With the bill known as ‘law against disinformation’, there are several provisions specifically related to the Law on the Regulation of Internet Broadcasts and Prevention of Crimes Committed through Such Broadcasts (“Law No. 5651”) and the Press Law. The amendment proposals related to the Law No. 5651 and the Press Law have been on the agenda for a while of the publication of the bill.
In addition to these issues discussed widely, with the bill, ‘over the top’ (OTT) services…
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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…
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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…
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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…
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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…
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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…
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