Pharmacovigilance Privacy Notice

SIDE EFFECT / ADVERSE EVENT AND QUALITY COMPLAINT PRIVACY NOTICE

1. Data Controller

As Santa Farma İlaç Sanayii A.Ş. (“Company” or “Santa Farma”), in our capacity as Data Controller pursuant to the Law No. 6698 on the Protection of Personal Data (“KVKK”), we would like to inform you within the scope of our obligation to inform under the KVKK.

Under the KVKK, personal data refers to any information relating to an identified or identifiable natural person.

This Privacy Notice has been prepared within the scope of notifications of side effects / adverse events / lack of efficacy and quality complaints to be made via the Santa Farma website or call center, pursuant to the Regulation on the Safety of Medicines and other relevant legislation.

2. Your Processed Personal Data

Within the scope of Side Effect / Adverse Event and Quality Complaint notifications, your personal data provided to us—including your name-surname, email address, phone number, address, and other personal data that may be contained in the message you send to us or in the file you upload as an attachment to your message (hereinafter referred to as “Personal Data”)—and your special categories of personal data provided to us, limited to your health data regarding your use of Santa Farma products that are the subject of the side effect / adverse event or quality complaint notification contained within your message (hereinafter referred to as “Special Categories of Personal Data”), may be processed.

In notifications regarding side effects / adverse events and quality complaints, we kindly ask you not to transfer personal data—especially health data—belonging to third parties, or to confirm that you have obtained their consent for such transfer. Please note that if third-party data is transferred to Santa Farma, you are responsible under the KVKK.

3. Purposes and Legal Grounds for Processing Personal Data

Pursuant to the KVKK, as Santa Farma in our capacity as Data Controller, your Personal Data will be processed within the framework explained below and limited to the purposes specified in the following paragraph, based on the legal grounds of being mandatory for the data controller to fulfill its legal obligations pursuant to Article 5/2 (ç) of the KVKK, being mandatory for the establishment, exercise, or protection of a right pursuant to Article 5/2 (e) of the KVKK, and being mandatory for the legitimate interests of the data controller pursuant to Article 5/2 (f) of the KVKK.

• Legitimate Interest: Necessary for conducting statistical analyses to improve services and products provided by Santa Farma and to plan and manage Santa Farma’s internal operations;
• Legal Obligation & Legitimate Interest: Necessary for managing general record-keeping processes to fulfill our legal obligations and for our legitimate interests;
• Establishment or Exercise of a Right: Necessary for routing the sent message to the relevant department within the Company to ensure our services are planned and executed correctly and efficiently, taking necessary actions within the company regarding your message, and contacting you regarding your message if needed;
• Meeting all requirements arising from applicable legislation.

The legal ground for processing your special categories of personal data pursuant to Article 6/3 (e) of the KVKK is that “it is necessary for the protection of public health, operation of preventive medicine, medical diagnosis, treatment and care services, and planning, management, and financing of healthcare services by persons subject to confidentiality obligations or authorized institutions and organizations.”

4. Collection Methods of Personal Data

Your personal data is collected via our website by filling out the notification forms on our website, through the messages you send us within the form, or directly via phone/email contact by Pharmacovigilance officers using the method shared by you.

5. To Whom and For What Purposes Personal Data May Be Transferred

Where necessary to fulfill the personal data processing purposes stated above, your personal data submitted to the Company may be shared with:

• Domestic third-party business partners, third-party companies from which we receive services / support / consultancy including lawyers, financial advisors, and auditors;
• Our suppliers;
• Public or private healthcare institutions where your treatment is conducted;
• Ministry of Health, Turkish Medicines and Medical Devices Agency, Turkish Pharmacovigilance Center, and other relevant public institutions and organizations.

Furthermore, pursuant to Article 9/4-a of the KVKK, within the framework of the agreement between the Turkish Medicines and Medical Devices Agency and the World Health Organization, data may be transferred to the World Health Organization via TÜFAM.

6. Your Rights

Regarding your personal data processed by Santa Farma, you may submit your requests under Article 11 of the KVKK at any time to the addresses below, in writing in accordance with the Communiqué on the Principles and Procedures for the Request to Data Controller, or by using registered electronic mail (KEP), electronic signature, mobile signature, or your email address previously notified to us and registered in our systems.

Data Controller: Santa Farma İlaç Sanayii A.Ş.

Address: H. Edip Adıvar / Boru Çiçeği Sokak / No:16 Şişli / İstanbul

Email Address: kvkk@santafarma.com.tr

KEP Address: santafarmaas@hs01.kep.tr