Developments in the field of Medical Devices
After the long-awaited Regulation on Medical Devices numbered 2017/745 (EU Regulation) prepared by the EU Commission entered into force, Turkey’s Medical Device Regulation, designed to be compatible with the EU’s Regulation, was published in the Official Gazette numbered 31499 on June 2, 2020. Several articles are expected to be brought into effect in accordance with the EU transition process to provide a similar transition process in Turkey. The Medical Device Regulation… »
REGIONAL COURT OF APPEALS: The Decision of the Turkish Medicines and Medical Devices Agency of Refusal of the Applications of the Original Medicine Owners to Obtain Information on Reference Product is Unlawful
As per Article 9 of the Regulation on Licensing of Human Medicinal Products (“Licensing Regulation”), which regulates “Abridged Application[s]”, 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. Referencing the authorization information of the original pre-licensed pharmaceutical is sufficient. However, because the subject product must be… »
Food Supplements, Food for Special Medical Purposes and Other Products
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. The Regulation is not only the first regulation specific to food supplements but also includes provisions for the control and approval mechanism for food supplements that is to be established. However due to the many legislative changes it can be expected that… »
Development of Telemedicine Activities in Turkey
Telemedicine is not explicitly regulated under Turkish law. The existing legal framework, including the Medical Deontology By-law and Ethical Principles for Physicians, prohibits remote examination, diagnosis, and treatment of patients. During the COVID-19 pandemic, the legal gap in telemedicine became more serious as private hospitals especially started to provide online healthcare services to patients who could not visit healthcare centres due to the COVID-19 risk. The fact… »
Supply of Pharmaceutical Products from Abroad and Patent Rights
The supply of pharmaceutical products to Turkey via the named patient programme (the “NPP”) is one of the exceptional importation regimes for pharmaceutical products. Where a pharmaceutical product is not granted marketing authorisation in Turkey, or it is granted marketing authorisation but not found in the market where there is a patient need, it can be supplied via this particular route by physician request. If the product is approved for the NPP, it is added to the… »
Eco-Friendly Advertisements!
When you watch the commercials, do you often feel like advertising companies are working hard to convince you that their products or services are “eco”, “environmentally friendly”, “nature friendly”, “green” and “recyclable”? Does environmentally-friendly feature of a product have any impact on your preference to purchase or use it? In fact, are we yet at the end of an era of advertising products that are not “green” enough but promoted to be “green”? The “green advertising”… »