Introduction
The Turkish Medicines and Medical Devices Agency
("TITCK") published Guidelines on Protection of Personal
Data in Pharmacovigilance Activities ("Guideline") on 1
August 2019.1 The
Guideline aims to protect personal data that is processed during
pharmacovigilance activities and, accordingly, to inform the data
processors regarding their incumbencies and the relevant procedures
and principles. The Guideline is based on Data Protection Law No.
6698 ("Law") and the relevant secondary legislation.
Pharmacovigilance
Pharmacovigilance is defined as the activities and scientific
studies with regard to exploring the determination, understanding
and preventing of adverse reactions and other problems related to
medicines. "Adverse reactions" are the dangerous and
undesirable responses that are developed to medicines.
"Adverse incidents" are the medical cases in which an
undesirable result that cannot be related to the prescribed
treatment has occurred to the
