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BALAS TRADING_Getting a health-supplement food license in Vietnam, lessons learned for new faces.

May 15, 2016

Getting a health-supplement food license in Vietnam, lessons learned for new faces.

As Vietnam market becomes increasingly attractive to Thai investors, it is essential to take into accounts proper planning right at initial stage of product registration, or else it may hinder the overall market-entry strategy. This is especially critical for SMEs who are eyeing to enter the lucrative health-related products market of 5.9 billion US dollar in 2018, with annual growth rate of 11% and is expected to reach 7.7 billion US dollars by 2020, according to data from BMI research agency.

Balas Service & Trading Co., Ltd., an Import & Distribution company founded in Vietnam 2018. The company started registering and importing an herbal drink, MORE – Bitter Gourd Juice with Cordyceps from Thailand in December 2018 to launch in 2019 as originally planned.

The product registration processes went well within 2 weeks as MORE was registered as “herbal beverage” like they do in Thailand. The company started introducing the MORE to Vietnam consumers in trade fairs, some local CVS stores and E-commerce platforms.

Confident with initial positive feedbacks from direct consumers, Balas approached the outlets of Vietnam healthcare system, drug stores. The company then realized that it needs a “Health Supplement” license for MORE rather than just “herbal Beverage” license to access healthcare system and carry out PR & advertisement of its benefits properly pertaining to Vietnam laws.

In May 2019, Balas started submitting for Health Supplement (or Functional Food) License. In June 2019, authority officer informed that approval could be on hold due to the “new law” was going to be effective on 1st July 2019. Key changes of the new law is “GMP certificate is mandatory for functional food manufacturing both local and import product”.

Even though MORE’s manufacturer, Moryathai - a long been traditional medicine factory in Thailand (founded in 2006), is certified with FMP (Fundamental Manufacturing Practice) by Food and Drug Administration, Ministry of Public Health in Thailand, it didn’t meet Vietnam requirements of GMP International Codex. The Manufacturer then started implementing GMP Codex in July and received GMP Codex certification in October 2019. While waiting for GMP certification, Balas company anticipated potential issues on product packaging, so the company decided to change the packaging at the same time.

Once all preparations including new packaging and GMP certification were ready, Balas then submitted the application again by mid-October 2019. Everything looked fine till 29 December the company received first rejection of the application.  Comment for rejection was wording in scope of the GMP was not consistent with Vietnam law, not “liquid product” but “herbal beverage” instead.

The company had no way but had to go back to the certified body headquarter in Malaysia, requesting for revision of the wording and reissue the Certificate for the manufacturer. It took few weeks but finally the company got it done and was able to resubmit the application by mid-February 2020.

In total the company received 6 rejections from the second submission till final approval. Reasons for rejection varried but mainly related to changes of wordings. However MORE functional food license (Công bố) was finally published on website of Vietnam Foods Administrations Ministry of Health on 9 April 2020. Consequently, MORE can now be found in many drugstores in Ho Chi Minh city and Mekong provinces, as well as in online healthcare platforms.

Strictly follow applicable laws is our policy but being smart is also crucial for business survival. Therefore, Balas has analyzed and summarized key lesson learned for our improvement and maybe others who might need to go there someday.

Here what we have learned.  

  1. Frequent changes of regulatory requirements is true. Those who think that saying was outdated please reconsider. Rules (both published and non-published) on approval procedures of health-related products are more and more tightened as low-quality products are rampant in the market.
  2. Interpretation of the laws could be dependent on individual reviewer/approvers, which at least 5 persons in the loop. There is no fixed rule. Applicants must be aware of that risk; best is trying to follow predecessors’ practice as much as possible. Trying to be creative or be the first may lead to more cost and time.
  3. Things considered “common” elsewhere could be extremely serious in Vietnam such as consistency of writing in document sets. Particularly for product name, manufacturer name, address, etc. For example, Ho Chi Minh City, TP. Ho Chi Minh, HCMC, Ho chi minh city maybe considered different words; big or small cap, backspace, abbreviation, all must be QC checked seriously before submission. It might take a long time to prepare but rejection because of this reason would be more headache.

Crucial set of documents are Certificate of Free Sale (CFS), Packaging of product, GMP Certificate, Letter of Authorization. Common issues from Thailand was “inconsistent spelling”, which often found in documents issued from different organizations especially the “address”.

  1. In Vietnam, benefits of food supplements can be advertised. Therefore, scientific research supporting claimed benefits must be proven and translated into Vietnamese language. The supporting research must be properly done, published by trusted institutions. Best to find ones that already available in Vietnamese database if not it would be consuming considerable time for officer to review. Beware that one product may not be able to claim all benefits the product can do, authority officer will recommend (allow) only those he or she found appropriate, normally 2-4 are considered great.