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Dietary Supplements & Sweeteners Registration

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Dietary Supplements

This group of products includes vitamins, minerals, amino acids, vegetal extracts, enzymes, chemical substances such as glucosamine, methylsulfonylmethane, hyaluronic acid, flavonoids, probiotics, and any other nutritional substances intended to complement our daily diet or reduce the risk of developing diseases. Dietary supplements must be marketed in a defined pharmaceutical dosage form as tablets, capsules, powders, pearls, gel capsules, and syrups, among others.

Dietary Supplements Classification
Vitamins Registration

• Vitamin A (retinol)

• Vitamin C (L-ascorbic acid, ascorbate)

• Vitamin D (ergocalciferol, cholecalciferol)

• Vitamin E (tocopherol, tocotrienol)

• B-complex vitamins:  Thiamin (B1), riboflavin (B2), B6, cobalamin (B12), biotin, niacin (B3), folate (folic acid), pantothenic acid

• Vitamin K (menadione, menaquinone)

• Choline

Inorganic Nutrients (minerals) Registration

• Calcium

• Zinc

• Magnesium

• Selenium

• Iron

• Boron

• Chloride

• Copper

• Chromium

• Fluorine

• Phosphorus

Fish Oil & Unsaturated Fatty Acids Registration

• Omega 3 family (ω-3) including linolenic acid, eicosapentaenoic acid or EPA, docosahexaenoic acid, or DHA
• Omega 6 family (ω-6) including linoleic acid and arachidonic acid

Amino Acids Registration

• Aspartic acid

• Glutamine (glutamic acid)

• Citrulline

• Ornithine

• Tyrosine

• Glycine

Essential Amino Acids Registration

• Arginine (L-arginine)

• Threonine

• Tryptophan

• Valine

• Methionine

• Leucine

• Isoleucine

• Lysine

• Phenylalanine

• Histidine and cysteine

Chondroitin & Glucosamine Registration

• Chondroitin sulfate

• Glucosamine sulfate, glucosamine hydrochloride

Spirulina & Blue-green Algae Registration

• Spirulina

Sweeteners

Sweeteners or sugar substitutes are products specifically formulated to give a sweet flavor to food and beverages without calories. This group of products must be consumed orally.

• Saccharin

• Aspartame

• Stevia

• Thaumatin (katemfe)

Manufacturers of dietary supplements and sweeteners must not claim diagnostic, therapeutic, or preventive properties. For example, “reduces high LDL”, “prevents heart disease”, “boosts the immune system”, and the like.

What We Offer

Regulatory Strategy

We will outline the optimal regulatory strategy for your products, according to their intended use.

Assessment

Evaluating technical and scientific documentation issued by the manufacturer.

Registration

Preparing a fully compliant registration dossier and submitting the registration application to DIGEMID.

Follow-up

Follow-up of applications. Replying to inquiries and amendment requirements by DIGEMID reviewers.

Other Services

Medical Devices

Class I, II, III, and IV Medical Devices, electromedical and systems.

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IVD

In Vitro Diagnostics, laboratory equipment, and reagents.

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Sanitary Products

Cosmetics, household hygiene products, and personal care products.

Pharmaceutical

Drugs, herbal products, sugar substitutes and dietary supplements.

Get in Touch

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    Over 15 years of experience will ensure you get the best guidance.