Legal Alerts

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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