Turkey: Healthcare

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Article
Borderline Products: Distinguishing Medicinal Products, Medical Devices And Cosmetics Under Turkish Law
A critical consideration before placing health and personal care products on the market is determining their correct regulatory classification. For borderline products – products that may exhibit characteristics of medicinal products, medical devices or cosmetics – this distinction has significant implications for the applicable regulatory requirements, market entry procedures, costs and ongoing compliance obligations.
Turkey Healthcare
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Paksoy
Article
Recent Developments In Healthcare Legislation – Issue 2026/2
Turkey's Medicines and Medical Devices Agency has introduced sweeping regulatory reforms across pharmaceuticals, medical devices, and cosmetics sectors. The amendments streamline biosimilar development by eliminating redundant testing requirements, establish new licensing frameworks for herbal products and aromatherapeutic oils, and impose stricter labeling standards for allergens in cosmetics. These changes fundamentally reshape compliance obligations for manufacturers, importers, and healthcare institutio
Turkey Healthcare
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Paksoy
Article
İlaç Bedellerinin Sosyal Güvenlik Kurumu Tarafından Karşılanma Şartları: Hukuki Süreç Ve Kanser İlaçları Özelindeki Durum
Turkey's Social Security Institution does not automatically cover all prescription medications, even those approved and prescribed by doctors. This article examines the strict legal framework governing drug reimbursement, particularly for cancer treatments not included in official coverage lists. Through analysis of recent court decisions and regulatory requirements, it explores when and how patients can seek judicial intervention to obtain coverage for life-saving medications excluded from standard
Turkey Employment
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Urey Law Firm
Article
Major Amendments To The Regulation On The Authorisation Of Traditional Herbal Medicinal Products
The Regulation Amending the Regulation on the Authorisation of Traditional Herbal Medicinal Products (the “Amendment Regulation”), published in the Official Gazette dated 2 July 2026 and numbered 33298, introduces significant amendments to the procedures and principles governing the authorisation of traditional herbal medicinal products.
Turkey Healthcare
OA
Ozbilen Aykut Attorney Partnership
Article
Tıbbi Bitki Çayları Hakkında Yönetmelik
2 Temmuz 2026 tarihli ve 33298 sayılı Resmî Gazete'de yayımlanan Tıbbi Bitki Çayları Hakkında Yönetmelik (“Yönetmelik”) ile tıbbi bitki çaylarının ruhsatlandırılması, üretimi, ithalatı, ambalajlanması, dağıtımı, piyasaya arzı ve denetimine ilişkin usul ve esaslar ilk kez kapsamlı şekilde düzenlenmiştir. Yönetmelik, yalnızca eczanelerde satılacak tıbbi bitki çaylarına yönelik ayrı bir ruhsatlandırma sistemi oluştururken, takviye edici gıdalar ile gıda niteliğindeki bitki ve meyve çaylarını kapsam dışında bırakmaktadır.
Turkey Healthcare
OA
Ozbilen Aykut Attorney Partnership
Article
Regulation On Medicıial Herbal Teas
The Regulation on Medicinal Herbal Teas (the “Regulation”), published in the Official Gazette dated 2 July 2026 and numbered 33298, establishes for the first time a comprehensive framework governing the authorisation, manufacture, importation, packaging, distribution, placing on the market and supervision of medicinal herbal teas. While the Regulation creates a separate authorisation system for medicinal herbal teas sold exclusively through pharmacies, it excludes food supplements and herbal and fruit teas marketed as food products from its scope.
Turkey Healthcare
OA
Ozbilen Aykut Attorney Partnership
Article
Kişisel Sağlık Verileri Hakkında Yönetmelikte Yapılan Önemli Değişiklikler
4 Temmuz 2026 tarihli ve 33300 sayılı Resmî Gazete'de yayımlanan Kişisel Sağlık Verileri Hakkında Yönetmelikte Değişiklik Yapılmasına Dair Yönetmelik (“Değişiklik Yönetmeliği”) ile kişisel sağlık verilerinin düzeltilmesine ilişkin mevcut düzenlemelerde değişiklik yapılmış ve ilk kez geçmişte konulmuş sağlık tanılarının güncel sağlık durumu esas alınarak yeniden değerlendirilmesine ilişkin usul ve esaslar düzenlenmiştir.
Turkey Healthcare
OA
Ozbilen Aykut Attorney Partnership
Article
The Regulation Amending The Regulation On Health Information Management Systems Was Published
Turkey's Ministry of Health has introduced significant changes to its health information management systems regulations, removing several certification requirements and streamlining registration procedures for service providers. The amendments eliminate mandatory CMMI and SPICE certifications while expanding deletion penalties and modifying procurement processes, fundamentally reshaping compliance obligations for healthcare technology vendors operating in the Turkish market.
Turkey Healthcare
MA
Moroglu Arseven
Article
Legal Developments Regarding Herbal Medicinal Products, Foods For Special Medical Purposes And Medical Devices
Turkey has introduced comprehensive new regulations governing aromatherapeutic products and medicinal herbal teas, establishing standalone licensing regimes that separate these products from food supplements and general food legislation. The regulatory package also brings significant amendments to existing frameworks for traditional herbal medicinal products, foods for special medical purposes, and medical device sales, introducing new obligations for manufacturers, distributors, and sales channels across p
Turkey Healthcare
P
Paksoy
Article
Takviye Edici Gıda Sektörü: İmalatçı Sorumlulukları
The legal framework governing dietary supplements in Turkey imposes significant compliance obligations on manufacturers to protect public health. These responsibilities span from pre-market technical documentation and conformity declarations to post-market product traceability and corrective action implementation, making systematic compliance policies essential for sustainable trade in today's food sector.
Turkey Healthcare
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CBC Law Firm
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