In recent weeks, the Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) published the Draft Guideline on the Application for New Health Claim and the Draft Guideline on the Packaging Information and Readability of Foods for Special Medical Purposes.
Please click on the relevant link below for our specific notes regarding the recent developments:
What Does the Draft Guideline on the Application for New Health Claim Bring?
On 7 June 2022, the TİTCK published the Draft Guideline on the Application for New Health Claim. The guideline regulates the procedures and principles regarding the new health claim applications to be submitted in accordance with the Draft Regulation on the Use of Health Claims.
Stakeholders can submit their opinions to email@example.com until 24 June 2022.
As per the guideline, applications must be submitted for a single relationship between a declared effect and a nutrient, other components, food or food group. The applications must specify the type of health claim and the justification regarding the data that cannot be presented.
Applicants must submit information regarding the food component, food or food group subject to the health claim such as the source, physical and chemical properties, description, nutrient content and the factors that may affect the absorption or use of the ingredient in the human body. Applicants must also submit a summary of the data obtained from appropriate studies that support the declared effect, as well as other summaries and general evaluations set forth in detail in the guideline to the TİTCK.
Applications must include all human and nonhuman studies whether published or supportive of the declared effect, except the resources for consumers or the public and the articles that did not pass peer review. Study results should be presented in the hierarchy according to study type and relative strength of evidence, as shown in the guideline. In addition to the offer on the expression of the health claim, information such as the target audience of the statement, the amount of nutrient required to fulfill the declared effect, the consumption method and the nutrients to be avoided should also be provided.
What Does the Draft Guideline on Packaging Information and Readability of Foods for Special Medical Purposes Regulate?
On 7 June 2022, the TİTCK published the Draft Guideline on Packaging Information and Readability of Foods for Special Medical Purposes based on the Draft Regulation on Foods for Special Medical Purposes. The guideline regulates the procedures and principles regarding packaging information and readability in license applications of foods for special medical purposes (ÖTAG).
Stakeholders can submit their opinions to tıbbi.firstname.lastname@example.org until 27 June 2022.
As per the guideline, the phrase “Food for Special Medical Purposes” must be clearly displayed on the ÖTAG packaging. The guideline exemplifies and regulates the names that can be given to ÖTAG and the order of the information to be provided, in detail.
ÖTAG components should be presented in decreasing order according to their amounts. The source, structure and composition information of the components, such as protein, fat, carbohydrate and fiber, should be provided on the packaging. The guideline also sets forth in detail the rules and provides examples regarding the energy and nutritional elements table. In this context, energy values should be specified as kilojoules or kilocalories and the ratio of contents such as carbohydrates, fat, protein and fiber to energy should be presented as a percentage.
The guideline regulates and exemplifies in detail the presentation of information such as the intended use of ÖTAG, warning information on special use, preparation instructions, storage conditions, the license holder and serial number.
The guideline sets out the rules regarding print size and type, layout and design of the information as well as the style of expression and the use of symbols on the inner and outer packaging of ÖTAG. Applicants must ensure that the packaging information complies with the guideline prior to applying to the TİTCK.
The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the guidelines and take the necessary actions to ensure compliance.