2021 — 2023
Japan removed the paper
Paper package inserts were abolished in principle from August 2021, with a GS1 barcode on the pack as the access key. The transition period closed on 31 July 2023.
Electronic product information (ePI) · GS1 Digital Link
Regulated product information,
live behind every pack.
Phinsert replaces the folded paper leaflet with governed electronic product information (ePI) — versioned, multilingual and ready for inspection. The patient scans the GS1 QR code on the package and reads — or listens to — the current, approved information for that exact medicine.
- Real timeUpdate text without a market recall
- AccessibleVoice conversation for low vision
- Per unitWorks when pharmacies sell loose units
GS1 Digital LinkGTIN identificationRole-based approvalFull version historyMultilingual insertsElectronic product information (ePI)
The problem with paper
A leaflet printed six months ago cannot tell the truth about a medicine today.
When prescribing information changes — a new contraindication, a corrected dose, an updated adverse reaction — the paper insert already sitting in thousands of boxes is instantly out of date. The only remedies are expensive: reprint, relabel, or recall product that is otherwise perfectly good.
And the patient often never receives the leaflet at all. In many markets pharmacies routinely dispense medicines by the unit — the blister leaves the counter, the box and its insert stay behind.
0Recalls needed to correct an insert
1Scan between patient and information
∞Revisions, each one fully versioned
Why now
This is not a trend to watch. It is a schedule to meet.
Electronic product information is already law in some markets and on a published timetable in others. The regulator is the medicines authority; GS1 Digital Link is the standard that carries the patient from the pack to the approved text.
2026
The EU begins
The EMA draft roadmap opens voluntary ePI go-live in Q3 2026 for vaccines and oncology products, with centrally authorised products phased from Q4 2026.
2026
Latin America moves
Argentina's ANMAT now requires a QR or Data Matrix linking to the approved leaflet on every medicine sold, with six months to cover the portfolio.
2027
GS1 Sunrise 2027
Retail and pharmacy scanners worldwide are expected to read 2D codes at the point of sale by the end of 2027. The code you print today is the one that has to still work then.
How it works
From printed code to approved information
You keep your existing GS1 2D code. Phinsert only needs the GTIN — lot, expiry and serial are ignored, so a single code serves every batch of that presentation.
-
01
Print the GS1 QR with Digital Link
Your artwork carries a GS1 Digital Link QR resolving on the GTIN —
/01/{GTIN}. Nothing else is required on the package. -
02
The patient scans with any camera
No app, no account, no download. The native camera on iPhone or Android opens the insert page directly.
-
03
Phinsert resolves the GTIN
We match the GTIN to the currently published, approved insert for that product — in the patient's language where you have provided one.
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04
Read, listen, download or bookmark
The patient can read the web insert, download the authorised scan as a PDF, talk to the voice insert, or save the URL for later — even from a pharmacy catalogue.
Three formats, one source of truth
Every insert, in the form the patient needs
Authorised scan
Upload the approved leaflet exactly as registered. The patient downloads a faithful PDF to an iPhone, Android or computer — the legal document, unchanged.
All plans
Web insert
The same content rebuilt as a fast, structured mobile page: collapsible sections, large type, searchable text and proper contrast. Built for a phone held at arm's length.
All plans
AI voice insert
A conversational voice the patient can actually talk to — answering strictly from the approved content of that insert, and nothing else. No general medical advice, no invention, no other product.
All plans
Accessibility
For the patient who cannot read six-point type.
A folded leaflet printed at the smallest legible size excludes a large part of the people who most need it — older patients, patients with low vision, patients who read little. The voice insert lets them simply ask.
- Ask in plain language. "Can I take this with food?" "What if I miss a dose?"
- Answers are fenced. The assistant is restricted to the approved text of that single insert.
- Anything else is refused. Out-of-scope questions are redirected to a healthcare professional.
- Every session is logged so your pharmacovigilance team can audit what was said.
The back office
Governed like a regulated document, not a web page
Your company workspace has named users, roles and permissions. Who may draft is not who may publish.
Technical Director
Administrator
- Publish and unpublish inserts
- Approve or reject changes
- Delete inserts
- Manage users and roles
Regulatory editor
Contributor
- Create drafts
- Upload scans and translations
- Submit for approval
- Cannot publish or delete
Viewer
Read only
- Read published and draft content
- Download audit exports
- No write access at all
Version history
Every revision retained with author, timestamp and the exact content that was live.
GTIN catalogue
One record per presentation, with the resolving Digital Link URL and a printable QR.
Scan analytics
Volume by product, country, language and device — evidence that patients are reaching the insert.
Multilingual
Publish one insert in many languages and let the patient's device choose — anywhere in the world.
Across the business
Publish a leaflet once. Four desks stop chasing it.
The obligation normally lands on one person. The relief does not. This is what changes for each of the four teams that handle product information.
Technical Director
Variations and approvals
TodayA wording change means artwork, reprints, and months of stock in pharmacies that contradicts your approval letter.
With PhinsertYou publish the new version and every pack already in the market points to it the same minute.
No recall to fix a sentence
How publishing worksQuality Assurance
Inspections and validation
TodayShowing what a pack said last March means rebuilding it from folders, emails and printouts.
With PhinsertThe version history reproduces the exact published text on screen, with its author and approval date.
Three retained versions, inspection-ready
See the validation packagePharmacovigilance
Signals and reporting
TodayA patient notices something and has no way to tell you that does not start with hunting for a phone number.
With PhinsertReports are captured next to the leaflet they concern, and the API feeds them straight into your safety system.
Every report timed and attributable
See the reporting APIPatient access
Reach and accessibility
TodayType too small to read, a leaflet left behind in the box at the counter, and nothing usable for a patient with low vision.
With PhinsertAny phone camera opens the approved text in the patient's language, and reads it aloud when asked.
No app, no account, no personal data
See the accessible pathEnterprise option
Your own scanner on the patient's phone, under your own name.
Most patients will meet your medicine through a phone camera and a browser, and that is enough. Some companies want the scanner itself to carry their brand — in the app stores, on the splash screen and on every leaflet the patient opens. That is the branded app.
$12,000 per year Included with Enterprise
Your listing in the stores
Your name, icon, screenshots and description on the App Store and Google Play, published under your developer account or under ours.
Your visual identity
Your palette, typography, splash screen and logo carried across every screen, from the scanner to the leaflet itself.
A scanner built for your codes
A GS1 Digital Link scanner tuned to your GTINs that opens your leaflet directly, with a clear message when a code is not one of yours.
The languages you choose
Ship the app in any of the eight interface languages, with the default set per market and the leaflet shown in the language it was approved in.
Safety notifications
Optional push alerts when a leaflet the patient has opened is superseded by a newer approved version. No account and no personal data required.
Readable without a signal
The last leaflet a patient opened stays available offline, labelled with the version held so it is never mistaken for the current text.
Your support and reporting routes
Your support contact and your pharmacovigilance form reachable from inside the app, feeding the same records as the web insert.
Maintained for you
We handle store submissions, operating-system updates and store review responses for as long as the subscription runs.
The branded app reads the same published leaflets, under the same version control and the same approval rules as the web insert, so it cannot display a version your technical director has not approved.
Integrations and API
Everything Phinsert records, readable by your own systems.
What the back office displays is also available over a REST API: the audit trail, pharmacovigilance reports, support tickets and every leaflet version as a PDF. Connect n8n, Make, Zapier, Power Automate or your own service, and show Phinsert data inside the tools your teams already work in.
Audit trail
Every action, with who and when
Publications, approvals, withdrawals, deletions and permission changes, each with the actor, the timestamp and the record affected.
GET /v1/audit-events
Pharmacovigilance
Reports, into your safety database
Suspected reactions and patient questions captured against a specific leaflet and version, in a shape your safety team can load.
GET /v1/pharmacovigilance/
Support
Tickets and their full history
Tickets, status changes and message history, so your service desk can mirror them in its own queue instead of watching a second inbox.
GET /v1/support/tickets
Leaflets
Current PDF and version history
The approved PDF for any GTIN, the retained version history behind it, and the exact text that was live on a given date.
GET /v1/leaflets/
Or let Phinsert push to you
Subscribe a webhook and receive each new pharmacovigilance report, support ticket or published version the moment it happens. This is the shortest path to an n8n or Make automation: one trigger, no polling.
Built to be integrated
API keys scoped to your company and sent as a bearer token, cursor pagination, ISO 8601 timestamps, and a sandbox key that returns test data without touching your live records.
API usage is billed separately from your plan
API calls are metered the way any AI or cloud API is metered: you pay for what you pull, on top of your subscription. Choose a prepaid balance that draws down as you call, or postpaid usage added to your monthly invoice.
| Data requests | $2.00 per 1,000 calls |
|---|---|
| Leaflet PDF retrievals | $0.05 each |
| Webhook deliveries | $1.00 per 1,000 deliveries |
| Included every month | 1,000 calls on Core and Standard · 25,000 on Team, Business and Business Pro · 100,000 on Enterprise |
Prepaid balance
Top up in advance and watch the balance draw down in the back office, with an alert at a threshold you set. When the balance reaches zero the calls stop, so nothing is ever charged that you did not fund. Available on every paid plan.
Postpaid on your invoice
Usage accrues through the month and appears as a line on your next invoice, under a monthly spending cap you set. Available on Team, Business, Business Pro and Enterprise.
The Free plan includes a sandbox key with 250 calls a month so you can build against the API before you pay for anything. Rates are in US dollars for the United States and, like plan pricing, may differ by country or region.
For your buying committee
Everything internal diligence asks for, one link each
An ePI decision is never made by one person. Five functions have to sign, and each one wants different evidence.
Regulatory affairs
Version control and the inspection view
Role-separated approval, three-version audit trail per insert, and a published version that can be shown to an inspector with its author, timestamp and exact content.
Quality assurance
Validation package
A computerised-system validation pack written for GxP review: validation plan, user requirements, risk assessment, IQ/OQ/PQ protocols, traceability matrix and the Part 11 / Annex 11 position.
IT and security
Architecture and data residency
No patient account, no patient login and no personal data captured on scan. Role-based access for the laboratory, encrypted transport, and an audit log of every write.
Procurement
Published pricing
Per-leaflet and fixed-subscription paths, published rather than quoted. No setup fee on Free or Standard, and no per-market surcharge.
Legal
Who may change the text
Only the technical director publishes or withdraws an insert. Promotional material is out of scope by design, and the assistant answers strictly from the approved text or not at all.
Change the words on the insert this morning. Every box already on the shelf is current by lunchtime.
Deployment and pricing
Transparent pricing. Start where you are.
Published prices, not quoted on request. Every plan includes the GS1 Digital Link QR on the GTIN, the version audit trail for cGMP and ISO 9001, the web leaflet and the AI conversational insert — from the free tier upward.
Per leaflet or up to 10 · for a focused portfolio
Trial
$0/ 7 days
7 days to try everything
- Up to 5 leaflets, for testing
- Every feature for 7 days
- AI conversational insert with voice
- Upload the scanned leaflet
- GS1 Digital Link QR on GTIN
- Version audit trail for cGMP / ISO 9001
- To test, download the Phinsert app from the App Store or Google Play
- Validation package
On day 8 the account and all its data are deleted.
Start 7-day trialCore
$150per leaflet · per month
Shared infrastructure · fully managed
- Full service: conversion, upload, management
- Web leaflet and downloadable scan
- AI conversational insert
- Multilingual publication of the same leaflet
- Roles, permissions and scan analytics
- Version audit trail for cGMP / ISO 9001
- Validation package
- Pharmacovigilance capture and forwarding
- Moves up to Standard automatically when the total reaches its price
Standard
$2,000/month
Up to 10 leaflets
- 10 leaflets included
- Full service: conversion, upload, management
- Web leaflet and downloadable scan
- AI conversational insert
- Multilingual publication of the same leaflet
- Roles, permissions and scan analytics
- Version audit trail for cGMP / ISO 9001
- Validation package
- Pharmacovigilance capture and forwarding
- $150 / month per leaflet beyond 10; moves up to Team automatically
Dedicated platform · for a portfolio at scale
Team
$4,400/month
Up to 50 leaflets
- 50 leaflets included
- Everything in Standard
- AI conversational insert across the portfolio
- Validation package included
- Dedicated instance, complete data isolation
- API integration with your systems of record
- $100 / month per leaflet beyond 50; moves up to Business automatically
Business
$8,500/month
Up to 100 leaflets
- 100 leaflets included
- Everything in Standard
- AI conversational insert across the portfolio
- Validation package included
- Dedicated instance, complete data isolation
- API integration with your systems of record
- $100 / month per leaflet beyond 100; moves up to Business Pro automatically
Most chosen
Business Pro
$12,500/month
Up to 200 leaflets
- 200 leaflets included
- Everything in Business
- Priority onboarding and migration support
- Validation package included
- Dedicated instance, complete data isolation
- SSO and custom domain
- $100 / month per leaflet beyond 200; moves up to Enterprise automatically
Enterprise
From $20,000/month
More than 200 leaflets · unlimited
- Unlimited leaflets, no overage
- Everything in Business Pro
- Your own branded scanning app included
- Validation package included
- Self-hosted option, full control of data residency
- SLA and named support contact
- Qualified deployment package
Add-ons
Private app · custom made
Your own branded patient app
Your brand in the app stores, scanning your codes and opening your leaflets. Included at no extra cost with Enterprise.
- Your listing in the stores
- Your visual identity
- A scanner built for your codes
- The languages you choose
- Safety notifications
- Readable without a signal
- Your support and reporting routes
- Maintained for you
Extra leaflets beyond the plan limit
$100–$150 / month, per leaflet
Each leaflet above a monthly plan adds $150 a month on Core and Standard, and $100 a month on Team, Business and Business Pro. When the plan plus its extra leaflets reaches the price of the next plan, the account moves to that plan automatically from the next invoice.
Validation package
Included from Team upward
The computerised system validation pack for your quality unit: validation plan, user requirements, risk assessment, IQ/OQ/PQ protocols, traceability matrix and the Part 11 / Annex 11 position.
Any questions about the plans? Write to us at onboarding@phinsert.com.
Prices shown are in US dollars and apply to the United States. Pricing in other countries and regions may differ; ask us for your market. AI voice is metered per character of synthesised speech and per second of transcription, published in your account before you enable it.
Questions
Frequently asked
Do we need a different QR code for each batch?
No. Phinsert resolves on the GTIN alone. Lot number, expiry date and serial number are not used, so one printed code serves every batch of that presentation.
Does the patient have to install anything?
No. The GS1 Digital Link QR opens in the phone's native camera and browser. The insert page can be bookmarked and revisited — useful when a pharmacy dispenses loose units and keeps the box.
Can the AI say something that is not in our insert?
The assistant is constrained to the approved content of that specific insert. Questions outside that scope are declined and the patient is directed to a healthcare professional. Conversations are logged for audit.
Who can change a published insert?
Only an administrator — typically the Technical Director. Regulatory editors prepare drafts and submit them; publication, unpublication and deletion are restricted, and every action is recorded.
Can we keep the scanned leaflet as the legal document?
Yes. Many companies publish the authorised scan as the reference document and use the web and voice formats as accessible presentations of the same approved content.
Which countries and languages are supported?
Phinsert is global. The interface — this site, the patient view and the back office — is available in eight languages: English, Spanish, Portuguese, French, German, Arabic, Japanese and Chinese. The leaflet itself is separate: you may publish it in any language your authorisation covers, and the patient sees the language the leaflet was approved in.
Your next insert change shouldn't cost a recall.
Create a free workspace, publish five inserts, print one QR — and see the whole thing work end to end.