Dietary Supplements Registration
Registration and certification of dietary supplements is an important step for manufacturers and distributors working in the field of food products and biologically active supplements. Every year, attention to the quality and safety of food products, including dietary supplements, is increasing, and regulatory requirements are becoming more stringent.
In the process of registering and certifying dietary supplements, many aspects are taken into account, including composition, properties, safety and labeling requirements. The legal consultants of Dextra Law company will help ensure compliance with all regulatory standards and requirements so that your dietary supplements are ready to enter the market with the highest standards of quality and safety.
What are dietary supplements, what types are there, and what falls under this criterion
Dietary supplements are products that can be added to daily nutrition to supplement the diet or provide additional beneficial substances. Depending on the manufacturing process and raw materials, dietary supplements can take various forms and types:
- concentrates of naturally occurring nutrients: beekeeping products, mumiyo, yeast, algae, fish caviar, mineral salts and others;
- traditional spices, herbs and tea blends;
- fortified foods;
- concentrates of nutrients and plants: extracts, tinctures, syrups, pastes, briquettes, balms and other products containing beneficial substances and plant extracts;
- standardized extracts and vitamin preparations;
- products obtained using bioengineering.
Depending on their functional role and effects, dietary supplements can be divided into several categories:
- Nutriceuticals. Are a source of nutrients such as vitamins and essential amino acids.
- Parapharmaceuticals. Substances that perform adaptogenic functions, provide prevention of pathogenic conditions, and are used as auxiliary agents to regulate the functional activity of human organs and systems.
- Eubiotics and probiotics. Contain live microorganisms such as bifido- and lactobacilli that have a positive effect on human health and immunity.
Dietary supplements are available in various forms including capsules, tablets, powders, liquids and others. Products in this group are regulated by various legislative standards and bodies in different countries, and requirements for their registration and certification may vary. It is important to comply with all requirements and standards to ensure the safety and quality of dietary supplements before placing them on the market.
Required Documents
Dietary supplement registration in Ukraine is a complex process that requires close attention to detail and compliance with all legal requirements. To carry it out, a package of the following documents must be prepared:
- Registration application indicating information about the manufacturer and distributor of the product.
- Technical product description: information on the composition of the dietary supplement, production methods, dosage, application and methods of use.
- Documents confirming the safety of the product, for example, results of clinical trials, toxicological data, etc.
- Dietary supplement license and certificates.
- Sample labeling and packaging containing information on composition, dosage, application, and possible warnings.
- Manufacturing documents.
- Patents and intellectual property: If there are patents or other intellectual property rights associated with the product.
- Documents confirming the integrity of the packaging.
- Documents confirming the stability of the product during the shelf life.
- Statement on the right to use intellectual property objects.
What is the cost and timing of the service
In accordance with Ukrainian legislation, the process of registration and certification of dietary supplements can take from 6 months to 1 year. The cost varies, taking into account the scope of work and services. Dextra Law offers affordable prices for services. Our employees will help you:
- develop Technical Conditions for dietary supplements;
- conduct laboratory research and obtain a protocol;
- certify dietary supplements of Ukrainian and foreign production;
- agree on a draft labeling for dietary supplements;
- obtain scientific reports on dietary supplements;
- determine the UKTZED code (HS code) for import and export.
Dextra Law Advantages
The Dextra Law team has deep knowledge in the field of dietary supplement certification, which allows effectively managing the process and preventing unnecessary delays. Thanks to experience and knowledge, our specialists will provide the necessary legal support to obtain dietary supplement licenses. Our advantages:
- experience and competence;
- individual approach;
- efficiency;
- consistency;
- information support;
- minimizing the risks of violations and discrepancies.
