Summary of Product Characteristics产品特性摘要
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.
Updated
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
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.
Translation checks
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.
Preparing medicinal product information for Chinese review? Separate professional information from patient-facing files →
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
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Walvax Biotechnology
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Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.