Advertise on podcast: Legal Alerts

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.