Insights
New Regulation on Licensing of Medicinal Products For Human Use
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… »
Removal of Products From Named Patient Programme List
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… »
Istanbul IP Court Reaches Landmark Decision on Precautionary Injunction
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… »
Remarks On 2021 Corruption Perceptions Index
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… »
Changes to the Enforcement and Bankruptcy Law under the 5th Judicial Reform Package
The Law Amending the Enforcement and Bankruptcy Law and Certain Other Laws No. 7343 (“Amendment Law”), known as the 5th Judicial Reform Package, which entered into force upon publication in the Official Gazette (31675) dated November 30th, 2021, introduced several important changes to the Enforcement and Bankruptcy Law No. 2004 (“Law No. 2004”), as well as Turkish Civil Law No. 4721 and Child Protection Law No. 5395. Several new arrangements particularly stand out, such as i)… »
Guideline on Named Patient Programme Updated
On 23 October 2021, the Turkish Medicines and Medical Devices Agency (the Agency) published its amended guideline on the named patient programme (Turkish language) (guideline). The most important amendments concern the bodies authorised to supply foreign drugs and the countries from which products can be supplied. The range of bodies authorised to supply foreign drugs has been broadened, and now in addition to the International Health Services (USHAŞ), Turkish Pharmacist… »
Draft Telemedicine Regulation Published
The Ministry of Health (MoH) published a draft Regulation on providing remote healthcare services (draft Regulation) and shared it with the stakeholders via the Turkish Industrialists' and Businessmen's Association for feedback. The draft Regulation is not currently publicly available. The draft Regulation aims to address the legal gap on telemedicine which has become a more pressing concern due to the COVID-19 pandemic. The most important provisions of the draft Regulation… »
Advertisement Board and Hygienic Products Ads
The advertisements and promotions pertaining to hygiene and health care products have increased in number in parallel with the necessities arising due to the COVID-19 pandemic. The advertisement types subject to special regulations of relevant legislation, including testimonial and comparative advertising practices, have been exercised. The diversity in the advertisements and promotions has been reflected in the decisions of the Advertisement Board and the fundamental notions… »
Permanent Injunction on the Infringing Pharmaceutical Products on the NPP List
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… »
An Overview of Vaccination and PCR Testing Policies at Workplaces
With wide-scale use of COVID-19 vaccines all around the world, vaccination and PCR testing policies at workplaces have become a hot topic both for employers and employees. Although there has not been any legislative activity yet, the Ministry of Labor and Social Security issued a general letter to guide the workplaces about the possible vaccination and PCR testing policies to be adopted, which has left questions whether employers could require mandatory vaccination or regular… »
District Court in Turkey Rules on Preliminary Injunction Assessments
Objectively, preliminary injunction decisions play a key role for the IP right holder particularly for patent holders to be dealt by Intellectual and Industrial Property Rights (IP courts) in an urgent matter due to the super technicality nature of such cases, commercial reasons, time pressure, etc. The preliminary injunction, which appears as a way out in cases where the definitive protection is not sufficient and a temporary legal protection is needed, can be requested… »
Directors & Officers Liability Insurance Gains More Importance Day by Day
Equity companies have enabled large investments and projects yet also caused company executives and managers to take great responsibilities and to be liable against the company, shareholders, and creditors for any losses incurred due to their faulty or negligent actions that may arise during the company management. Such responsibility leads to serious losses as a result of both board members and managers’ faulty or negligent actions and therefore makes them hesitate to manage… »