Patient Support Program

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Gun + Partners

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Gün + Partners is a full-service institutional law firm with a strategic international vision, providing transactional, advisory and dispute resolution services since 1986. The Firm is based in Istanbul, with working offices Ankara and Izmir. The Firm advises in life sciences, energy, construction & real estate, technology, media and telecoms, automotive, FMCG, chemicals and the defence industries.”
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.
Turkey Food, Drugs, Healthcare, Life Sciences

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 "Regulation on the Delivery of Home Care Services," to train patients and / or their relatives or healthcare professionals in the clinic / health institution about the product application, or to establish a call center to obtain information about the product application by the patients' relatives.

Due to the COVID-19 pandemic, it has become necessary for many companies to convert face-to-face training meetings of the ongoing patient support programs to online or electronic meetings. This issue required both contract amendments, and the preparation of new clarification and consent texts, due to the processing of personal data through different methods.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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