Claim OwnershipLegal Alerts
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© Esin Attorney Partnership 2021
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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.
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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.
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