Data Breach Notification
The Data Protection Law requires data controllers to notify the relevant data subject and the Board as soon as possible when being made aware of such data breach. In its decision dated January 24, 2019 and numbered 2019/9, the Board clarified the rules and procedures to be applied in data breach incidents. The Board takes the GDPR approach in terms of timing of breach notifications, and clarified that the term of “as soon as possible” within the Data Protection Law must be… »
Data Controllers’ Registry (VERBIS)
According to Article 16 of the Data Protection Law, an obligation to register in the Data Controllers Registry has been introduced for data controllers. In 2018, the Board issued decisions granting exemptions from registration obligation to certain professional groups, associations, and political parties. The Board also granted a general exemption to local data controllers that have less than 50 employees, and actively less than TRY 25 million on their balance sheets. Data… »
Consequences of Data Breach
The Data Protection Law envisages both administrative fines and criminal liability. With regard to criminal penalties, the Data Protection Law refers to the relevant provisions of the Turkish Criminal Code that detail sanctions for the unlawful recording, or disclosing, or transferring of personal data. In addition to criminal sanctions, the Data Protection Law also contains provisions detailing administrative fines that are to be applied in the event of a breach. There are… »
Judicial Review of Board Decisions
The Data Protection Law does not include an explicit provision concerning the appeal process of Board decisions imposing administrative fines; however, it is accepted that criminal courts of peace are the authorized courts pursuant to Law No. 5326 on Misdemeanours dated 30/3/2005 since the title of Article 18 of the Data Protection Law is “Misdemeanours,” and administrative fines are issued as per Article 18 of the Data Protection Law. Having this in mind, decisions imposing… »
Planned Amendments to the Data Protection Law
Processing Sensitive Personal Data Proposed amendments to the Data Protection Law, which have been drafted by the DPA and which introduce some modifications to certain disputed provisions of the Data Protection Law, have been presented for the related institutions and organisation’s consideration. Articles proposed to be amended are Article 6, regulating the legal grounds for processing sensitive personal data and Article 9, regulation transfer of personal data abroad. Under… »
Draft Guidelines on Cookies Applications
The DPA prepared draft guidelines (“Guidelines”) on January 11, 2022, explaining cookies and practical advice for data controllers who process personal data through cookies. The Guidelines was published on the official website of the DPA on January 11, 2022, to gather views on the same. Within the scope of the Guidelines, which is still at the draft stage, cookies in general and their types are regulated. It also categorises cookies based on their timeframe, intended purpose… »
Pharmaceutical Licensing Regulation Harmonized with EU Legislation
The new Regulation on Licensing of the Human Medicinal Products (“Regulation”) prepared by Turkish Medicines and Medical Devices Agency (“Agency”) has entered into force following its publication in the official Gazette numbered 31686 and dated December 11, 2021. The purpose of the Regulation is reflecting processes already existing in the Agency’s practice which were not regulated under the Regulation on Licensing of the Human Medicinal Products dated 2005 (“previous… »
Guidelines on Licensing Allergen Products Published
On 9 March 2022, the Turkish Medicines and Medical Devices Agency (Agency) published on its official website the Guidelines on Licensing of Allergen Products (Turkish language). The Guidelines were prepared in accordance with the Regulation on Licensing of Human Medicinal Products (Regulation) which was recently published (see Legal update, New Regulation on licensing of medicinal products for human use (Turkey)). The Regulation divided the abridged marketing authorisation… »
New Guidelines on Authorisation and Packaging of Homeopathic Medicinal Products
On 24 December 2021, the Regulation on Licensing of Homeopathic Medicinal Products (Regulation) was published in the Official Gazette. Pursuant to the Regulation, on 15 March 2022 the Medicines and Medical Devices Agency published the Guidelines on Licensing of Homeopathic Medicinal Products (Turkish language) and the Guidelines on Packaging and Product Information, Readability and Tracking of Homeopathic Medicinal Products (Turkish language). The Guidelines regulate the… »
A Fairer Way to Determine Royalties in Turkish Compulsory Licensing
Compulsory licensing, which is regulated by both Article 99 of the repealed Decree Law 551 and Article 129 et seq of the Industrial Property Law, which follows Article 31 of the Trade-Related Aspect of Intellectual Property (TRIPs), is a fairly recent institution in Turkey. However, covid-19 has given new urgency to the debate on this issue. Even though it has never actually been applied, compulsory licensing has been widely discussed, not only as a convenient tool to… »
How Should Turkish Private Sector Read the 2021 Corruption Index?
The term corruption is often defined as the abuse of entrusted power for private gain. Corruption does not only kill public trust, but also prevents countries from unleashing their potential. Many studies indicate the negative correlation between corruption and sustainable economic growth. Entrepreneurship, investment, and business expansion all depend on transparency and accountability and may only flourish in an environment where corruptive attempts are fought back… »
Amendments on the Communiqué Concerning the Mergers and Acquisitions Calling for the Authorization of the Competition Board
Merger and Acquisitions of 2021 Being 309 merger and acquisition notifications were notified to and reviewed by the Turkish Competition Authority (“TCA”) in 2021. TCA has granted authorization to 277 of them, conditional authorization to 3 of them, and has found that 29 of them are not subject to an authorization at all. It is seen that 37 of the merger and acquisition notifications examined in 2021, were related to the chemical and mining sectors, 32 of them were related to… »