Recent Developments

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

Background

In April of 2017, the TİTCK published the Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use (the “Regulation”) based on the corresponding EU directives. The Regulation tightens the obligations regarding the packaging and labeling of medicinal products for human use and requires that all medicinal products for human use include manuals with the minimum mandatory content. The TİTCK later published the Guidelines in July of 2017, setting out the main principles regarding the minimum content of the information on the packages and manuals, as well as the explanations thereof. For more information on the Regulation and the Guidelines, please see our previous alerts dated May 10, 2017 and July 27, 2017.

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 and take the necessary steps to ensure compliance.