Lawyers Yiğit Acar

Yiğit Acar

Yiğit Acar

Esin Attorney Partnership

Yiğit is an associate at Esin Attorney Partnership.


He specializes in pharmaceuticals and healthcare law. He also focuses his practice on data privacy, IT/C law, commercial law, contracts law and product liability law.

 

Practice Areas & Work Department

Information Technology & Communications

International Commercial & Trade

Healthcare

 

Languages

Turkish

English

 

Memberships

Admitted to Istanbul Bar, 2020.

Sağlık & Yaşam Bilimleri Bülteni - Kasım 2023

Türkiye İlaç ve Tıbbi Cihaz Kurumu (“Kurum”) geçtiğimiz haftalarda Tıbbi Cihaz Yönetmelikleri Kapsamında Değerlendirilmeyen Ürünler Hakkında Duyuru’yu yayımladı. Kurum, ayrıca Özel Hastaneler Yönetmeliği ve Sözleşmeli Farmakovijilans Hizmet Kuruluşları ile Ruhsat Sahiplerince Yürütülen Farmakovijilans Çalışmalarının Usul ve Esasları Hakkında Kılavuz’da değişiklik yaptı ve Kozmetik ve Biyosidal Ürünlerin Piyasa Gözetimi ve Denetimi ile İlgili Üçüncü Çeyrek Sonuçları’nı açıkladı.

20.12.2023

Esin / Healthcare & Life Sciences Newsletter - November 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Announcement on Products Not Considered Within the Scope of Medical Device Regulations. The TİTCK also amended the Regulation on Private Hospitals and the Guideline on the Procedures and Principles of Pharmacovigilance Activities Conducted by Contracted Pharmacovigilance Service Organizations and Marketing Authorization Holders. It also announced the Third Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products.

19.12.2023

Sağlık & Yaşam Bilimleri Bülteni - Ekim 2023

Türkiye İlaç ve Tıbbi Cihaz Kurumu (“Kurum”) geçtiğimiz haftalarda Ruhsatlı Beşeri Tıbbi Ürünlerde Yeniden Ruhsat Düzenlenmesini Gerektiren Hallere İlişkin Kılavuz ve Beşeri Tıbbi Ürünlerin Ruhsatlandırma Başvurularının Takvimlendirme Süreçlerine İlişkin Kılavuz’u yayımladı. Kurum, ayrıca (i) Beşeri Tıbbi Ürünler İçin Bilimsel Tavsiye Kılavuzu, (ii) Yurt Dışı Üretim Tesislerinin GMP Denetimleri için Yapılacak Müracaatlara Dair Kılavuz, (iii) Tıbbi Cihaz Yönetmeliğinin Ek XVI’sında Listelenen Tıbbi Amaçlı Olmayan Ürün Gruplarına Yönelik Ortak Spesifikasyonları Belirleyen Kılavuz’da değişiklik yaptı.

20.11.2023

Esin / Healthcare & Life Sciences Newsletter - October 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Guideline on the Conditions Requiring the Renewal of Marketing Authorization for Pharmaceuticals and the Guideline on the Scheduling Processes of Applications for Marketing Authorization of Pharmaceuticals. The TİTCK also amended (i) the Guideline on Scientific Advice for Pharmaceuticals, (ii) the Guideline on Applications for GMP Audits of Foreign Production Facilities and (iii) the Guideline on Common Specifications for Nonmedical Product Groups Listed in Annex XVI of the Medical Device Regulation.

17.11.2023

Esin / Healthcare & Life Sciences Newsletter - September 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Guideline on Scientific Advice for Pharmaceuticals. The TİTCK also amended (i) the Regulation on Pharmacists and Pharmacies, (ii) the Regulation on Bespoke Prosthetic and Orthotic Centers and Hearing Aid Centers, (iii) the Regulation on Opticianry Establishments, (iv) the Guideline on Scientific Meetings and Educational Activities to be Held within the Scope of the Regulation on Sale, Advertising and Promotion of Medical Devices, and (v) the Regulation on the Use of Health Claims for Food and Food Supplements. It also announced the Second Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products as well as the Second Quarter Results for 2015 on Market Surveillance and Inspection of Cosmetic and Medical Devices.

09.10.2023

Sağlık & Yaşam Bilimleri Bülteni - Ağustos 2023

Türkiye İlaç ve Tıbbi Cihaz Kurumu (“Kurum”) geçtiğimiz haftalarda Sağlık Hizmetlerinde Tanıtım ve Bilgilendirme Faaliyetleri Hakkında Yönetmelik’i yayımladı. Kurum ayrıca Faz 1 Klinik Araştırma Merkezleri Hakkında Kılavuz ve İyi Klinik Uygulamaları Denetimleri İçin Başvuru Kılavuzu’nda değişiklik yaptı. Ek olarak, Cumhurbaşkanlığı Beşeri Tıbbi Ürünlerin Fiyatlandırılmasına Dair Karar’da değişiklik yaptı.

06.10.2023

Esin / Healthcare & Life Sciences - August 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Regulation on Promotion and Information Activities in Healthcare Services. The TİTCK also amended the Guideline on Phase 1 Clinical Research Centers and the Guideline on Application for Good Clinical Practice Audits. In addition, the Presidency amended the Decree on the Pricing of Pharmaceuticals.

18.09.2023

Esin / Healthcare & Life Sciences - July 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Regulation on the Marketing Authorization of Homeopathic Medicinal Products and Announcement on the Extension of the Approval Periods for the Use of Off-Label and Foreign Pharmaceuticals.

02.08.2023
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