SANOVEL İLAÇ SANAYİ VE TİCARET ANONİM ŞİRKETİ PRIVACY NOTICE REGARDING THE PROCESSING OF PHARMACOVIGILANCE DATA AT UNDER THE PERSONAL DATA PROTECTION LAW no.6698
As Sanovel İlaç Sanayi ve Ticaret Anonim Şirketi (“Sanovel”), we take the utmost care to protect the personal data of those who contact us. In this context, acting as the “data controller” under the Personal Data Protection Law No. 6698 (“KVKK”), we process your personal data in compliance with the KVKK and within the scope of the purposes and limitations specified below. For this reason, this “Privacy Notice Regarding the Processing of Pharmacovigilance Data” (“Privacy Notice”) has been prepared to inform healthcare professionals (physicians, pharmacists) (“HCPs”) who report adverse events, or patients and their relatives, about our processes for processing their personal data.
Pharmaceutical companies are required to conduct activities related to the detection, evaluation, identification, and prevention of adverse reactions (side effects) and other potential drug-related issues that may arise during drug use. Through these activities, known as pharmacovigilance, it becomes possible to monitor drug safety and, when necessary, take certain measures at the national or international level to protect public health.
Data received by Sanovel regarding the pharmacovigilance activities covered by this Privacy Notice will be used solely within the framework of pharmacovigilance activities. During the processing of adverse reaction reports for pharmacovigilance purposes, in addition to the reporter’s personal data, we may also need to collect additional personal data related to the medical history and health of the person who experienced the adverse reaction. We kindly ask that you refrain from sharing any personal data other than that which is associated with the use of our products. Healthcare Professionals (HCPs) are obligated under the Personal Data Protection Law (KVKK) to inform the Patient before transmitting the Patient’s personal data to Sanovel. A copy of this Privacy Notice must be provided to the Patient by the HCP. Furthermore, we ask that the Patient’s relatives cooperate with us and direct the data subject to this Privacy Notice available on our website. The data subject may access this Privacy Notice via our website at any time. In any case, these data are collected and processed in compliance with the KVKK and relevant regulations.
Accordingly, if you contact us as a “Reporter” or “Patient,” the personal data we will process, along with the purposes and legal grounds for such processing, are as follows.
Personal Data and Data Categories Regarding the Reporter
| Data Categories | Processed Personal Data |
|---|---|
| Identification Information | First Name and Last Name |
| Contact Information | Phone Number, Address, Email Address, Fax Number |
| Professional Experience Information | Occupation, Employer, and Department |
| Other | Country of Operation |
Purpose and Legal Grounds for the Processing of Personal Data Concerning the Reporter
| Category of Data Processed | Purpose of Data Processing | Legal Basis for Data Processing |
|---|---|---|
| Identification Information, Contact Information, Professional Experience Information | Tracking reports of adverse reactions; conducting activities to detect, evaluate, identify, and prevent potential drug-related issues; fulfilling pharmacovigilance requirements in accordance with Ministry of Health regulations | Pursuant to Article 5(2)(c) of the Personal Data Protection Law (KVKK); the processing is necessary for the data controller to fulfill its legal obligations |
Patient-Related Personal Data and Data Categories
| Data Categories | Processed Personal Data |
|---|---|
| Identification Information | Initials of First and Last Name, Gender, Date of Birth |
| Contact Information | Phone Number |
| Health Information | Pregnancy Information, Height and Weight Information, Health Information Related to Product Use |
Purpose and Legal Basis for the Processing of Personal Data Regarding the Patient
| Category of Data Processed | Purpose of Data Processing | Legal Basis for Data Processing |
|---|---|---|
| Identification Information, Contact Information | Tracking reports of adverse reactions; conducting activities to identify, assess, characterize, and prevent potential drug-related issues; and fulfilling pharmacovigilance requirements in accordance with Ministry of Health regulations | Pursuant to Article 5(2)(c) of the Personal Data Protection Law (KVKK); the processing is necessary for the data controller to fulfill its legal obligations |
| Health Information | Compliance with pharmacovigilance requirements under Ministry of Health regulations; collection of adverse event and follow-up reports | Pursuant to Article 6(3)(e) of the KVKK: It is necessary for the protection of public health, the provision of preventive medicine, medical diagnosis, treatment, and care services, as well as the planning, management, and financing of health services by persons or authorized institutions and organizations subject to a duty of confidentiality |
To Whom and For What Purposes Are Your Personal Data Transferred?
Your personal data collected and processed within the scope of this privacy notice may be transferred to the recipient groups specified in the table below for the purposes also specified in that table. Your personal data is transferred abroad in accordance with Article 9 of the KVKK because the servers of our infrastructure service providers’ data storage and backup systems are located outside Turkey. Additionally, your personal data may be shared with law enforcement agencies and authorized public institutions and organizations to fulfill official requests made in written communications from such entities.
| Recipient Group | Purpose of Transfer | Personal Data Transferred |
|---|---|---|
| Authorized Public Institutions and Organizations (Ministry of Health) | To fulfill reporting obligations arising from legislation | Identification Information, Contact Information, Professional Experience Information, Health Information, Other Personal Data |
| Archiving Service Provider | Archiving of physical documents | Identification Information, Contact Information, Professional Experience Information, Health Information, Other Personal Data |
| Email and Data Storage Infrastructure Service Provider | Use of email and data storage services | Identification Information, Contact Information, Professional Experience Information, Health Information, Other Personal Data |
Our company is required to report certain pharmacovigilance data to health authorities in Europe and other parts of the world, including countries with varying levels of data protection. However, while these reports contain detailed information about the incident, they include only a limited amount of personal data:
Patients: Age or date/year of birth, gender, and information including the patient’s initials (the patient’s full name is not disclosed).
Reporter: Information provided to enable the organization to track the reporting individual, such as name, profession, first and last initials, address, email, and phone number.
How Is Your Personal Data Collected?
Your personal data is collected for the purposes specified above through the “Adverse Event Reporting Form” available on the Sanovel website at, telephone calls you make to us via our call center, emails and physical mail you send to our address urunguvenligi@sanovel.com.tr designated specifically for adverse event reports, and the information and documents you provide to us via.
How Long Are Your Personal Data Retained?
Because pharmacovigilance data (adverse reaction reports) is important for public health, it must be retained for at least 10 years after the drug is withdrawn from the market in the last country where it was marketed.
Your Rights and Contact Information
Under the legislation regarding the protection of personal data, to exercise your rights pursuant to Article 11 of the Personal Data Protection Law (KVKK), in accordance with the “Communication on the Procedures and Principles for Applications to the Data Controller”:
In writing to the address “Esentepe Mah. Bahar Sokak No: 13 Kat: 10 River Plaza, Levent, Istanbul,”
kvkk@sanovel.com.tr by sending an email from the email address you previously provided to the Company and which is registered in the Company’s system to, or,
sanovelilac@hs03.kep.tr by sending an email from your registered email address to the registered email address.
If your request incurs an additional cost, you may be required to pay the fee set forth in the tariff established by the Personal Data Protection Board.
Best regards,
Sanovel İlaç Sanayi ve Ticaret A.Ş.
Last Updated: 20 August, 2026
