The Turkish Medicines and Medical Devices Agency has published a new regulation on Licensing of Medicinal Products for Human Use in the Official Gazette (Turkish language) numbered 31686 of 11 December 2021. This Regulation introduces new provisions that amount to a comprehensive amendment of the abolished Regulation of the same name. The noteworthy new provisions of the Regulation are as follows:
In the definitions section of the Regulation, some of the concepts are defined…
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The Turkish data protection authority, Kişisel Verileri Koruma Kurumu, has proposed amendments to the most controversial provisions of the Law on Personal Data Protection numbered 6698. The provisions have been heavily criticized by academia and business circles due to their inapplicability and inadequacy to meet needs. The amendments were actually part of the Economic Reforms, and specific tasks were introduced under the Economic Reforms to comply with the EU General Data…
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The Turkish Medicines and Medical Devices Agency ("Agency") published the new Guidelines for Drug Supply and Use from Abroad ("Guidelines") on 23 October 2021.
The Guidelines regulate the procedure of drug supply from abroad for drugs that are not authorized in Turkey or authorized but not available in the market for various reasons. The Guidelines were first published in 2014, updated in 2015, 2017, and 2020 and finally, the final version was published on 23 October…
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As a result of the cooperation between the Turkish Patent and Trademark Office (TURKPATENT) and WIPO,Turkey has taken its place among thecountries that enable applicants to file their international trademark applications directly through the Madrid e-Filing service.
Before this change, the MM2 form - the application form for the registration of international trademark applications - had to be filled in manually and submitted to TURKPATENT via the EPATS - TURKPATENT’s…
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Background
The amendments made in Notification Law 7201 in 2019 expanded the scope of persons notified by e-notifications to include:
public institutions and organisations;
lawyers;
notaries;
experts; and
mediators.
Following this development, the Regulation on Notification via Electronic Means came into force in 2019.
Both the Notification Law and the Regulation on Notification via Electronic Means provide that "the electronic notifications are deemed to have been served…
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Pharmaceutical products that are not licenced in Turkey and/or licenced but not have been made available to the market can be supplied by Turkish Pharmacists’ Association, Social Security Agency (SSA) and institutions and organizations that are deemed suitable for foreign drug supply by the Turkish Medicines and Medical Devices Agency (“Agency”) (“Foreign Drug Suppliers”) as per to the provisions of the Guideline on Drug Supply and Use from Abroad (“Guideline”).
Pursuant to…
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