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- Published
- Updated
Receiving a translated submission document may not explain its source version or the review performed. Sponsors should manage the output together with its supporting source and review history. The specific evidence or declaration needed should be assessed separately for the country and application context rather than presumed identical everywhere.
Decision framework
Identify the source version, target language, translation coverage and limits of specialist review. Do not treat a provider's declaration as the sole proof of accurate content. The local regulatory owner should verify applicable language and presentation conditions. This example does not claim that every country requires the same form of certificate.
Worked example
For example, a package contains an apparently correct translation but the provider's supporting document refers to an earlier source version. The team examines actual coverage and revisions rather than matching names alone. Appropriate evidence and review are completed where needed. Adding a new cover sheet cannot turn an unperformed content check into a completed assessment.
Implementation checks
- Match each translated output with its source version, target language and the evidence of review actually supplied with it.
- State the limits of partial translation or review of changed sections so the package does not imply unjustified completeness.
- At handover, confirm that relevant evidence is accessible and consistent with requirements assessed for the intended local submission.
Acceptance and boundaries
Accept handover when recipients can explain the translation's basis and coverage. Distinguish a commercial service certificate from formal country-specific acceptance conditions. Suitable reviewers should assess meaning, document integrity and the source connection; an image of a stamp or signature alone is not an adequate content assessment.
Frequently asked questions
- Does every translation need the same evidence?
- No. Appropriate specialists should verify language, country and submission requirements.
- Does a provider declaration remove the need for content review?
- No. Assess review according to intended use and relevant risk.