Insights Life Sciences & Healthcare

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
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
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
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
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
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
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
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
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
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
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
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
30.10.2024

Regulation on Cannabis Cultivation for Active Pharmaceutical Ingredients Published

The Regulation governing the procedures for the cultivation of cannabis for the production of flowers and leaves to obtain active pharmaceutical ingredients has entered into force.

CBC Law Firm
23.10.2024

Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliğinin Uygulanmasına İlişkin Kılavuz Güncellendi

Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliğinin Uygulanmasına İlişkin Kılavuz Türkiye İlaç ve Tıbbi Cihaz Kurumu (“TİTCK”) tarafından güncellendi.

Moroğlu Arseven
21.10.2024

Beşeri Tıbbi Ürünlerin Ve Özel Tıbbi Amaçlı Gıdaların Tanıtım Faaliyetleri Hakkında Yönetmelik Taslağı İkinci Kez Görüşe Açıldı

Türkiye İlaç ve Tıbbi Cihaz Kurumu, 2024 yılının ikinci çeyreğinde resmi internet sitesinde bir duyuru yayınlayarak Beşeri Tıbbi Ürünlerin ve Özel Tıbbi Amaçlı Gıdaların Tanıtım Faaliyetleri Hakkında Yönetmelik Taslağını dış görüşe sunmuştu.

Gün + Partners
21.10.2024

Healthcare & Life Sciences Newsletter - October 2024

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published i) the Announcement on Applications for Product Tracking System (ÜTS) of Medical Devices That Will Not Be Certified By The Manufacturer In Accordance With The New Medical Device Regulation (MDR), and ii) the Announcement on Suspension of Health Declaration.

Esin Attorney Partnership
17.10.2024

Second Round of Comments on Draft Regulation for Pharmaceutical Promotions

In the second quarter of 2024, the Turkish Medicines and Medical Devices Agency published an announcement on its website, opening the Draft Regulation on the Promotional Activities of Human Medicinal Products and Food for Special Medical Purposes for external comments.

Gün + Partners
15.10.2024

The Guide on The Implementation of the Regulation on the Sale, Advertising, and Promotion of Medical Devices Has Been Updated

The Guide on the Implementation of the Regulation on the Sale, Advertising, and Promotion of Medical Devices has been updated by the Turkish Medicines and Medical Devices Agency. This update, replacing Version 2, entered into force as of September 27, 2024, with Version 3 now published on TMMD’s website.

Moroğlu Arseven
15.10.2024

İlaç Etkin Maddesi için Kenevir Yetiştiriciliği Konusunda Yönetmelik Yayımlandı

İlaç etkin maddesi elde etmek amacıyla çiçek ve yaprak üretimi için kenevir yetiştiriciliğine yönelik işlemlerin ve bu süreçteki görev ile sorumlulukların düzenlendiği Yönetmelik yürürlüğe girdi.

CBC Law Firm
12.10.2024

From Plant to Pill: Introducing Cannabis to the Pharma Industry

The Regulation on the Cultivation and Control of Cannabis for the Production of Active Pharmaceutical Ingredients prepared by the Ministry of Agriculture and Forestry was published and came into force upon being published in the Official Gazette numbered 32661 dated 13 September, 2024.

Gün + Partners
12.10.2024
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