Dear Healthcare Professional,
Before submitting an Adverse Event Notification through our platform, your patients must be informed about the processing of their personal data in compliance with the Republic of Turkey Ministry of Health, Turkish Medicines and Medical Devices Agency (TİTCK) regulations.
To facilitate your clinical practice, you can find a sample consent and information text below, prepared in accordance with the TİTCK Guideline on the Protection of Personal Data in Pharmacovigilance Activities. You may reproduce this text to inform your patients.
This information text is prepared to inform you about how your personal data will be processed during the reporting of adverse events (undesirable effects) that may have occurred concerning the drug/medical device you are using.
1. Data Controller The license holder company of the medical product you are using is the data controller. Your physician/pharmacist, who is submitting the relevant notification, carries out this process in accordance with the legislation.
2. Purpose of Processing Your Personal Data Your name and surname initials, age, gender, and medical history data are processed to monitor the safety of the drug, protect public health, and fulfill adverse event reporting obligations (pharmacovigilance activities). This data is strictly not used for commercial purposes.
3. Transfer of Your Personal Data Pursuant to the legislation, your adverse event-related data will be transferred to the Republic of Turkey Ministry of Health, Turkish Medicines and Medical Devices Agency (TİTCK), Turkish Pharmacovigilance Center (TÜFAM), and the license holder of the medical product.
4. Data Collection Method and Legal Basis Your personal data is collected through the forms filled out following your consultations with your physician/pharmacist and is processed based on the legal grounds of "protection of public health" and "explicitly provided for by the laws" specified in Articles 5 and 6 of the Personal Data Protection Law (KVKK).
I hereby declare that I have read and understood the information above and I consent to the transfer of my personal data to the relevant institutions during the adverse event reporting process.
Patient Name Surname:
Date / Signature: