The Guide on Packaging Information and Readability of Package of Foods for Special Medical Purposes Entered Into Force

On 23.06.2023, The Guide on Packaging Information and Readability of the Package of Foods for Special Medical Purposes was published on the website of the Turkish Medicines and Medical Devices Agency. The Guide is prepared in accordance with the Regulation on Licensing of Foods for Special Medical Purposes, which entered into force by being published in the Official Gazette dated 28.01.2023 and numbered 32087 (“Regulation”).

The Guide includes provisions that exemplify and elaborate further the regulations set forth by the Regulation.

• For instance, subjects that are regulated under general provisions in the Regulation such as name of the product and its placement on the package, list of ingredients and details to be indicated in the list, table of energy and nutrients and the composition of the table are regulated in detail in the Guide and examples concerning different ingredients have been provided.
• In addition to these provisions, the Guide set forth the obligation that the intended use of foods for special medical purposes should be indicated on the package, together with information on the specific composition of these foods, the target age group, and the amount of use.
• Similarly, the package of foods for special medical purposes should include warnings concerning the specific use of the food, instructions for preparation, method of use and storage conditions. In addition, the expiration date and shelf life must also be indicated.
• Information on the licensee, place of manufacture, license number and serial number should also be included on the packaging.
• According to the Guide, except for the elements that may be deemed as incentive or promotional, symbols or diagrams to clarify other information that may be useful for patients and that are compatible with the packaging information may be placed on the packaging upon submission to and approval by the Turkish Medicines and Medical Devices Agency.
• The final provisions of the Guide includes regulations on the design and technical details regarding the readability of packaging information.

With its detailed provisions and related visual and written examples provided, the Guide may eliminate many uncertainties that may arise in practice. Due to this reason, the Guide is a comprehensive reference source for real persons and legal entities who will apply for or hold a license concerning foods for special medical purposes.

You can access the full text of the Guide on Packaging Information and Readability of Package of Foods for Special Medical Purposes through this link (Only available in Turkish)