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Guideline on Circumstances Requiring Reissue of a Marketing Authorization For a Licensed Pharmaceutical

Updates -

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… »

Advertisement Board is Again Able to Block Access

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… »

Application Fee for Scientific Meetings of Pharmaceuticals and Medical Devices Has Been Introduced

Updates -

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… »

Interactions with HCPs, Transfer of Values and Payments

Updates -

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… »

Named Patient Program

Updates -

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.… »

The Current Approach Regarding the Determination of the Termination Type in Reinstatement Actions

Updates -

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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