Lawyers Fatma Sevde Tan

Fatma Sevde Tan

Fatma Sevde Tan

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Istanbul Bar Association

Türkiye İlaç ve Tıbbi Cihaz Kurumu Tıbbi Cihaz Sektör Belgesi Yayınlandı

Türkiye İlaç ve Tıbbi Cihaz Kurumu (“TİTCK”) tarafından tıbbi cihaz sektöründeki son yıllardaki gelişmeler ile birlikte pazarın mevcut durumunu ortaya koymak üzere hazırlanan Tıbbi Cihaz Sektör Belgesi 4 Nisan 2024 tarihinde TİTCK internet sitesinde yayınlanmıştır.


Turkish Medicines and Medical Devices Agency Published the Industry Report on Medical Devices

On April 4, 2024, the Industry Report on Medical Devices, prepared by the Turkish Medicines and Medical Devices Agency ("Agency") to present the current state of the market together with recent developments in the medical device industry, was published on the Agency’s website.


Named Patient Program in Turkey - 2024

Named Patient Program (“NPP”) is one of the exceptional pharmaceutical importation regimes for products that are not authorized or authorized but unavailable in the Turkish market for various reasons.


Yurt Dışından İlaç Temini Usulünde Yapılan Son Değişiklikler

Türkiye’de ruhsatlandırılmamış veya ruhsatlı olmakla birlikte piyasada bulunmayan ilaçlara hastaların ihtiyaç duyduğu durumlarda; söz konusu ilaç, özel izinle yurt dışından ilaç temini olarak adlandırılan istisnai ithalat rejimi ile ülkemizdeki hastalara tedarik edilebilmektedir.


Recent Changes in the Named Patient Program

Pharmaceuticals not authorized in Turkey or authorized pharmaceuticals not available in the market, shall be procured from abroad as per a special authorization (named patient program) in cases where patients require such pharmaceuticals. While this exceptional import regime for pharmaceuticals was until recently regulated by the Medicines and Medical Devices Agency ("Agency") through guideline, the Regulation on Supply of Pharmaceuticals from Abroad ("Regulation") was published in the Official Gazette dated 3 February 2023 and numbered 32093. The Guideline on Supply of Pharmaceuticals from Abroad ("Guideline"), which contains the guiding provisions regarding the implementation of the Regulation, was once again updated on 22 September 2023, after being updated in April.


Healthcare Regulation 2024 in Turkey - Part 2

The Ministry of Health (MoH) is the main body in charge of health services in Türkiye. It regulates all healthcare institutions in the country, which includes patient care facilities such as hospitals, clinics and diagnostic centres and the practice of medical and other health professions. The Turkish Medicines and Medical Devices Agency (Agency) is a regulatory agency of the government that acts as the highest sanitary authority in terms of medical safety on medicines, health products, cosmetics and personal care products.


Healthcare Regulation 2024 in Turkey - Part 1

Turkey's healthcare system, governed by the Fundamental Law on Healthcare Services No. 3359, falls under the Ministry of Health's purview. Social Security Institution (SSI) health insurance covers the active population, retirees, and dependents, while co-payments apply to certain services. The Health Services Pricing Commission regulates pricing, and the Regulation on Drug Reimbursement governs reimbursement. Licenses for private hospitals require Ministry of Health approval. Foreign companies cannot provide healthcare services. Competition law applies to private hospitals and clinics, subject to Turkish Competition Authority oversight.


New Euro Fx Rate For Drug Prices

The Turkish government has increased the euro exchange rate used to price medicinal products by 30.5%. The new exchange rate is TRY14.0387, up from TRY10.7577. The increase is effective from July 24, 2023.

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