Insights
COVID-19: Medicines and Medical Devices Agency Advises on Transfer of Value Notifications
On 6 May 2021, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language) about the transfer of value notifications to be made regarding scientific and product promotion meetings that were postponed or cancelled due to the pandemic. Turkish market authorisation holders must notify the Turkish Medicines and Medical Devices Agency regarding any transfer of value made to healthcare professionals or healthcare organisations (HCOs) exceeding the… »
Regional Court of Appeal Issues Controversial Reversal Decision
The Ankara Regional Court of Appeal has recently reversed three first-instance decisions by relying on Article 353/1-a-6 of the Code of Civil Procedure No 6100 (CCP), which reads as follows: Following a preliminary examination, the Regional Court of Appeal, without holding a hearing and as a final decision, shall send the file back to the court which rendered the original decision or another court in the same jurisdiction without examining the merits of the dispute in the… »
Guidelines on Electronic Scientific and Product Promotion Meetings Has Been Published
The Regulation on the Promotional Activities of Medicinal Products for Human Use (“Regulation”) defines the scientific and product promotion meetings and regulates how the marketing authorization holders can support or organize these activities. However, the Guidelines on the Application of Electronic Scientific Meetings and Product Promotion Meetings (“Guidelines”) which has been prepared taken into consideration the electronic scientific meetings and electronic product… »
Increase on the Corporate Income Tax Rate
The Law on Amending the Law on the Procedure for the Collection of Public Receivables and the Law and Certain Laws numbered 7316 (the “Law”) was published in the Official Gazette numbered 31462 and dated 22.4.2021. Even though seven different laws have been amended with the Law, the most important regulation that is important for entities seems the amendment made in the Corporate Tax Law (the “CTL”). Pursuant to the Provisional Article 13 added to the CTL with Article 11 of… »
Developments for Local Storage in Turkey
Developments for Local Storage in Turkey Introduction and Executive Summary The National Cyber Security Strategy and Action Plan (2020-2023) was published by the Ministry of Transport and Infrastructure on December 29, 2020. It was emphasized for critical infrastructures that issues such as keeping domestically produced data within the country will play a key role in studies to be carried out to protect such infrastructures and to increase their strength. On the other hand… »
Terms of Termination Ban and Unilateral Unpaid Leave Have Been Extended Once Again March 2021
As per the Presidential Decree 3592, published in the Official Gazette (31418) dated 09 March 2021, the termination ban and unilateral unpaid leave have been extended for a further two months as of 17 March 2021. In this regard, the termination ban and unilateral unpaid leave are currently projected to end on 17 May 2021. However, the President is entitled to extend these terms until 30 June 2021. »
A Closer Look at the Turkish Court of Cassation’s Supervisory Power and Its Boundaries
The Turkish Court of Cassation has been one of the most important authorities of the Turkish judicial system, which has been on duty since mid-1800s. Since the establishment of the Court of Cassation, it has served as the supreme court of our judicial justice system. But the recent decisions of the Court of Cassation made us question its supervisory power as the supreme court as well as the boundaries of this power. Until the regional courts of appeal were established in… »
Assignment of Copyrights
Law on Intellectual and Artistic Works No. 5846 (the “LIAW”) takes a very formalistic approach regarding the transfer of copyrights arising from these types of work. Under Turkish copyright law, the general principle is that the person who actually creates a work is the author of that work. The “work made for hire” concept is not accepted under Turkish law. The right transfers should be made in writing, once the work is embodied, indicating, expressly, which rights are… »
Transfer of Data Abroad
Sensitive and non-sensitive personal data can be transferred abroad if the explicit consent of the data subject is obtained. Furthermore, other legal grounds will also apply to the transfer of personal data to the foreign country. However, the destination country must have “sufficient protection” in order to conclude the transfer abroad based on legal grounds (except for having obtained explicit consent). A list of jurisdictions that provide sufficient protection is to be… »
Significant Amendments to Preliminary Examination
Civil Procedure Code No. 6100 (“CPC”) entered into force on 01 October 2011 by replacing the former Civil Procedure Code No. 1086. One of the most significant mechanisms introduced by the CPC was preliminary examination. Under Turkish law, first stage of a trial is the initiation of a lawsuit and exchange of petitions, which is followed by the preliminary examination. During the preliminary examination, the court examines the causes of action, initial objections, points of… »
IP Court Issues Preliminary Injunction Against Drug in Turkey’s Named Patient Programme
The Istanbul Civil Court for Intellectual and Industrial Rights has granted a preliminary injunction to remove a pharmaceutical product from the foreign drug list of the Turkish Medicines and Medical Devices Agency (TMMDA). The drug was supposed to be supplied via the named patient programme (NPP) and was removed on the grounds of patent infringement. Further, the supplier company has been prevented from directly or indirectly commercialising the product, which includes its… »
New Euro Exchange Rate For Drug Prices For 2021
On 19 February 2021, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language), stating that the foreign exchange rate between the euro and Turkish lira for drug prices would be raised to EUR1 to TRY4.5786 as of 20 February 2021. The euro exchange rate used for approval of drug prices in Turkey is determined as per the Decision on the Pricing of Human Medicinal Products (decision). Pursuant to the decision, the euro exchange rate is… »