493 results found

Türkiye İlaç ve Tıbbi Cihaz Kurumu geçtiğimiz haftalarda biyosidal ürünler, Yurtdışı İlaç Listesi, Tıbbi Cihaz Yönetmeliği uyarınca sınıfı değişen ürünler, yurtdışı ve yurtiçi İyi Üretim Uygulamaları sertifikasyon ve denetim ...

The Regulation introduces new bans and restrictions on tobacco products' packaging.

In Turkey, while there are some laws that have applicable provisions, the most relevant legislation on promotion is the Promotion of Pharmaceutical Products.

Early this year, on February 6th, 2017, the Ministerial Cabinet has published its decision on Pricing of Human Medicinal Products ("Decision") and announced that the requirements of the Communiqué on Pricing of Human Medicinal Products (published in 2015) that do not conflict with the Decision, shall remain applicable.

The Ministry of Health ("Ministry") published the Regulation on Pharmaceutical Businesses and Products in the Pharmaceutical Businesses ("Regulation") in the...

Türkiye İlaç ve Tıbbi Cihaz Kurumu ("TİTCK") 8 Ağustos 2019 tarihinde Kozmetik Yönetmeliği'nde ("Yönetmelik") değişiklik yapacağını duyurdu.

In Turkey, pharmaceutical products for human use cannot be marketed unless they are authorized by the Ministry of Health ("MoH"). In order to grant pharmaceutical license and marketing authorization...

Turkey's Ministry of Agriculture and Forestry has updated technical regulations governing vegetable oils in response to climate-induced changes affecting sunflower and hazelnut oil parameters.

Turkey has issued a new Food Codex Communiqué establishing comprehensive administrative and scientific procedures for novel foods and traditional foods from other countries. The regulation introduces consultation mechanisms for determining novel food status, detailed application requirements including toxicological studies and allergenicity assessments, and specific timelines for regulatory review processes. Food business operators must now navigate structured pathways for market authorization, with pr

In Turkey, a process called an "abbreviated application" allows generic drug producers to apply for marketing authorization without submitting information about tests and clinical trials, if a data exclusivity period does not exist, in certain circumstances.

Parallel to the harmonisation process of Turkish legislation with European Union law, the legal environment regarding veterinary products is also evolving in Turkey.

In recent weeks, the Turkish Pharmaceuticals and Medical Devices Authority (TITCK) published the Draft Guideline on the Application for New Health Claim and the Draft Guideline on the...

Online sale of over the counter ("OTC") pharmaceutical products is banned in Turkey because the legislative framework does not specifically address this market segment.

Turkey's tobacco market is already highly and strictly regulated.

The "Guide for Import Applications and Market Placement Permits" ("Guide") was updated on May 27, 2024, by the Turkish Medicines and Medical Devices Agency...

The COVID-19 pandemic has driven mankind to question sufficiency and sustainability of business models, social and moral norms, and Law-practices, which cannot be separated from society and its needs.

While the European Union has long determined its approach to trademark issues for parallel imports and repackaging of pharmaceuticals, Turkish courts and legislation lack a unified and established practice on the issue.