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Kilinc Law & Consulting
The Medical Device Directive ("MDD") of the European Council numbered 93/42/EEC, which came into force in 1993 and amended in 2007 with the Directive 2007/47 /EC...
Gun + Partners
The coronavirus (Covid-19) crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices.
Turkey
Gun + Partners
Bu yılki raporumuzda, Türkiye'de ilaç, tıbbi cihaz ve sağlık hukukunda en tartışılan ve önemli görüğümüz konuları ana hatlarıyla ele alıyoruz.
Gun + Partners
COVID-19'un etkisi artmaya devam ediyor ve benzeri görülmemiş bu durumla karşı karşıyayız. Bu süreçte, şirketlerin ivedilikle doğru kararlar vermesi ...
Deris IP Attorneys
Turkish Medicines and Medical Devices Agency ("The Agency") has recently published an informative letter related to the procedures prior the clinical researches on Covid-19 vaccines.
Esin Attorney Partnership
Türkiye İlaç ve Tıbbi Cihaz Kurumu, 25 Temmuz 2020 tarihinde yaptığı duyuruda COVID-19 pandemisi nedeniyle klinik araştırmalarda alınacak tedbirler hakkında Sıkça Sorulan Sorular dokümanını ve COVID-19 Pandemisi ...
Esin Attorney Partnership
On July 25, 2020, the Turkish Medicine and Medical Devices Authority ("TİTCK") updated its Frequently Asked Questions (FAQ) document and COVID-19 measures document regarding clinical trials.
Gun + Partners
On 1 July 2020, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language) stating that declarations of conformity for medical ...
Esin Attorney Partnership
Türkiye İlaç ve Tıbbi Cihaz Kurumu ("Kurum"), Uluslararası Uyum Konseyine (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
Esin Attorney Partnership
The Turkish Medicine and Medical Devices Authority ("TİTCK") announced that it officially became a regulatory member of the International Council for Harmonization of Technical Requirements for...
ELIG Gürkaynak Attorneys-at-Law
The Board recently published its reasoned decision on the application for negative clearance or exemption introduced by Roche
ELIG Gürkaynak Attorneys-at-Law
The Turkish Medicine and Medical Devices Agency ("Agency") of the Ministry of Health issued an announcement on April 27, 2020 updating the Guidelines for Scientific Meetings and Educational...
Kilic Cayli & Partners
29.12.2019 tarihli Cumhurbaşkanlığı Kararı ile yürürlüğe giren ‘Devlet Malzeme Ofisi Ana Statüsü' nün 5. Maddesinde DMO'nun amacı; "kamu hukukuna tâbi olan ...
Balcioglu Selçuk Ardiyok Keki Attorney Partnership
Çeşitli bireysel hassasiyetler ve inançlar sebebiyle bağışıklama (immunisation) çalışmalarında istenen seviyede yaygın uygulanamasa da aşılama faaliyetleri...
Gun + Partners
On 27 April 2020, the Turkish Medicines and Medical Devices Agency published Guidelines on Scientific Meetings and Educational Activities regarding Medical Devices
Gun + Partners
Turkey's first official diagnosis of COVID-19, which is considered to have begun in China's Whuan city in December 2019 and which has spread to millions worldwide in the following months, was announced on 11 March 2020.
Gun + Partners
On 20 March 2020, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language) on precautions to be taken in clinical trials due to the COVID-19 pandemic.
Gun + Partners
In accordance with general precautions established by the government due to the COVID-19 pandemic, the Turkish Medicines and Medical Devices Agency published new arrangements in March.
Gun + Partners
Due to COVID-19 pandemic, precautions needed to be taken in the field of clinical trials where it is requisite to ensure the protection of the rights, safety and wellbeing of trial participants.
Esin Attorney Partnership
Türkiye İlaç ve Tıbbi Cihaz Kurumu, 27 Nisan 2020 tarihinde Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliği Kapsamında Gerçekleştirilecek Bilimsel Toplantı ve Eğitsel Faaliyetler Hakkında Kılavuz'u güncelledi.
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