The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently announced the necessary actions to fulfil the requirement of Braille alphabet usage under the Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use (the “Regulation“).
What Does the Announcement Say?
Pursuant to the TİTCK’s announcement, as indicated in the Regulation, procedures for the transition to Braille alphabet within the scope of the Regulation should be completed by December 31, 2018 and all products produced as of January 1, 2019 should contain Braille alphabet on their external packages.
The licensed companies should apply to the TİTCK for the transition to the Braille alphabet by submitting the necessary documents and information listed in the TİTCK’s website.
The TİTCK continues to demonstrate its commitment to providing comprehensive guidelines for companies engaged in medicinal products for human use. Companies should take note of the new updates, take the necessary steps to ensure compliance and carefully follow the entire process prior to and after the application.