Turkey: Food and Drugs Law

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

Türkiye İlaç ve Tıbbi Cihaz Kurumu tarafından yapılan düzenlemeler, biyobenzer ilaçların geliştirilmesini hızlandırırken, tıbbi cihazlar, kozmetik ürünler ve klinik araştırmalara ilişkin...

The Turkish Food Codex Regulation on Flavourings introduces comprehensive rules for the use, authorization, production, labeling and notification of flavouring substances and food ingredients with flavouring properties. The regulation establishes source material restrictions, usage limits and special transition provisions, requiring food businesses to review their product, supply, production and labeling processes to ensure compliance by 31 December 2026.

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.

The European Commission's proposed EU Pharmaceutical Package significantly expands the Bolar exemption beyond traditional regulatory approval activities to include pricing, reimbursement, health technology assessments, and public procurement participation. This expansion raises critical questions about whether such broad exceptions remain compatible with TRIPS Article 30 requirements, particularly when commercial activities like tender submissions may constitute offers for sale rather than purely regulatory

The EU Pharma Package proposes a significant expansion of the Bolar exemption, extending it beyond regulatory preparation to include commercial activities like public procurement.

Following the structural changes introduced in 2023 to the regulatory framework governing health claims on food and dietary supplements, the subsequent period has been characterised less by new legislative...

Counterfeit and illicitly traded health products remained a persistent concern in Türkiye throughout 2025, as reflected both in enforcement statistics and in external reporting on supply chain integrity.

NPPs operate as special import regimes that enable access to medicines that are either not authorised in Türkiye or are temporarily unavailable on the domestic market, upon the request of a treating physician.