SSI Publishes Amendment to the Alternative Reimbursement Regulation Upon Annulment of the State Council
In the cancellation action filed by the Turkish Pharmacist Union against some of the provisions of the Alternative Reimbursement Regulation (“Regulation”), the 10th Chamber of the Council of State decided to annul the attacked provisions of the Regulation on the ground that the Regulation was issued by the Social Security Institute (“SSI”) without obtaining prior opinion of the Ministry of Health. Upon the service of the court decision to SSI, due to the requirement to comply… »
Regulation on Pharmaceutical Warehouses and Products Available in Pharmaceutical Warehouses Published
On 15 June 2022, the Regulation on Pharmaceutical Warehouses and Products Available in Pharmaceutical Warehouses (Turkish language) (Regulation) was published in the Official Gazette numbered 31867. The Regulation abrogated the prior regulation dated 20 October 1999 and is now in line with Directive 2001/83/EC on medicinal products for human use. Pharmaceutical warehouses are defined as establishments where one or all of the activities of procurement, storage, sale… »
Medical Devices: Draft Communiqué on Instructions For Use in Electronic Form Published
On 30 May 2022, the Turkish Medicines and Medical Devices Agency (Agency) published an announcement (Turkish language) on its official website, stating that a draft Communiqué on the Instructions for Use in Electronic Form for Medical Devices (Draft) has been prepared and asked stakeholders to provide feedback on the Draft. As part of Turkey's alignment process with EU law, the Draft has been prepared in accordance with Commission Implementing Regulation (EU) 2021/2226 laying… »
New Regulation on Medical Device Clinical Trials Published
On 8 July 2022, the Regulation on Medical Device Clinical Trials (Turkish language) (Regulation) was published in the Official Gazette numbered 31890, repealing the former regulation dated 6 September 2014. The Regulation, which came into force on its day of publication, introduces amendments to ensure clinical trials comply with the Turkish Medical Device Regulation. The Regulation sets rules in connection with the functionality date of the European Database on Medical… »
Decision on Pricing of Medicinal Products For Human Use Amended
On 8 July 2022, the Decision Amending the Decision on Pricing of Medicinal Products for Human Use (Turkish language) was published on the Official Gazette numbered 31890. The Decision on Pricing of Medicinal Products for Human Use (Decision) is the legislation which set the rules on pricing of the human medicinal products. The amendments to the Decision include: An increase in pharmacist profit rates to be applied when determining the retail sale price of the products. A new… »
Regulation on Clinical Trials of Medicines and Biological Products Amended
On 6 July 2022, amendments (Turkish language) made by the Turkish Medicines and Medical Devices Agency to the Regulation on Clinical Trials of Medicines and Biological Products were published in the Official Gazette numbered 31888. The amendments: Introduce new provisions regarding the clinical trial application procedure, exceptional trials and the Agency's authority to obtain scientific opinion from a scientific consultancy committee while evaluating clinical trial… »
Patent and Trademark Office Implements Service by Publication Procedure
There previously used to be delays in the notifi cation of documents to applicants due to their failure to inform the offi ce ofaddress changes A provision was added to the IP Code in order to fi nd a solution to the issue of serving documents to rights holders All documents that could not be served due to an address change have now started to be served via publication through an Official Bulletin In the past, there used to be delays in the notifi cation of documents to… »
Artificial Intelligence and Blockchain Technologies and Their Impacts on Brand Protection
In recent years, developments in digitalization have started to make crucial impacts on many fields, including intellectual property, from creation to monetization and enforcement levels. Brand owners and brand protection professionals are heeding updates in artificial intelligence (AI) and blockchain-based technologies such as smart contracts, metaverses and non-fungible tokens (NFTs), with total market trading volume of approximately $12.13 billion only for the first… »
Validity of Release in Settlements Made Before Mediators
Release agreements that concern employee receivables from employers are subject to certain formal requirements under article 420 of the Code of Obligation No. 6098 (TCO). In this regard, the following conditions must be met: release agreements that concern employee receivables from employers must be executed in writing; at the date of release, at least one month must pass from the date of the termination of employment; the type and amount of the receivable subject to release… »
New Rules on Advertisements with Price Information and Advertisements for Discount Sales
Regulation on Commercial Advertising and Unfair Commercial Practices (“Regulation”) was amended in a way to include new measures and rules to regulate advertisements containing misleading price information and to protect consumers against unfair commercial practices. The amendments were enacted on February 1, 2022 and entered into force on March 1, 2022. According to new rules enacted in the Regulation; additional measures were implemented to protect consumers against… »
How to use Right to Seek New Employment During Notice Period
Introduction Indefinite-term employment agreements can be terminated by complying with notice periods, unless either party has a just cause for termination. Article 27 of the Labour Law regulates the right for employees to seek new employment during their notice periods: Within the notice periods, the employer is obliged to grant the employee the leave to seek new employment within the work hours and without making any salary deduction. Time of the leave to seek new… »
Effective Date of Additional Obligations on Consumer Protection Approaches
The Law No. 7392, published in the Official Gazette numbered 31796 on April 1, 2022, has introduced significant changes to many issues regulated under the Consumer Protection Law (the “Law”). The provisions of the new law that relate to timeshare and long-term vacation agreements entered into force on April 1, 2022, before the summer season. However, most of the changes, including those below, will come into effect on October 1, 2022. As the changes are substantial, we… »