Patient leaflet & SmPC

Review a patient leaflet and its SmPC

EryonOne helps compare a patient leaflet and an SmPC, both ways, when the documents are provided as main document and reference.

Leaflet / SmPC comparison Sensitive sections PDF for now French and English

Benefits

What the tool helps check

Leaflet / SmPC consistency

Identify possible divergences between indications, posology, contraindications, warnings, interactions or adverse effects.

Patient readability

Spot complex, ambiguous or overly technical wording to prepare a rewrite by the relevant teams.

Versions and missing information

Highlight duplicates, contradictions, dosage gaps, incomplete cross-references or sections to review.

Use cases

When to use it

  • Before a submission, a variation or a documentary update.
  • After modifying an SmPC to prepare the patient leaflet review.
  • During a multi-product, multi-dosage or multilingual harmonisation.

Limits

EryonOne does not validate a leaflet or an SmPC

EryonOne is an assistant, not a validator. Business responsibility (regulatory, medical, quality, legal) stays with your teams. The report is working material, not an approval.

Frequently asked questions

FAQ

Can a patient leaflet be compared with an SmPC?

Yes. EryonOne can help spot discrepancies between a patient leaflet and an SmPC when both documents are provided.

Which types of discrepancies can be flagged?

Terminology, posology, contraindications, precautions, adverse effects, storage or missing information.

Does EryonOne validate a leaflet compliance?

No. The tool prepares the documentary review, but regulatory validation stays human.

Can it be used before a variation or an update?

Yes. It is a useful preparatory usage to structure the points to check before internal validation.

Next step

Test a leaflet / SmPC consistency check

Create an account to launch a first project, or write to us to frame the use case.

Create an account See the covered frameworks What you can upload See pricing

More about EryonOne

What AI-assisted review changes

What AI-assisted review changes for a regulatory affairs team: spot, justify, arbitrate. The decision stays with your team.

The frameworks we cover

MDR by class, IVDR, ANSM doctrine, Directive 2001/83/EC, French Public Health Code: the exact scope of every active framework, and the ones planned next.

The requirements you can upload

Procedures, charters, claim matrices, licensed standards: the sector-by-sector list of documents to upload as requirements in EryonOne.

The product roadmap

What is shipped, in progress and planned in EryonOne: dated releases, upcoming work announced by quarter.