Recent Development
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”). The updates concern the requirement to include animal sources in product manuals.
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 certain mandatory information.
In July of 2017, the TİTCK published the Guidelines setting out the main principles regarding certain mandatory information on the packages and manuals, as well as the explanations about the content and use of the relevant product. The TİTCK regularly updates the Guidelines to ensure harmonization with the applicable Turkish and EU legislations, as well as the current standards. For more information on the Regulation and the Guidelines, please see our previous alerts dated July 27, 2017 and October 4, 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.
