The Turkish government has increased the euro exchange rate used to price medicinal products by 30.5%. The new exchange rate is TRY14.0387, up from TRY10.7577. The increase is effective from July 24, 2023.

The Presidential Decree 6932, issued on July 23, 2023, amends the Decision on Pricing of Medicinal Products for Human Use. Euro value in Turkish Lira for pricing increased by 30.5% to 14.0387 TRY in July 2023. Offsetting process won't apply during this change. Price thresholds are set at 48.41 TRY for price-protected products and 25.30 TRY for others. Previous increases up to 4 TRY aren't considered. The regulation, effective immediately, addresses the rapid exchange rate increase and ensures pharmaceutical availability.

Beşerî Tıbbi Ürünlerin Fiyatlandırılmasına Dair Karar’da (“Karar”) Değişiklik Yapılması Hakkında 6932 sayılı Cumhurbaşkanı Kararı 23 Temmuz 2023 tarihli 32257 sayılı Resmi Gazete’de yayınlanmıştır. Karara eklenen geçici maddeler ile, Beşerî tıbbi ürünlerin fiyatlandırılmasında kullanılacak Türk lirası cinsinden 1 avro değerinin 2023 yılı temmuz ayında %30,5 oranında arttırılarak 14,0387 TL olması belirlenmiş, bu artış uygulanırken Karar’ın 3/3 maddesindeki mahsuplaşma işleminin uygulanmayacağı belirtilmiş,Kurdaki değişime paralel olarak Karar’da geçen fiyat baremleri güncellenerek, bu tutarlar fiyat korumalı ürünler için 48,41 TL, diğer ürünlerde 25,30 TL olarak belirlenmiştir. Dönemsel avro değeri güncellemesinde Karar’ın Geçici 7. maddesi kapsamında uygulanan 4 TL’ye kadar olan artışların dikkate alınmayacağı, güncelleme sonrasında 4 TL’ye kadar olan artışlar, TL değerinde değişiklik yapılmadan, ürünlerin depocuya satış fiyatları üzerine ekleneceği belirtilmiştir.Yeni düzenleme yayımı takip eden gün yürürlüğe girmiştir.

The Guidelines regulate the procedures to be implemented to prevent unsafe and non-conforming medical devices from being placed on the market and the responsibilities of the relevant parties pursuant to Law No 7223 on Product Safety and Technical Regulations. In this regard, the Guidelines indicate the procedure on withdrawal and recall of medical devices and in vitro diagnostic devices from the market, and duties, authorities and responsibilities of the Agency and the medical devices companies.

The Regulation Amending the Regulation on Licensing of Human Medicinal Products was published in the Official Gazette on 27 May 2023. The amended provisions introduce a new reason for license suspension related to license transfer applications. To avoid suspension, license holders must provide proof of Good Manufacturing Practice compliance and a Production Site Authorisation Certificate for the active substance production site in Turkey. License holders must now notify the Medicines and Medical Devices Agency of license application rejections or withdrawals in other countries. The deadline for submitting notified body opinions or CE certificates for medicinal products with integrated medical devices is extended to 31 December 2028.

Alternatif Geri Ödeme Yönetmeliği ile ilgili olarak yapılan yeni düzenlemeler, Yönetmeliğin 2016'daki hükümlerine benzerlik göstermektedir. Öne çıkan değişiklikler şunlardır: Alternatif geri ödeme modellerinin tanımında, yurtdışından temin edilen ürünlerin yerli üretime geçmesi veya piyasada bulunurluğunun sağlanması gibi unsurlara yer verilmemiş, bunun yerine iskonto oranlarının belirlenebileceği ve alım garantisi verilerek sağlık hizmetlerinin ödeme kapsamına alınabileceği belirtilmiştir. Ayrıca Komisyon toplantılarına ilişkin takvim belirlenmiş ve gizlilik hükümleri yeniden yürürlüğe konulmuştur. Yeni düzenlemeler, firmaların ihtiyaçlarına hizmet etmek amacıyla alternatif geri ödeme modellerinin geliştirilmesine odaklanmaktadır. Ruhsat sahiplerinin başvurularını güncellemeleri ve sözleşme süresi biten sağlık hizmeti geri ödemeleri için başvuruda bulunmaları gerekmektedir.

As a result of lawsuits filed against the provisions of the Alternative Reimbursement Regulation, certain articles were canceled due to a formal deficiency. The new Social Security Institution Alternative Reimbursement Regulation has been published, and notable developments include the explicit definition of alternative reimbursement models and the establishment of a meeting schedule for the Alternative Reimbursement Commission. The regulation also reinstates provisions regarding confidentiality. The new regulation aims to serve the needs of companies by providing predictability and confidentiality in the development of alternative reimbursement models. Marketing authorization holders have been instructed to update their applications, and reimbursement applications must comply with the new regulation.

Türkiye'de ruhsatı olmayan veya piyasada bulunmayan ilaçlar, hasta talebi ve özel izinle yurt dışından tedarik edilebilir. Yeni Yurt Dışından İlaç Temin Yönetmeliği'ne göre, Yurt Dışından İlaç Temin Kılavuzu güncellenmiştir. Kılavuz, yurt dışı ilaç temin kaynağının kriterlerini ve temsilci yükümlülüklerini belirtir. İlaçlar, yetkili kuruluşlara beşeri tıbbi ürün tedariki yapan yurt dışındaki kuruluşlardan temin edilmelidir. İlaç temin kaynağı, üretici/ruhsat sahibi, yetkili ilaç otoriteleri tarafından ruhsatlandırılmış ecza deposu veya lisans verilen firma olmalıdır. Temsilci, yazılı olarak yetkilendirilmiş yerli bir kişi veya kuruluş olmalıdır. Kaynak ve temsilcinin yükümlülükleri Kılavuzda ayrıntılı olarak belirtilmiştir. Yönetmelik ve Kılavuz, ilaç temini sürecini düzenlemekte olup mali yükümlülükler anlaşmaya bağlıdır.

The Regulation on Supply of Pharmaceuticals from Abroad, recently published in Turkey, introduces new rules for procuring pharmaceuticals not authorized or available in the domestic market. The Guidelines accompanying the Regulation have been updated to reflect these changes. The Guidelines outline criteria for foreign pharmaceutical supply sources, specifying requirements for manufacturers/license holders, pharmaceutical warehouses, and authorized companies. The Regulation emphasizes obtaining products directly from authorized sources and ensuring quality and safety. The Guidelines also address the obligations of the representative appointed by the foreign pharmaceutical supply source, including pharmacovigilance and encoding processes. The Guidelines provide further details and examples not fully covered in the Regulation. The named patient program aims to charge costs to foreign companies, but it could be argued that the state should cover these expenses as part of its responsibility to provide healthcare services to citizens.

On 2 April 2023,  regulations amending the Turkish Medical Device Regulation (Turkish language) and the Turkish In Vitro Medical Device Regulation (Turkish language) were published in the Official Gazette numbered 32151.  They amend he transitional provisions stipulated in the which was published in the Official Gazette numbered 31499 to be in line with the transitional provisions applicable to  Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

On 14 March 2023, the Presidential Decree numbered 6932 Amending the Decision on Pricing of Medicinal Products for Human Use was published in the Official Gazette numbered 32132.

The Legislative Proposal on the Amendment of the Law on Pharmaceuticals and Medical Preparations No. 1262, Certain Laws and Decree Law No. 663 dated March 20, 2023, and numbered 2/5006 is an omnibus bill having some amendment offers regarding the regulating legislation of the health sector.

Pharmaceutical prices in Turkey have always been one of the most controversial issues. The prices of medicines that are to be marketed are set under the Decision on Pricing of Human Medicinal Products and the Communiqué on the Pricing of Human Medicinal Products of September 29, 2017, issued by the Ministry, which is vested with the competencies to regulate this area.

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 and reimbursement rules did not apply to innovative products.

Although there is no explicit provision in Turkish Law for the acceptance of the ongoing opposition or appeal proceedings before the European Patent Office as a “pending issue” due to the principle of procedural economy, in practice, pending issue decisions may be given by the Civil Courts of Intellectual and Industrial Property Rights according to the particular circumstances.

The Regulation on the Importation, Production, Processing and Supply of Food Supplements was published by the Ministry of Food and Forestry on May 2, 2013, in the Official Gazette and came into force on August 2, 2013.

As per article 9 of the Regulation on Authorization, which regulates “Abridged Application”, if a pharmaceutical has been authorized before, it is not necessary to repeat the tests and research, and the data of these tests doesn’t have to be submitted for authorizing again, …

Türkiye’de ruhsatlandırılmamış veya ruhsatlı olmakla birlikte piyasada bulunmayan ilaçlara hastaların ihtiyaç duyduğu durumlarda; söz konusu ilaç, hekimlerin talebi ve özel izinle yurt dışından tedarik edilebilmektedir. İlaçlar için öngörülen bu istisnai ithalat rejimi, yakın bir zamana kadar Türkiye İlaç ve Tıbbi Cihaz Kurumu (“TİTCK”) tarafından yayınlanmış olan Yurt Dışından İlaç Temini Kılavuzu ile düzenlenmekteydi. 3 Şubat 2023 tarihli 32093 sayılı Resmî Gazete’de Yurt Dışından İlaç Temin Yönetmeliği (“Yönetmelik”) yayınlanarak eski kılavuz yürürlükten kaldırılmıştır.

Pharmaceuticals that are not authorized in Turkey and/or not available in the market despite being authorized, shall be procured from abroad upon request of physicians and special authorization in cases where patients require such pharmaceuticals. Until recently, this exceptional import regime for pharmaceuticals was regulated by the Guideline on the Supply of Pharmaceuticals from Abroad published by the Turkish Medicines and Medical Devices Agency ("Agency").

On December 14, 2022, the Turkish presidential decree numbered 6546 was published in the Official Gazette, amending the Decision on Pricing of Medicinal Products for Human Use, which increases the value of 1 Euro in Turkish lira by 36.77% in December 2022. As a result, the price scales stipulated in the Decision were updated, and the threshold value for price-protected products has been determined as TRY 37.10 while it has been determined as TRY 19.39 for other products in line with the change in the exchange rate. This is the third time this year the exchange rate has been updated, and the amendment also indicates that there will be no revaluation in 2023.