Public binding texts are on us. What you add here is what is yours alone: your procedures, your charters, the standards you hold a licence for. That pile is what turns a generic review into yours.
This is the only thing to understand before you start. The two piles do not serve the same check, and a document filed on the wrong side will not be used the way you expect.
What your document is allowed to say.
Regulations, standards, procedures, charters, internal rules. Everything that judges the wording, regardless of what it claims.
What your document has grounds to say.
Publications, evaluation reports, internal data. Everything that supports a specific claim, figure by figure.
Some documents are both. The SmPC is the textbook example.
It is binding and promotional material must comply with it: that makes it a requirement. It carries the tolerability and posology data: that makes it evidence too. Upload it on both sides. The same goes for an approved leaflet, a clinical evaluation report or a health technology assessment opinion.
We do not claim to know everything, and we are not allowed to distribute everything. The split is simple.
Regulations, codes, authority doctrine. They are modelled by our regulatory team, with a published scope. You have nothing to upload.
Today: MDR, IVDR, ANSM doctrine, Directive 2001/83/EC, the French Public Health Code and the conditional texts that apply to your file. Planned: FDA, ISO 13485, EMA, ICH.
ISO, EN and IEC standards are not freely distributable. We are not allowed to supply them to you. You, on the other hand, have bought your copy.
First check that your licence permits upload to a hosted tool. Failing that, upload the internal procedure that implements it: it belongs to you, and it is often the one that counts.
By definition, only you have them. This is the most useful pile and the least often uploaded: it encodes your doctrine, the one written down nowhere else.
Today our team sets them up for your account. Self-service upload from your own interface is coming.
An indicative list, not an exhaustive one. The set that applies depends on the exact status of your product and on the target market: when you create a project, EryonOne reads your document and proposes the applicable frameworks for you to confirm. If a document looks borderline to you, send it over and we will tell you whether it is usable.
All sectors · the pile that makes the difference
Promotional review charter or approval procedure
Who approves what, in which order, against which criteria.
Labelling and leaflet management procedure
In-house mandatory mentions, order of blocks, required formats.
Internal medical information rules
What a field response may state, and in what form.
Matrix of approved claims, and of prohibited ones
The document that prevents the most arguments.
Glossary and mandated terminology
Product names, abbreviations, units, how values are written.
Editorial charter and brand guidelines
Feeds the form axis: structure, headings, typography, footer mentions.
Mandatory templates and models
The skeleton expected for each document type.
Commitments made to an authority or a notified body
The corrections promised after an audit or an inspection finding.
Manufacturers · authorised representatives · QARA
Regulation (EU) 2017/745, MDR
Scope covered: technical file (annexes II and III), leaflet, labelling and UDI traceability, clinician materials.
Regulation (EU) 2017/746, IVDR
Scope covered: the four IVD classes (A to D), in vitro diagnostics, complementary to the MDR.
ISO 13485, quality management system
Document control, review and approval.
ISO 14971, risk management
Consistency between the risks identified and what the leaflet says about them.
ISO 15223-1, symbols to be used with information to be supplied by the manufacturer
The most mechanical check, and the one that raises the most findings.
ISO 20417, information to be supplied by the manufacturer
Minimum content of labelling and of the leaflet.
IEC 62366-1, usability engineering
Legibility and comprehension of the instructions by the intended user.
EN ISO 14155, clinical investigation
For protocols and investigator brochures.
MDCG guidance applicable to your class
Public documents. Specify the version that applies to you.
MedTech Europe Code of Ethical Business Practice
For materials aimed at healthcare professionals.
Additional French and European texts, depending on the file
Medical device advertising (French Public Health Code, L.5213-1 et seq.), clinical investigations (L.1125-1 et seq.), electronic instructions for use (Implementing Regulation (EU) 2021/2226). Active, to be selected when you create the project.
Pharmaceutical companies · promotional review · medical affairs
ANSM recommendations on advertising
Scope covered: promotional materials aimed at professionals, approvals and doctrinal compliance, mandatory mentions, detail aids, brochures, monographs, e-learning modules.
French Public Health Code, articles L.5122-1 to L.5122-16
Scope covered: articles L.5122-1 to L.5122-16 and the applicable R.5122 provisions. This is the text the ANSM doctrine rests on.
Directive 2001/83/EC, Title VIII
Scope covered: the European framework for medicinal products for human use, including Title VIII on advertising. Required as soon as a medicinal-product framework is selected.
Approved SmPC, patient leaflet and labelling
Binding and evidence at the same time. To be uploaded in both piles.
Promotional information charter and certification framework
The rules governing sales-rep detailing and prospecting.
LEEM code of practice, EFPIA code
Industry commitments applicable to your materials.
Marketing authorisation scope and internal off-label positions
What the medical team may answer, and where the answer stops.
EMA guidelines, including the QRD (Quality Review of Documents) templates
For the SmPC and the patient leaflet.
ICH guidelines
Not covered to date. For protocols and clinical reports.
Additional European texts, depending on the file
Centralised marketing authorisation (Regulation (EC) No 726/2004), clinical trials (Regulation (EU) No 536/2014). Active, to be selected when you create the project.
Product claims · consumer communication
Cosmetics
Regulation (EC) No 1223/2009
The general framework for cosmetic products.
Regulation (EU) No 655/2013, common criteria for claims
Truthfulness, fairness, evidential support. The central text for a claims review.
ARPP recommendation on cosmetic products
For consumer-facing communication.
Your product information file and your claim substantiation
On the evidence side: what supports each effect you claim.
Food supplements and foodstuffs
Regulation (EC) No 1924/2006, nutrition and health claims
Together with the register of authorised claims.
Regulation (EU) No 1169/2011, food information to consumers
Labelling, legibility, mandatory particulars.
Quality · accreditation · service providers
HAS certification manual for healthcare establishments
For quality documents, protocols and patient information materials.
ISO 15189, medical laboratories
Document control within the accreditation framework.
Your procedures, protocols and standard operating procedures
The quality framework as it actually applies in your organisation.
The client's brief
For an agency: the client's rules, on top of your own.
The client's approval charter
What your deliverable will be judged on at handover.
Every regulatory team has settled the same questions dozens of times. Those decisions live in email threads, in review comments, and in the heads of two people. They are written in no regulation, and yet they are what actually decides things internally.
Upload them. A plain list of “we already settled this, this way, for this reason” is enough. This is the framework that makes a review recognisably yours, and that stops a closed debate from reopening every month.
A carelessly uploaded framework produces vague findings. These five points take five minutes and save you a disappointing review.
Text, not an image
A digital PDF, with selectable text: it is the only format accepted today. A photographed scan makes it impossible to quote a passage to the line, and therefore impossible to trace a finding back to its source.
A dated version
The one that is authoritative in your organisation, with its date of application. Two versions of the same procedure produce two different verdicts, and that is normal.
Original numbering kept
Keep article, section and paragraph numbers. That is what lets the report write “§4.2” rather than “your procedure”.
An extract is enough
If only chapter 4 concerns you, upload chapter 4 with its original pagination. A shorter, relevant text beats a whole corpus.
The point to check before uploading a standard
ISO, EN and IEC standards are licensed. Check that yours permits upload to a hosted tool. If it does not, upload instead the internal procedure that implements it: it belongs to you, it is often more precise than the standard, and it is the one your notified body will ask you to apply.