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June 28, 2018

Vietnam Prime Minister Issues Directive on Combatting Pharmaceutical and Cosmetics Fakes

On June 19, 2018, Vietnam’s prime minister issued Directive No. 17/CT-TTg on strengthening the fight against smuggling, commercial fraud, and the production and trade of fake goods and low-quality goods for pharmaceuticals, cosmetics, and functional foods (Directive 17). Directive 17 states that, while tens of thousands of cases have been discovered and handled, the situation still needs improvement, as infringers are using more complex methods and are located not only in urban areas, but also in many remote regions.

The prime minister implores the relevant ministries and authorities to redouble their efforts and be more aware and proactive. It is noted that, in the age of the Internet, products are broadly advertised online, and although consumers can access a wealth of information on health products, that information is often inaccurate. This leads to an urgent situation where products can have dangerous effects on health and the market.

To rectify the situation, the prime minister assigned the relevant authorities to undertake several urgent tasks. For example, the Ministry of Health was tasked to:

  • Update relevant legal documents on technical standards and the inspection of pharmaceutical and cosmetics products;
  • Increase the application of technology to control the origin and quality of raw materials; privatize testing services; share information on licensing of products; and cooperate with other relevant authorities to fight against smuggled, low quality, and fake goods; and
  • Increase investigations into activities in the licensing, circulation, advertising, testing, and certification of drugs and cosmetics, and increase ad hoc inspections.

The Ministry of Science and Technology was also tasked to strengthen the handling of IP violations in pharmaceuticals and cosmetics. The Market Surveillance Department (MSD) was specifically requested to conduct a general inspection all over the country into manufacturers of pharmaceuticals, cosmetics, and functional foods and strictly handle violations, including IP infringements. This is a new development as the MSD was previously only entitled to inspect traders and products on the market level, rather than manufacturers. Other tasks were assigned to the Ministry of Public Security, Ministry of Defense, Ministry of Industry and Trade, Ministry of Finance, Ministry of Information and Communications, Ministry of Justice, and Steering Committee No. 389 (in charge of the fight against smuggling and anti-counterfeiting).

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In April 2021, the Vietnamese government made public a draft decree to amend Decree No. 43/2017/ND-CP of the Government dated April 14, 2017, on goods labeling (“Decree 43”), which is the primary legislation in Vietnam on the labeling requirements for domestically circulating goods and imported goods. Some noteworthy differences between the draft and the current Decree 43 include the following: 1. Original labels for imported products For imported goods, the draft adds a requirement on compulsory information for original labels, which is not mentioned in Decree 43. In particular, the original product label for goods being imported to circulate on the Vietnam market must contain the following compulsory information in a foreign language or in Vietnamese before customs clearance: Product name; Name and address of the entities responsible for the products; Product origin or place where the final production stage to complete the product was conducted. (If this information is not presented on the original product label, it must be included in the import documents accompanying the product.) 2. Vietnamese labels for imported products Under the draft, if it is impossible to determine the product origin under rules/guidance on determining product origin in Vietnam, it is acceptable to instead indicate on the product label the place(s) where the final production stage to complete the product was conducted. 3. Nutritional information for food Instead of being optional information as mentioned in Decree 43, “nutritional value” is compulsory information on labels for some food products under the draft. The Ministry of Health will have a roadmap for carrying out nutritional labeling and will provide appropriate guidance to manufacturers and importers, as well as issue regulations on types of food that are partially or entirely exempt from declaration of nutritional value. The draft has not yet been finalized and is subject to