2. Product Categories
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Ingredients Regulation Overview for Ingredient Manufacturers
Vietnam


This section provides the regulatory definition of the ingredients' categories in scope.

2.1 Pharmaceutical Product

Drug means a preparation containing a pharmaceutical ingredient or medicinal materials for the purpose of prevention, diagnosis, cure, treatment, or mitigation of human diseases or modification of physiological functions of the human body. Drugs include pharmacochemical drugs, drugs made from medicinal materials, traditional drugs, vaccines, and biological products. 

Drug materials are components forming a drug, including pharmaceutical ingredients, medicinal materials, adjuvants, and capsules used in the course of drug manufacture.

Pharmaceutical ingredient (also called active ingredient) means a substance or mixture of substances used to manufacture a drug and having pharmacological effects or direct effects in the prevention, diagnosis, cure, treatment, or mitigation of disease or in the modification of physiological functions of the human body.

2.2 Health Supplement

A health supplement is any product that is used to supplement a diet and to maintain, enhance, and improve the healthy function of the human body and contains one or more, or a combination of the following:

  1. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances;
  2. Substances derived from natural sources, including animal, mineral, and botanical materials in the forms of extracts, isolates, concentrates, and metabolites;
  3. Synthetic sources of ingredients in a) and b).

Health supplements are considered food in Vietnam. 

2.3 Veterinary Drugs

Veterinary drugs are substances or compounds including medicinal products, vaccines, bio-preparations, microorganisms, and chemicals that are permitted to be used for animals for prevention, treatment, diagnosis, rehabilitation, and/or improvement of growing and reproductive functions of animals.

2.4 References

1. Law on Pharmacy 2016 (Law 105/2016/QH13)

https://faolex.fao.org/docs/pdf/vie178850.pdf


2. Law on Food Safety

https://faolex.fao.org/docs/pdf/vie99786.pdf


3. Law on Veterinary Medicine 2015 (Law 79/2015/QH13)

https://faolex.fao.org/docs/pdf/vie168546.pdf



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