Patient Support Programs
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… »
Jurisdiction in Online Infringement of IP Rights
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… »
Harmonisation with the EU Medical Devices Regulation
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… »
Supervisory Power of the Court of Cassation
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… »
Promotion of Medical Devices
With medicines, the rule is clear: The general public cannot be the audience of any promotional activity, whatsoever, of pharmaceutical products. However, with medical devices, the rule in place in the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Medical Device Promotion Regulation”) notes more confusing regulation. The rule states that medical devices that are sold, adapted or applied in hearing aid centers, custom-made prosthesis and orthotics… »
Food Supplements
The Regulation on the Importation, Production, Processing and Supply of Food Supplements (the “Regulation”) was published by the Ministry of Food and Forestry (the “MoA”) on 2 May 2013 in the Official Gazette, and came into force as of 2 August 2013. The said Regulation is not only the first regulation that has been drafted, particularly on food supplements, but also includes unique provisions with regard to the control and approval mechanism to be established over food… »