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July 4, 2023

Practical Law: Life Sciences Regulation in Vietnam 2023

Practical Law Company

Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world.

The Life Sciences Global Guide is divided into two sections: Commercialization (see more details here) and Regulation, which covers the following topics:

  • Pharmaceuticals: Laws and regulatory authorities
  • Clinical trials: Legal, regulatory, and procedural requirements
  • Manufacturing and distribution
  • Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations
  • Data privacy
  • Packaging, labeling, and tracking
  • Biological medicines
  • Medical devices: Legislation and regulatory authorities, definition and classification
  • Healthcare IT
  • Combination products and borderlines
  • Natural health products
  • Recent developments and reform proposals

Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas.

The full “Life Sciences Regulation in Vietnam” section can be found on the Practical Law website.

RELATED INSIGHTS​ 

March 7, 2023
According to the Ministry of Health of Vietnam, many healthcare facilities in the country are facing a shortage of drugs, medical devices, and materials/chemicals. To address the urgent needs of medical examination and treatment in public healthcare facilities, on March 4, 2023, the government of Vietnam promulgated Resolution No. 30/NQ-CP on continuing to implement solutions to ensure the availability of drugs, medical equipment, and healthcare supplies (“Resolution 30”). Resolution 30 amends item 4 of Resolution No. 144/NQ-CP dated November 5, 2022, allowing medical examination and treatment expenses to continue to be covered by health insurance for technical services carried out with medical devices supplied by contractors after winning tenders to supply materials and chemicals. The new mechanism brings more benefit to patients by removing the previous ending date of November 5, 2023, and will be applicable until there is further guidance from the government. Resolution 30 also allows the use of medical devices that were donated or gifted by domestic and foreign entities (including those that were provided under now-expired joint ventures or cooperation contracts) regardless of whether those entities have fulfilled the procedures for ownership establishment. Technical services that are performed by such devices will be covered by health insurance. This provision will help address the shortage of medical devices used in public hospitals. The determination of bid price is also a highlight of Resolution 30, which pilots a simpler price determination procedure for the purchase of drugs and medical devices. Instead of requiring purchasers to obtain quotations from three suppliers, Resolution 30 allows them to compare prices based on the quotations actually received, even from only one or two suppliers. Alternatively, price determination can be based on the winning bid price for a similar medical device procurement package that was awarded within the last 120 days. This
February 21, 2023
On December 28, 2022, the Ministry of Health of Laos issued Decision No. 3789/MOH on the Control of Hemp for Medication and Products (the “Decision”). The Decision approves the regulated cultivation, extraction, production, processing, storage, distribution, utilization, import-export, and transport of hemp. The Decision also authorizes the use of hemp and hemp-related products by the general population, although use of certain products is limited to those with medical prescriptions. Background In 2019, the Lao government established an ad hoc committee to consider the legalization of cannabis, as reported previously. The government permitted certain local companies to grow cannabis in specific zones under pilot programs, although it continued to strictly prohibit the use and commercialization, as well as consumption, of cannabis-related products, regardless of the level of psychoactive tetrahydrocannabinol (THC) in the products. Overview of the Decision The Decision was issued by the Ministry of Health (which led the ad hoc committee) and permits authorized companies to engage in certain activities involving the use of hemp and the consumption of hemp and hemp-related products. The Decision defines hemp (“porkeo” in Lao) as a “plant that belongs to the same family as ganja and bears the scientific name Cannabis Sativa L. (Cannabis sativa L. subsp. sativa var. sativa) which is a subspecies of ganja (Cannabis Sativa L.).” This definition aims at differentiating hemp from the general definition of ganja or marijuana, which continues to be listed as a prohibited narcotic in Laos. The Law on Narcotics (2007) and the Penal Code (2017) still prohibit the production, trade and use of all types of cannabis. These laws will need to be amended to ensure that they are aligned with changes set out in the Decision.  Authorized Hemp Activities The Decision allows approved companies to engage in the cultivation, extraction, production, processing, storage,
February 9, 2023
Vietnam’s Ministry of Finance is drafting a circular on determining the origin of imported and exported goods. This circular, a draft version of which has been released for public comment (“Draft Circular”), consolidates prevailing regulations and guidelines on determining the origin of imported and exported goods that are stipulated in the following legal documents, which the Draft Circular would replace when it comes into effect: Circular No. 38/2018/TT-BTC dated April 20, 2018, of the Ministry of Finance regulating the determination of origin of imported and exported goods, as amended by Circular No. 62/2019/TT-BTC dated September 5, 2019, of the Ministry of Finance; Circular No. 47/2020/TT-BTC dated May 27, 2020, regulating the time to submit documents proving the origin of goods and form of the documents proving the origin of imported goods applied during the Covid-19 pandemic; and Circular No. 07/2021/TT-BTC dated January 25, 2021, regulating the time to submit documents proving the origin of imported goods under the EU-Vietnam Free Trade Agreement (EVFTA). Generally speaking, the Draft Circular does not increase the administrative procedures for importers and exporters, but rather seeks to codify the recent practices implemented by the customs authorities. The Draft Circular focuses on providing comprehensive guidance for importing/exporting companies when carrying out administrative procedures to certify the origins of imported and exported goods to be in line with current trade practices and international commitments under new-generation free trade agreements. In particular, the Draft Circular supplements guidelines on declaring origins and submitting Certificates of Origin (C/Os) of imported goods under the EVFTA and the Regional Comprehensive Economic Partnership Agreement (RCEP). The Draft Circular also provides some new guidelines to facilitate exports (and imports) and overcome some obstacles and issues when implementing the prevailing regulations. For example, the submission of C/Os online, which was only applicable during the
January 27, 2023
The opening weeks of 2023 have already seen a sharp increase in enforcement against violations of product labeling and advertising rules in Cambodia, in line with a notice issued by the country’s Directorate-General for Consumer Protection, Competition, and Fraud Repression (CCF) last year. Since the Law on Consumer Protection was adopted in 2019, a major legislative push has been seen, with general rules coming out focusing on providing consumers with sufficient information on products and services, for example via product labeling or advertising rules. Then, more detailed regulations were adopted for specific product categories, for example for food products and cosmetics. Khmer language requirements have been a key feature of the recently adopted rules on advertising and labeling. Despite the Khmer language mandates in consumer protection laws and regulations, enforcement and compliance was low. Most products on the market—especially imports—did not comply with the language requirement. In line with the revamped regulatory framework, the CCF has increased its enforcement, enabled by recent substantial budget increases. They have adopted clear implementing regulations for their officers to enforce in a practical yet effective manner, and they have been issuing notices reminding companies to comply with the new rules. A September 2022 notice announced that increased CCF enforcement of product labeling rules would start on January 1, 2023. As noted above, this has already proven to be true, and enforcement is now proceeding in earnest. Companies should take heed of this notice and ensure compliance with the Khmer language requirements (detailed below), as the CCF has shown that it readily acts against violators, from small retailers to large conglomerates. Khmer Language Requirement A sub-decree issued November 4, 2022 requires all commercial advertising of products and services—by any channel—to use Khmer as the primary language. If foreign-language text is used in advertisements, it