Health Supplement Registration in Vietnam: Know How and What to Do

In line with the desire the improve the living standards, the demand for health care products in Vietnam has grown tremendously in the last couple of years. With regards to health products, Vietnam was rather late in welcoming them, compared to other countries in the world. Only during the 1990s that health products finally made their way to the Vietnamese market. The majority of these products were imported, mainly from the United States, China and South Korea. Given this situation, Vietnam still largely depends on imported health products in general.

Based on statistics, currently there are approximately 4,000 companies in Vietnam, both local and foreign, that sell health products, with a total of over 10,000 varieties. As mentioned above, foreign brands are still dominating the market with target consumers coming from middle and upper classes. These health products are mostly sold in pharmacies, retail stores as well as health stores.

If you are interested in penetrating the health supplement market in Vietnam, you need to pay attention to important details. This article provides you the ultimate guide you need to succeed in starting your business in the health supplement sector.

Competent Authority

Vietnam Food Administration under Ministry of Health (MOH) is the competent authority for health supplements and health food products.

Regulations Framework

If you want to sell health supplements in the market, you are required to register them with the authority and submit your application to the Vietnam Food Administration.

Types of Food

Products that human beings eat and drink, be it fresh, raw, processed or preserved, are considered food. Several sub-definitions of different kinds of food exist too. Nutritional food, fresh food, genetically-modified food, functional food, irradiated food, packaged food and even street food belong to the latter.

Among the different types of food, functional food is food that can enhance and support the functions of human body and provide nutritional effects to reduce pathogenic risks in the body. Health supplement, then, is defined as a type of functional food.

Latest Announcement

Vietnam Food Administration (VFA) announced on February 2, 2018 that Decree 15/2018/ND-CP in regards to Guidance on the Implementation of a Few Articles of the Food Safety Law will replace the previous Decree 38/2012/ND-CP and Article II of the Joint Circular 13/2014/TTLT-BYT-BNNPTNT-BCT, effective immediately. The authority will also set out food safety audit and inspection responsibilities for agencies.
In addition, the new regulatory outline will include issues including food product advertising and labeling, packaged food self-declaration procedures, specialized products registration (children’s food, GMO products), food safety certificate, as well as requirements for food manufacturing and trading.

Registration Requirements

Labeling

MOH’s Circular 43/2014/TT-BYT of 2014 that became effective in February 2015 is the key legislation for the labeling of functional food Circular 43 entering into force on 01 February 2015.

The labeling of these products must comply with the requirements set out by MOH. Moreover, it is mandatory to meet all the following requirements:

• Product label must show specific phrase for product's sub-group such as health supplement, supplemented food, special food for medical purposes, and food for special dietary use.
• The label must also display nutrient contents, such the quantity of vitamins, minerals, amino acids, biological substances, enzymes and fatty acids..
• "This product is not a medicine, nor effective to replace medicine" statement must be printed. The statement is required to have a contrasting font color to the label's background color. In addition, the font size must be at least 1.2 mm high.
• If health supplement product name happens to be the same as one of the main active ingredients, this ingredient quantity must be listed on the label.

Safety and Hygiene

All firms and product owners who want to manufacture and trade health supplements are required to fulfill conditions on health, safety and hygiene in order for products to be licensed and sold. The Certificate on Satisfaction of Standards on food hygiene and safety must be obtained and all standards concerning health, safety and hygiene must be maintained and improved as long as the business is valid. Such maintenance applies to workshops or stores, processors, importers, equipment, any premises used for production, storage, sales and serve, according to Hygienic Environmental Requirements.

The owner and all employees from the stage of production to sales who will have direct contact with the health supplement have to go through a periodic health check-up to ensure that their health conditions satisfy the standards by MOH. A training certificate is mandatory as well for owner and employees to make sure they fully understand the requirements for food safety and hygiene, and will perform their jobs in accordance with these regulations.

Application Dossier

Health supplements are food and thus producers and businesses that produce and market health supplement in Vietnam must submit product self-declaration or product declaration registration to MOH, pursuant to Article 6.1, 8.1.a of Decree No. 15/2018/ND-CP.

Registration Procedure

The registration process of health supplement dossiers takes 3 to 4 weeks to complete upon submission. Once approved, the certificate is issued by MOH and does not have termination.

For health supplement imported to Vietnam, the required documents are:

• Declaration form
• Original notarized copy of food safety testing result of product issued within 12 months before the date of submission made by a designated laboratory or a laboratory complying with ISO 17025
• Scientific evidence of the effects of product or ingredients (original or authenticated copy). If scientific evidence of effects of ingredients is used, daily dose must be greater or equal to 15% of the content of such ingredients mentioned in the document
• Certificate of Good Manufacturing Practice (GMP) or an equivalent certificate. This is applicable starting 01 July 2019 (authenticated copy)

If you have any needs or questions, please feel free to contact service@cirs-group.com.

Original article from Cekindo