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 ...»
Is your country party to any bilateral or multilateral treaties for the reciprocal recognition and enforcement of foreign judgments? What is the country’s approach to entering into these treaties, and what, if any, amendments or reservations has your country made to such treaties?
Except for multilateral treaties on family law, Turkey is not a signatory to multilateral treaties for the reciprocal recognition and enforcement of foreign judgments. However, Turkey is a ...»
The Turkish Patent and Trademark Office has upheld Red Bull’s opposition against an application for a composite mark intended for energy drinks.
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 third-p...»
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, manufactu...»
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 ...»
1 Must an award take any particular form (e.g., being in writing, signed and dated, place of issuance, requirement to provide reasons, and delivery)?
Article 14(A) of the Turkish International Arbitration Law (TIAL) provides that an award must include:
the names, surnames, titles and addresses of the parties, their representatives and lawyers;
the legal grounds upon which the award is based, and, if there is a claim for compensation, the amount of compensation;
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 certif...»
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 survei...»
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 authori...»
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 increas...»
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 relati...»
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...»