On 5 January 2022, the Turkish Medicines and Medical Devices Agency (Agency) announced on its website that a guideline on drugs that are counterfeit, smuggled or out of the legitimate supply chain has been published. The guideline aims to define the responsibilities of stakeholders in combatting drugs that are counterfeit, smuggled or out of the legitimate supply chain and to guide the procedures to be carried out accordingly. Notably, the guideline:
States that regulated…
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• The long-awaited TRABIS System, which replaces the Nic TR system, will become effective in the near future• The most important change is that extensions such as ‘com.tr’, ‘org.tr’, ‘net.tr’ will be allocated on a ‘first come, first-served’ basis• A new dispute resolution mechanism is due to come into effect
Since 1998 Nic TR, under the Middle East Technical University, has been authorised by ICANN to register and manage ‘.tr’ domain names. Recently, it has been announced…
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Transparency International, a non-governmental organization combatting corruption worldwide, released the 2022 Corruption Perceptions Index (“CPI”) on January 25, 2021. As a composite indicator, the Index combines various sources to measure the perceptions of businesspeople and country experts, on corruption in the public sector. Accordingly, it ranks 180 countries/territories by their perceived level of public sector corruption on a scale from 0 (highly corrupt) to 100 (very…
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The trigger point and the timing of a request for a precautionary injunction (PI) is crucial. However, in pharmaceutical patent enforcement, most damage occurs from the launch of the Gx product, which can account for a price cut of as much as 40% from the originator’s drug. Therefore, the PI must be filed and granted before the Gx launches, yet while there is sufficient proof available to overcome the so-called Bolar exemption hurdle. The PI filing date serves this aim…
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The Turkish named patient programme (NPP) is an exceptional importation regime for pharmaceutical products. Following a 5 December 2018 amendment to Law No 984 on Commercial Pharmaceutical Warehouses and Shops that Sell Poisonous Chemical Substances Used in Arts and Agriculture (Law on Warehouses), it is mandatory to apply for marketing authorisation within three years of a drug's inclusion on the NPP list. It is also mandatory to obtain marketing authorisation within two…
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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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