TL;DR — in 60 seconds
- Most digital leaflet RFPs circulating in the pharma industry ask about features. The right RFPs ask about architecture.
- The eight questions below filter out 95% of current market offerings — because they demand integration, standards-compliance and pharma-native design that very few suppliers can actually deliver.
- At the end of this article you will find a copy-paste-ready RFP block. Use it verbatim.
If you are preparing or running a digital leaflet RFP, you are probably asking the wrong questions. Most templates circulating in the industry are written by consultants who treat digital leaflets as a marketing tool. They ask about "customisable patient experience", "brand-aligned design", "intuitive CMS".
These are features. They do not filter for infrastructure readiness. And infrastructure readiness is what separates a durable 10-year investment from a 3-year patch that will need re-platforming the moment the EU ePI Common Standard is operational.
Below are the eight questions your RFP actually needs. Each one includes three sections: why to ask it, what a standard-grade answer looks like, and how PharmaTag answers — with evidence. If the alternative provider can't match, that is your signal.
For the logic behind these questions, see the manifesto and the 5-layer architecture.
The 8 questions
Are you compliant with the EU ePI Common Standard — today, or on a dated roadmap?
The proposed Article 58(3) of the 2023 Pharma Package revision mandates this standard once operational. Any solution not aligned will require re-platforming, at the MAH's cost.
"Yes. Every leaflet is published in EU ePI Common Standard format, synchronised with EMA SPOR master data. Here is our implementation timeline."
Architected on the EU ePI Common Standard — SPOR master data sync, zero proprietary schema. Ready to comply on day one of the standard being operational.
Is your NFC-chip URL unique per lot, or per SKU?
Lot-level traceability is the difference between a €50k surgical recall and a €5M stock-wide recall. SKU-level URLs make lot-targeted recalls impossible.
"Unique per lot. Each physical lot produced has its own addressable URL. We can retire specific lot URLs on recall in under 2 minutes."
Unique URL per lot, retired via SaaS in under 2 minutes in case of recall. Patient scanning a recalled lot receives the recall notice on page load.
Does your patient page work without any app download?
App-gated experiences fail 60-80% of real patients: low digital literacy, low trust, low free memory. The CMDh readability guidance requires accessibility, which an app gate breaks.
"Yes. Native browser experience. No app, no app store, no login. Opens in under 2 seconds on any NFC-enabled smartphone."
Web-first by architecture. Zero apps, ever. Loads under 2 seconds on every modern smartphone.
What data do you collect on patients — first-party or anonymous only?
First-party data collection triggers full GDPR consent infrastructure, degrades patient experience, and creates compliance risk with no regulatory benefit. The ePI framework requires none of it.
"Zero first-party patient data. Only anonymous scan behaviour, aggregated at SKU / lot / country / language level. Operating under GDPR Article 6(1)(f) legitimate interest — no consent screens."
Anonymous by architecture. No PII captured, ever. No consent screen required. Every engagement aligned with GDPR Article 6 legitimate interest.
Want to see PharmaTag answer all 8 questions on your own SKUs in 30 minutes?
Request a demoHow does your platform handle CMDh readability, TTS audio and EU Accessibility Act compliance?
The EU Accessibility Act (Directive 2019/882) is legally binding since 28 June 2025. A non-accessible digital leaflet exposes the MAH to enforcement action.
"TTS in 6+ EU languages. WCAG 2.1 AA compliance. Large-text mode. High-contrast mode. Font scaling. All native, not a paid add-on."
TTS in EN/FR/NL/DE/ES/IT by default. WCAG 2.1 AA. Serves the ~30 million visually impaired Europeans by architecture.
Can you synchronise multi-language content across 27 Member States from one source?
Any solution requiring per-country manual publishing is operationally unsustainable at MAH scale. Multi-language content drift is a pharmacovigilance liability.
"Single source of truth. Auto language detection on scan. Multi-SmPC synchronisation. Per-country content overrides only where required by the NCA."
One SaaS, 27 Member States, multi-SmPC native. Language auto-detected from phone locale at first scan.
Do you integrate with pharmacovigilance and variation workflows?
Without PV and variation integration, the digital leaflet lives in a silo out-of-sync with the regulatory state of the product. That is a compliance gap waiting to be audited.
"Every content version traced to a variation. PSUR-compatible usage exports. Optional adverse-event reporting embedded in the patient page."
Variation-aware versioning (Type IAin / IB / II). PSUR-compatible anonymous exports. PV adverse-event reporting module optional.
What happens in a product recall — can you retire specific lots via the NFC-chip URL?
This is the single question that tests whether the supplier understands pharma operations at all. If the answer is hesitant, the supplier is a marketing tool with an NFC coat.
"Yes. We retire the NFC-chip URL for specific affected lots within minutes of the MAH decision. Patients scanning a recalled lot see the recall notice on the first scan."
Lot-level URL retirement in under 2 minutes via SaaS console. Automatic patient notification on the affected-lot scan.
The copy-paste RFP block
Drop this block into Section 3 (Technical Requirements) of your digital leaflet RFP. Adapt the header text to your house style.
RFP · Technical Requirements · Digital Leaflet Infrastructure
Each bidder must answer every item below with a binary "yes" + evidence, or "no". "Partially" and "on our roadmap" disqualify the proposal.
- Are you natively compliant with the EU ePI Common Standard, synchronised with EMA SPOR?
- Is your NFC-chip URL unique per lot (not per SKU)?
- Does your patient-facing page work as a native web page with no app download?
- Do you collect zero first-party patient data — only anonymous scan behaviour aggregated at SKU / lot / country / language level?
- Do you comply with the EU Accessibility Act (Directive 2019/882), including TTS audio in 6+ EU languages and WCAG 2.1 AA — by default, not as a paid add-on?
- Do you synchronise multi-language content across the 27 EU Member States from one source, with auto language detection on scan?
- Do you integrate content versioning with variation procedures (Type IAin / IB / II) and offer PSUR-compatible usage exports?
- Can you retire specific lots via NFC-chip URL in under 5 minutes in the event of a product recall, with automatic patient-notification on scan?
Get PharmaTag's written answers to all 8 — live on your SKUs.
In a 30-minute call, we walk you through each question with live evidence on your own product line. You leave with a written test-result document you can present internally.
Request a demo