Promotional activities of human medicinal products, enteral nutrition products, and infant formulas for special medical purposes, are regulated under the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated 3 July 2015.
Pursuant to the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the Internet…
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There is no public disclosure rule for value transfers made by pharmaceutical companies. However, according to the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated 3 July 2015, the pharmaceutical companies shall notify TITCK of any value transfers that exceed 10% of the current monthly gross minimum wage, to health institutions, organizations, universities, health professionals, and members of professional…
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An obligation for marketing authorisation holders to apply to the TITCK and obtain permission for training and support programs for patients/healthcare professionals for the rational use of drugs was regulated via Circular numbered 2016/4 dated March 14 2016, published by the TITCK.
With the program, the marketing authorisation holder signs a contract with an organisation that has been licensed within the framework of the “Regulation on the Delivery of Home Care Services” to…
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Jurisdiction in the case of online infringement of intellectual and industrial property rights has always been a subject of discussion in Turkish practice. While the claimants suffering from the violation of their rights mostly presuppose that online infringement takes place anywhere in Turkey, so there shall be no geographical boundary on seeking their rights, the parties accused of violation generally rely on the general jurisdiction rules in the civil procedures and assert…
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After the long-awaited Regulation on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has entered into force, Medical Device Regulation (“Regulation”) which has been designed following MDR, has been published in the Official Gazette numbered 31499 on June 2 2020. Various effective dates have been foreseen for several articles in accordance with the EU transition process to provide a transition period for the new regulations introduced by the…
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Before the establishment of regional courts of appeal, the Court of Cassation (“CoC”), the highest court of the Turkish judicial system, used its judicial power as a review of expediency by examining the merits of the case, as required by the binary justice system. In the new period following 2016, when the regional courts of appeal began to operate, the primary duty assigned to the CoC is to act as a court of precedents.Even though the regional courts of appeal started to…
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