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…
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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…
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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…
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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…
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Compulsory licensing, which is regulated by both Article 99 of the repealed Decree Law 551 and Article 129 et seq of the Industrial Property Law, which follows Article 31 of the Trade-Related Aspect of Intellectual Property (TRIPs), is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…
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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…
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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…
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Standard essential patent (SEP) appears to be the new buzzword of patent law considering the upward trend in patent litigation arising from SEPs. Indeed, the continuous technological advancement supports the creation of SEPs so this trend is likely to continue in the near future.
Accordingly, SEPs is a concept arising from the interaction between patent rights, which provide exclusive use of an invention and ‘standards’ aimed at the widespread and mandatory use of this…
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Pharmaceutical prices in Turkey have always been one of the most controversial issues. The prices of medicines that are to be marketed are set in accordance with the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of 29 September 2017, issued by the Ministry of Health (“MoH”), which is vested with the competencies to regulate this area.
The Decision provides for a reference pricing…
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Introduction and Developments
With the Presidential Circular on Information and Communication Security Measures which came into force once published on July 6, 2019 (the "Circular"), it was aimed to mitigate and neutralize serious security risks encountered in the digitalization process and ensure the security of critical data for public institutions and organizations and enterprises providing critical infrastructure services.
The Information and Communication Security Guide…
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The New Regulation on Licensing of Human Medicinal Products (the “Regulation”) prepared by the TITCK entered into force upon its publication in the Official Gazette numbered 31686 and dated December 11 2021. It has been seen that the purpose aimed with the Regulation is reflecting up-to-date processes present in the TITCK practice but did not exist in the previous regulation dated 2005 and providing compatibility of the legislation with the EU directive numbered…
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It is not a secret that Turkey has an important geographical location for production and sales of counterfeit products as well as the ones in transit. Most of the smuggled products entering Turkey also turn out to be counterfeits. This requires brand owners to take an active role in Turkey to combat the counterfeits, cover all possible basis, and also seek alternative and creative approaches.
There are certain civil and criminal actions that can be taken while combatting…
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