Recent Development
The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently published on its website the Guidelines on the Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use (available here in Turkish). The TİTCK also published opinions submitted by institutions and associations as well as its assessment of these opinions.
Background
Back in April this year, 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 all medicinal products for human use to be provided with a manual containing the minimum mandatory content as described under the Regulation. For more information on the Regulation, please see our previous alert dated May 10, 2017.
What the Guidelines Say
The TİTCK published the following three guidelines on the implementation of the Regulation.
- The Guidelines on Package Information and Manuals of Medicinal Products for Human Use set out the main principles regarding the minimum content of the information placed on the packages and manuals as well as the explanations thereof.
- The Guidelines on the Legibility of the Package Information and Manuals of Medicinal Products for Human Use lay down the technical specifications, including the minimum point size, sequence, placement, use of symbols and images, etc.
- The Guidelines on the Auxiliary Substances in the Package Information and Manuals of Medicinal Products for Human Use establish the auxiliary substances that must be indicated on the package information and manuals.
Conclusion
The TİTCK continues its commitment to providing guidance for companies engaged in pharmaceutical products and medicinal products for human use. Companies, therefore, should closely follow the announcements made by the TİTCK and take the necessary steps to ensure compliance with any recent development that may affect their activities.
