Recent Development

The Turkish Medicines and Medical Devices Agency (“TITCK”) recently announced updates to the Guidelines on Package Information, Manuals and Tracking of Medicinal Products for Human Use ("Guidelines").

What Does the Announcement Say? 

The Guidelines were prepared and adopted in July 2017 in accordance with the Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use, which was published in the Official Gazette No. 300048 on April 25, 2017.

The updates to the Guidelines provide further information regarding the minimum mandatory requirements in relation to the form and content of package information and manuals of medicinal products for human use, including explanations regarding external packaging and products licensed for production within the scope of the localization process. The updated Guidelines and a comparison chart presenting the updates are available here (in Turkish). The updated Guidelines entered into force on February 23, 2018.

Conclusion

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 in the Guidelines and take the necessary steps to ensure compliance.