Quality Complaint Privacy Notice

SANOVEL İLAÇ SANAYİ VE TİCARET ANONİM ŞİRKETİ PRIVACY NOTICE REGARDING THE QUALITY COMPLAINT PROCESS UNDER THE PERSONAL DATA PROTECTION LAW

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, and we take the necessary administrative and technical measures accordingly. For this reason, this “Information Notice Regarding the Quality Complaint Process” (Privacy Notice”) has been prepared to inform healthcare professionals (physicians, pharmacists) (“HCPs”) or pharmacy warehouse employees who file complaints, as well as patients who use the product in question.

Data received by Sanovel regarding quality complaints, which constitute the subject matter of this Information Notice, will be used solely within the framework of our product safety activities. During the processing of quality complaints, we may need to collect additional personal data related to the patient in addition to the reporter’s personal data. SMMs who submit a technical product complaint regarding a product used by a specific patient are obligated, in accordance with the Personal Data Protection Law (KVKK), to inform the patient before disclosing the patient’s personal data to Sanovel. A copy of this Information Notice must be provided to the patient by the SMM.

  1. Personal Data and Data Categories Regarding the Reporter

Data CategoriesProcessed Personal Data
Identification InformationFirst Name, Last Name
Contact InformationPhone Number, Business Address, Email Address
Professional Experience InformationOccupation, Employer, and Department
  1. Purpose and Legal Grounds for Processing Personal Data Regarding the Reporter

Category of Data ProcessedPurpose of Data ProcessingLegal Basis for Data Processing
Identification Information, Contact Information, Professional Experience InformationTo ensure the safe use of our products, to manage complaint processes regarding our products, to receive feedback on product quality, to accept product returns for quality inspections, and to provide samples to patients for the continuation of treatmentPursuant 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
  1. Personal Data and Data Categories Relating to the Patient

Data CategoriesProcessed Personal Data
Identification InformationFirst Name, Last Name
Contact InformationPhone Number, Email Address
Health InformationHealth Information Related to Product Use
  1. Purpose and Legal Basis for the Processing of Personal Data Regarding the Patient

Category of Data ProcessedPurpose of Data ProcessingLegal Basis for Data Processing
Identification Information, Contact InformationTo ensure the safe use of our products, to manage complaint processes regarding our products, to receive feedback on product quality, to accept product returns for quality inspections, and to provide samples to the patient for the continuation of treatmentPursuant 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 InformationIn connection with your quality complaints, we do not expect you to share your health data with us. However, we process any potential health information related to your product experience that we may access as part of the complaint for the purposes of providing feedback regarding product quality investigations, conducting a quality review by accepting the product return, and providing a sample to the patient for continued treatment. Please do not share more personal data with us than is necessary.In accordance with Article 6(3)(e) of the Personal Data Protection Law (KVKK), where 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
  1. To Whom and For What Purposes Are Your Personal Data Transferred?

Your personal data collected and processed under this privacy notice may be transferred to the recipient groups listed in the table below for the purposes specified in the same table. This data may also be entered into the World Health Organization’s database in an anonymized form as part of the Drug Monitoring and Collaboration Program. Your personal data is transferred abroad in accordance with Article 9 of the Personal Data Protection Law (KVKK) because the servers of our infrastructure service providers’ data storage and backup systems are located outside Turkey. Furthermore, 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 GroupPurpose of TransferPersonal Data Transferred
Authorized Public Institutions and Organizations (Ministry of Health)To fulfill reporting obligations arising from legislationIdentification Information, Contact Information, Professional Experience Information, Health Information
Email and Data Storage Infrastructure Service ProviderProcurement of email and data storage servicesIdentification Information, Contact Information, Professional Experience Information, Health Information, Other Personal Data
  1. How Are Your Personal Data Collected?

Your personal data is collected from the information and documents you provide to us via the “Contact Us” form on the Sanovel website, telephone calls you make to our call center, and emails and physical mail you send to our addresses, sanovelkalitedirektorlugu@sanovel.com.tr, and —which are designated for quality complaints—for the purposes specified above.

  1. How Will Your Personal Data Be Stored?

Your personal data will be stored in secure storage areas with restricted access for at least 10 years following the expiration of the drug’s license that you provided to us.

  1. 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”:

  1. In writing to the address “Esentepe Mah. Bahar Sokak No: 13 Kat: 10 River Plaza, Levent, Istanbul,”

  2. by sending an email from the email address you previously provided to the Company and which is registered in the Company’s system to kvkk@sanovel.com.tr, or

  3. sanovelilac@hs03.kep.tr by sending a message from your registered email address to the Company’s 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: August 20, 2026