Insights
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… »
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… »
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… »
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… »
Dilemma Over Well-Known Trademark Registry Continues in Turkey
We have previously reported on the Turkish Court of Cassation’s decision concluding that the Turkish Patent and Trademark Office has no authority to create and maintain a registry for well-known trademarks and discussed the possible repercussions of this decision for trademark owners (Well-known Trademark Registry Is Again Open for Debate). In this article we will examine how practice has been shaped in the light of this decision, offer tips for brand owners during this… »
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… »
Cosmetics and Other Products
The packaging and labelling requirements for cosmetic products are regulated under Cosmetic Law numbered 5324 (the “Law”) and the Regulation on Cosmetics (the “Regulation”) of the TITCK of the MoH. In addition to the Law and the Regulation, the Guidelines on the Promotional Activities of Cosmetic Products and the Regulation on the Health Claims of the Products that are Offered for Sale with a Health Claim (“Health Claim Regulation”) are still applicable, which means… »
Personal Health Data Protection
The protection of personal data (including personal health data) is regulated under Personal Data Protection Law (“DPL”) numbered 6698. The DPL provides legal reasons for the processing of personal data and for sensitive personal data (data relating to race, ethnic origin, political beliefs, philosophical beliefs, religion, denomination, or other faiths, clothing and attire, membership of an association, charity or union, criminal convictions, and security measures, as well… »
Is VR+ a Trademark or a Generic Name?
In Turkey, according to Article 5/1(b) and Article 5/1(c) of Industrial Property Code (“the IP Code”) numbered 6769, respectively, “signs which are devoid of any distinctive character” and “signs which consist exclusively of or includes as an essential element of signs or indications which serve in trade to designate the kind, type, characteristics, quality, quantity, intended purpose, value, geographical origin, or the time of production of the goods or rendering of the… »