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Lawyers Fatma Sevde Tan

Fatma Sevde Tan

Fatma Sevde Tan

Gün + Partners
[email protected]
BIOGRAPHY
INSIGHTS

Practice Areas & Work Department

Life Sciences

Intellectual Property

Patent and Utility Models


Languages

English

Turkish


Memberships

Istanbul Bar Association

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.
Dicle Doğan
Fatma Sevde Tan
18.03.2024

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.
Dicle Doğan
Fatma Sevde Tan
27.12.2023

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.
Dicle Doğan
Fatma Sevde Tan
20.12.2023

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.
Özge Atılgan Karakulak
Dicle Doğan
Fatma Sevde Tan
Beste Turan
05.10.2023

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.

Özge Atılgan Karakulak
Dicle Doğan
Fatma Sevde Tan
Beste Turan
02.10.2023

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.
Dicle Doğan
Fatma Sevde Tan
04.09.2023

Decision on the Pricing of Drugs Has Been Amended

The Presidential Decree 6932, issued on July 23, 2023, amends the Decision on Pricing of Medicinal Products for Human Use. Euro value in Turkish Lira for pricing increased by 30.5% to 14.0387 TRY in July 2023. Offsetting process won't apply during this change. Price thresholds are set at 48.41 TRY for price-protected products and 25.30 TRY for others. Previous increases up to 4 TRY aren't considered. The regulation, effective immediately, addresses the rapid exchange rate increase and ensures pharmaceutical availability.

Dicle Doğan
Fatma Sevde Tan
Beste Turan
23.08.2023

İlaç Fiyatlandırılmasına Dair Karar’da Değişiklik

Beşerî Tıbbi Ürünlerin Fiyatlandırılmasına Dair Karar’da (“Karar”) Değişiklik Yapılması Hakkında 6932 sayılı Cumhurbaşkanı Kararı 23 Temmuz 2023 tarihli 32257 sayılı Resmi Gazete’de yayınlanmıştır. Karara eklenen geçici maddeler ile, Beşerî tıbbi ürünlerin fiyatlandırılmasında kullanılacak Türk lirası cinsinden 1 avro değerinin 2023 yılı temmuz ayında %30,5 oranında arttırılarak 14,0387 TL olması belirlenmiş, bu artış uygulanırken Karar’ın 3/3 maddesindeki mahsuplaşma işleminin uygulanmayacağı belirtilmiş,Kurdaki değişime paralel olarak Karar’da geçen fiyat baremleri güncellenerek, bu tutarlar fiyat korumalı ürünler için 48,41 TL, diğer ürünlerde 25,30 TL olarak belirlenmiştir. Dönemsel avro değeri güncellemesinde Karar’ın Geçici 7. maddesi kapsamında uygulanan 4 TL’ye kadar olan artışların dikkate alınmayacağı, güncelleme sonrasında 4 TL’ye kadar olan artışlar, TL değerinde değişiklik yapılmadan, ürünlerin depocuya satış fiyatları üzerine ekleneceği belirtilmiştir.Yeni düzenleme yayımı takip eden gün yürürlüğe girmiştir.
Dicle Doğan
Fatma Sevde Tan
Beste Turan
21.08.2023
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