Turkey: Food, Drugs, Healthcare, Life Sciences

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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
P
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
P
Paksoy
Article
Beşeri Tıbbi Ürünlerin Fiyatlandırmasında Yeni Fiyat Kararı sonrası Tebliğ yayınlandı: Avro Kurunun Bir Önceki Yıl Ortalama Değerinin %65’ine yükseltilmesi, İlk Eşdeğer/Jenerik Ürüne Fiyat Teşviği Detayları
Turkey's pharmaceutical pricing system undergoes significant transformation with new regulations introducing a 65% Euro/TL conversion rate, incentive mechanisms for first generic products, and the groundbreaking introduction of value-based pricing concepts. The new framework aims to accelerate generic market entry while addressing long-standing challenges in patient access to innovative treatments.
Turkey Healthcare
G+
Gun + Partners
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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
P
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
P
Paksoy
See more
Article
New Pricing Communiqué Following The New Pricing Decision For Medicinal Products For Human Use: Increase Of The Euro Conversion Rate To 65% Of The Previous Year’s Average And Details Of The Pricing Incentive For The First Equivalent/Generic Product
Turkey's pharmaceutical pricing system undergoes a major restructuring with the publication of the New Pricing Communiqué on August 29, 2026, implementing significant changes including increased Euro/TRY conversion rates, incentive mechanisms for first generic market entry, and the introduction of value-based pricing concepts. The new regulations establish detailed provisions for special product categories while leaving certain implementation details to future secondary legislation.
Turkey Healthcare
G+
Gun + Partners
Article
İlaç İsimlerine İlişkin Güncel Gelişme - Beşeri Tıbbi Ürünlerin İsimlendirmesine Dair Kılavuz Yayımlandı
Turkey's Pharmaceutical and Medical Devices Agency has published new guidelines establishing comprehensive naming standards for medicinal products, introducing systematic evaluation criteria and procedures for assessing name similarity and acceptability. The guidelines implement a scoring system through TIBAS that compares proposed names against existing databases, while also addressing international nonproprietary name conflicts and promotional language restrictions.
Turkey Healthcare
G+
Gun + Partners
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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
P
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
P
Paksoy
See more