Guide to Health Supplements Registration in Vietnam

In comparison to other countries, the Vietnamese health product market started to boom quite late. It was in the 1990s when the first imported products entered Vietnam with the majority of products imported from the United States, China, South Korea or Belgium.

Now, with the growing nation’s demand for health-related as well as personal care products, the market is seeing a rapid increase every year.

This article provides an essential overview of what foreign investors, entering the health supplement market in Vietnam, should be aware of in order to succeed from the very first step of health supplements registration.

Related article: Vietnam Import Export: Your Simple Guide to Customs Procedures

Legal Background

The competent authority for health supplements and health food products in Vietnams is the Vietnam Food Administration (VFA) under the Ministry of Health (MoH). This authority is not only responsible for collecting and approving registrations of investors who intend to sell their health supplements in Vietnam, but also for the issuance of related regulations.

Earlier this year (February 2018), VFA announced and updated the Guidance on the Implementation of a Few Articles of the Food Safety Law. The authority also set out a food safety audit and inspection responsibilities for agencies.

What Does It Mean ‘A Health Supplement’ in Vietnam?

Products that humans eat or drink are considered food without any restrictions based on their forms such as fresh, raw, processed or preserved. However, medical products, tobacco or cosmetics are excluded from this definition.

Furthermore, there are several sub-definitions of different kinds of food such as nutritional food, genetically-modified food (GMOs), fresh food, functional food, irradiated food or even packaged food.

Functional food defines food that is used to enhance and support human body functions and to provide nutrition in order to minimise pathogenic risks to the body. Importantly, health supplements are considered one of the functional foods.

How to Register Health Supplements in Vietnam?

Before we get to the registration process itself, let us specify several requirements with which entrepreneurs who want to register their health supplements in Vietnam must comply.

Labelling

On top of the standard regulations, the following are the key requirements for labelling health supplements in Vietnam:

• A product must be specified, and its label must include a specific phrase for the product’s sub-group such as health supplements.
• A label must display the nutrient contents such as quantity of vitamins, minerals, enzymes, fatty acids, amino acids or biological substances.
• ‘This product is not a medicine, nor effective to replace medicine’ statement must be printed on a label after its effects or recommendation if any.
• In case a product name of a health supplement happens to be the same as one of its main ingredients, the label must specify the ingredient’s quantity.

Safety and Hygiene

In order to get your products licenced and be able to sell them on the Vietnamese market, the conditions on health, safety and hygiene must be met.

Specifically, all firms and product owners must obtain The Certificate on Satisfaction of Standards on food hygiene and safety. Hygienic Environmental Requirements further state that workshops or stores, processors, importers, equipment, any premises used for production, storage, sales and services must be well-maintained and constantly improving.

The establishment’s owner and all employees from production to sales who have direct contact with health supplements must go through regular health checks to ensure their current health conditions meet the standards given by MoH.

On top of that, a training certificate is a required document for these employees. This is to make sure that they fully understand the processes and requirements for food safety and hygiene.

Application Dossier

As health supplements are one of the sub-categories of food, businesses that produce and distribute health supplements in Vietnam must submit so-called product self-declaration, also known as product declaration registration, to MoH.

Registration Procedure

The process of health supplement registration usually takes 4 weeks from the dossier submission. Noticeably, once approved, the certificate issued by MoH does not have a specific termination.

For imported health supplements, the mandatory documents include:

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

Consult the Professional

Health supplements registration is not a task that should be underestimated as it determines your future success on the Vietnamese market. Consult the professionals, contact Cekindo in Vietnam and we will get back to you with a free quotation and assist you during the whole procedure.