Patient Support Program
Through Circular numbered 2016/4 published by the Turkish Medicines and Medical Device Agency (“TITCK”) an obligation for marketing authorization holders to apply to TITCK and obtain permission for training and support programs for patients / healthcare professionals for the purpose of the rational use of drugs was regulated. With the program, the marketing authorization holder signs a contract with an organization that has been licensed within the framework of the… »
Localization of Imported Products
Following the announcement of the Structural Transformation Program Action Plan for Healthcare Industries on 7 November 2014, Turkey commenced adopting measures to localize the production of a substantial number of pharmaceutical products sold in Turkey. On 10 December 2015, the 64th Government announced the 2016 Action Plan (64th Government Action Plan), which included a statement that measures would be taken to prioritize domestically produced medical supplies and medical… »
New Guidelines Published For Promoting Medical Devices
On 12 February 2021, the Turkish Medicines and Medical Devices Agency published new guidelines (Turkish language) for the implementation of regulation on sales, advertising and promotion of medical devices. The new guidelines introduce detailed provisions on implementing some of the significant amendments that were made to the Regulation on Sales, Advertising and Promotion of Medical Devices on 2 September 2020. Under the guidelines, in addition to advertising and promotional… »
Developments on Signature Specimen and Signature Circular
Amendments Related to Signature Specimen The Amending Law Related to the Technology Development Zones and Certain Other Laws (the "Law No. 7263") was published in the Official Gazette on February 3, 2021 and entered into force on the same date. Article 22 of the Law No. 7263 amended Article 40 of the Turkish Commercial Code with respect to issue of signature specimen. In this regard, the amendment provides that signature samples of real person merchants and authorized… »
Arbitration Proceedings Regarding Determination of Reasonable Amount for Employee’s Invention
In 2020, an arbitration judgment was held in accordance with the ISTAC serial arbitration procedure regarding the compensation request for employee invention and, as far as it is known, this is the first and pilot file in which the Regulation on Employee Inventions, Inventions in Higher Education Institutions and Public Funded Projects, will determine the price tariff for employees’ inventions and the arbitration procedure to be followed in case of dispute. Within the scope… »
Declaration of Use and Compulsory License
The new IP Law (the “Law”) numbered 6769 abolished the provisions on “The use requirement of patents,” and “The evidence of use” of the Decree Law Pertaining to the Protection of Patent Rights. The Law now focuses on the requirements of use for patents within the provision of a Compulsory License. Accordingly, a patent owner must make use of the patented invention within three years following publication of its granted decision in the Official Bulletin (‘the Bulletin’), or… »