The transfer of pharmaceutical marketing authorizations (“MA”) entails intricate and interconnected procedures. Especially when it comes to imported pharmaceuticals, comprehensive contracts control the process when the foreign licensor company gives a license to a distributor in Türkiye and the products are offered for sale in the Turkish market. Before the MA transfer application is submitted to the Turkish Medicines and Medical Devices Agency (“Agency”), the license…
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Turkish Constitutional Court (“Court”) annulled the paragraph 12 of Article 77 of the Consumer Protection Law, which granted the Advertisement Board (“Board”) the power to partially or entirely block access to websites containing unlawful advertising content. The relevant rule was considered to be unconstitutional pursuant to the Court’s decision dated 13 September 2023 and numbered 2022/70 E. - 2023/152 K. which was published on the Official Gazette dated 27 October 2023 and…
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With the regulations published in the Official Gazette numbered 32169 and dated April 20, 2023, comprehensive amendments were made to the legislation on the use of health claims for food and food supplements and the use of nutrition claims. Thus, the Turkish Food Codex Regulation on Nutrition Claims under the authority of the Ministry of Agriculture and Forestry and the Regulation on Health Claims for Food and Food Supplements under the authority of the Agency, has entered…
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The Agency first announced on its official website on 4 January 2024, that the Guidelines on Scientific Meetings and Educational Activities to be Conducted within the Scope of the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Guidelines”) was amended, and that the most significant change introduced by the amendment to the Guideline is the collection of fees by the Agency for scientific meetings and applications for educational activities. According…
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The Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”), dated July 3, 2015, regulates the promotional activities of medicinal products for human use.
Under the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the Internet, is prohibited. Pharmaceutical products may be promoted only to physicians…
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Named Patient Programs (“NPP”) is one of the exceptional pharmaceutical importation regimes for products that are not authorized or authorized but unavailable in the Turkish market for various reasons.
In cases where a product does not have marketing authorization in Türkiye or has marketing authorization but cannot be found on the market, and patients need the product in question, it is possible to procure the pharmaceutical via this method upon the request of a physician.…
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Due to the rapid increase in the current exchange rates, pharmaceutical prices have been one of the most controversial issues in Türkiye in 2023. The price of medicines for sale are set under the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of September 29, 2017, issued by the Ministry, which is vested with the competencies to regulate this area.
The Decision provides a reference…
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In disputes arising from the termination of the employment agreement by the employer, although the issue of whether the employment agreement is terminated with just cause or valid reason does not have an impact in terms of the evaluation of the reinstatement request, it is crucial in terms of requesting employment claims.
Yet, when the employment agreement is terminated with a valid reason or just cause, the reinstatement request shall be rejected in both cases, whereas the…
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In a case involving a registrant whose domain name was transferred to a complainant by a WIPO panel at the end of UDRPproceedings, the Turkish Court of Cassation has clarified that it is not possible to request “cancellation” of WIPO panel decisionsrendered pursuant to the UDRP.
Background
The plaintiff (registrant in the UDRP proceedings) registered the gTLD ‘donerstop.com’ on 6 June 2014. The defendant (complainantin the UDRP proceedings) applied to register the trademark…
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The 11th Civil Chamber of the Court of Cassation (CoC) has ruled that there is a likelihood of confusion between the trademarks N11 and OTEL 11 (15 February 2024, 2023/3633 E (Merits), 2024/1117 K).
Background
The applicant filed a trademark application for OTEL 11 in Class 43.
The opponent, one of the largest online shopping websites in Türkiye, requested refusal of the application on the following basis:
OTEL 11 created a likelihood of confusion with its earlier…
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On June 11, 2024, the Turkish Medicines and Medical Devices Agency (“Agency”) announced on its official website that the “Guideline on the Packaging Information and Instructions for Use of Medicinal Products for Human Use”, “Guideline on the Readability of the Packaging Information and Instructions for Use of Medicinal Products for Human Use” and “Guideline on Excipients in the Packaging Information and Instructions for Use of Medicinal Products for Human Use” have all been…
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The Regulation on Procedures and Principles Regarding the Cross-border Transfer of Personal Data (the “Regulation”) is published in the Official Gazette on 10 July 2024. Additionally, the Personal Data Protection Board (the “Board”) announced the standard contract texts, binding corporate rules application forms and supplementary guidelines about essential issues required to be covered by binding corporate rules.
Except for cross-border transfers that are irregular, occur on…
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