493 results found

The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently published the i) Guideline on the Labeling of Research Products and Auxiliary Pharmaceuticals...

Bu kapsamda, Yönetmelik'in öne çıkan yeni hükümlerine aşağıda yer verilmektedir.

This article provides a comprehensive guide on accessing orphan drugs in Türkiye, covering the Named Patient Program (NPP) and the Compassionate Use Program (CUP).

The long awaited Regulation on Promotional Activities of Medicinal Products for Human Use (New Regulation) is eventually published in the Official Gazette dated August 26, 2011.

The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") has published announcements on the authorized laboratories, support of healthcare professionals attending scientific meetings...

The Regulation on Medicinal Herbal Teas (the “Regulation”), published in the Official Gazette dated 2 July 2026 and numbered 33298, establishes for the first time a comprehensive framework governing the authorisation, manufacture, importation, packaging, distribution, placing on the market and supervision of medicinal herbal teas. While the Regulation creates a separate authorisation system for medicinal herbal teas sold exclusively through pharmacies, it excludes food supplements and herbal and fruit teas marketed as food products from its scope.

Legal aspect of clinical trials occupies the agenda of medical and pharmaceutical sector as of the cancellation action filed by the Turkish Medical Association ("TMA") in March 2009.

These rules also apply for tobacco cases which include a few packages together.

European and Turkish courts are reshaping how second medical use patent infringement is determined, moving beyond simple SmPC carve-outs to examine real-world prescribing patterns and market behavior. Recent landmark decisions establish that generic pharmaceutical companies may face liability even when patent-protected indications are removed from product documentation, if off-label or cross-label use occurs to a sufficient extent. The evolving legal framework now requires courts to assess both objective ma

Duyurumuz, TBMM Genel Kurul'unda kabul edilen 7445 sayılı Kanun'un 17. Maddesi ile 5237 sayılı Türk Ceza Kanunu'nun 188. Maddesinde düzenlenmiş olan...

The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently published the Guideline on Cosmetic Product Information File, Responsible Technical Personnel...

Research and Development (“R&D”) activities are an investment field that has become more of an issue in Turkey in recent years.

Turkey has introduced a comprehensive new framework for pricing human medicinal products through a Presidential Decision that fundamentally restructures the reference pricing system, calculation methodologies, and regulatory oversight mechanisms.

It is essential to establish a fair balance between the interests of originator pharmaceutical companies who bear all the costs and effort required for inventions, and the interests of generic...

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

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

A patent is an intellectual property right that provides the owner of an invention with the exclusive right to benefit from the commercial use of the product, such as producing, selling and exporting for a set period time.