We are pleased to release Moroğlu Arseven’s 5 Years of best practice in competition law. This publication aims to offer a comprehensive overview on competition law trends of Türkiye and landmark decisions as there were important developments between the years 2018-2022.Topics covered include: (i) information on the Turkish Competition Authority’s increased information gathering powers and jurisdiction in light of its recent decisional practice, (ii) developments regarding recently introduced commitment and settlement procedures, (iii) the headline figures from 2018-2022, (iv) significant decisions of the Competition Board, and (v) information on current as well as upcoming legislative developments.

Beşerî tıbbi ürünlerin güvenlik ve kalitesinin sağlanması amacıyla yayınlanan Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliği, Türkiye İlaç ve Tıbbi Cihaz Kurumu'na kılavuz yayımlama yetkisi vermişti. Bu kapsamda çıkarılan Ortak Pazarlanan Beşerî Tıbbi Ürünlere İlişkin Kılavuz, ortak pazarlama sürecini düzenlemektedir. Kılavuzda, ruhsat başvuruları için gereken belgeler ve başvuru sürecinde dikkat edilmesi gereken hususlar belirtilmiştir. Ayrıca, ana ürünün ruhsatının askıya alınması veya iptal edilmesi durumunda uygulanacak düzenlemeler de yer almaktadır. Kılavuz, 17 Şubat 2023 tarihinde yürürlüğe girmiştir.

The Turkish Constitutional Court (TCC) has made a significant decision regarding the amendments to the Law No. 4054 on the Protection of Competition through the Law No. 7246. The decision provides insights into the balance between the constitutional rights granted to undertakings and the obligations imposed on the Turkish Competition Authority. The TCC evaluated the annulment request filed by deputies under three categories: amendment of Article 9 regarding structural remedies, amendment of Article 15 concerning on-site inspections, and amendments regarding the status and appointment of Authority personnel. The TCC ruled that the amendments related to structural remedies and on-site inspections were in line with the principles of legality, legitimate purpose, and proportionality. However, the amendments regarding personnel status and appointment were annulled for being incompatible with the Constitution. This decision establishes a balance between regulatory powers and fundamental rights, leaving room for potential scrutiny of future laws and amendments.

The Regulation on Licensing of Medicinal Products for Human Use aims to ensure the security and quality of such products. The Turkish Medicines and Medical Devices Agency (TMMDA) has the authority to issue guidelines for the application of the Regulation. In line with this, the Guideline on Co-marketed Medicinal Products for Human Use has been implemented by TMMDA. The Guideline provides instructions for the licensing and evaluation of co-marketed products, including application requirements, documents to be submitted, and the suspension or cancellation of licenses. It became effective on 17 February 2023.