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Turkish e-PIL (e-KT) → EU ePI mapping guide

How package leaflet and SmPC content prepared in the Turkish regulatory format (TİTCK) is turned into the European electronic product information (ePI) standard: sections, identifiers and access.

1Summary

In Türkiye, the Turkish Medicines and Medical Devices Agency (TİTCK) requires an electronic package leaflet — the e-KT (Elektronik Kullanma Talimatı) — accessible from the pack via QR code. Every package leaflet (KT) and Summary of Product Characteristics (KÜB) published on eKT.one in the TİTCK format is also generated in the EU ePI standard, with no additional data entry. Generation happens at the moment of publication, so the approved text, the archived text and the ePI output always belong to the same version. The output is served through an open service with the same structure as the European Medicines Agency's (EMA) ePI API.

There are three key differences between the Turkish e-KT and the EU ePI:

• Number of sections. The Turkish package leaflet has 5 sections; the EU QRD template has 6. Section 6 ("Contents of the pack and other information") is not a separate section in Türkiye — its content sits in the composition box at the top of the leaflet and the footnote at the end. eKT.one assembles these parts into section 6 automatically.
• Identifiers. The EU ePI links products and companies through identifiers from EMA's SPOR master data (PMS, OMS). These identifiers do not exist in Türkiye; eKT.one uses the pack barcode (GTIN) and the marketing authorisation holder's name.
• Validation. The output is automatically checked against the structural rules of the implementation guide. Full validation with the official HL7 FHIR validator and submission to EMA are outside the scope of this service.

2Document-level mapping

A separate FHIR Bundle (type = document) is generated for each language and document type. All Bundles of a product are listed under a List resource.

3Section mapping

Section codes come from EMA's QRD code system (http://ema.europa.eu/fhir/CodeSystem/200000029659) and have been checked against the value sets of the implementation guide. As the guide requires, the numbered sections are nested as sub-sections within a single top-level container section.

3.1 Package leaflet (KT) → Package Leaflet (6 sections)

The {product} placeholder is filled with the product name in the ePI. Section headings are defined in Turkish, English, Arabic, German and French.

3.2 The 5-vs-6 section gap: how section 6 is built

Section 6 of the EU template covers the active and other ingredients, what the product looks like and the pack contents, the marketing authorisation holder and manufacturer, and the date the leaflet was last revised. In the Turkish package leaflet the same information is found in two places:

• At the top: the active substance and excipients box (composition)
• At the end: the marketing authorisation holder, the manufacturing site and the "This leaflet was approved on …" footnote

eKT.one builds section 6 by combining these two parts. If the content does not follow the standard template, section 6 is compiled from the point where the marketing authorisation holder is mentioned. If neither is found, the section is flagged and the regulatory affairs specialist can complete it manually; manual text is preserved even if the content is regenerated later.

3.3 Additional sections specific to Türkiye

Some Turkish package leaflets include product-specific additional sections after section 5 (for example hypoglycaemia and hyperglycaemia information for insulins, or pen/device instructions). The EU template has no dedicated section for these. eKT.one places these additional sections at the end of section 5 in the ePI: no content is lost and the section order is preserved.

3.4 SmPC (KÜB) → SmPC (12 sections)

The Turkish SmPC follows the same 1–12 numbering as the EU SmPC. Sections 11 and 12 are mandatory only for radiopharmaceuticals.

3.5 How sections are identified

No data is re-entered from the existing content. Sections are identified in three steps:

1. Structural markers: eKT.one content templates mark each section with a fixed identifier. This is the most reliable route.
2. Heading matching: if there is no marker, section headings are compared with the catalogue headings.
3. Compilation: for package leaflet section 6 only (3.2).

The result is shown to the regulatory team per language, section by section, together with how each section was found. It is frozen at publication; the ePI is generated only from this frozen copy.

Coverage across existing eKT.one content (September 2026; 32 products, 11 languages, 102 package leaflets):

Sections that are not found are flagged and can be completed manually.

4Identifier mapping

The EU ePI links the product and the company through identifiers in EMA's SPOR system. Türkiye has no central product or organisation identifier other than the TİTCK marketing authorisation number and the barcode, so the mapping is as follows:

An ePI reader can find a product by its pack barcode (GTIN) or by its eKT.one product code. Search by PMS ID or regulatory agency is not supported, as these identifiers do not exist in Türkiye.

5Accessing the ePI

Published ePIs are served through an open service with the same structure as EMA's ePI API (FHIR REST, read and search): a List is the product's ePI index, and a Bundle is a single document in a single language. The service requires no key and only returns the latest version of published products.

curl "https://ekt.one/api/v1/epi/fhir/List?data-carrier-identifier={GTIN}"
curl "https://ekt.one/api/v1/epi/fhir/Bundle?data-carrier-identifier={GTIN}&language=en&document-type=pil"

Responses are application/fhir+json; errors are returned as a FHIR OperationOutcome. document-type accepts pil/kub or the EMA document type code. The full parameter list is in the metadata response. eKT.one users can also preview the ePI and download it as a file from the publication version screen.

6Scope and limitations

eKT.one does not submit ePIs to EMA. Submitting an ePI to EMA is the marketing authorisation holder's own procedure. eKT.one generates the ePI in the standard format and serves it with the same structure as EMA's API.

• Validation: the output is checked against the structural rules of the implementation guide; no official HL7 validator report is provided.
• Identifiers: PMS/OMS identifiers are not included in the ePI; the Turkish marketing authorisation number is included only if entered (section 4).
• Images: diagrams and illustrations are shown on the patient page but are not yet included in the ePI output.
• Languages: standard section headings are defined in Turkish, English, Arabic, German and French; in other languages the ePI uses the approved content's own section headings.
• Footnote placement: in some ePIs generated before late September 2026, the marketing authorisation holder and approval date footnote may appear at the end of section 5. No information is lost; these ePIs are regenerated in corrected form at the product's next publication.
• Coverage date: ePIs are generated for versions published from September 2026. Products published earlier are covered automatically at their next publication.

·Sources

• EU ePI FHIR Implementation Guide v1.0.0 — European Medicines Regulatory Network
• Description and demo of ePI API — EMA
• EMA ePI Developer Portal

Questions: destek@eKT.one