Guidelines on Named Patient Programme Amended in 2021
The Turkish Medicines and Medical Devices Agency's guidelines on the Named Patient Programme (Turkish language) explains the procedure for the supply from abroad of drugs that are not authorised in Turkey or not available on the Turkish market. The guidelines were first published in 2014, amended in 2015, 2017 and 2020, and finally published in the most current version on 9 August 2021. The latest amendment made to the guidelines introduces the definition of generic products… »
Red Bull Triumphs in Opposition Before the Turkish Patent and Trademark Office
The Turkish Patent and Trademark Office has upheld Red Bull’s opposition against an application for a composite mark intended for energy drinks. Background The applicant, a food company established in 1996, sought to register the below trademark in Class 32 – particularly for energy drinks. (BLACK TALLBOSS mark) This application passed the initial examination and was published in the Official Trademark Bulletin of the Turkish Patent and Trademark Office, for possible… »
Medical Device Regulation Has Been Published
Medical Device Regulation (“Regulation”) has been published in the Official Gazette numbered 31499 on 2 June 2020. With the Regulation prepared in accordance with the EU Medical Device Regulation numbered 2017/745 (“MDR”), it is aimed to provide a safer use for manufacturers and medical device users with a transparent and sustainable system. In this context; new noteworthy provisions are the definition of a medical device, classification of products, distance sales… »
Significant Amendments to the Administrative Jurisdiction Procedure Law
The Law Amending the Criminal Procedure Code and Certain Other Laws No. 7331 (“Law No. 7331”) -known as the 4th Judicial Reform Package - which entered into force by publication in the Official Gazette dated July 14, 2021, significantly reduced the time limits foreseen in the Administrative Jurisdiction Procedure Law No. 2577 (“Law No. 2577”) in terms of the administrative authorities in the application procedures before filing of administrative actions. Accordingly: As per… »
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… »
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… »
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… »
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… »
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… »
Data Protection Officer Within the Scope of the Personal Data Protection Law and the GDPR
Data protection officer (“DPO”) is a concept regulated under the General Data Protection Regulation (“GDPR”), which came into force in May 2018 in the European Union. The purpose of regulation of the DPO is to appoint a person who will be responsible for monitoring compliance of data controllers with data protection legislation. The GDPR imposes an obligation to appoint a data protection officer on data controllers who meet a number of criteria as well as regulates the duties… »
Does Technical Function Impede Copyright ?
Background The dispute is based on the claim that appearance features of Brompton Bicycles, which have been produced and sold in the same form since 1987 by the Designer SI and Brompton Bicycle Limited Company and can be adjusted to three different positions (folded, unfolded and stand-by) are copied in the production of ‘Chedech Bicycles’ by Get2Get, thus infringing the copyright in the Brompton Bicycle. The dispute commenced at the local level before the Belgian Court… »
Influencer Marketing Practices in Turkey
“The Guideline on Commercial Advertisement and Unfair Commercial Practices Conducted by Social Media Influencers” (“Guideline”), which was adopted by Advertisement Board (“Board”) as per its decision numbered 2021/2 and dated 4 May 2021, is preliminary and substantial legislation regarding social media influencer’s advertising activities. Nevertheless, the Board imposed several sanctions on the social media influencers prior to the Guideline on the grounds of the dispositions… »