Recent Developments The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently announced that following a four-year evaluation and inspection process, it became a member of the Pharmaceutical Inspection Co-operation Scheme (the “PIC/S”). What the Membership Means The PIC/S is a convention founded by the pharmaceutical inspection authorities from various countries; it is the most […]
Recent Developments The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently announced updates to the Guidelines on the Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use (the “Guidelines”). Background In April of 2017, the TİTCK published the Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human […]
Recent Developments The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently announced an update to the Regulation on Cosmetics. What Does the Announcement Say? The TİTCK announced that certain annexes of the Regulation on Cosmetics were updated to harmonize the Regulation with the corresponding EC Regulation 1223/2009. In August of 2017, the European Commission […]
Recent Development The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently published on its website the draft Regulation on Variations in Medicinal Products for Human Use (the “Variation Regulation”) and the relevant guidelines thereof. What’s New? The draft Variation Regulation was prepared based on EC Regulation No. 1234/2008, EC Regulation No. 712/2012 and EC […]
On 27 September 2017, Naci Ağbal, the Ministry of Finance, announced the following tax increases during the Medium Term Program meeting (2018-2020): A new legislative proposal increasing corporate income tax from 20% to 22% for the finance sector will be submitted to the Turkish Parliament. Undistributed dividends will be subject to 1% withholding tax. The […]
Recent Development Our last client alert announced that the regulations regarding participation insurance (takaful) were underway. While the Insurance Law No. 5684 (“Law”) did not previously regulate the participation insurance model, with respect to the Supplementary Article 1 of the Law, the Undersecretariat of Treasury now regulates takaful insurance through the Regulation on Operating Procedures […]
Recent Development The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently published on its website new Guidelines on Notifications Made by the Manufacturers of Medicinal Products for Human Use (the “Guidelines”). What’s New? The Guidelines are adopted based on Article 10 of the Regulation on Manufacturing Plants of Medicinal Products for Human Use, which […]
Recent Development The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently announced that the Good Manufacturing Practice (GMP) Guide for Manufacturing Plants of Medicinal Products for Human Use (the “Guide”) was updated. What Does the Announcement Say? The TİTCK has announced that to harmonize the practical implementation among the members of the Pharmaceutical Inspection […]
The regulation on takaful (risk-sharing) insurance products is underway and expected to enter into force before the year-end. Takaful insurance, also known as Islamic insurance, consists of a co-operative system of reimbursement in case of loss by pooling the insurance premiums and losses among participants. The demand for takaful products increased, especially with the rise […]
Recent Development The Ministry of Customs and Trade recently published the Regulation Amending the Consumer Boards Regulation (the “Amending Regulation“), introducing significant procedural changes affecting the consumer complaint process. The Amending Regulation was published in the Official Gazette and entered into force on August 11, 2017. What’s New? The amendments to the Consumer Boards Regulation […]
