Evidence report — transformation check

Check c564a3af-8f05-4399-a03d-0f280e16b914 · generated on 11 September 2026, 11:29:40 UTC

Meets the acceptance criterion32 sections read · 1 changed · 31 preserved · 0 errors · 0 warnings

Dossier

Product: DemoMed 40 mg filmomhulde tabletten
Active substance: demostatine
Marketing authorisation holder: Demo Life Sciences B.V.
Marketing authorisation: EU/1/26/DEMO/001 (gecentraliseerde procedure, Europese Unie)
Document type: SmPC
Language of the document: en
Run by: preflight

Sections read32

Sections changed1

Sections preserved31

Non-narrative contentpreserved

Removed text is struck through, added text is underlined. The surrounding text is shown unchanged, so the change can be judged in context.

1 word removed · 1 word added

ProductX CompanyY 100 mg hard capsules ProductX CompanyY 400 mg hard capsules

DemoMed CompanyY 100 mg hard capsules ProductX CompanyY 400 mg hard capsules

These 31 sections came back word for word from the round trip, as in the source.

200000029791 SUMMARY OF PRODUCT CHARACTERISTICS
200000029793 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
200000029797 3. PHARMACEUTICAL FORM
200000029798 4. CLINICAL PARTICULARS
200000029799 4.1 Therapeutic indications
200000029800 4.2 Posology and method of administration
200000029801 Posology
200000029803 Method of administration
200000029805 4.3 Contraindications
200000029806 4.4 Special warnings and precautions for use
200000029809 4.5 Interaction with other medicinal products and other forms of interaction
200000029811 4.6 Fertility, pregnancy and lactation
200000029815 4.7 Effects on ability to drive and use machines
200000029816 4.8 Undesirable effects
200000029818 Reporting of suspected adverse reactions
200000029819 4.9 Overdose
200000029821 5. PHARMACOLOGICAL PROPERTIES
200000029822 5.1 Pharmacodynamic properties
200000029827 5.2 Pharmacokinetic properties
200000029834 5.3 Preclinical safety data
200000029836 6. PHARMACEUTICAL PARTICULARS
200000029837 6.1 List of excipients
200000029838 6.2 Incompatibilities
200000029839 6.3 Shelf life
200000029840 6.4 Special precautions for storage
200000029841 6.5 Nature and contents of container
200000029842 6.6 Special precautions for disposal
200000029844 7. MARKETING AUTHORISATION HOLDER
200000029845 8. MARKETING AUTHORISATION NUMBER(S)
200000029846 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
200000029847 10. DATE OF REVISION OF THE TEXT

ELK ePI MVP contract · passed · 0 errors, 0 warnings

HL7 FHIR Validator CLI 6.9.12 + EMRN ePI 1.0.0 · passed · 0 errors, 0 warnings

Severity	Code	Location	Message
information	`code-invalid`	`Bundle.entry[0].resource/Composition/null/.language`	The value provided ('en') could not be validated in the absence of a terminology server

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Source hash (SHA-256): c61f2afb31182276e22561b07993a69b5075f698a54e9dd61bc63a09a8c577de
Origin: openbaar EMA-voorbeeld uit de EMRN ePI Implementation Guide
Input hash (SHA-256): c1ddad33bf5157d9a27d26f3e1b800dfb225b041c163f5b8d520fd6ae55c6755
Output hash (SHA-256): 1ec3d914fef49ebe8e731bd6d1cabf8594a5375d34e65f73d262ae7b6640a9c1
Rule set: EMRN ePI + QRD basisset 1.0.0 (pinned)
Rule set hash (SHA-256): fa6203079e7ee4b1dfd4f0b7b5be3eed20786217e37a364c26ea4439dd63bad9
Template version: 1.0
Transformation version: 0.2.0-mvp
Tool version application: 0.1.0-SNAPSHOT
Tool version saxon-he: 12.10
Tool version docx4j: 17.0.0
Tool version hl7-validator-cli: 6.9.12