Obligation to Apply for and Obtain Marketing Authorization is Regulated for the Drugs Supplied from Abroad on a Named Patient Basis
The Omnibus Act Amending Some Laws and Decree-Laws related to Health (“the Act”) is published on the Official Gazette dated 5 December 2018 and numbered 30616. Article 1, 2, 3 and 4 of the Act amended the Law on Commercial Pharmaceutical Warehouses and Shops that Sell Poisonous Chemical Substances Used in Arts and Agriculture (“Law on Warehouses”) numbered 984, Article 8 of the Act amended the Pharmaceuticals and Medical Preparations Law numbered 1262 and Article numbered 31… »
What Can Big Data Offer to Insurers and Insureds?
Insurance market has been heavily relying on its conventional tools of risk assessment. This is now under the transformative and disruptive impact of technology. In particular, big data -i.e. large volumes of data sets that are hard to process using traditional data processing methods (“Big Data”) – are claimed to have the potential to replace the conventional tools of risk assessment by their more efficacious equivalents. The provisions of insurance under Turkish Commercial… »
Document Production in International Arbitration: The Good or the Evil?
Document production is one of the most important and controversial topics in international arbitration. Some practitioners consider the document production as “an essential element of justice”, whereas some others consider it as “a waste of time and money”. So, where does the truth lie? Does Common Law Provide Better Justice than Civil Law or Vice Versa? In common law countries, the rationale for discovery suggests that justice can only be established if both sides have… »
Legitimate Interest in Turkish DPL Compared with GDPR and Directive
Legitimate interest has been the subject of various interesting discussions in the European data protection practice. As the Turkish Data Protection Law is modeled on Directive 95/46/EC and also includes some concepts from the GDPR, legitimate interest became an important topic also in the Turkish data protection practice. Although the wording of legitimate interest as a lawful basis under the DPL is similar to the directive and the GDPR, there are important differences. The… »
New Tools for TMs
Turkey’s Industrial Property Code No. 6769 (IPC) came into force on 10th January 2017 and brought in a number of new rules, with the major amendments relating to: letters of consent; non-use defence in opposition and litigation proceedings; and time limits for cancellation actions. Importantly, the IPC introduces the principle of coexistence into Turkish trade mark law. Accordingly, letters of consent from the senior trade mark owner or trade mark application owner have… »
Online Notification of Sanctions Issued to Medical Device Companies
Online notification of sanctions issued to medical device companies Dicle Doğan and Fatma Sevde Tan, Gun + Partners The Turkish Medicines and Medical Devices Agency has announced that sanctions for breaches of the provisions governing the online notification of scientific and educational meetings (Turkish language) shall be imposed automatically via the online system only. Pursuant to Article 21 of the Regulation on the Sale, Advertisement and Promotion of Medical Devices and… »