Insights
Harmonization with the EU Medical Devices Regulation
Regulations on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has been published, and was planned to be enter in force on 26 May 2020. However, the MDR’s implementation date has been delayed for a year to enable healthcare institutions and economic operators to prioritize the fight against the Covid-19 pandemic. The legislation in Turkey continues the process of harmonization with the new rules set by the MDR. On 1 February 2020, Presidential… »
Madrid e-Filing Now Available to Applicants in Turkey
As a result of the cooperation between the Turkish Patent and Trademark Office (TURKPATENT) and WIPO,Turkey has taken its place among thecountries that enable applicants to file their international trademark applications directly through the Madrid e-Filing service. Before this change, the MM2 form - the application form for the registration of international trademark applications - had to be filled in manually and submitted to TURKPATENT via the EPATS - TURKPATENT’s… »
Extension of the Deadline Regarding Amendments to the Communiqué With Respect to Capital Loss and Negative Equity
The Communiqué (the “Amending Communiqué”) published in the Official Gazette on November 8, 2022, extended the deadline provided under Provisional Article 1 of the Communiqué on the Procedures and Principles Regarding Implementation of Article 376 of the Turkish Commercial Code No. 6101 (the “Implementation Communiqué”). The Implementation Communiqué was previously amended on December 26, 2020, and certain loss items were excluded from the calculation of capital loss or… »
Amendment to Press Labour Law
Under Turkish law, journalists are subject to Law No. 5953 on Arrangement of Relations Between Employers and Employees in the Field of Press (“Press Labour Law”), which sets out the terms and conditions of their employment. Former wording of Article 1 of Press Labour Law stated that the law covered those who work in any kind of intellectual or artistic works at news and photo agencies, periodical publications and newspapers published in Turkey and who fall outside the… »
Failure to Send Information Message by SMS or Email Regarding E-Notification Will Not Affect Term or Validity
Background The amendments made in Notification Law 7201 in 2019 expanded the scope of persons notified by e-notifications to include: public institutions and organisations; lawyers; notaries; experts; and mediators. Following this development, the Regulation on Notification via Electronic Means came into force in 2019. Both the Notification Law and the Regulation on Notification via Electronic Means provide that "the electronic notifications are deemed to have been served… »
How to File an Individual Application with Constitutional Court
Introduction According to article 45 of the Code on Establishment and Procedure Rules of the Constitutional Court (No. 6216) (the Code), anyone can apply to the Constitutional Court on the grounds that their fundamental rights and freedoms – protected under the Turkish Constitution, the European Convention on Human Rights and any additional protocols to which Turkey is a party – have been violated by public force. Any and all administrative and judicial remedies regarding the… »
New e-commerce Regulation Sets Out Details of Takedown Procedure For Infringing Content
A new regulation complementing Law No 7416 on e-commerce came into effect on 1 January 2023 The regulation clarifies the takedown procedure upon receipt of a legitimate complaint by an IP rights holder While this will help rights holders to take down infringing products quickly, ambiguities regarding the procedure may still create problems in practice Background A new law on e-commerce (No 7416), which was published in the Official Gazette dated 7 July 2022, came into… »
Turkey Appealed the Decision of the World Trade Organization Panel on the Localisation Policy Regarding Pharmaceutical Products
In Turkey, specific healthcare services are reimbursed by the government due to the social state principle. Accordingly, a large portion of the prescribed pharmaceutical products have been included in the reimbursement list of the Social Security Institution (“SSI”) and the payments of the treatments have been completely or partially made by the SSI. According to the legal framework, pharmaceutical products with the marketing authorization can be included in the… »
Amendment on the Decision on Pricing of Medicinal Products for Human Use
The Presidential Decree numbered 6365 Amending the Decision on Pricing of Medicinal Products For Human Use (“Decision”) was published in the Official Gazette numbered 32008 on 9 November 2022. The following paragraph has been added to Article 2 of the Decision: “Discount practices that cause temporary price changes in country/countries where the product is offered for sale, special practices related to product classification and taxation practices shall not be taken into… »
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… »
How to use Right to Seek New Employment During Notice Period
Introduction Indefinite-term employment agreements can be terminated by complying with notice periods, unless either party has a just cause for termination. Article 27 of the Labour Law regulates the right for employees to seek new employment during their notice periods: Within the notice periods, the employer is obliged to grant the employee the leave to seek new employment within the work hours and without making any salary deduction. Time of the leave to seek new… »
COVID-19: Update on Precautions to be Taken in Clinical Research in 2021
On 20 March 2020, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language) titled "Precautions to be Taken in Clinical Research Due to COVID-19 Pandemic". This announcement was updated on 24 July 2020. On 19 July 2021, based on the normalisation process regarding COVID-19, the Agency published a further updated version of the announcement. According to the latest update, for initial applications for clinical research and applications… »