Insights
Consultation on Draft Licensing Regulation on Homeopathic Medicinal Products
On 9 September 2021, the Medicines and Medical Devices Agency published the draft Licensing Regulation on Homeopathic Medicinal Products (Turkish language) (Draft Regulation). The purpose of this regulation is to regulate the procedures and principles to be applied in licensing, packaging and distributing homeopathic medicinal products, which have protective, supportive or curative effects on human health, to ensure their effectiveness, safety and quality. The Draft… »
Guideline on Biosimilar Medicinal Products Has Been Updated
Biological Medicinal Products are characterized as products that their active ingredient or ingredients are produced from a biological source or products that are homogenized from a biological source. Biosimilar Medicinal Products, however, are human medicinal products that demonstrate high level of similarity to a licensed biological reference medicinal product and their licencing procedures are executed by the Regulation on Licencing of Human Medicinal Products (the… »
Higher Board Decides in Favour of UGG Based on Well-known Trademark Status and Principle of Interdependence
The Re-examination and Evaluation Board (the Higher Board) of the Turkish Patent and Trademark Office has issued its decision in a case involving the marks UGG and UGG WATCH, applying the principle of interdependence and considering the well-known status of the UGG mark as a criterion for the likelihood of confusion analysis. Background The trademark application for UGG WATCH was filed for “jewellery (including imitation jewellery); gold, jewellery, precious stones and… »
Declaration of Ultimate Beneficial Ownership in Turkey
In order to prevent tax evasion and ensure financial transparency, the Turkish Revenue Administration under the Ministry of Treasury and Finance issued General Communiqué No. 529 on Tax Procedure Law (the “Communiqué”) imposing an obligation to make ultimate beneficial ownership declaration on a wide range of entities, notably, corporate taxpayers. The Communiqué was published in the Official Gazette on July 13, 2021, and entered into force the same day. The deadline for… »
Should the Lawyer Follow the Judge’s Misdirection?
Judges represent the state while exercising their judicial power on behalf of the nation. In this respect, it is the principle that the judge, who is expected to be independent first to the state and then to the parties, should be bound only by the rules of law. A thinker has said in this direction, “Judges are both masters and slaves of the law”. A lawyer, on the other hand, is self-employed, but also serves in the public sector as he/she participates in the distribution of… »
Processing of Personal Data Related to COVID-19 Test Results and Vaccination-Infection Status of Employees
During the Covid-19 pandemic, when many companies provide opportunities to their employees to work remotely, hybrid working models are also being considered recently. For many purposes related to occupational health and safety, reduction of infection risks at workplaces and determination of new working conditions, the employers need to collect personal data of their employees such as their PCR/antibodies test results and information about whether they are vaccinated and had… »
Comparing the Role of the DPO Under the GDPR and Turkish law
Appointment of a data privacy officer is regulated in detail under the EU General Data Protection Regulation. Mandatory DPO appointment is imposed under certain circumstances, and legal requirements are determined for the DPO role in terms of qualification as well as authorization. Under the Law on Protection of Personal Data numbered 6698 in Turkey, there is no legal requirement to appoint a DPO for data controllers, but there is a role introduced for the purposes of… »
Remote Working in the New Normal After COVID-19
Global COVID-19 pandemic, which has been going on for over a year now, had inevitable impacts on the business life. During the pandemic, various measures have been taken into place at workplaces to fight this outbreak. Remote working was one of the most prominent measures of all. It is beyond question that remote working model will maintain its significance at workplaces even after the pandemic. As per the Turkish Labour Act (the “TLA”), remote working is an employment… »
Commitments on The Transfer of Data Abroad
In lieu of a comprehensive list of countries that personal data can be transferred to freely, the procedure for data transfers outside of Turkey is more complicated than most. Begüm Okumuş and Selin Başaran Savuran, Managing Associate and Senior Associate respectively at Gün + Partners, explore this process and how it is likely to evolve in the future. In an increasingly digitalised and globalised world, the need for transferring personal data abroad is inevitable and… »
New Medical Device Regulation Published
Under the Regulation, the processes for placing a medical device on the market, putting it into service and distance selling are now explicitly regulated. Devices that are in conformity with the relevant harmonised standards shall be presumed to be in conformity with the requirements of the Regulation. Where the manufacturer of a device is not established in an EU member state or Turkey, the device may only be placed on the market if the manufacturer designates a sole… »
In Vitro Medical Device Regulation Published
The Regulation aims to protect the health and safety of patients and users of medical devices, supply high quality medical devices, support innovation, and create a transparent, robust and sustainable medical device market. The Regulation includes new rules regarding: · Device classification. · Stricter oversight of manufacturers by notified bodies. · The responsible person. · Unique Device Identifier marking for devices. · EUDAMED registration. · Increased post-market… »
Transition Process for Product Tracking System
The announcement clarifies the status of certified documents, product registration and movement requirements relating to medical devices in the context of the transition to the Regulation. The announcement states due dates for the certified documents and new product registrations that take into consideration the Product Tracking System registrations. The announcement also sets out rules for the status of: · Products certified by British notified bodies. · Products with… »