For an extended period, the pharmaceutical industry needed a unique model of reimbursement where its conditions could be set together through negotiation with the SSI, and the regular price...

Named Patient Programs ("NPP") is one of the exceptional importation regimes of pharmaceuticals without marketing authorization in Turkey or with marketing authorization...

Pharmaceuticals that are not authorized in Türkiye or authorized but not available on the market shall be procured from abroad as per a special authorization and on a case by case basis (Named Patient Program-NPP).

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...

In the presence of alternative reimbursement models developed globally for pharmaceutical reimbursement systems, such as payback, value-based, indication-based reimbursements...

On 26 May 2023, significant changes were made to the Medical Device Promotion Regulation.

On 28 September 2022, the Turkish Medicines and Medical Devices Agency (Agency) published guidelines (Turkish language) on donation from abroad of human medicinal products...

On 4 January 2024, the Turkish Medicines and Medical Devices Agency ("Agency") announced on its official website that the Guidelines on Scientific Meetings and Educational...

Recent regulatory developments in Turkey's medical devices sector signal a fundamental shift toward enforcement-driven market discipline, with Law No. 7557 introducing expanded administrative sanctions targeting...

In Türkiye, a rapid rise in exchange rates and adverse economic developments have led to difficulties in sourcing certain life sciences products on the market...

NPPs operate as special import regimes that enable access to medicines that are either not authorised in Türkiye or are temporarily unavailable on the domestic market, upon the request of a treating physician.

As a consequence of the lawsuits filed against the provisions of the Alternative Reimbursement Regulation dated 10 February 2016, due to the regulation being published...

Discovery of evidence requests are specially regulated under Civil Procedural Law No. 6100. Discovery of evidence serves the purpose of determining a fact that has...

Since Turkey's inclusion as a member of the EPC, a hot topic has been the enforcement or invalidity of Turkish validation of European Patent(s)...

According to Article 9 of the Industrial Property Law No. 6769 ("IPL"), if a trademark is not used in five years as of its registration date or its use...

Gün + Partners will once again celebrate the World IP Day with a discussion on significant role of IP on SMEs' growth: the story of WeWalk.

The Guideline on Co-Marketing of Medicinal Products for Human Use ("Guideline") contains regulations on the evaluation of marketing authorization applications for co-marketed products...

In accordance with the Regulation on Licensing of Human Medicinal Products, the Guideline on the Working Procedures and Principles of the Priority Assessment Board for Human Medicinal Products ("Guideline")...

Reklam Kurulu, 2020 yılının son ayında Türk mutfağı ve Türk yemek kültürüne ilişkin hassasiyetini kanıtlar nitelikte bir karar ile bir konserve ton balığı ürününe dair reklamların durdurulmasına hükmetmiştir.

The Advertisement Board rendered a recent guiding decision implementing Article 7/2 of the Regulation on Commercial Advertisement and Unfair Commerce Practices ("Regulation") titled "Accuracy and Honesty" and...