Emtract Ingest
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Title (English)
Title (German)
Obligations
Use authorised or permitted substances
Meet compositional, purity and migration requirements
Manufacture according to good manufacturing practice
Provide labelling and traceability
Issue and maintain declarations of compliance
Maintain supporting compliance documentation
Provide instructions for repeated-use articles
Description (English)
Compile testing conditions and results, calculations, modelling, analyses, safety evidence and reasoning demonstrating compliance, including composition and purity documentation for substances.
Description (German)
Prüfbedingungen und -ergebnisse, Berechnungen, Modellierungen, Analysen, Sicherheitsnachweise und Begründungen zum Konformitätsnachweis zusammenstellen, einschließlich Unterlagen zur Zusammensetzung und Reinheit der Stoffe.
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Emtract Ingest