You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

December 7, 2020

New Decree on Administrative Penalties in Vietnam Healthcare Sector

Subscribe to Updates
Informed Counsel

Vietnam’s efforts against the outbreak of COVID-19 in the country have been largely successful, and despite two distinct spikes of local transmission, in both cases the spread was halted relatively quickly. As these complications from the COVID-19 pandemic have been playing out in Vietnam throughout 2020, it became clear that effective and strong enforcement of healthcare regulations, especially those related to disease control, was crucial.

On September 28, 2020, the government of Vietnam took action on this by issuing Decree No. 117/2020/ND-CP (“Decree 117”), which provides penalties for administrative violations in the healthcare sector. Some provisions of Decree 117—mostly those related to disease control and epidemic situations—took effect immediately, with the remainder taking effect on November 15, 2020. The decree, which was based on a draft proposed by the Ministry of Health, replaced Decree No. 176/2013/ND-CP on the same matter.

The main administrative penalties under Decree 117 are reprimands and fines. Depending on the severity of the violation, violators may also be subject to additional penalties such as suspension of a certificate of eligibility for pharmaceutical business (CEPB), a license for healthcare operation, or other licenses and practicing certificates for up to 24 months; confiscation of illegal items; suspension of operations for up to 24 months; or deportation. Furthermore, remedial measures such as forced return of illegal earnings, compulsory quarantine and medical examination, public correction, or compulsory payment of treatment fees may also be applied.

Some key highlights of Decree 117 are discussed below.

  • In relation to disease control, the maximum fine for failure to comply with quarantine is doubled to VND 20 million (USD 855) for infected people of type-A contagious diseases, and VND 10 million (USD 427) for those who are not infected but are asked to quarantine. Failure to declare one’s contagious disease to a doctor could be subject to a fine up to VND 3 million (USD 130), which is 10 times higher than the penalty provided in the repealed decree. These penalties took effect on September 28, 2020.
  • Exploiting an epidemic situation by price gouging of medicine or medical supplies is subject to a fine of up to VND 30 million (USD 1,300) for individuals or VND 60 million (USD 2,600) for companies and organizations. Violators may also be forced to suspend operations (which includes CEPB suspension for pharmaceutical business entities) for up to 24 months, and any illegal earnings will have to be returned to the buyers or sellers.
  • The decree also provides a number of new penalties for the pharmaceutical sector. A fine of up to VND 10 million (USD 427) is imposed for various violations in pharmaceutical practice, such as being the chief pharmacist at two or more pharmaceutical business entities simultaneously, or practicing pharmacy not in accordance with the scope of practice stipulated in the relevant certificate. Engaging in the sale of pharmaceuticals without a CEPB or at an address different from the one stated in the CEPB is subject to a fine of up to VND 120 million (USD 5,155). The operations of the violator may also be suspended for up to nine months.
  • Borrowing or lending a CEPB is punishable by a fine of up to VND 60 million (USD 2,600) and suspension of the CEPB for up to 24 months.
  • Foreign-invested entity (FIE) importers that conduct activities directly related to drug distribution (except for drugs manufactured in Vietnam by the FIE importer) could be subject to a fine of up to VND 160 million (USD 6,900).
  • For a drug that has been granted a marketing authorization in Vietnam, failure to notify the relevant authority of the recall of that drug in any country other than the country issuing the certificate of pharmaceutical product could subject the violator to a fine of VND 140 million (USD 6,000). The same fine is also applicable to submission of drug registration documents that are not based on actual research or manufacturing data. Remedial measures include compulsory recall of the drug and recommending that the relevant authority revoke the marketing authorization.
  • Decree 117 also introduces some provisions on violations relating to the use and sale of liquor and beer. Employing minors in advertisements for liquor and beer is subject to a fine of up to VND 40 million (approximately 1,700). Selling or providing liquor and beer to minors is subject to a fine of up to VND 3 million (USD 130) for individuals or VND 6 million (USD 260) for companies and organizations.

Altogether, Decree 117 sharply escalates the penalties for some violations that have been proliferating amid the COVID-19 pandemic, while some other penalties remain unchanged or are slightly amended. Multinational pharmaceutical companies should note, in particular, the new penalties applicable to FIE importers, as drug distribution remains a sensitive area in Vietnam, and enforcement can be unpredictable.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

September 6, 2024
Addressing technical barriers to trade is a key priority for the Association of Southeast Asian Nations (ASEAN) as part of trade facilitation in achieving the single market and production base under the ASEAN Economic Community directive agreed in 2015. The region has been undertaking positive steps toward standard harmonization in ASEAN priority sectors, integrating and bringing about regulatory convergence by taking into account the diversities that exist in the ten ASEAN member states. Health supplements in ASEAN are under the responsibility of the Traditional Medicine and Health Supplement Product Working Group (TMHS PWG). One of the TMHS PWG’s outputs is the ASEAN Agreement on a Regulatory Framework for Health Supplements, which includes various technical requirements for health supplements that participating member states must adopt by adjusting their domestic regulations. The key ingredients of these health supplements are vitamins and minerals. While all ASEAN countries allow the use of vitamins and minerals in health supplements, the amounts allowed for use vary, depending on the nutritional requirements deemed appropriate by each country. Partly in response to these efforts for regional harmonization, there have been important changes to vitamin and mineral limits in certain ASEAN countries that are worth monitoring. Some of these are outlined below. Thailand In January 2024, the Thai Food and Drug Administration (TFDA) updated the Thai Recommended Daily Intake (Thai RDI) guidelines for the Thai population. Subsequently, the TFDA adjusted the vitamin and mineral limits in order to comply with the updated Thai RDI and to follow the ASEAN Agreement on a Regulatory Framework for Health Supplements. The TFDA’s adjustment of vitamin and mineral limits for use in food supplements came in Notification of the Ministry of Public Health (No. 448) B.E. 2566 (2023) Re: Food Supplements (No. 5), which was published in the Government Gazette on January
Read More
August 8, 2024
On July 19, 2024, Thailand’s Ministry of Public Health Notification No. 450 B.E.2567 (2024) came into effect after being published in the Government Gazette the day before. The notification introduces significant updates to the labeling requirements for prepackaged foods. This new regulation consolidates and updates Thailand’s rules for food labeling by repealing and replacing several previous notifications. The notification’s key changes and their implications for food businesses are identified below. 1. Clarified “Best Before” Definition The notification aligns the definition of “best before” with Codex standards. It now refers to the date marking the end of the period during which the food maintains its best quality under stated storage conditions. After this date, food quality may change, and the product cannot be marketed. 2. Updated Labeling Exceptions Certain foods are exempt from labeling requirements, with the latest list including: Foods sold directly to consumers by manufacturers who can provide product information. Unprocessed foods. Some fresh foods not sold directly to consumers. Prepackaged foods produced and sold for immediate consumption in food service settings. However, any of these exempt foods that have received food serial numbers must still have labels that comply with the notification. 3. Expiration Date and Best-Before Date Display The notification provides clearer language for displaying the expiration date and best-before date. If specific wording is required by other notifications, it must be followed. English equivalents are now permitted alongside Thai text. 4. Warning Displays Multiple applicable warnings can now be consolidated and displayed together, provided the complete message is included as specified. 5. Claims about Substances or Ingredients New guidelines have been established for making claims about food additives and ingredients. Claims should be factual, not deceptive, and provably not false. 6. Label Placement and Design Labels must be permanently affixed, proportionate to the packaging, and
Read More
August 8, 2024
Tilleke & Gibbins has contributed the Thailand chapter to the 2024 edition of Pharmaceutical Advertising from the International Comparative Legal Guides (ICLG) series published by Global Legal Group. This detailed guide offers an in-depth examination of pharmaceutical advertising laws and regulations in multiple jurisdictions around the globe. Each chapter of the guide, structured in a Q&A format, is organized into comprehensive sections covering various aspects of pharmaceutical advertising, including: General rules and codes of practice governing pharmaceutical advertising Required arrangements for ensuring compliance with advertising regulations Procedures for obtaining advertising approvals from regulatory authorities Penalties for non-compliance with advertising rules Guidelines for providing information prior to product authorization Requirements for advertisements directed at healthcare professionals Restrictions on the content of pharmaceutical advertisements The complete Thailand chapter is available as a PDF below. The Thailand chapter—and the full Pharmaceutical Advertising guide—are also freely available on the ICLG website.
Read More
July 31, 2024
On July 18. 2024, Vietnam’s Ministry of Health issued Circular No. 12/2024/TT-BYT promulgating National Technical Regulation QCVN 20-1:2024/BYT on the limits of contaminants for health supplements (“Circular 12”). The new national technical regulation is the very first relating to health supplements, and is expected to have a great impact on the control of health supplement quality in Vietnam. Circular 12 will take effect on August 1, 2025. Contents of Circular 12 The new circular prescribes limits of contaminants (heavy metals and microorganisms), testing samples and testing methods, management requirements, and responsibilities of entities manufacturing and trading in health supplements. Supplemented alcohol products which are declared as health supplements are notably excluded from the scope of the regulation. Transitional Provisions Health supplements which (i) have been granted a declaration registration certificate, and (ii) are manufactured before August 1, 2025, are allowed to continue to be imported, traded, and circulated until the expiry date of the product, even if it is not aligned with Circular 12, except when there is food safety warning. Declaration registration dossiers for health supplements submitted before August 1, 2025, will continue to be handled in accordance with the prevailing regulations at the time of submission. From August 1, 2025, if a health supplement with a granted declaration registration certificate has a manufacturer’s standard that does not comply with Circular 12, the party manufacturing/trading in the product must adjust the product standard to conform to Circular 12 and notify the authority of this adjustment.
Read More