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 Sale, Advertisement, and Promotion of Medical Devices (“Medical Device Promotion Regulation”), the legislation containing detailed provisions on the sales, advertising, and promotion activities of companies, was significantly amended on May 26, 2023, and introduced number of new procedures to the medical device sector. These procedures, which are not essentially considered as promotional activities, are governed by the Medical Device Promotion Regulation…
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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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The export of products manufactured and imported for the Turkish market, may restrict patients' access to treatment after their launch. In addition, pharmaceutical prices in Türkiye are much cheaper compared to many other countries, and this has an impact on prices in other markets. The Circular No. 2014/11 on the Availability of Medicines in the Market issued by the Agency stated that necessary measures will be taken to prevent problems in pharmaceutical supply that may…
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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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