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… »