In accordance with the Personal Data Protection Law No. 6698 (KVKK), SANOVEL PHARMACEUTICAL INDUSTRY AND TRADE INC., ASET İLAÇ SANAYİ VE TİCARET A.Ş., and ADİLNA İLAÇ SANAYİ VE TİCARET A.Ş. (the “COMPANY”), acting as Data Controllers, wish to inform you regarding the collection and processing of your personal data in connection with our pharmacovigilance activities, in accordance with Article 10 of the Law titled “The Data Controller’s Obligation to Provide Information,” and wish to inform you regarding the collection and processing of your personal data in connection with our pharmacovigilance activities. You can access detailed information regarding the processing of your personal data under this Information Notice in the COMPANY’s Personal Data Protection and Processing Policy available at https://www.sanovel.com.tr/bize-ulasin/kisisel-verilerin-korunmasi.
1. Purpose of Processing Personal Data
Pharmaceutical companies are required to carry out activities related to the detection, evaluation, identification, and prevention of adverse reactions (side effects) and other potential issues associated with the use of medications. These activities, known as pharmacovigilance, enable the monitoring of drug safety and, when necessary, the implementation of certain measures at the national or international level to protect public health.
All personal data received by our company regarding adverse drug reactions and other pharmacovigilance activities is used solely for pharmacovigilance purposes. Your personal data is collected and processed in compliance with the Personal Data Protection Law (KVKK) and relevant regulations.
During pharmacovigilance activities, we collect the reporter’s name, contact information, and profession/affiliation. If necessary during the processing of adverse events for pharmacovigilance purposes, we may also need to collect additional personal data related to the medical history and health of the person who experienced the adverse event.
2. Parties to Whom Personal Data May Be Transferred and the Purpose of the Transfer
The information you provide will be used to fulfill the legal obligations set forth in the legislation regarding the monitoring of drug safety and may be shared with the Turkish Medicines and Medical Devices Agency. Your 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.
Our company may share the information you provide with our parent company, subsidiaries, business partners, and service providers (suppliers, legally authorized institutions and organizations, and legally authorized private legal entities) to process the information you provide to us in the global pharmacovigilance database as necessary and to comply with pharmacovigilance regulatory requirements.
Our company is also required to report certain pharmacovigilance data to other health authorities in Europe and around the world, including countries with varying levels of data protection. However, while these reports contain detailed information about the event, they include only a limited amount of personal data:
- Patients: Information including age or date/year of birth, gender, and the initials of the patient’s name (the patient’s full name is not disclosed).
- Reporter: Information provided to enable the institution to track the reporting individual, such as name, profession, first and last initials, address, email, and phone number.
3. Method of Collection and Legal Basis for Personal Data
Pursuant to Article 11 of Law No. 6698, as the data subject, you have the following rights:
- to learn whether your personal data has been processed,
- To request information regarding the processing of your personal data,
- To learn the purpose of the processing of your personal data and whether it is being used in accordance with that purpose,
- To know the third parties to whom your personal data has been transferred, both domestically and abroad,
- To request the correction of your personal data if it has been processed incompletely or incorrectly,
- To request the erasure or destruction of your personal data if the grounds justifying its processing no longer exist, even if it was processed in accordance with Law No. 6698 and other relevant laws, and to request that this action be communicated to third parties to whom your personal data has been transferred,
- To object to a decision made solely through the automated analysis of your processed data that results in a negative outcome for you,
- To request compensation for damages incurred as a result of the unlawful processing of your personal data.
However, in accordance with pharmacovigilance regulations, our company may not be able to delete or restrict the processing of data that has been processed for pharmacovigilance purposes.
As data subjects, you may submit requests regarding the rights listed below to the Company using the methods specified in the Company’s Personal Data Protection and Processing Policy, available at https://www.sanovel.com.tr/bize-ulasin/kisisel-verilerin-korunmasi, your requests will be reviewed and resolved by our Company as soon as possible and, in any case, within 30 (thirty) days.
SANOVEL PHARMACEUTICAL INDUSTRY AND TRADE INC.
ASET PHARMACEUTICAL INDUSTRY AND TRADE INC.
ADİLNA PHARMACEUTICAL INDUSTRY AND TRADE INC.
Contact Information: https://www.sanovel.com/bize-ulasin
