Short articles on current developments in Turkish regulation of human medicinal products, from marketing authorisation and pricing to labelling and package leaflets, and what they mean for companies.
7 November 2026Türkiye’s 2026 price change period: products with unchanged prices must apply tooUnder a transitional rule of Türkiye’s 2026 pricing Communiqué, almost every product must apply in this year’s period. Timetable, exemptions and consequences.Read more →7 November 2026Marketing authorisation renewal and GMP validity in Türkiye: the cost of missing the deadlineIn Türkiye, MA renewal is due 9 months before the fifth year and TİTCK GMP certificates run for 3 years. Deadlines, file pitfalls and the risks of being late.Read more →7 November 2026ePIL becomes mandatory in Türkiye on 1 January 2027: what MAHs need to have in placeUnder TİTCK’s packaging guideline Rev.18, electronic PILs become mandatory on 1 January 2027. Scope, technical conditions and a readiness checklist.Read more →7 November 2026PIL readability: full user test or bridging?Not every leaflet needs a new user test. What TİTCK expects and, under the CMDh recommendations, when bridging or a focus test is enough.Read more →
