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News & Insights

October 12, 2017

Turkey Cracks Down on Counterfeit and Illegal Products

Legal Alerts
Healthcare

Recent Development The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently announced the results of its 2017 market inspection for counterfeit and illegal products. What the Announcement Says The TİTCK published the list of counterfeit and illegal products detected during 2017. The TİTCK detected 73 products as counterfeit or illegal, meaning they are in circulation […]

October 10, 2017

Crowdfunding Regulation On The Way

Legal Alerts
Capital Markets

The Turkish government began planning an omnibus bill regulating crowdfunding to connect young entrepreneurs that have innovative business plans with investors who are able to support them. Crowdfunding is an alternative financing method providing financing to entrepreneurs from various sectors – primarily technology – who have encountered difficulties in accessing traditional financing instruments after the […]

October 5, 2017

Turkey Becomes PIC/S Member

Legal Alerts
Healthcare

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 […]

October 4, 2017

Turkey Updates Guidelines on Package Information, Manuals and Tracking of Medicinal Products for Human Use

Legal Alerts
Healthcare

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 […]

October 3, 2017

Turkey Updates Cosmetics Regulation

Legal Alerts
Healthcare

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 […]

September 29, 2017

Turkey Publishes Draft Regulation on Variations in Medicinal Products for Human Use

Legal Alerts
Healthcare

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 […]

September 28, 2017

Turkish Ministry of Finance Announces New Tax Rate Increases

Legal Alerts
Tax

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 […]

September 28, 2017

Participation (Takaful) Insurance Details Revealed

Legal Alerts
Insurance

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 […]

September 18, 2017

Turkey Publishes New Guidelines on Notifications Made by the Manifacturers of Medicinal Products for Human Use

Legal Alerts
Healthcare

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 […]

September 15, 2017

Turkey Updates GMP Guide for Manifacturing Plants of Medicinal Products for Human Use

Legal Alerts
Healthcare

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 […]

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