling), the FPP specifications and/or test procedures.
WHO should be notified as soon as the variation has been approved by the relevant SRA. Applicants will receive an email acknowledgment of notification of the variation within 45 calendar days of receipt. In some instances, further information regarding the variation may be requested.