Expert Dietary Supplement and Specialized Nutrition Product Registration Services

At our law office, serving Serbia and the broader Balkan region, we have successfully registered a vast array of:

1. Dietary products, including starter and transitional formulas and foods for special medical purposes,

These products are typically defined and regulated under the broader category of foodstuffs, with specific subcategories for each type of product. The definitions are usually in line with European Union regulations and standards, as Serbia harmonizes its laws with EU directives as part of its integration process. Here’s a general overview of how these categories might be defined:

1. Dietary Products: These are often referred to as foods for particular nutritional uses or special dietary uses. They are intended to meet particular dietary requirements which cannot be met by normal foods. They might be designed for certain medical conditions or specific stages of life.
2. Starter and Transitional Formulas: These are infant formulas designed for the dietary management of babies and young children. Starter formulas are typically for newborns and infants up to 6 months, while transitional or follow-on formulas are for infants from 6 months to a year old, usually introduced as part of a mixed diet.
3. Foods for Special Medical Purposes (FSMP): These are foods created to meet the nutritional requirements of individuals with certain disorders, diseases, or medical conditions. They are intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods.

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1. Supplements

In Serbian legislation, dietary supplements are typically defined and regulated as a specific category of products. They are usually described as products intended to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect.

The 5 key characteristics of supplements as defined in Serbian legislation often include:

Supplement Composition: Dietary supplements may contain vitamins, minerals, amino acids, essential fatty acids, fibers, various plants, and herbal extracts. They are meant to provide nutrients that might not be consumed in sufficient quantities in a person’s regular diet.

Form of the Supplements: These products are commonly available in forms such as capsules, tablets, liquid, powder, etc., and are meant to be taken in measured small unit quantities.

Labeling and Marketing: Supplements must be properly labeled and cannot be marketed with claims of preventing, treating, or curing human diseases. The labels should provide clear instructions on the recommended daily consumption and warnings about exceeding the stated dose.

Regulatory Oversight: In Serbia, dietary supplements are regulated by the Ministry of Health, and they must comply with national regulations that are in harmony with EU directives. This means that supplements must be safe for consumption, properly labeled, and their production and distribution must meet certain quality standards.

Registration and Approval: Before being placed on the market, dietary supplements usually need to go through a registration or notification process with the relevant health authorities to ensure compliance with health and safety standards.

We offer comprehensive support throughout the three crucial steps of the registration process:

1. Documentation Preparation and Submission: Our team expertly handles the preparation and submission of documents required for obtaining professional opinions, categorization, and label approval.

In particular:

• Professional Opinions refer to gathering and presenting scientific and technical data to support the safety and efficacy of the product. It may include clinical studies, scientific literature, and details of the manufacturing process.
• Categorization refers to determining the appropriate category for the product based on its ingredients and intended use. This step is crucial as it affects the type of regulatory oversight and labeling requirements.
• Label Approval refers to preparing labels in accordance with Serbian regulations. Labels must include necessary information like ingredients, nutritional information, recommended usage, warnings, and any claims about the product. These labels must be reviewed and approved by the relevant regulatory body.

1. Health Institution Compliance Reporting: We facilitate the process of obtaining a health institution’s report on the safety and compliance of your dietary product.

This typically concern the following two matters:

• Safety and Compliance Report: Obtaining a report from a recognized health institution or a certified laboratory that verifies the product’s safety for consumption and compliance with established standards. This report may involve laboratory testing of the product to confirm that it meets health and safety guidelines.
• Quality Assurance Documentation: Providing evidence of quality control processes and certifications, ensuring the product is manufactured, stored, and transported under conditions that maintain its quality and safety.

1. Registry Completion and Ongoing Communication:

   • Seamless interaction with the Ministry of Health: Regular communication with the Ministry of Health or the designated regulatory authority to ensure all requirements are understood and met. This might involve responding to queries from the ministry or attending meetings.
   • Meticulous dossier preparation and entry into the Dietary Product Register: Creating a comprehensive dossier that includes all necessary documentation, such as product formulas, safety reports, labels, and manufacturing details. This dossier is then submitted for entry into the Serbian Dietary Product Register.
   • Handling amendments and renewals in the register to maintain compliance: Monitoring the product’s status in the register and making any necessary updates or renewals. This could include changes to the product formula, packaging, or labeling, and must be reported to the regulatory authorities to ensure ongoing compliance.

With our expertise in navigating the complex regulations surrounding dietary supplements and specialized nutrition products, we ensure a smooth, hassle-free registration process. Let us guide you through every step, ensuring your product not only meets the regulatory standards but also stands out in the market.

Choose us for a streamlined journey to product registration and market success in the dietary supplement and specialized nutrition industry.