The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently published on its website new Guidelines on Notifications Made by the Manufacturers of Medicinal Products for Human Use (the “Guidelines”).
The Guidelines are adopted based on Article 10 of the Regulation on Manufacturing Plants of Medicinal Products for Human Use, which requires manufacturers or importers to notify the TİTCK of any change that occurs to the license information or the manufacturing plant of a product, such as the place of manufacturing and contracted laboratories. In this scope, the TİTCK aims to provide guidance for the manufacturers or importers regarding the procedural steps to be followed when submitting a notification to the TİTCK thereof.
The Guidelines specifically lists the type of changes that must be notified by the manufacturers as well as other procedural issues, such as the documentation requirements and the time periods in which the notifications must be made. The Guidelines are available here (in Turkish).
The TİTCK continues to provide guidelines for companies engaged in medicinal products for human use. Companies should carefully review the requirements set forth under the Guidelines to ensure compliance when submitting a notification of change to the TİTCK.