A marketing authorisation in Türkiye cannot be completed without readability data, and that includes generics and products used only by healthcare professionals. But not every leaflet needs a full 20-participant user test. Choosing the right route early makes a real difference in time and budget.
What does TİTCK expect?
- Readability data goes in Module 1.3.4 of the application. If the full test is not ready at submission, a protocol can be submitted, but the full test must be provided before the procedure is completed.
- A test performed abroad is accepted with a Turkish translation. Where the reference product has a publicly available readability test, bridging can be used.
- Testing is not generally requested for authorised products, but a focus test may be requested with a variation.
When is bridging enough?
In bridging, the results of a successfully tested “parent” leaflet are used for a similar leaflet. Under the CMDh guidance this requires similar key messages for safe use and the same design (font and size, heading structure, layout, colour, pictograms). Typical cases:
| Situation | General approach |
|---|---|
| Different strengths or forms of the same active substance | Bridging is normally accepted. With a different method of administration such as an inhaler, pen or patch, a focus test on that section is added. |
| Same therapeutic class (e.g. statins) | Accepted where the key safety messages are similar; normally not accepted for critical groups such as anti-arrhythmics and anti-epileptics. |
| Combination products | The combination leaflet is usually the parent. |
| Short leaflets for very low-risk products | Can rely on other successful tests in the portfolio. |
Summary: which route?
| Your product | Route |
|---|---|
| No suitable parent leaflet | Full user test (target: at least 16 of 20 participants answer each question correctly) |
| A tested parent leaflet with the same design and similar key messages | Bridging report |
| Differs from the parent on one or two points (new device, new route, new safety message) | Bridging plus focus test |
| SmPC/PIL update for an authorised product | Focus test if TİTCK requires it |
A bridging report compares the key messages, design and language of the parent and daughter leaflets; the parent’s test must already have been submitted and approved. The report can be brief for different strengths of the same product, but needs far more detail across therapeutic classes.
From choosing the right route to test protocols, bridging reports and Turkish translation, we at Melvin Consultancy would be glad to give you the most professional support at every step. See our PIL Readability Testing and Bridging service or get in touch.
Sources: Regulation on the Labelling, Package Leaflet and Tracking of Human Medicinal Products, Art. 8; TİTCK Guideline on Labelling and Package Leaflets (İRD-KLVZ-07), Rev. 18, 11.08.2026, section 2.12; TİTCK Marketing Authorisation Department FAQ (16.02.2024); CMDh/100/2007, Rev. 3, December 2017. This article is for general information; current legislation and TİTCK announcements prevail.
