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… »