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Esin Attorney Partnership

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Gün + Partners

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Moroğlu Arseven

Moroğlu Arseven

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Healthcare & Life Sciences Newsletter - January 2025

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies must carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.
Esin Attorney Partnership
Can Sözer
Yiğit Acar
Berk Furkan Derici
Başak Dadaş
Erdoğan Karadağ
12.01.2025

The Regulation Amending the Regulation on the Licensing of Homeopathic Medicinal Products Has Been Published

The Regulation Amending the Regulation on the Licensing of Homeopathic Medicinal Products was published in the Official Gazette dated December 3, 2024, and numbered 32741, and entered into force on its publication date.
Moroğlu Arseven
Gökçe İzgi, LL.M.
Merve Altınay Öztekin
Gökçe Bal
24.12.2024

Pharmaceuticals, Medical Devices, Digitalization: What Awaits the Healthcare Sectors in the 12th Development Plan and the 2025 Presidential Annual Program?

The 12th Development Plan 2024–2028 and the 2025 Presidential Annual Program set the development goals and strategic policies for various sectors in Türkiye.
Gün + Partners
Özge Atılgan Karakulak
Dicle Doğan
Ece Ataseven
24.12.2024

The Regulation Amending the Regulation on the Licensing of Human Medicinal Products Has Been Published

The Regulation Amending the Regulation on the Licensing of Human Medicinal Products was published in the Official Gazette dated December 3, 2024, and numbered 32741, and entered into force as of its publication date.
Moroğlu Arseven
Gökçe İzgi, LL.M.
Merve Altınay Öztekin
Gökçe Bal
24.12.2024

The Regulation Amending the Regulation on Marketing Authorization of Traditional Herbal Medicinal Products Has Been Published

The Regulation Amending the Regulation on Marketing Authorization of Traditional Herbal Medicinal Products was published in the Official Gazette 32741 dated 3 December 2024 entering into effect the same day.
Moroğlu Arseven
Gökçe İzgi, LL.M.
23.12.2024

International Update

The World Health Organization (WHO) gives pharmaceutical substances international non-proprietary names (INNs) so that each substance can be identified by a distinct name.
Gün + Partners
Dicle Doğan
Ayşenur Çıtak Bozdağ
23.12.2024

Evaluating Disparaging Practices against Competitors in the Pharmaceutical Sector: A Competition Law Perspective

The competition investigation initiated by the European Commission against Vifor Pharma on June 20, 2022, has attracted attention due to the fact that this is the first investigation in which the act of disparaging competitors will be considered as a violation of competition law alone.
Gün + Partners
Özge Atılgan Karakulak
Beste Turan
18.12.2024

Sosyal Güvenlik Kurumu İlaç Geri Ödeme Yönetmeliğinde Değişiklik Yapılmasına Dair Yönetmelik Yayımlandı

Sosyal Güvenlik Kurumu İlaç Geri Ödeme Yönetmeliğinde Değişiklik Yapılmasına Dair Yönetmelik 28 Kasım 2024 tarihli ve 32736 sayılı Resmî Gazete’de yayımlandı ve yayımı tarihi itibariyle yürürlüğe girdi.
Moroğlu Arseven
Ezgi Baklacı Gülkokar, LL.M.
Selen Aksakal
17.12.2024

The Regulation Amending the Regulation on Drug Reimbursement of the Social Security Institution Has Been Published

The Regulation Amending the Regulation on Drug Reimbursement of the Social Security Institution was published in the Official Gazette dated 28 November 2024 and numbered 32736, and entered into force as of its publication date.
Moroğlu Arseven
Ezgi Baklacı Gülkokar, LL.M.
Selen Aksakal
10.12.2024

Beşeri Tıbbi Ürünlerin ve Özel Tıbbi Amaçlı Gıdaların Piyasa Kontrolü Hakkında Yönetmelik Yayımlandı

21.11.2024 tarihli ve 32729 sayılı Resmî Gazete’de yayımlanan Beşeri Tıbbi Ürünlerin ve Özel Tıbbi Amaçlı Gıdaların Piyasa Kontrolü Hakkında Yönetmelik ile tıbbi ürünler, etkin maddeler ve özel amaçlı gıda ürünlerine ilişkin piyasa kontrol faaliyetleri kapsamlı bir şekilde ele alınmıştır.
Moroğlu Arseven
Ezgi Baklacı Gülkokar, LL.M.
Büşra Bıçakcı, LL.M.
10.12.2024

The Regulation on Market Surveillance of Medicinal Products for Human Use and Foods for Special Medical Purposes Has Been Published

The Regulation on Market Surveillance of Medicinal Products for Human Use and Foods for Special Medical Purposes, published in the Official Gazette dated November 21, 2024, and numbered 32729, comprehensively addresses market surveillance activities concerning medicinal products, active substances, and foods for special medical purposes.
Moroğlu Arseven
Ezgi Baklacı Gülkokar, LL.M.
Büşra Bıçakcı, LL.M.
06.12.2024

Kanser İlaçlarının Sosyal Güvenlik Kurumu Tarafından Karşılanması İçin İzlenilmesi Gereken İdari ve Hukuki Süreçler

Kanser tedavisi için hayati önem taşıyan ilaçların Sosyal Güvenlik Kurumu (SGK) tarafından karşılanması, sosyal devlet ilkesi ve yaşam hakkı bağlamında ele alınması ve tartışılması gereken önemli bir konudur.
SEKA Consulting | Law | IP
Ajda Aktunalı
Irmak Kazancı
Elif Savrun
27.11.2024

Beşeri Tıbbi Ürünler ve Özel Tıbbi Amaçlı Gıdaların Geri Çekilmesi Hakkında Yönetmelik Yayımlandı

Beşeri Tıbbi Ürünler ve Özel Tıbbi Amaçlı Gıdaların Geri Çekilmesi Hakkında Yönetmelik 23 Ekim 2024 tarihli ve 32701 sayılı Resmî Gazete’de yayımlanmış ve yayım tarihi itibariyle yürürlüğe girmiştir.
Moroğlu Arseven
Ezgi Baklacı Gülkokar, LL.M.
Merve Altınay Öztekin
25.11.2024

Regulation on the Withdrawal of Medicinal Products for Human Use and Foods for Special Medical Purposes was Published

The Regulation on the Withdrawal of Medicinal Products for Human Use and Foods for Special Medical Purposes was published in the Official Gazette dated October 23, 2024 and numbered 32701 and entered into force as of the date of publication.
Moroğlu Arseven
Ezgi Baklacı Gülkokar, LL.M.
Merve Altınay Öztekin
21.11.2024

Healthcare & Life Sciences Newsletter - November 2024

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies must carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.
Esin Attorney Partnership
Can Sözer
Yiğit Acar
Ayça Doğu Öztürk
Berk Furkan Derici
Erdoğan Karadağ
20.11.2024

İlaç Endüstrisinde Yapay Zeka Destekli Patentler

Yeni bir reçeteli ilacın geliştirilmesi pahalı ve uzun bir süreçtir. Tufts İlaç Geliştirme Araştırma Merkezi’nin bir çalışmasına göre, bir ilacın piyasaya sürülmesinin tahmini maliyeti yaklaşık 2,558 milyar dolardır.
Gün + Partners
Selin Sinem Erciyas
19.11.2024

New Regulations on Hemp Cultivation for Medicinal Active Ingredient Production and Its Control

The Regulation on Hemp Cultivation for Medicinal Active Ingredient Production and Its Control (“Regulation”), published in the Official Gazette No. 32661 on September 13, 2024, regulates the procedures and principles regarding the procedures to be applied within the scope of cannabis cultivation ...
Moroğlu Arseven
Gökçe İzgi, LL.M.
Ece Berkman
07.11.2024

Amendments to the Decree on Pricing of Pharmaceuticals

On 24 October 2024, the Presidency of the Republic of Türkiye amended the Decree on Pricing of Pharmaceuticals. The amendments introduced by the Decree entered into force on 25 October 2024.
Esin Attorney Partnership
Can Sözer
Yiğit Acar
Ayça Doğu Öztürk
Berk Furkan Derici
Erdoğan Karadağ
07.11.2024

The Medicines and Medical Devices Agency of Turkey Has Re-Evaluated Some of the Health Declaration Statements in the Guideline on the Use of Health Declaration in Food and Food Supplements

In accordance with the Regulation on the Use of Health Declarations in Food and Food Supplements and the Guideline on the Use of Health Declarations in Food and Food Supplements, health declarations may be used in food and food supplements.
Moroğlu Arseven
A. Başak Acar, LL.M.
Merve Altınay Öztekin
05.11.2024

Calendarization Process for the Market Authorization of Medicines

The Guidelines for the Calendarization Process of Medicinal Products for Human Use aims to regulate the process for the market authorization applications on medicinal products for human use filed with the Turkish Medicines and Medical Devices Agency.
Gün + Partners
Dicle Doğan
Fatma Sevde Tan
30.10.2024
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