Regulatory & Compliance

DRAFT GUIDELINE ON PACKAGING INFORMATION AND READABILITY OF FOODS FOR SPECIAL MEDICAL PURPOSES HAS BEEN PUBLISHED

“Draft Guideline on Packaging Information and Readability of Foods for Special Medical Purposes” (“Guideline”), which legislation work continues, has been published on the website by Turkish Medicines and Medical Devices Agency (“Agency”) on 07.06.2022. In this letter, we will share some basic information regarding the content of the aforementioned Guideline.

WHAT ARE THE PURPOSE AND THE SCOPE OF THE GUIDELINE?
The purpose of the guideline is to determine the procedures and principles regarding work to be carried out concerning packaging information and readability in license applications of foods for special medical purposes.
The aforementioned Guideline consists of foods for special medical purposes which were industrially prepared and real persons or legal entities who have applied for or been granted a license for them.

WHAT DOES THE GUIDELINE REGULATE?
Draft Guideline on Packaging Information and Readability of Foods for Special Medical Purposes is constituted in two parts. The first part of the Guideline includes regulations regarding Packaging Information of Foods for Special Medical Purposes. The second part of the Guideline provides regulations regarding the Readability of Packaging Information. Some of the regulations provided in the aforementioned Guideline are briefly as follows;

Regulations On Packaging Information Of Foods For Special Medical Purposes And Information On Food For Special Medical Purposes;

  • The phrase “Food for Special Medical Purposes” (“ÖTAG”, derived from the Turkish version of this tem) must be clearly displayed and readable on a visible part of the package.
  • The name of the Food for Special Medical Purposes which forms a basis for license accepted by the Agency must include the name of ÖTAG and information regarding flavor, package
    quantity, and presentation form, if available.
  • The name of ÖTAG may be either the name of ÖTAG's license holder or the name given together with the trademark, or the name of ÖTAG's license holder or one of the scientific
    names given with the trademark.
  • Detailed information must be provided regarding the issues such as protein, fat composition, carbohydrate source, and fiber source contained in ÖTAG.
  • The age or age group in which ÖTAG will be used and cannot be used must be indicated.
  • Information regarding storage condition sand, if applicable, special storage conditions must be provided.
  • This part also regulates many issues including the rules regarding energy and nutrients elements table, information on the intended purpose of foods for special medical purposes and the name and address of the license holder, serial number, expiration date, symbols and other information.

Regulations on Readability of Packaging Information;

  • An easily readable font type font should be chosen.
  • The components that need to be especially emphasized (for instance; allergenic ingredients) must be expressed in bold fonts.
  • Special Emphasis should be given to the spaces between lines and the use of white space to increase the readability of the information presented.
  • An active expression style should be used instead of a passive voice. (For instance; instructions should be phrased as “Consume 2-3 bottles“ instead of “2-3 bottles should be consumed”)

    CONCLUSION

Draft Guideline on Packaging Information and Readability of Foods for Special Medical Purposes is supported by various examples to guide the practitioners. Stakeholders can submit their opinions to be evaluated by the agency via the email address  tıbbi.beslenme@titck.gov.tr . We hope that this Guideline will be helpful to all companies operating in the health sector.

Feyza Gülseren

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