Guidelines on Packaging Information and Instructions for Use of Pharmaceuticals have been Updated

On June 11, 2024, the Turkish Medicines and Medical Devices Agency (“Agency”) announced on its official website that the “Guideline on the Packaging Information and Instructions for Use of Medicinal Products for Human Use”, “Guideline on the Readability of the Packaging Information and Instructions for Use of Medicinal Products for Human Use” and “Guideline on Excipients in the Packaging Information and Instructions for Use of Medicinal Products for Human Use” have all been amended.

Pursuant to the Guideline on Packaging Information and Instructions for Use of Medical Products for Human Use, the name of each medicinal product for human use for which a marketing authorization has been applied or granted must be chosen in such a way as to avoid any confusion with the name of any other medicinal product for human use. With the amendment to the Guideline, the exception to this rule has been removed.

In the previous version of the Guideline, the name of a medicinal product for human use could be used by a different applicant/marketing authorization holder, provided that the trademark owner consented, and the indications of the products were the same but the strengths were different.

From now on, it will not be possible to use the same trademark on products with the same indication and different strengths, even with the consent of the trademark owner.

According to the Guidelines, the name of a medicinal product for human use may be one of the following:

• — A name invented to avoid confusion with the common name of the medicinal product for human use,
• — The name of the marketing authorization/permit holder/licensor of the medicinal product for human use or the common name with the trademark,
• — The name of the marketing authorization/permit holder/licensor of the medicinal product for human use or the scientific name with the trademark.

Within the scope of the amendment made to the Guideline on the Readability of the Packaging Information and Instructions for Use of Medicinal Products for Human Use, a provision for positioning the "QR" letters in Braille on the multimedia QR code in order to indicate the location of the QR code on the outer packaging of the medicinal product for the visually impaired and the update date of the instructions for use in a specific sentence format in Braille were added.