ePIL becomes mandatory in Türkiye on 1 January 2027: what MAHs need to have in place

7 November 2026 · Melvin Consultancy

Revision 18 of TİTCK’s Guideline on the Labelling and Package Leaflets of Human Medicinal Products (İRD-KLVZ-07), dated 11 August 2026, sets out the final rules for the electronic package leaflet (e-KT, ePIL). Under Transitional Article 3 of the guideline, the ePIL obligations apply from 1 January 2027. From that date, products in scope must carry an ePIL.

Which products are in scope?

The rule is broad: an ePIL is mandatory for all human medicinal products, with three exceptions:

• Products intended to be administered only by healthcare professionals (including those supplied through pharmacies, e.g. vaccines, radiopharmaceuticals, hospital products)
• Products that qualify as small packages under the Regulation on the Labelling, Package Leaflet and Tracking of Human Medicinal Products
• Products without an outer carton

Does the printed PIL disappear?

No, it becomes optional. In the guideline’s words, the ePIL is mandatory and the printed leaflet is optional. A printed PIL may still be included in the pack, but every product must have at least one leaflet, printed or electronic.

Companies that keep a printed PIL for products with a QR code on the carton must add the statement directing patients to scan the code for detailed and up-to-date information.

Technical conditions for the ePIL

Section 2.11/A of the guideline lists the following conditions:

1. The ePIL is accessed through a QR code on the outer carton. This can be part of the multimedia QR code defined in the guideline or a separate, stand-alone QR code.
2. The ePIL must match the current approved PIL. When the PIL is updated, the ePIL must be updated within 30 days of approval of the new PIL.
3. The QR code must not, by its size or position, impair the legibility of other information on the pack.
4. The QR code must be accompanied by the statement “Bilgilendirme medyası için kodu okutunuz.” (scan the code for information media).
5. Users must be able to reach the ePIL by scanning a single QR code with the device camera, without installing any additional software.
6. No permission other than personal data protection (KVKK) consent may be requested when accessing the ePIL.
7. The ePIL may be a PDF or HTML document, but the whole leaflet may not be a single image (jpg, png, etc.).
8. The MAH must submit an undertaking that the ePIL content is identical to the current approved PIL.
9. The website hosting the ePIL must be live before the application is submitted to TİTCK.

What to complete before 1 January 2027

Based on these conditions, we summarise the steps companies need to complete:

• Portfolio screening: scope check for each product (HCP-administered, small pack, no outer carton) and a list of products that need an ePIL.
• Printed PIL decision: whether to keep the printed leaflet, and if so, adding the mandatory statement to the PIL text.
• Hosting: a website for the ePILs that needs no app, asks for no permission other than KVKK, and is live before submission.
• Content conversion: a text-based PDF or HTML ePIL produced from the approved PIL. HTML is the better option for readability and accessibility on phones.
• Artwork update: position and size of the QR code on the carton and the required statement next to it.
• Undertaking and submission: the undertaking that the ePIL matches the approved PIL, and the application to TİTCK.
• Update procedure: an internal procedure that ensures the ePIL is updated within 30 days of each PIL approval.

A QR code linking to an audio PIL for visually impaired patients remains optional. If used, it can sit within the multimedia QR code or be a separate code, and it must also be updated within 30 days of a PIL update.

Source: TİTCK, Guideline on the Labelling and Package Leaflets of Human Medicinal Products (İRD-KLVZ-07), Rev. 18, 11.08.2026; Part 2, sections 2.11 and 2.11/A, and Transitional Article 3. This article is for general information; current legislation and TİTCK announcements prevail.