The Turkish Medicines and Medical Devices Agency ("TİTCK") published a new Circular on Medicine Safety Inspection Forms (“Circular”) updating the medicine safety inspection forms and patient consent forms.
Medicine safety inspection and patient consent forms are used within the scope of the Regulation on Medicine Safety to monitor serious adverse effects that may occur during the use of certain medicines. The medicine safety inspection and patient consent forms updated through the Circular applicable for different types of medicines are available at here (in Turkish).
The TİTCK continues to provide guidance for pharmaceutical companies. Companies should carefully review the updated medicine safety inspection and patient consent forms and take the necessary steps to ensure compliance.