Audit Standards for Information Security Processes
Introduction and Developments With the Presidential Circular on Information and Communication Security Measures which came into force once published on July 6, 2019 (the "Circular"), it was aimed to mitigate and neutralize serious security risks encountered in the digitalization process and ensure the security of critical data for public institutions and organizations and enterprises providing critical infrastructure services. The Information and Communication Security Guide… »
New Regulation on Licensing of Human Medicinal Products
The New Regulation on Licensing of Human Medicinal Products (the “Regulation”) prepared by the TITCK entered into force upon its publication in the Official Gazette numbered 31686 and dated December 11 2021. It has been seen that the purpose aimed with the Regulation is reflecting up-to-date processes present in the TITCK practice but did not exist in the previous regulation dated 2005 and providing compatibility of the legislation with the EU directive numbered… »
Challenges and Opportunities When Combatting Counterfeits in Turkey
It is not a secret that Turkey has an important geographical location for production and sales of counterfeit products as well as the ones in transit. Most of the smuggled products entering Turkey also turn out to be counterfeits. This requires brand owners to take an active role in Turkey to combat the counterfeits, cover all possible basis, and also seek alternative and creative approaches. There are certain civil and criminal actions that can be taken while combatting… »
Named Patient Programs
Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceuticals without marketing authorization (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons. In cases where a pharmaceutical does not have an MA in Turkey, or has an MA, but cannot be found on the market, and patients are in need the pharmaceutical in question, it is possible to procure the pharmaceutical via this special… »
Interactions with HCPs
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… »
Transfers of Value
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… »
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… »