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Thought Leadership

COVID-19 HUB

COVID-19 HUB

Our COVID-19 HUB is designed to keep our stakeholders updated and help them understand the legal effects of COVID-19 outbreak, and take steps to maintain their businesses in Turkey.

Trademark Law in Turkey Key Developments and Predictions - 2021

Trademark Law in Turkey Key Developments and Predictions - 2021

We have compiled our articles on various topics of trademark law that we deem important for brand owners, which we have developed over the course of the last year.

Patent Law in Turkey Key Developments and Predictions - 2021

Patent Law in Turkey Key Developments and Predictions - 2021

We focus on the key aspects of patent litigation in Turkey, and the most important or challenging issues in Turkish Patent Law.

Life Sciences Law in Turkey Key Developments and Predictions - 2021

Life Sciences Law in Turkey Key Developments and Predictions - 2021

We focus on the key aspects of life sciences in Turkey, the most important and challenging issues in Turkey’s life sciences industry.

Data Protection and Privacy Law in Turkey Key Developments and Predictions 2021

Data Protection and Privacy Law in Turkey Key Developments and Predictions 2021

We focus on the key aspects of data privacy matters and developments in Turkey, and the most important or challenging issues regarding the same.

Copyright Law in Turkey Key Development and Predictions 2021

Copyright Law in Turkey Key Development and Predictions 2021

In the report, we outline seven controversial issues that we often encounter in Turkish copyright Law.

Commercial Dispute Resolution Under Turkish Law Rules, Developments and Insights - 2020

Commercial Dispute Resolution Under Turkish Law Rules, Developments and Insights - 2020

We focus on the four main topics of commercial dispute resolution under Turkish law, and the most important and challenging issues in commercial dispute resolution under Turkish law.

Media and Advertising Law in Turkey Key Developments and Predictions - 2020

Media and Advertising Law in Turkey Key Developments and Predictions - 2020

We focus on the key aspects of media and advertising law in Turkey, and the most important or challenging issues in Turkish media and advertising Law.

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Monthly Newsletters

September 2021

September 2021

We are pleased to publish our monthly newsletters to update our community and clients about legal developments in Turkey.

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Promotion of Medical Devices

Articles -
Life Sciences || Gün + Partners

With medicines, the rule is clear: The general public cannot be the audience of any promotional activity, whatsoever, of pharmaceutical products. However, with medical devices, the rule in place in the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Medical Device Promotion Regulation”) notes more confusing regulation. The rule states that medical devices that are sold, adapted or applied in hearing aid centers, custom-made prosthesis and orthotics c...»

Harmonization with the EU Medical Devices Regulation

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Life Sciences || Gün + Partners

Regulations on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has been published, and was planned to be enter in force on 26 May 2020. However, the MDR’s implementation date has been delayed for a year to enable healthcare institutions and economic operators to prioritize the fight against the Covid-19 pandemic. The legislation in Turkey continues the process of harmonization with the new rules set by the MDR. On 1 February 2020, Presidential Circul...»

Patient Support Program

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Life Sciences || Gün + Partners

Through Circular numbered 2016/4 published by the Turkish Medicines and Medical Device Agency (“TITCK”) an obligation for marketing authorization holders to apply to TITCK and obtain permission for training and support programs for patients / healthcare professionals for the purpose of the rational use of drugs was regulated. With the program, the marketing authorization holder signs a contract with an organization that has been licensed within the framework of the “Regulatio...»

Transfers of Value

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Life Sciences || Gün + Partners

There is no public disclosure rule for value transfers made by pharmaceutical companies. However, according to the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated 3 July 2015, the pharmaceutical companies shall notify TITCK of any value transfers that exceed 10% of the current monthly gross minimum wage, to health institutions, organizations, universities, health professionals, and members of professional associ...»

Interactions with HCPs

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Life Sciences || Gün + Partners

Promotional activities of human medicinal products, enteral nutrition products, and infant formulas for special medical purposes, are regulated under the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated 3 July 2015. Pursuant to 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, i...»

Named Patient Programs

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Life Sciences || Gün + Partners

Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceuticals without marketing authorization (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons. In cases where a pharmaceutical does not have an MA in Turkey, or has an MA, but cannot be found on the market, and patients are in need the pharmaceutical in question, it is possible to procure the pharmaceutical via this special m...»

Localization of Imported Products

Articles -
Life Sciences || Gün + Partners

Following the announcement of the Structural Transformation Program Action Plan for Healthcare Industries on 7 November 2014, Turkey commenced adopting measures to localize the production of a substantial number of pharmaceutical products sold in Turkey. On 10 December 2015, the 64th Government announced the 2016 Action Plan (64th Government Action Plan), which included a statement that measures would be taken to prioritize domestically produced medical supplies and medical d...»

Market Access-Reimbursement Agreements

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Life Sciences || Gün + Partners

For a long period of time, the pharmaceuticals industry needed a special model of reimbursement where the reimbursement conditions could be set, together through negotiation with the SSI, and the normal price and reimbursement rules did not apply for innovative products. With the enactment of Law of the Social Security and General Health Insurance Law numbered 6552, in September, 2014, alternative reimbursement models also became an important topic in the Turkish healthcare i...»

Pricing of Pharmaceuticals and the Fixed Exchange Rate

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Life Sciences || Gün + Partners

Pharmaceutical prices in Turkey have always been one of the most controversial issues. The prices of medicines that are to be marketed are set in accordance with the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of 29 September 2017, issued by the Ministry of Health (“MoH”), which is vested with the competencies to regulate this area. The Decision provides for a reference pricing syste...»

Commercialisation of Healthcare 2021 in Turkey

Guides -
Life Sciences || Özge Atılgan Karakulak and Dicle Doğan

A Q&A guide to the commercialisation of healthcare in Turkey. This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Turkey. It covers the key requirements for manufacturing, marketing and advertising medicines, medical devices, biological products and natural health products. Medicines 1.What is the definition of medicine (or equivalent) in your jurisdiction? Under the Law on Pharmaceuticals and Medical Preparations...»

New Guidelines Published For Promoting Medical Devices

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Life Sciences || Dicle Doğan and Fatma Sevde Tan

On 12 February 2021, the Turkish Medicines and Medical Devices Agency published new guidelines (Turkish language) for the implementation of regulation on sales, advertising and promotion of medical devices. The new guidelines introduce detailed provisions on implementing some of the significant amendments that were made to the Regulation on Sales, Advertising and Promotion of Medical Devices on 2 September 2020. Under the guidelines, in addition to advertising and promotional...»

Developments on Signature Specimen and Signature Circular

Articles -
Corporate and M&A || Görkem Bilgin and Yalçın Umut Talay

Amendments Related to Signature Specimen The Amending Law Related to the Technology Development Zones and Certain Other Laws (the "Law No. 7263") was published in the Official Gazette on February 3, 2021 and entered into force on the same date. Article 22 of the Law No. 7263 amended Article 40 of the Turkish Commercial Code with respect to issue of signature specimen. In this regard, the amendment provides that signature samples of real person merchants and authorized signato...»