A summary of product characteristics is the approved reference document for a medicinal product in the EU that sets out the product’s qualitative and quantitative composition, therapeutic indications, posology, contraindications, warnings, adverse reactions, and pharmacological properties. It serves as the basis for prescribing information, labeling, and patient information in each member state where the marketing authorization is valid.
In translation and localization, SmPC texts are core documents in EU marketing authorization and labeling projects. Translators often translate the full SmPC into multiple languages for national submissions, then adapt patient package leaflets and packaging from it. Strict consistency with approved terms and headings is required.
A common error is treating SmPC headings and standard phrases as marketing copy and rewriting them, which can diverge from the approved EU reference text. Inconsistent translations of indications, posology, or contraindications across languages may lead to prescribing errors, regulatory queries, or delayed national approvals.
FDA, CE/MDR and NMPA reviewers assess the submitted wording itself. Regulatory bodies require traceable, accountable translation, and an inconsistent term can delay or fail a submission.
Angel Translation locks terms like this into a project terminology base before expert review begins, so the same source term resolves to the same target term across every document in a submission — and stays consistent in the next revision. See the 8-step AI + expert workflow.
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