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News & Insights

February 28, 2018

Changes to Pharmaceutical Packages: TİTCK Announces Mandatory Braille Alphabet Usage

Legal Alerts
Healthcare

Recent Development The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently announced the necessary actions to fulfil the requirement of Braille alphabet usage under the Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use (the “Regulation“). What Does the Announcement Say? Pursuant to the TİTCK’s announcement, as indicated in the Regulation, […]

February 27, 2018

Recent Developments on Turkish Capital Markets Regulations

Legal Alerts
Capital Markets

Recent Development The Capital Markets Board (“CMB”) amended the Communiqué on Shares No. VII-128.1 and Communiqué on Disclosure of Material Events No. II-15.1. The amendments were published and entered into force on February 13, 2018. What’s new? Before the amendment to the Communiqué on Shares, in relation to public companies’ capital increases, if the ratio […]

February 27, 2018

Turkey to Align with EU Medical Device Regulation: Current Progress

Legal Alerts
Healthcare

Recent Development The Turkish Medicines and Medical Devices Agency (“TITCK”) recently announced that the legislative process for the adoption of the EU Regulation No. 2017/745 on Medical Devices (“MDR“) is ongoing. In this scope, the TİTCK published a Turkish translation of the MDR to be taken as a basis during the adoption period. What’s New? […]

February 20, 2018

FX Loan Balances Must be Reported to the Central Bank

Legal Alerts
Banking & Finance

Recent Development The Central Bank of the Republic of Turkey (“CBRT“) published the Regulation on the Principles and Procedures for Monitoring Transactions Affecting FX Positions (the “Regulation“) in the Official Gazette No. 30335 on 17 February 2018. The Regulation entered into force on the same day. What’s new? Enterprises (except banks and financial institutions) whose […]

February 19, 2018

A New Era for E-Commerce Websites: Safety Stamp Protocol Signed

Legal Alerts
International Commercial and Trade

Recent Development The Ministry of Customs and Trade recently announced that the safety stamp protocol (the “Protocol“) was signed with the Union of Chambers and Commodity Exchanges of Turkey (tr.,“TOBB“), authorizing the TOBB to grant e-commerce websites safety stamps. Background The Ministry of Customs and Trade published the Safety Stamp Communiqué (“Communiqué“) to address security […]

February 16, 2018

RTÜK to Supervise Internet Broadcasts

Uncategorized
IT & Communications

Recent Development The Draft Law on the Amendments to the Tax Laws and Certain Laws and Decrees (“Draft Law”), recently submitted to the Turkish Parliament, introduces highly significant restrictions in relation to internet broadcasting. Pursuant to the new Article 29/A to be added to Law No. 6112 on the Establishment of Radio and Television Enterprises […]

February 9, 2018

Cosmetics Safety: Turkey Continues Cracking Down on Unsafe and Non-Compliant Cosmetic Products

Legal Alerts
Healthcare

Recent Development The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently announced the results of its cosmetics sector market surveillance and inspection conducted between September and December 2017. What do the Results Say? The TİTCK’s Cosmetics Supervision Department published the list of unsafe and non-compliant cosmetics products detected during the fourth quarter of 2017. Of […]

February 8, 2018

Quality in Cosmetics Manufacturing: Application Procedures for GMP Certificates Announced

Legal Alerts
Healthcare

Recent Development The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently announced that Good Manufacturing Practice (GMP) Certificates will be issued for the manufacturing sites of cosmetic products. What Does the Announcement Say? The TİTCK issues GMP Certificates for cosmetic manufacturing sites only for export purposes. Manufacturing sites deemed compliant with the GMP requirements are […]

February 5, 2018

Safety First: TİTCK Announces the Certified Pharmacovigilance Service Providers

Legal Alerts
Healthcare

Recent Development The Turkish Medicines and Medical Devices Agency (“TİTCK“) recently published on its website the list of the certified pharmacovigilance service providers. What is Pharmacovigilance? Pharmacovigilance refers to the scientific activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. In this scope, marketing authorization holders may […]

February 2, 2018

Amendment Makes Turkish IPOs Even Easier

Legal Alerts
Capital Markets

Recent Development The Capital Markets Board (“CMB“) amended the Communiqué on Shares No. VII-128.1 and eased the conditions for initial public offerings. The amendments were published and entered into force on January 26, 2018. What’s new? In an initial public offering, the issuer’s total assets must be a minimum of TRY 10 million and its […]

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