Legal Alerts: Recent Episodes
Esin Attorney Partnership
As Esin Attorney Partnership, we are pleased to present our legal alerts summarizing significant legal and regulatory developments in Turkey. Disclaimer: Podcasts are not legal advice. Laws and regulations may change after a podcast is recorded.
Recent developments I The Regulation on the Collection, Maintenance and Disclosure of Insurance Data (the “Regulation“) was published in Official Gazette No. 31987 dated 18 October 2022 and entered into force through its publication.
Recent Developments The Draft Omnibus Law on Changes to Various Laws has been under discussion before the Turkish Grand General Assembly (TGGA) for a while. On Thursday, 13 October 2022, the TGGA adopted the Amendment Law.
Recent development The Decree on Electronic Export Incentives was published in the Official Gazette dated 25 August 2022. The Decree sets out the procedures and principles on incentives to be provided to companies, marketplaces and retail e-commerce sites in their export processes from the Support and Price Stabilization Fund.
The Regulation on the Amendment of the Distance Sales Regulation was published in the Official Gazette on 23 August 2022. Save for provision regarding the obligation of the card issuer on refunds of the amount transferred by the seller, service provider or intermediary service provider, which will enter into force on 1 January 2023, the amendments will enter into force on 1 October 2022.
The Turkish Pharmaceuticals and Medical Devices Authority recently published the Guidance on Good Distribution Practice for Medicinal Products for Human Use and the Guidance on Risk-Based Good Clinical Practice Audits. In addition, it has amended the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation. Moreover, the Ministry of Health recently amended the Regulation on the Cascading of Health Service Providers.
Recent Developments | Article 73 of Banking Law No. 5411 authorizes the Banking Regulatory and Supervisory Authority to determine the scope, form, procedures and principles regarding the sharing and transferring of client information.
Recent Developments On 5 August 2022, the Turkish Personal Data Protection Authority (DPA) published the Guidelines on Protection of Personal Data in the Banking Sector. The Guidelines provide detailed explanations on data processing activities and give examples of good practices in the banking sector.
The Law on the Amendment to the Consumer Protection Law and Property Ownership Law, introducing significant changes to Consumer Protection Law No. 6502, was published in the Official Gazette on 1 April 2022. Save for the amendments regarding time-share vacation, which entered into effect on 1 April 2022, the other provisions will enter into effect in less than two months, on 1 October 2022.
The Turkish Pharmaceuticals and Medical Devices Authority recently published the results of its cosmetics sector market surveillance and inspection in Q2 of 2022 and the Medical Device Clinical Trials Regulation, and it has amended the Regulation on Clinical Trials of Drugs and Biological Products and the Regulation on the Safety of Medicines
In recent weeks, minimum salary has been increased pursuant to the decision of the Minimum Salary Determination Commission dated 1 July 2022, which was published in the (secondary) Official Gazette dated 1 July 2022. Along with the increase in the minimum salary, the monetary limits set forth for the promotional activities of companies operating in the healthcare sector have also changed.
In the recent weeks, the Turkish Pharmaceuticals and Medical Devices Authority published the (1) Guideline to Good Pharmacovigilance Module 10 — Premarketing Benefit/Risk Assessment, (2) Guideline to Good Pharmacovigilance Module 11 — Post-marketing Benefit/Risk Assessment and (3) Draft Guideline on the Use of Health Claims
The Ministry of Health published the Regulation on Pharmaceutical Businesses and Products in the Pharmaceutical Businesses in the Official Gazette on 15 June 2022.
On 11 January 2022, the Personal Data Protection Authority published the Draft Guideline on Use of Cookies and on 20 June 2022, it published the Guideline on Use of Cookies. With the Guideline, the Authority aims to bring forward recommendations to ensure compliance of cookie usage procedures followed by data controllers with the Personal Data Protection Law.
The Regulation Amending the Regulation on Non-Cash Lotteries and Draws of the General Directorate of the National Lottery was published in the Official Gazette dated 16 June 2022. The Regulation introduces new application processes for the organization of non-cash lotteries and draws.
The Law on the Amendment of Environmental Law and Other Laws was published in the Official Gazette on 15 June 2022. The Law introduces significant changes to Law No. 7221 on Amendments on Geographic Information Systems Law and Other Laws.
Recent developments I On 16 June 2022, the Turkish Personal Data Protection Authority (DPA) published the Draft Guideline on Processing of Personal Data in Loyalty Programs ("Guideline") for public consultation. Stakeholders can convey their opinions to the DPA until 16 July 2022.
In recent weeks, the Turkish Pharmaceuticals and Medical Devices Authority published the Draft Guideline on the Application for New Health Claim and the Draft Guideline on the Packaging Information and Readability of Foods for Special Medical Purposes.
Recent development I On 3 June 2022, the Data Governance Act (DGA) was published in the Official Journal of the European Union. The DGA will enter into force on 23 June 2022 and will be applicable for companies 15 months later. The adopted text is available online here.
The Ministry of Health published the draft communiqué on The Electronic Instructions For Use of Medical Devices, which was prepared in line with the Commission Implementing Regulation (EU) 2021/2226.
The Ministry of Trade amended the Customs Regulation regarding certain regulations such as declaration with exceptional value, delivery of goods, incomplete declaration and supplementary declaration in the export regime, and goods that can be stored in warehouses. The Ministry regulated the simplified statement within the scope of the authorized sender authority.
Recent development The Turkish Constitutional Court's Decision No. 2018/6707, dated 31 March 2022, regarding the violation of a doctor's freedom of expression was published in the Official Gazette on 26 May 2022. The Constitutional Court evaluated the freedom of expression within the scope of scientific discussions.
Recent Development The recent developments in the healthcare sector are: (1) the Draft Guideline on the License Application for Foods for Special Medical Purposes, (2) the Draft Guideline on the Stability Studies of Foods for Special Medical Purposes published by the Turkish Pharmaceuticals and Medical Devices Authority and (3) the Guideline on the Distance Health Information Systems (USBS) published by the General Directorate of Health Information Systems.
Recent Development The Constitutional Court's Decision No. 2018/11988 regarding an applicant's right to request the protection of their personal data was published in the Official Gazette dated 19 April 2022. The Constitutional Court evaluated the legal grounds for processing biometric data.
Recent development The Turkish Constitutional Court's Decision No. 2017/39464 dated 23 February 2022 regarding the violation of a teacher's freedom of expression was published in the Official Gazette on 27 April 2022. The Constitutional Court evaluated the freedom of expression of public personnel in general.
The Authority recently published the (1) Good Pharmacovigilance Practices Guideline Module 9 Annex I -Training Materials and Module 8 - Safety Communication and (2) Guideline on Crisis Management in Pharmacovigilance Activities.
The Turkish Pharmaceuticals and Medical Devices Authority recently published the (1) Guideline on the Classification of Diversification and Variation Applications; (2) Guideline on Communication, Organization and Responsibilities of Stakeholders in Market Control Programs; (3) Guideline on the Good Manufacturing Practices in Human Medicinal Products Manufacturing Plants; (4) Announcement on Annotation/Revision Procedures and Transition to the New Type Licenses; and (5) updated the Precautions to Adopt in Clinical Trials against the COVID-19 Pandemic.
Recent Developments The Turkish Medicines and Medical Devices Agency recently announced the results of its cosmetics sector market surveillance and inspection conducted in January, February and March 2022.
Recent Development On 15 April 2022, the Advertising Board of the Ministry of Trade published the Guideline on the Advertisements and Commercial Practices with Price Information and Discounted Sales pursuant to the Consumer Protection Law and the Regulation on Commercial Advertisements and Unfair Commercial Practices. The Guideline aims to inform all advertising industry stakeholders, including advertisers, advertising agencies and platforms as well as sellers, service providers, and intermediary service providers regarding the advertising of price information and discounted sales.
Recent development On 6 April 2022, the European Parliament adopted the Data Governance Act. As part of the European Data Strategy, the Act will become law after it is adopted by the Council of the European Union.
Recent development The Turkish Constitutional Court's new decision, No. 2019/21340 dated 22 February 2022, on the violation of an applicant's freedom of expression was published in the Official Gazette on 5 April 2022. The Constitutional Court evaluated the balance between freedom of expression and protection of honor and reputation of others in the decision.
The Turkish Pharmaceuticals and Medical Devices Authority recently published: (1) the Guideline on the License Application for Homeopathic Medicinal Products and Guideline on the Packaging, Homeopathic Medicinal Product Information, Legibility and Tracking of Homeopathic Medicinal Products; (2) the Guideline on the Implementation of the Regulation on Quality Compliance and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices; and (3) the Basic Requirements Guideline for COVID- 19 Vaccines' Risk Management Plans.
Recent Development On 22 March 2022, the Ministry of Industry and Technology amended the Regulation on the Technological Products Investment Support Program. The amendments expand the scope of the Regulation; regulate the announcements on the technological product investment support program, application conditions and the scope of support; and amend the procedures and principles to be applied in the evaluation process.
The Law on the Amendment to the Consumer Protection and Property Ownership Law was published on the Official Gazette on 1 April 2022. The Law, which consists of 20 articles in total, introduces significant changes to Consumer Protection Law No. 6502.
New Development | The decision of the 3rd Civil Chamber of the Supreme Court with File No. 2021/8941 and Decision No. 2022/656 was published in the Official Gazette on 18 March 2022. The Decision includes essential remarks concerning the exertion of optional rights granted to consumers regarding defective products.
Recent development | The Constitutional Court's decision No. 2019/20472 regarding an applicant's right to request protection of their personal data regarding respect to privacy was published in the Official Gazette dated 18 March 2021. The Constitutional Court decided that the right to request protection of personal data had been violated on the grounds that the authorized body failed to conduct an in-depth review into the allegations during the investigation stage.
New Development | On 15 March 2022, the Presidential Decree Amending the Decree on the Implementation of Certain Articles of the Customs Law No. 4458 was published in the Official Gazette. The Decree introduced notable amendments to the customs duty rates and relevant product groups to be imported via mail, cargo or along with passengers. The amendments will enter into force on 1 May 2022.
The Presidency of Health Institutes of Turkey published the Regulation on the Structure and Execution of the Activities of the Turkish Institute of Health Data Research and Artificial Intelligence Applications ("Regulation"). The Regulation sets forth important issues such as the duties and authorities of the Turkish Institute of Health Data Research and Artificial Intelligence Applications ("Institute").
The Turkish Pharmaceuticals and Medical Devices Authority recently published the Guideline on Licensing of Allergen Products , the Guideline on the Application for Inspection of Good Clinical Practice and the Draft Regulation on the Use of Health Claims.
The Legislative Proposal on the Amendment to the Consumer Protection Law was brought to the attention of the presidency of the Grand National Assembly of Turkey on 8 March 2022 and accepted by the relevant commission on 9 March 2022. The Legislative Proposal, which consists of 19 articles in total, envisages significant changes to Consumer Protection Law No. 6502.
The Turkish Pharmaceuticals and Medical Devices Authority recently published the Guideline on the Inspection of Good Distribution Practices, the Guideline on Triggers of Routine and/or "for a Specific Reason" Inspections, the Guideline on Triggers of Inspections on Bioavailability/Bioequivalence Studies and the inspection results of the final quarter of 2021 on cosmetics and type 1 and type 19 biocidal products.
Recent development On 23 February 2022, the European Commission proposed the draft Data Act, which is part of the European Data Strategy together with the Data Governance Act. With the Data Act, the European Commission aims to increase access to data and provide a fair environment for the use of data.
The Turkish Pharmaceuticals and Medical Devices Authority recently announced that the Medical Device Clinical Trials Regulation is open for public consultation. The Draft Regulation introduces certain amendments to ensure the medical device clinical trial process's compliance with the Medical Device Regulation.
The Ministry of Trade introduced certain amendments to the Price Tag Regulation with the Regulation on Amendment of the Price Tag Regulation, which was published on 18 February 2022.
Recent development | With its decision No. 2021/DK-YED/402 dated 22 December 2021, the Information Technologies and Communication Authority (BTK) approved the Regulation on Amending the Number Portability Regulation ("Regulation") and the Procedures and Principles for Amending the Procedures and Principles on the Number Portability Implementation Process ("Procedures and Principles"). The Regulation came into force when it was published in the Official Gazette No. 31748 dated 12 February 2022.
The Ministry of Health has recently published the Regulation on the Provision of Distance Health Services and the Regulation on the Cascading of Health Service Providers.
The Ministry of Trade introduced new regulations upon the repeal of the Regulation on Market Surveillance and Inspection published in the Official Gazette on 1 April 2020. The newly published Regulation on Market Surveillance and Inspection of Goods sets forth the procedures and principles regarding market surveillance to ensure that consumer products are safe and comply with the relevant technical regulations.
The Turkish Pharmaceuticals and Medical Devices Authority has recently published the Guideline on the Issuance of a "Pharmaceutical Product Certificate," "Free Sales Certificate" and "Pharmaceutical Product License Status Statement" and the Draft Regulation on Permission for Foods for Special Medical Purposes, and amended the application form within the scope of the Regulation of Marketing Authorization for Pharmaceuticals.
The Turkish Pharmaceuticals and Medical Devices Authority recently announced that the draft amendments to the Regulation on Clinical Trials of Pharmaceuticals and Biological Products and the European Commission's Implementing Regulation Draft regarding the nonmedical product groups listed in Annex 16 of Regulation (EU) 2017/745 on medical devices are open for public consultation.
Recent Development | On 1 February 2022, the Ministry of Trade amended the Regulation on Commercial Advertisements and Unfair Commercial Practices. In addition to the important amendments in the content of commercial advertisements, new obligations are imposed on sellers, service providers, intermediary service providers and complaint platforms. The amendments to the Regulation will enter into force on 1 March 2022.
New Development | The decision of the 3rd Civil Chamber of the Supreme Court with File No. 2021/4000 and Decision No. 2021/11403 ("Decision") was published in the Official Gazette on 25 January 2022. The Decision includes essential remarks concerning the liability of intermediary service providers for the content, and goods and services subject to such content, in the electronic environment they provide.
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The Turkish Data Protection Authority has published a principal decision on blacklisting in the car rental industry. The Turkish Data Protection Authority has evaluated the privacy violations arising out of the blacklisting and also introduced the joint controller concept for the first time.
The Information Technologies and Communication Authority amended the Regulation on Consumer Rights in the Electronic Communication Sector. The main areas that are subject to the amendments are the execution, content and implementation of subscription agreements; restriction, suspension and termination of services; and informing consumers.
The Turkish Pharmaceuticals and Medical Devices Authority has published announcements regarding (i) testing, control and calibration of medical devices, (ii) medicines that are counterfeit or illegal and that go outside the legal supply chain, (iii) amendments to regulations regarding biocidal products, and (iv) the recall process.
The Personal Data Protection Authority has published the Draft Guideline on Use of Cookies. With the Guideline, the Authority aims to bring recommendations to ensure the compliance of website operators with the Personal Data Protection Law. The Guideline is open for public consultation until 10 February 2022. Interested stakeholders may convey their opinions and suggestions to the Authority in written form or via email to cerez@kvkk.gov.tr.
The Turkish Constitutional Court evaluated Law No. 5651 on the Regulation of Internet Broadcasts and Prevention of Crimes Committed through Such Broadcasts in its newly published pilot decision on freedom of expression and the press. The Constitutional Court pointed out the relationship between freedom of expression and the press and Article 9 of the Internet Law and made recommendations to the Turkish Grand National Assembly for the reformulation of the relevant article.
The Ministry of Trade amended the Customs Regulation and ratified the decision of the EU-Common Transit Countries Joint Committee amending the Convention on the Common Transit Procedure on 30 December 2021. Additionally, new import communiqués were published and the Import Regime Decision and Decision Regarding the Application of Additional Customs Duty on Imports were amended on 31 December 2021
The Constitutional Court evaluated the balance between employees' freedom of expression and employers' honor and reputation in its new decision on freedom of expression. The Constitutional Court stated that the interference to the freedom of expression should be evaluated as a whole. It also reiterated its position that public officials have to endure more criticism on matters related to their duties.
The asset peace incentive introduced with Law No. 7256 provides various opportunities for the assets held abroad or located in Turkey but not included in the business records to be brought to Turkey or be recorded. With the publication of Presidential Decree No. 5058, the deadline for the notices to be made to avail of the asset peace has been extended from 31 December 2021 to 30 June 2022.
Law No. 7346 amending certain laws was published in the Official Gazette on 25 December 2021 and became effective on the same date. We now set out below more details regarding the regulations under the New Law concerning the electric vehicle charging stations.
The Turkish Medicine and Medical Devices Authority published the new Regulation on Marketing Authorization of Pharmaceutical Products. The Regulation sets forth new rules on critical issues such as application processes for marketing authorizations and approval for emergency use.
The Turkish Medicine and Medical Devices Authority published the Regulation on Variations to Pharmaceuticals with Marketing Authorization. The Regulation on Variations defines new rules that will be applied to the changes to pharmaceuticals with marketing authorization.
Recent Development A draft bill that aims to amend the Capital Markets Law to set the legal framework regarding crypto assets, which are one of the hot topics on Turkey's agenda, has been put on the table in the Grand National Assembly of Turkey.
Recent Developments The Regulation on the Operation Principles of Digital Banks and Service Model Banking previously published by the Banking Regulatory and Supervisory Authority as a draft regulation, aiming to determine the principles of branchless banking and service banking, was published in the Official Gazette on 29 December 2021 and will enter into force on 1 January 2022
In accordance with the protocol signed between the Middle East Technical University and the Information Technologies and Communications Authority on 21 December 2018, all authorizations regarding the management and allocation of ".tr" domain names have been transferred from Nic.tr to the Authority. Nic.tr recently informed users that the transfer of management of ".tr" domain names to the Authority is expected to be completed by January 2022. Once the transfer is completed, the Nic.tr platform will be shut down completely and the ".tr" Network Information System will become operational shortly after. The activation of the System will bring about radical changes to several procedures, such as the allocation, transfer and renewal of ".tr" domain names.
The Ministry of Trade introduced amendments to monetary thresholds and fines in customs legislation and the date of temporary limitation concerning applications for authorized operator certificates with the (1) Customs General Communiqué (Customs Transactions) (Serial No: 181) and (2) the Regulation Amending the Regulation on Facilitating Customs Procedures.
In accordance with the protocol signed by the Middle East Technical University and the Information Technologies and Communications Authority on 21 December 2018, all authorizations regarding the management and allocation of ".tr" domain names have been transferred from Nic.tr to the Authority. Nic.tr recently announced to its users that the transfer of management of ".tr" domain names to the Authority is expected to be completed by January 2022. Following the completion of the said transfer, the Nic.tr platform will be closed completely and the ".tr" Network Information System will become operational in the near future. Once the System period begins, there will be significant amendments to the currently used concepts, definitions and abbreviations related to ".tr" domain names.
Recent Development Consumer complaints against sellers and manufacturers may be brought before Turkish consumer courts only if the amount in dispute is above a certain threshold. These thresholds are determined shortly before the beginning of each calendar year. Consumer complaints below the jurisdictional thresholds may only be brought before a consumer arbitral tribunal. Through the Communiqué on Raising the Monetary Limits Set Forth in Article 68 of Law No. 6502 on the Protection of Consumers and Article 6 of the Consumer Arbitral Tribunals Regulation, Turkey set the threshold for 2022, raising it by 36.20%.
Recent Development Effective 1 January 2022, higher fines will be imposed for certain violations under the Law No. 6502 on Protection of Consumers. The fines will increase by 36.20% from 2021.
The Turkish Pharmaceuticals and Medical Devices Authority has published announcements on biocidal products, the Overseas Drug List, products whose class has changed in accordance with the Medical Device Regulation, international and domestic Good Manufacturing Practices (GMP) certification and inspection processes.
The Constitutional Court made evaluations regarding the freedom of expression of students with its latest decision on the right to education. Within the scope of the Decision, the Constitutional Court evaluated that as the education level of the students increase, the restrictions on the freedom of expression must be limited proportionally. Furthermore, the Constitutional Court set out that restrictions on actions and expressions of students that are pursued outside of educational institution premises must only apply if the institutional order is seriously affected.
The Bill on the Amendment of Certain Laws was brought to the attention of the Presidency of the Grand National Assembly of Turkey on 16 November 2021. The Bill, which consists of 38 articles in total, envisages making significant changes to several laws, including the Law on Intellectual and Artistic Works numbered 5846.
The enforcement of the Internet Domain Names Regulation, published by the Information Technologies and Communications Authority in 2010, which regulates the procedures and principles regarding ".tr" domain names, was delayed until the ".tr Network Information System" becomes operational. In accordance with the recent announcement, the Nic.tr platform, where the procedures for the allocation of ".tr" domain names have been carried out since 1991 in Turkey, will be shut down and the System will start operating. The Regulation, which will come into force at the beginning of the System period, clearly stipulates that ".tr" domain names may be subject to the transactions for sale and transfer, which has not been regulated before
The Judges and Prosecutors Council issued a decision on the establishment of new specialized courts. Further to the Council's decisions, cybercrimes and financial crimes will now be heard in specialized courts.
The decisions of the Judges and Prosecutors Council on the establishment of new specialized courts were published in the Official Gazette dated 30 November 2021. In this context, the establishment of specialized courts in many fields that require legal expertise has been decided.
The Ministry of Treasury and Finance published the Sustainable Finance Framework setting the standards for green, social and sustainable transactions in financial markets on its website on November 12, 2021.
The Ministry of Interior introduced significant amendments to the Regulation regarding the Principles and Procedures of Collection of Aid. Among the main changes are defining the expressions regarding aid and aid collection activities in detail, including aid collection activities on the internet within the scope of the Regulation, amendments in aid collection permit applications, and operation of aid collection activities.
A proposal that seeks to make amendments to Turkish energy market legislation was presented to the Turkish Parliament on 16 November 2021. In this alert, we only summarize the general content and the purpose of the Legislative Proposal. We will publish a detailed note after the enactment of amendments. Please stay tuned.
Operations for the allocation of ".tr" domain names in Turkey have been managed by the Middle East Technical University since 1991, through the platform called Nic.tr. Pursuant to Article 35 of the Electronic Communication Law No. 5809, the Ministry of Communication and Substructure decided that the management and allocation of ".tr" domain names will be undertaken by the Information Technologies and Communication Authority.
The most recent Turkish Competition Board decisions once again show the Board’s sensitivity regarding any irregularities in dawn raids and particularly its zero tolerance policy regarding any data wiping during on-site inspections. Last week, four new reasoned decisions on obstructions of on-site inspections were published on the Turkish Competition Authority’s website. The Board imposed administrative fines for obstructing on-site inspections on Eti Food Industry and Trade Inc., Istanbul Fertilizer Industry Inc., UNMAŞ Bakery Products Industry and Trade Inc., and Çiçek Sepeti Internet Services Inc. with its decisions numbered 21-24/278-123, 21-38/544-265, 21-26/327-152, and 21-27/354-173, respectively. The decisions have one thing in common: in all four cases, employees of the said undertakings’ deleted certain WhatsApp conversations during the on-site inspections.
Recent development The expansion of the scope of application of the e-Hearing System, which enables participation in hearings by means of audio and video transmission in civil proceedings, has been on the agenda for quite some time. Due to the COVID-19 pandemic, important steps have been taken to expand the e-Hearing System and provide online access to more courts. In this regard, the Ministry of Justice initiated the pilot applications of the e-Hearing System on 15 September 2020. As of 9 November 2021, the e-Hearing System has been implemented in all provinces, and online access is now available to 1,400 civil courts.
With its decision published in the Bulletin dated November 11, 2021 and No. 2021/57, the Capital Markets Board of Turkey decided that the sales can commence until December 1, 2021 for initial public offerings to take place with offering circulars covering the half year financial statements for 2021.
On 5 November 2021, the Ministry of Trade amended the Customs Regulation and Inward Processing Regime Communiqué (Export: 2006/12). The amendments specify the cases where proof of origin is not required and introduce additional periods for the inward processing permit documents and permits, and the subsequent submission of documents evidencing the origin of the goods.
The European Court of Human Rights has published a new decision relating to freedom of expression. In the decision, the imprisonment of the applicant by a Turkish court for insulting the president of the Republic of Turkey was found to constitute a violation of his right to freedom of expression. The European Court of Human also stated that affording increased protection to a state president by means of special legal provisions is not compatible with the European Convention on Human Rights.
The Turkish Pharmaceuticals and Medical Devices Authority has published announcements on the authorized laboratories, support of healthcare professionals attending scientific meetings, European Database on Medical Devices, drugs supplied from abroad, and Social Security Institution Communiqué on Health Practices.
Recent development | The Regulation on the Amendment of the Regulation regarding the Procedures and Principles on Implementation of the Electronic Signature Law prepared by the Information Technologies and Communication Authority entered into force on 15 October 2021 after being published in the Official Gazette.
On 1 October 2021, the International Chamber of Commerce (ICC) published the Uniform Rules for Digital Trade Transactions. The Rules define digital trade transaction, set out principles that are applicable to each party of a digital transaction and regulate the presentation of electronic records as evidence in transactions.
On 1 October 2021, the general approach to the Data Governance Act was adopted by European Union Ambassadors. A negotiation mandate was also issued for negotiations of the European Union Commission and the Parliament. The Data Governance Act is a legislative proposal published by the European Commission on 25 November 2020 as part of the European Data Strategy
The Ministry of Agriculture and Forestry made remarkable changes with respect to the licensing or annulment of the license for plant protection products with the Turkish Food Codex Pesticide Residue Regulation. The developments mainly consist of the maximum residue limits and the market availability time of pesticides.
The Turkish Personal Data Protection Authority (DPA) has published its announcement regarding vaccination information and test result applications within the scope of combating COVID-19. Referring to the letters of the Ministry of the Interior and the Ministry of Labor and Social Security, the DPA evaluated the data processing activities carried out within the scope of the operations of public institutions and organizations authorized by law to constitute an exception for the applicability of the Personal Data Protection Law (DPL).
New Development The Ministry of Trade amended the Customs Regulation on 24 September 2021. The amendments regulated the permitted consignor authorization and updated the provisions on the conditions for operators of temporary storage sites and investment permissions. The provisions relating to the permitted consignor authorization will enter into force on 1 January 2022. The Regulation is available here (in Turkish).
The Turkish Pharmaceuticals and Medical Devices Authority has published announcements on the amendments to the regulation on cosmetic products, licensing homeopathic medical products and free promotional samples and press release.
The Turkish Pharmaceuticals and Medical Devices Authority has published announcements on the testing, control and calibration of medical devices as well as the Investigational Medicinal Product Dossier that must be submitted during clinical researches..
Modifications to the Assignment of the Testing, Control and Calibration Institutions
The Authority publishes Draft Investigational Medicinal Product Dossier
The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) has published announcements on the supply of medicines from foreign countries and the exportation of products subject to pre-approval.
Recent Development On 4 June 2021, the European Commission published modernized Standard Contractual Clauses (SCC) for data transfers under the General Data Protection Regulation (GDPR). The modernized SCCs were published as two sets: the first set regulates the cross-border transfers to third countries outside the EU and is a replacement to old SCCs, whereas the second set is for data transfers between data controllers and data processors.
Recent Development
The European Data Protection Board's (EDPD) "Guidelines 07/2020 on the concepts of controller and processor in the GDPR (General Data Protection Regulation No. 2016/679)," providing guidance on the concepts of data controller, joint controller and data processor, was first published on 2 September 2020. After a term of public consultation, the second version of the guidelines was published on 7 July 2021 ("Guidelines"). The English text of the Guidelines is available here.
New Development The Draft Communiqué Amending the Communiqué on Dispute Resolution Mechanism concerning Internet Domain Names was published through decision No. 2021/İK-BTD/220 of the Information Technologies and Communication Authority (ITCA) on 10 August 2021. The Draft Communiqué will be open to public consultation on ITCA's website for 15 days. The Draft Communiqué is available here (in Turkish).
Recent Amendment Pursuant to Article 30 of the Law No. 5684 on Insurance which entered into force in 2007, arbitration has been foreseen as a dispute resolution method for insurance related disputes. Rules and procedures regarding arbitration in insurance are regulated under the Regulation on Arbitration in Insurance No. 11554 ("Regulation") and there have been some changes to the Regulation in the Official Gazette No. 31564, dated 10 August 2021, which are summarized below.
New Development The Information Technologies and Communication Authority (ITCA), through an announcement published on its website on 28 July 2021, opened the Draft Regulation Amending the Regulation regarding the Procedures and Principles on Implementation of the Law on the Electronic Signature to public consultation, which was drafted with the ITCA's Decision No. 2021/İK-BTD/192 of 13 July 2021. The Draft Regulation will be accessible through the ITCA's website for public consultation for a period of 30 days. The Draft Regulation is available here (in Turkish).
New Development The Regulation on Amendment of the Regulation on Workplace Opening and Operation License was published in the Official Gazette No. 31553 on 30 July 2021. The amendment extend the compliance period for certain types of workplaces.
The Turkish Pharmaceuticals and Medical Devices Authority has published announcements on the implementation of the Medical Device Regulation and the normalization process following the COVID-19 pandemic.
New Development | The General Regulation on Market Surveillance and Inspection of Goods ("Regulation") entered into force pursuant to Presidential Decree No. 4269 published in the Official Gazette No. 31537 on 10 July 2021. The Regulation contains provisions concerning placing on the market appropriate and safe products aimed at maximizing the protection of the public interest as per the general product safety and technical regulations legislation, the duties and responsibilities of authorized authorities and coordination and cooperation in this field. The Regulation supersedes the Regulation on Market Surveillance and Inspection of Goods, which took effect with the Decision of the Council of Ministers on 13 November 2001.
New Development The Regulation on the Process of Identity Authentication of Applicants in the Electronic Communications Sector ("Regulation") of the Information Technologies and Communication Authority (ITCA) was published in the Official Gazette No. 31523 on 26 June 2021. The Regulation, which will enter into force on 31 December 2021, lays down the procedures and principles for authenticating identity during the creation of electronic documents for subscription contracts and applications for transfer of phone number, change of operator, qualified electronic certificate and SIM card change in the electronic communications sector. The Regulation is available here (in Turkish).
Recent Development Within the scope of the measures taken due to the COVID-19 pandemic, a unilateral termination prohibition was imposed on employers on 17 April 2020. Pursuant to Law No. 7252 on the Establishment of Digital Platforms Commission and Amendment of Certain Laws ("Law"), the president of the Turkish Republic was authorized to extend the termination prohibition and unpaid leave until 30 June 2021. Thus, the termination prohibition and unpaid leave was lastly extended until 30 June 2021 with Presidential Decision No. 3930. As of 1 July 2021, the termination prohibition and unpaid leave have ended.
Recent Development | The Regulation on Environmental Inspection and Decision No. 1286 of the Grand National Assembly of Turkey concerning the Extension of the Term of Office of the Commission working on Minimization of the Effects of Global Climate Change and Effective Use of Water Resources was published in Official Gazette No. 31509 on 12 June 2021.
Recent Development | The Regulation on CE Sign ("CE Regulation"), the Regulation on Adequacy Assessment Establishments and Approved Establishments ("Establishment Regulation") and the Regulation concerning the Adequacy Assessment Methods ("Assessment Regulation") drafted pursuant to Article 24(2)(a) and (b) of Law on Product Safety and Technical Requirements ("Law") No. 7223 were published and came into force on the Official Gazette No. 31493 on 27 May 2021. Subject regulations set forth crucial changes in terms of manufacturer's liabilities and the adequacy assessment establishments and approved establishment's obligations. The CE Regulation is available here (in Turkish). The Establishment Regulation is available here (in Turkish). The Assessment Regulation is available here (in Turkish).
Recent Development | The Ministry of Health published the Regulation on Units Concerning Neuromuscular Diseases ("Regulation") in the Official Gazette No. 31501 on 4 June 2021. The Regulation sets forth new rules to open units concerning neuromuscular diseases, such as amyotrophic lateral sclerosis (also known as ALS) or spinal muscular atrophy (also known as SMA), in health institutions and the minimum requirements. The Regulation is available here.
As vaccinations have been accelerating, Turkey aims to soon come to the end of its fight against COVID-19, which has been going on for more than a year. According to the latest statement made by the Ministry of Health on 14 June 2021, vaccination priority was given to all employees registered with the Social Security Institution (SSI). However, some employees may not want to be vaccinated. What options do employers have in such cases? We would like to provide you with a quick guide regarding this issue, which is a hot topic for many employers. The information in this guide is presented as of 17 June 2021, and as the situation evolves, there may be changes in the laws affecting employers as well as this guide. We kindly request the information contained in this guide not to be taken as comprehensive legal advice regarding the subject matter.
Our Understanding SPACs - SPAC Opportunities for Turkish Businesses webinar will take place on 1 June, 2021, Tuesday at 14.00 pm (Turkey) / 12:00 pm (UK) time. The majority of us will still be working from home for the foreseeable future. Although our physical reach is limited, we can still prepare ourselves for what's ahead in the ECM arena. We therefore want to help you prepare by offering a webinar on SPACs and how they work. A Special Purpose Acquisition Company (SPAC) raises capital through an initial public offering (IPO) for the purpose of acquiring an existing operating company. Subsequently, such operating company can merge with or be acquired by the publicly traded SPAC and become a listed company in lieu of executing its own IPO. In this webinar we will focus on: What is a SPAC, commonly used SPAC structures and market trends SPAC lifecycle Which stock exchanges are popular for SPAC listings Advantages and disadvantages for target companies compared to a traditional IPO QA
The Medical Device Regulation ("Regulation") was published in Official Gazette No. 31499 on 2 June 2021. The Regulation, which is fully harmonized with the European Union (EU) legislation, aims to enhance the quality of medical devices and provide a more secure use for medical device users and patients. The Regulation is available (in Turkish) here.
Recent Development On 18 May 2021, the Turkish Medicine and Medical Devices Authority (TİTCK) updated the Guidelines on Non-Clinical Assessment for Vaccines ("Guidelines"). The Guidelines were developed following feedback from the healthcare industry. The update contains detailed guidance on various issues that were left unclear in the previous version of the Guidelines.
Recent Development The Radio and Television Supreme Council ("RTUK") issued amendments to certain media regulations, which were published in Official Gazette No. 31485 on 18 May 2021. Under the amendments, the signature circular of the representatives of the applicant media company no longer has to be submitted for broadcasting license, transmission authorization and tender applications.
Recent Development On 5 May 2021, the Advertising Board of the Ministry of Trade published the Guideline on Commercial Advertising and Unlawful Commercial Practices Social Media Influencers pursuant to the Consumer Protection Law. The Guideline aims to inform all advertising industry stakeholders, including advertisers, advertising agencies and platforms, on how the advertising activities of social media influencers are regulated.
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On 7 May 2021, the Turkish Medicine and Medical Devices Authority ("TİTCK") published a new announcement on the value transfers concerning donations to health institutions/organizations and scientific meetings and product promotion meetings that were postponed or canceled due to COVID-19 restrictions.
Recent Development Decision no. 2021/DK-YED/80 ("Decision") of the Information Technologies and Communication Authority (ITCA) regarding the Amending Regulation on Authorization in the Electronic Communication Sector ("Regulation") and the Rules on Conditions and Terms of Authorization Application have been published. The Regulation entered into force after being published in the Official Gazette on 1 May 2021. The Decision introduced amendments and innovations on various matters, including the scope of the conditions of authorization application and obligations of operators, authorization terms and competency control periods, changes of indirect control of operators, and authorization cancellation of operators that do not provide services. In addition to the amendments in the Regulation, the ITCA published the following documents on authorization in the electronic communication sector within the scope of its Decision:
Draft Notification Form
Draft Application Form for Right of Usage
Definition, Scope and Duration of Services, Networks and Infrastructures of Electronic Communication
Recent development | On 17 April 2021, the Workplace Opening and Operation License Regulation was amended with Presidential Decree No. 3835, published in Official Gazette No. 31457. The new amendment brings certain changes to the Workplace Opening and Operation License application process.
On 28 April 2021, the Turkish Medicine and Medical Devices Authority (TİTCK) announced the suspension of product promotion representatives' visits to pharmacies and health organizations during the full lockdown as part of the measures against the COVID-19 pandemic.
The Turkish Medicine and Medical Devices Authority published a number of announcements covering critical topics such as new practices for registration, the evaluation process of medical devices post-Brexit, the Product Tracking System registration requirement for medical service providers and the document upload procedure on Product Tracking System related to medical devices used during the health service provided by health service providers by using the service purchase method.
Recent Development | On 14 April 2021, the Ministry of Transportation and Infrastructure, the Ministry of Environment and Urbanization and the Ministry of Internal Affairs published the Electronic Scooter Regulation on the Official Gazette No. 31454. The Regulation, which took effect on the date of publication, brings a set of new rules that govern the electronic scooter market.
The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") published a number of announcements covering various topics, including biocidal products, electronic scientific meetings and readability tests during the first quarter of 2021.
Recent Developments | On March 16, 2021, the Turkish Medicine and Medical Devices Authority ("TİTCK") published a document, which provides guidance on quality and immunogenicity data that must be submitted for clinical trial applications for COVID-19 vaccines.
Recent Development | On 24 March 2021, the Data Protection Authority (DPA) discussed the commitment letters for cross-border personal data transfers and touched upon the procedures and principles to be followed for applications in its Wednesday Seminar. As is known, the Law on the Protection of Personal Data ("Law"), sets forth certain rules on cross-border transfer of personal data. Preparing a commitment letter between the transferor and the transferee and obtaining the DPA's approval appears as one of those mechanisms. Two template forms are published on the DPA's website for this purpose: one is for transfers from data controller to data controller, and another for transfers from data controller to data processor. You may access these templates (in Turkish) here. After the Law came into effect in 2016, the DPA announced its first approval of a commitment letter on 9 February 2021 and its second approval on 4 March 2021.
Recent Development | The Regulation on Remote Identification Methods to be used by Banks and the Establishment of Contractual Relationships in Electronic Media, which will enter into force on 1 May 2021, was published on 1 April 2021 in the Official Gazette No. 31441. You can refer to our legal alert dated 25 September 2020 for information on the Draft Communiqué on Remote Identification Methods to be used by Banks, which is the draft text of the Regulation
Recent Developments | On March 23, 2021, the Ministry of Treasury and Finance published the Economic Reforms Action Plan. The Plan contains a number of action plans concerning various fields, including domestic trade and market surveillance and inspection, which will be implemented by the end of March 2023.
Recent Development | On February 2, 2021, the Turkish Patent and Trademark Office Re-Examination and Evaluation Board issued a ground breaking decision that under certain circumstances, repeat trademark filings would constitute bad faith, and set benchmarks in this regard.
Recent Development | The Ministry of Trade introduced amendments to the Customs Regulation. The amendments were published in the Official Gazette No. 31394 on February 13, 2021. According to the amendments, traders will have until June 30, 2021 to submit certificates of origin and supplier declarations for goods with customs declarations registered before February 13, 2021, and postal administrations will be able to submit the exit declarations for postal shipments to the customs authorities.
Recent Development | The Turkish Medicines and Medical Devices Agency recently announced the extension of the validity period of GMP certificates due to the pandemic.
Recent Development The Regulation Amending the Regulation on the Electronic Tender, the Regulation Amending the Regulation on the Service Procurement Tender, the Regulation Amending the Regulation on the Goods Procurement Tender, and the Regulation Amending the Regulation on Construction Works Tender entered into force after publication in the Official Gazette on January 26, 2021.
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The Ministry of Trade amended the Regulation on Commercial Advertisements and Unfair Commercial Practices on 3 February 2021. The amendment added a new example of a misleading commercial practice to the "Examples of Unfair Commercial Practices" list in the appendix of the Regulation.
Recent Development On January 15, 2021, the Turkish Medicine and Medical Devices Authority (”TİTCK”) announced the practices for the registration and evaluation processes of medical devices post-Brexit. The TİTCK’s announcement is available online here (in Turkish).
Recent Development The Regulation on Medical Devices Manufactured Utilizing Animal Origin Tissue (“Regulation“) was published on the Official Gazette on January 14, 2021. The Regulation entered into force on the date of its publication.
On January 6, 2021, the Turkish Medicine and Medical Devices Authority (“TİTCK”) presented the draft Regulation on Cosmetic Products for public opinion. The TİTCK announced that it updated the Guideline on the Registration of Technical Service Providers and Relevant Technical Personnel. The TİTCK also issued new announcements regarding the Pharmaceuticals Tracking System, List of Overseas GMP Inspected Facility, and Activities and Early Access Programs for Pharmaceuticals.
Recent Development On December 29, 2020, Turkey and the United Kingdom signed a Free Trade Agreement (“Agreement“). The Agreement entered into force on January 1, 2021.
Recent Development The Ministry of Agriculture and Forestry (“Ministry”) published the Amendment Regulation of Procedures and Principles Regarding the Production and Trade of Tobacco Products and the Amendment Regulation of Procedures and Principles Regarding Tobacco Production, Processing, Domestic and International Trade (“Amendment Regulations“) in the Official Gazette No. 31351 on December 31, 2020.
New Developments The Regulation Amending the Organized Natural Gas Wholesale Market Regulation, which was published in the Official Gazette on 12 January 2021 (“Amending Regulation“) and became effective on the same date, brought new provisions regarding the natural gas futures market.
Recent Development Effective 1 January 2021, higher fines will be imposed for certain violations of the Law No. 6502 on Protection of Consumers (“Consumer Protection Law“). The fines will increase by 9.11% from 2020.
Recent Development Consumer complaints against sellers and manufacturers may be brought before Turkish consumer courts only if the amount in dispute is above a certain threshold. These thresholds are determined shortly before the beginning of each calendar year. Consumer complaints below the jurisdictional thresholds may only be brought before a consumer arbitral tribunal. Through the Communiqué on Raising the Monetary Limits Set Forth in Article 68 of Law No. 6502 on the Protection of Consumers and Article 6 of the Consumer Arbitral Tribunals Regulation, Turkey set the threshold for 2021, raising it by 9,11%.
Recent Development Turkey introduced its new domestic and national eSIM technology on December 24, 2020. The Minister and the Deputy Minister of Transport and Infrastructure and the President of Information Technologies and Communication Authority (“ITCA“) presented the new technology to the public.
Recent Development The Regulation on Authorization Certificate Given to Copyright Collecting Societies (“Regulation“), prepared by the Ministry of Culture and Tourism, entered into force as of January 1, 2021. The Regulation annuls the Regulation on Authorization Certificate Given by Owners of Intellectual and Artistic Works dated September 4, 1986. As per the Regulation, the owners of intellectual and artistic works, affiliated beneficiaries and other financial beneficiaries should submit an authorization certificate in accordance with the principles of the Regulation and the conditions determined by copyright collecting societies in order to become a member of the society.
Recent Development The amendment introduced to the Capital Movements Circular on December 21, 2020 (“Amendment”) extends the scope of PPP exception that applies to the FX loan ban.
Recent Development The Banking Regulation and Supervision Agency (“BRSA“) previously introduced temporary measures to weather the negative impacts of the COVID-19 pandemic on the banking sector. The BRSA issued a statement on December 8, 2020 that they extended the duration of some of these measures and ended others.
The Turkish Medicine and Medical Devices Authority (“TİTCK”) updated Guidelines for Clinical Trial Applications on December 4, 2020. TİTCK also published a new Circular on Registration of Technical Technical Service Providers and Relevant Technical Personnel, and a new announcement on Medical Devices Sold in Pharmacies on December 11, 2020. Please click on the relevant link below for our specific note regarding recent developments:
Recent Development The Banking Regulatory and Supervisory Authority amended the Regulation on the Outsourced Services Procured by Banks on December 11, 2020.
Recent Development With the amendment introduced to the Capital Movements Circular on December 8, 2020, the Republic of Turkey's Ministry of Treasury and Finance introduced a new exception to the FX loan ban which applies to Turkish residents who have no FX income.
The Energy Market Regulatory Authority published its decision dated 3 December 2020 in the Official Gazette on 8 December 2020. The Decision determines the general quality indication rates applicable for electricity distribution and authorized supply companies quoted on the stock exchange. The general quality indication is a variable used as a performance incentive in the formula of revenue cap, which is utilized as a basis in the calculation of tariffs.
New Developments The Competition Authority published the Draft Communiqué on Commitments for Preliminary Investigations and Investigations on Anticompetitive Agreements, Concerted Practices, Decisions and Abuse of Dominant Position on its website on November 27, 2020. The Draft Communiqué aims to limit anti-competitive damages and save time and resource costs in detailed examination processes required for extensive competition investigations. Opinions, suggestions and evaluations on the Draft Communiqué may be submitted to the Competition Authority until December 28, 2020.
Recent Development The Turkish Medicine and Medical Devices Authority announced that it re-evaluated the limitations on product promotion representatives leaving promotional materials during their visits to healthcare organizations within the scope of measures in response to the COVID-19 pandemic. Accordingly, product promotion representatives will be able to leave promotional materials for doctors, dentists, and pharmacists who request it during visits. You may find this announcement of the Authority from the announcements section of the website.
Recent Development In its decision no. 2020/1714 - 2020/2652 dated October 2, 2020, the 15th Civil Chamber of the Court of Cassation rendered that if a dispute subject to arbitration proceedings involves a foreign element, an agreement executed between two Turkish parties in a foreign language does not violate the Law No. 805 on the Compulsory Use of Turkish in Economic Enterprises.
Recent Developments Law No. 7256 on the Restructuring of Certain Receivables and Amendment of Certain Laws has been published in the Official Gazette No. 31307, dated 17 November 2020 (“Law“), and has entered into force. The Law introduces new incentives and supports relating to working life.
According to the announcement published on the Competition Authority’s (“Authority”) website on 06.11.2020, the Competition Authority applied the newly adopted commitment mechanism, a novelty of changes to the Law No. 4054 on Protection of Competition (“Law No. 4054“), for the first time with the Competition Board’s (“Board”) decision dated 05.11.2020.