Clarification Text On The Protection Of Personal Data Within The Scope Of Pharmacovigilance
Pursuant to the Law No. 6698 on the Protection of Personal Data (LPPD), as SANOVEL İLAÇ SANAYİ VE TİCARET A.Ş., ASET İLAÇ SANAYİ VE TİCARET A.Ş. VE ADİLNA İLAÇ SANAYİ VE TİCARET A.Ş. (ŞİRKET), as Data Controller, we would like to inform you about the collection and processing of your personal data regarding our pharmacovigilance activities in accordance with Article 10 of the Law titled "Data Controller's Obligation to Inform".Detailed information regarding the processing of your personal data within the scope of this Clarification Text can be found in the COMPANY Personal Data Protection and Processing Policy at https://www.sanovel.com.tr/en/contact-us/protection-of-personal-data
1. Purposes of Processing Your Personal Data
Pharmaceutical companies are required to perform activities related to the detection, evaluation, identification and prevention of adverse reactions (side effects) and other potential problems related to medicines. As a result of these activities called pharmacovigilance, it becomes possible to monitor drug safety and protect public health by taking certain measures at national or international level when necessary.All personal data received by our company regarding adverse drug reactions and other pharmacovigilance activities are used only for pharmacovigilance activities. Your personal data is collected and processed in compliance with the LPPD and relevant regulations.During pharmacovigilance activities, we collect the name, contact details and profession/affiliation of the reporter. During the processing of adverse events for pharmacovigilance purposes, we may also need to collect additional personal data relating to the medical history and health of the person who experienced the adverse event, if necessary.
2. Parties to whom Personal Data may be Transferred and Purpose of Transfer
The information you provide will be used to fulfill the legal obligations stipulated in the legislation for monitoring drug safety and may be shared with the Turkish Medicines and Medical Devices Agency. This data can also be anonymized and entered into the database of the World Health Organization within the scope of the Drug Monitoring and Cooperation Program.Our Company may share the information you provide to us with our main group company, affiliates, business partners and service providers (suppliers, legally authorized institutions and organizations and legally authorized private legal entities) in order to process it in the global pharmacovigilance database and to fulfill the requirements of pharmacovigilance legislation.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 incident, they contain a limited amount of personal data:
Patients: Information including age or date/year of birth, gender, patient's initials (Patient name is not reported explicitly).
Reporter: Information such as name, occupation, first and last name initials, address, e-mail, telephone number, etc. provided for the organization to trace the reporting person.
3. Method and Legal Grounds for Collection of Personal Data
Your personal data is collected in paper or electronic media. Your data regarding pharmacovigilance are processed for the purposes of protecting public health and preventive medicine in the third paragraph of Article 6 of Law No. 6698 and on the basis of this article; your personal data are processed within the scope of "it is mandatory for the data controller to fulfill its legal obligation" in subparagraph (ç) of the second paragraph of Article 5 of Law No. 6698.
Due to the public health importance of pharmacovigilance information (adverse event reports), reports should be kept for a minimum of 10 years after withdrawal from the market in the last country where the medicine was marketed.
5. Rights of Data Subjects
Pursuant to Article 11 of Law No. 6698, you have the following rights as a personal data subject:
Being aware of whether their personal data are processed,
Requesting information regarding the personal data if they are processed,
To find out whether your personal data are used in accordance with the purpose of processing and their purpose
Be aware of the third parties to whom personal data are transferred at home or abroad,
Requesting correction of the personal data in case they are incomplete or wrong processed and the transaction performed under this scope to be informed to the third parties to whom the personal data are transferred,
Request the erasure or destruction of personal data in the event that the reasons requiring processing are eliminated despite being processed in accordance with the provisions of the Law No. 6698 and other relevant laws, and request the notification of the transaction made within this scope to the third parties to whom the personal data are transferred,
Objecting to the emergence of a result against the person by analyzing the processed data exclusively through automated systems,
Requesting compensation in case of loss due to unlawful processing of personal data.
However, due to pharmacovigilance regulatory obligations, our company may not delete or restrict the processing of data processed for pharmacovigilance.As personal data owners, if you submit your requests regarding your rights stated below to the Company by the methods specified in the COMPANY Personal Data Protection and Processing Policy at https://www.sanovel.com/bize-ulasin/kisisel-verileri-koruma-kanunu, your requests will be evaluated and finalized by our Company as soon as possible and in any case within 30 (thirty) daysSANOVEL İLAÇ SANAYİ VE TİCARET A.Ş. ASET İLAÇ SANAYİ VE TİCARET A.Ş. ADİLNA İLAÇ SANAYİ VE TİCARET A.Ş. Contact Information: https://www.sanovel.com.tr/en/contact-us