Pricing
Pricing per document, per axis, by page volume and, for scientific review, by reference count. Price shown before validation.
EryonOne
Use cases Leaflet and SmPC
Check that the leaflet says exactly what the SmPC says
With every variation, a gap opens on one side only: a posology corrected in the SmPC, a leaflet still on the old schedule. EryonOne compares both texts both ways, section by section, and for each gap quotes the leaflet passage and the SmPC passage.
01 Checks
What EryonOne checks, section by section
Six checks drawn from Directive 2001/83/EC and your own rules, run on the leaflet against the current SmPC.
From the SmPC to the leaflet
Indications, posology, contraindications, warnings, interactions, pregnancy, side effects, storage: every SmPC item the patient needs must reach the leaflet.
Directive 2001/83/EC, Art. 59From the leaflet back to the SmPC
Every leaflet sentence needs an anchor in the SmPC. A sentence without one is either an explanation useful to the patient, with nothing promotional, or a gap to deal with.
Directive 2001/83/EC, Art. 62Expected sections and statements
Leaflet sections in the order the Directive sets, the invitation to report side effects and, for a medicine under additional monitoring, the black triangle and its sentence.
Directive 2001/83/EC, Art. 59A leaflet the patient understands
Unexplained technical terms, long sentences, ambiguous instructions: the leaflet must be clear and understandable, and let the patient act appropriately.
Directive 2001/83/EC, Art. 63The same state of the authorisation
SmPC revision date, leaflet revision date, language versions: both texts must describe the same version of the authorisation.
Directive 2001/83/EC, Art. 11 and 59Your own rules
Patient glossary, style guide, approved wording, leaflet template: uploaded as requirements, they are checked just like official texts.
Your internal requirements
02 Common gaps
The gaps we come across most often
The first version is reviewed with care. Gaps open with updates: a section corrected on one side only, a language version left behind.
Posology for a special population
Renal or hepatic impairment, elderly, children: SmPC section 4.2 moves on, the leaflet keeps the old schedule.
SmPC 4.2 · leaflet, section 3
A side effect updated on one side only
A side effect added to section 4.8, or a frequency changed, with no matching update in the leaflet and no change to the frequency category.
SmPC 4.8 · leaflet, section 4
A contraindication turned into a warning
The SmPC moves an item from contraindications to warnings; the leaflet leaves it under “Do not take”, or the other way round.
SmPC 4.3 and 4.4 · leaflet, section 2
A forgotten excipient with known effect
The composition changes in SmPC section 2, but the dedicated statement in the leaflet is not updated.
SmPC 2 and 4.4 · leaflet, section 2; SmPC 6.1 · leaflet, section 6
Storage after opening missing
The shelf life after first opening or reconstitution appears in SmPC section 6.3, but not in the leaflet.
SmPC 6.3 · leaflet, section 5
A revision date that did not follow
A variation affects the leaflet, but the date on its last line did not follow, and a language version sometimes stays on the previous state.
Leaflet, section 6
03 How it works
A review, end to end
The leaflet, the SmPC, a few minutes, then your call. The example shows a finding as it appears in the report.
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1You upload the leaflet and the SmPC
The leaflet as main document, the current SmPC as reference, in PDF. Add your patient glossary or style guide if you have one.
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2You choose the framework and axes
Directive 2001/83/EC, regulatory, scientific, language or format axes. The price shows before launch: nothing is charged without your approval.
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3EryonOne returns its findings
Within minutes. Each finding quotes the leaflet passage, the SmPC passage and the requirement at stake, with, where available, a confidence score.
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4You decide
Accept or dismiss each finding: the decision is kept, and the report exports for your regulatory affairs team.
04 Use cases
When to use it
After an SmPC change: variation, pharmacovigilance signal, new indication.
Before sending a revised leaflet, in national and European procedures alike.
Across a portfolio of products, strengths or languages to harmonise.
05 Limits
An assistant, not a leaflet approval
EryonOne is an assistant, not a validator. It replaces neither patient consultation nor the authority's assessment, and the decision to correct stays with your regulatory affairs team. The report is working material.
Frequently asked questions
Your questions about this use case
Does EryonOne replace readability testing?
No. The leaflet must reflect the consultation of target patient groups (Directive 2001/83/EC, Article 59(3)). EryonOne flags complex or ambiguous wording beforehand; it does not replace that test.
Are the QRD templates covered?
Not yet: the European guidelines on the SmPC and the leaflet, including the QRD templates, are among the upcoming frameworks. Meanwhile, upload the template you apply as an internal requirement: it is checked like an official text.
Can a leaflet in another language be reviewed?
Yes. The reviewed document may be in French, English, Spanish, German, Italian, Portuguese or Dutch, and the report comes out in French or English. Review each version against the SmPC in the same language: that is where versions left behind hide.
Who makes the final decision?
Your regulatory affairs team. EryonOne spots and justifies each point; it does not validate a leaflet or an SmPC.
Can you review against our patient glossary?
Yes. Upload it as an internal requirement, with your style guide or approved wording: the related findings quote it, like an official text.
How much does a review cost?
The price depends on the number of pages, the axes you choose and, for the scientific axis, the number of references to check. It shows before every launch (pricing), and the first review of a new account is free, for a document of up to 10 pages.
Do my documents stay confidential?
Yes. Documents are processed in France, in Roubaix, on a SecNumCloud-qualified OVHcloud offer, and are never used to train a model.