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New Guidelines for Off-label Use of Drugs Published

Dicle Doğan and Fatma Sevde Tan, Gun + Partners On 8 February 2019, the Turkish Medicines and Medical Devices Agency published new Guidelines for the Off-Label Use of Drugs (Turkish language) and abrogated the previous version of the Guidelines, dated 18 July 2014. The new Guidelines entered into force upon publication. The Guidelines reference a new system for applications for the off-label use of drugs. The system is named as the “System on Administration of Unauthorized… »

New 2019 Euro FX Rate for Drug Prices for 2019

Özge Atılgan Karakulak and Fatma Sevde Tan, Gun + Partners The Euro exchange rate used for approval of medicine prices in Turkey is determined as per the Decision on Pricing of Human Medicinal Products. The Decision which was published in the Official Gazette numbered 29989, dated 24 February 2017, set the Euro exchange rate as 70% of the average Euro value of the previous year. However, on 14 February 2019, an amendment (Turkish language) was published in the Official… »

Changes to Minimum Wage, Severance Payments and Administrative Fines in 2019

Minimum wage, severance payments and administrative fines prescribed by the Labour Act are revised at the beginning of each calendar year. Minimum wage The minimum wage rate for 2018 was TL2,029.50 (gross) per month. As of 1 January 2019, this has increased to TL2,558.40 (gross) per month. The new rate applies from 1 January 2019 to 31 December 2019. Minimum wage applies to all employees, regardless of age, industry and experience. The only exceptions are the coal and lignite… »

Is a Public Interest Compulsory Licence on the Way?

Compulsory licensing (CL) has been one of the most important concepts in the new Turkish IP Law which entered into force in 2017. Although the concept is not new, the new Article 129, among others, provides the following possible conditions for granting a CL: (i) failure to work or insufficient working that does not meet the national market needs before the expiration of a period of four years from the date of filing of the patent application or three years from the date of… »

Corruption Perceptions Index 2018 Has Been Released

Introduction Transparency International announced the results of the 2018 Corruption Perceptions Index (the “2018 Index”) on January 29, 2019. As known, this study has been carried out and published by Transparency International since 1995, and reflects the public sector corruption perspective of experts, non-governmental organisations and representatives of the business world on a scale from 0 (highly corrupt) to 100 (very clean). When compared to the 2017 results, Turkey… »

Minister of Health Announces That Prices of Medicines Will Be Raised by 26,4% from 19 February 2019

The Euro exchange rate used for approval of medicine prices in Turkey is determined as per the Decision on Pricing of Human Medicinal Products (“Decision”). The Euro exchange rate which has long been fixed to TRY 1.9595 and not updated according to the current rate was determined as 70% of the average Euro value of the previous year by the new Decision which was published on 24 February 2017. Accordingly, the Price Evaluation Commission would gather within the first 45 days… »

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