TİTCK e-KT obligation in Türkiye starts on
Read before use. One approved text — e-KT and ePI.
Electronic patient leaflet management for pharma: approval, version control and QR publishing for Türkiye's e-KT, and EU ePI (FHIR) generated from the same approved text.
No app required
KVKK · GDPR · WCAG 2.1 AA
TİTCK compliance matrix
Requirement · response
| Requirement | How eKT.one meets it |
|---|---|
| Access to the e-KT via a code on the outer pack (2.11/A-1) | A permanent address and QR code per leaflet, with print-ready QR output. |
| The statement "Scan the code for information media." next to the code (2.11/A-4) | The QR print output includes the statement in Turkish. |
| Access with the device camera in one scan, no extra software (2.11/A-6) | The leaflet opens in the browser; no app needed. |
| No permissions requested beyond the privacy notice (2.11/A-7) | No login, form or permission is needed to open the page. |
| PDF or HTML; the whole leaflet cannot be a single image (2.11/A-8) | Published as structured HTML, also downloadable as PDF. |
| Updated within 30 days of approval of the current leaflet (2.11/A-2) | The deadline is calculated automatically; the responsible person gets a task as it nears. |
| MAH declaration that the e-KT matches the approved current leaflet (2.11/A-9) | A "declare and publish" step; every publication is kept as a version with date and publisher. |
Source: TİTCK İRD-KLVZ-07, revision 18 (11 August 2026), section 2.11/A; applies from 1 January 2027 under Transitional Article 3. Guideline (PDF, Turkish) (opens in a new tab)
How it works
Upload · approve · publish
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Upload
Upload your approved leaflet as PDF or HTML. AI turns it into a structured draft, which you review.
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Approve
An Editor prepares, an Approver approves, a Publisher signs the declaration and publishes. Every step is logged.
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Publish
The leaflet goes live at the permanent address behind the QR. The text can change; the QR stays. EU ePI (FHIR) is generated from the same approved content.
By role
Regulatory · QA · IT · Procurement · Field
Regulatory Affairs
- Does the ePI need separate authoring?
- No. FHIR ePI is generated from the same approved content as the e-KT.
- Does the live text always match the approved text?
- Only an approved version with a publishing declaration goes live; every version is archived.
- Can I show which version was live, and when?
- Version history is kept with dates and publishers.
Quality Assurance
- Is it traceable who approved what?
- Approval and publishing steps are logged with user and time.
- How is segregation of duties ensured?
- Editor, Approver and Publisher are separate roles, enforced server-side.
- Does AI output go live directly?
- No. AI output is always a draft; publishing requires an authorised person's declaration.
IT
- Is there anything to install?
- No. The platform runs in the browser; patients need no app either.
- Can we pull data into our own systems?
- Yes. Analytics and signal data are available over a REST API with an API key; ePI is served as FHIR.
- Where is data hosted?
- On servers in Germany (EU). The infrastructure provider is ISO/IEC 27001:2022 certified.
Procurement
- How is pricing set?
- By leaflet count: the per-leaflet price of the tier your count falls into applies to all leaflets. See the pricing section.
- Can we try it without paying?
- A 14-day free trial with one leaflet. You can leave during the trial from the My Account screen without being charged.
- What are the contract and billing terms?
- One-year subscription, renewing for the same period. Monthly statements, paid in advance by saved card or bank transfer, with a Turkish e-invoice.
Medical Representative
- How do I show it to a doctor or pharmacist?
- Scan the QR on the pack; the page opens on the phone.
- Which languages are available?
- Each leaflet can be published in the languages the company enables.
- Do visitors have to give personal data?
- No. No login or form is needed to open the page.
Pricing
Starting price · three scenarios
Starting price: TRY 285 per leaflet per month
Three scenarios
- 12 leaflets TRY 3,420 / month Tier S · TRY 285 per leaflet
- 60 leaflets TRY 13,680 / month Tier L · TRY 228 per leaflet
- 250 leaflets TRY 45,000 / month Tier E+ · TRY 180 per leaflet
Tiers (per leaflet per month)
- S 1–25 leaflets TRY 285
- M 26–50 leaflets TRY 257
- L 51–100 leaflets TRY 228
- E 101–200 leaflets TRY 200
- E+ 201–400 leaflets TRY 180
- E++ 401+ leaflets TRY 160
- Prices exclude Turkish VAT; card charges include VAT.
- One-year subscription; statements are monthly and paid in advance.
- AI usage (assistant, content generation, translation, audio) is charged separately from prepaid credit.
- One-off services such as onboarding and training are optional and quoted separately.
Trust and compliance
Data location · KVKK & GDPR · audit trail
- Data location
- Platform data is held on servers in Germany (EU). The infrastructure provider is ISO/IEC 27001:2022 certified; the certificate is the provider's. Full backups run daily (targets: at most 24 hours of data loss, service restored within 4 hours).
- KVKK and GDPR
- eKT.one complies with KVKK and the EU General Data Protection Regulation (GDPR). People who scan the QR are never asked for identity, location permission or a login. Product pages carry no third-party analytics; IP addresses are not stored, only an irreversible hash. Country and city come from a local database on the server.
- Audit trail
- Every published version is stored as an immutable record; approval and publishing rights are enforced per role on the server.
FAQ
Straight answers to objections
- We sell in the EU. What do we get beyond e-KT?
- EU ePI in FHIR format, generated from the same approved content — no second authoring.
- Does the printed leaflet disappear entirely?
- For products where e-KT is mandatory, the printed leaflet becomes optional; both can be used. Products administered only by healthcare professionals (vaccines, radiopharmaceuticals, hospital products), small packs and products without an outer pack are exempt from e-KT. Every product must still carry at least one leaflet, printed or electronic, so these products can also use e-KT instead of print (revision 18).
- Do patients need to install an app?
- No. The phone camera scans the QR; the leaflet opens in the browser.
- Does the QR on the pack change when the leaflet is updated?
- No. The QR points to a permanent address that always shows the current live version.
- How do we migrate existing leaflets?
- Upload the approved PDFs; AI prepares the draft and it is published after your approval.