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The year 2024 marks a challenging period for the Turkish healthcare industry.

On 24 October 2024, the Presidency of the Republic of Türkiye amended the Decree on Pricing of Pharmaceuticals ("Decree"). The amendments introduced by the Decree entered into force on 25 October 2024.

Additionally, in the waived proceedings, the proxy fee and litigation expenses will be decided to be paid by both parties.

Biological Medicinal Products are characterized as products that their active ingredient or ingredients are produced from a biological source or products that are homogenized from a biological source.

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

The Social Security Institution's ("SSI") Regulation on Drug Reimbursement ("Regulation") was published in the Official Gazette no. 31934, dated 25.08.2022.

Human medicinal products are launched to market and made available for public use after going through a set of critical clinical trials ...

On June 7, 2022, the Turkish Medicines and Medical Devices Agency ("Agency") published the Draft Guidelines on Packaging Information and Legibility of Foods for Special Medical Purposes...

As stated in our previous article, Turkey introduced new plain packaging rules for tobacco with the Regulation on Methods and Procedures for Manufacturing, Labelling and Control of Tobacco Products ...

Bu yılki raporumuzda, Türkiye'de ilaç, tıbbi cihaz ve sağlık hukukunda en tartışılan ve önemli görüğümüz konuları ana hatlarıyla ele alıyoruz.

The determination of evidence, one of the most important temporary legal protection measures regulated in Turkish law, is an institution that ensures the protection of evidence which will...

The trigger point and the timing of a request for a precautionary injunction (PI) is crucial. However, in pharmaceutical patent enforcement, most damage occurs from the launch of the Gx product...

The supply of pharmaceutical products to Turkey via the named patient programme (the "NPP") is one of the exceptional importation regimes for pharmaceutical products.

Determination of evidence, which is one of the most important temporary legal protection measures regulated in our law, is an institution that ensures the protection of evidence that will assist the proving of the matter.

Regulations other than those whose effective date is specified below will enter into force on 1 January 2024.

Turkey has introduced a new Food Codex Communiqué that fundamentally restructures how food lot identification markings must be determined and displayed on product labels. The regulation shifts responsibility for lot number determination directly to food producers, expands record-keeping obligations, and establishes new compliance requirements that all food business operators must meet by the end of 2026.

A decision last year from the highest body within the Turkish Court of Appeal system held that the addition of a house mark does not mitigate likelihood of confusion.