Insights
Named Patient Program
Named Patient Programs (“NPP”) is one of the exceptional pharmaceutical importation regimes for products that lack market authorisation or which are authorized but unavailable in the Turkish market for various reasons. In cases where a product does not have marketing authorization in Turkey or has a marketing authorization but cannot be found on the market, and patients need the product in question, it is possible to procure the pharmaceutical via this particular method upon… »
Current Practice of Bolar Exemption in Turkish Patent Law
Article 85(3)/(c) of the Industrial Property Law No. 6769 (“IPL”) regulates the Bolar Exemption, which stipulates the exclusion of experimental acts containing the invention subject to the patent from the scope of the patent right, including the licensing of pharmaceuticals and the necessary tests and experiments thereof. Undoubtedly, the purpose of the Bolar Exemption is to ensure that a generic medicinal product can be put on the market without losing time once the patent… »
Interactions with HCPs
Promotional activities of human medicinal products is regulated by the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated July 3, 2015. Under the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the Internet, is prohibited. Pharmaceutical products may be promoted only to physicians, dentists and… »
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… »
The Guideline for Environmental Claims in Advertising Has Been Published
The Guideline for Environmental Claims in Advertising (“Guideline”), enacted by the Advertisement Board at the meeting dated 13.12.2022 and numbered 328, has been published. The purpose of the Guideline is to inform persons, institutions and organizations on legal compliance of their environmental claims contained in commercial advertisements and commercial practices conducted by advertisers, advertisement agencies and media organizations. Highlights of the Guideline… »
The Euro Value Applied to Pharmaceutical Prices was increased by 36.77%
On 14 December 2022, the presidential decree numbered 6546 (“Decree”) amending the Decision on Pricing of Medicinal Products for Human Use (“Decision”) was published in the Official Gazette numbered 32043. With the provisional clause added to the Decision, the effective date of the changes made in real source price or ex-factory price as per Article 10 of the Communique on the Pricing of Medicinal Products for Human Use, was determined to be the publication date of this… »
New Provision Introduced to Decision on Drug Pricing
On 9 November 2022, the Presidential Decree numbered 6365 Amending the Decree on Pricing of Medicinal Products for Human Use (Turkish language) (Decision) was published in the Official Gazette numbered 32008. The following paragraph has been added under Article 2 of the Decision: "Discount practices that cause temporary price changes in the country/countries where the product is offered for sale, special practices related to product classification and taxation practices shall… »
Guidelines on Donation of Non-Approved Drugs
On 28 September 2022, the Turkish Medicines and Medical Devices Agency (Agency) published guidelines (Turkish language) on donation from abroad of human medicinal products that are not approved in Turkey on its official website. The guidelines have been prepared to determine the procedures and principles regarding donation from foreign companies within the scope of the Regulation on Licensing of Human Medicinal Products. The most significant provisions of the guidelines are… »