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Announcement on New Medical Device Requirements

Dicle Doğan and Fatma Sevde Tan, Gun + Partners The EU Medical Devices Regulations ((EU) 2017/745) (MDR) will become applicable on 26 May 2020. As a non-EU country, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language) on 30 December 2019 advising that harmonisation of Turkish regulations with the new rules is to continue. The announcement notes that the MDR sets new principles for manufacturers, importers and distributors, and new… »

A Comparative Analysis of Content-of-Laws Inquiry and its Importance for International Commercial Arbitration

Updates -

How is the content of laws determined, and by whom, in international commercial arbitration? This topic mainly concerns an old legal assumption: iura novit curia, the Latin legal maxim for “the court knows the law”. While somewhat reasonable and predictable on the face of it since anyone can reasonably expect the court to know the law, the assumption paves the way for some serious practical consequences: If the court knows the law, parties are mostly expected to furnish the… »

CJEU Declares the Criteria to be Considered in Determination of Bad Faith

Updates -

In its judgement of 12 September 2019, the European Union Court of Justice (“CJEU”) held that the applicant was acting in bad faith when he filed the application for the trademark taking the earlier business relationship between the applicant and the opponent and ruled how the conditions sought for bad faith should be examined. In the judgment C-104/18 P, which was handed down by the CJEU on 12.09.2019, it was declared which criteria should be taken into consideration for the… »

Amendment on Commercial Communication Regulation in Turkey

With the “Regulation Amending the Regulation on Commercial Communication and Commercial Electronic Messages” (“Regulation”) published on 4 January 2020, new obligations were imposed on commercial electronic messaging that would affect all those using electronic messages. Under the new regulations, the most crucial obligation is registry with the newly established Message Management System called IYS.  “Data, audio and video content messages that are sent for commercial… »

Circular on the Notifications Made Through the Pharmaceutical Tracking System

The Pharmaceutical Tracking System (İlaç Takip Sistemi, “ITS”) is the system adopted by the Turkish Medicines and Medical Device Agency (the “Agency”) for pharmaceutical industry, enabling to determine the locations of pharmaceuticals in the supply and distribution chain in Turkey. A data matrix is printed on the products’ packaging which allows the tracking of each transaction in the supply chain as of the product’s production or importation. ITS is defined under the… »

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