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

May 27, 2021

New Regulations on Penalties in Animal Husbandry in Vietnam

Subscribe to Updates

On March 1, 2021, the government of Vietnam promulgated Decree No. 14/2021/ND-CP on Penalties for Administrative Violations Involving Animal Husbandry (Decree 14). The new decree took effect on April 20 and, among other contents, repeals the regulations on animal feed found in Decree No. 64/2018/ND-CP dated May 7, 2018.

In the field of animal feed, notable penalties of Decree 14 include the following:

Penalty forms and levels

For each administrative violation, the violator will be imposed a monetary penalty, which is the main penalty form. For the same violation, the monetary penalty level applied to an organization is double the amount applied to an individual.

In addition, based on the nature and extent of the violation, additional penalties may be imposed on the violators, including confiscation of violating items, and confiscating Certificates of Eligibility to manufacture animal feeds.

Violations of regulations on declaring product information

A fine of up to VND 3 million (USD 130) will be imposed for the act of changing information on product labels that has been published on the Portal of the Ministry of Agriculture and Rural Development (MARD) without conducting the notification procedure to inform the MARD of such change.

A fine of up to VND 7 million (USD 300) will be imposed for the act of deliberately falsifying or erasing contents of documents or making false declarations in the applications for animal feed products on the Portal of the MARD.

Violation of regulations on quality in importing animal feed

A fine of up to VND 25 million (USD 1,080) will be imposed for the act of importing each animal feed having (i) a quantitative content of each quality criterion lower than the minimum level or higher than the maximum level compared with the standards announced or written on the goods label; or (ii) each safety criterion/each harmful microbiological criterion exceeding the allowable threshold under technical regulations or applied standards, depending on the specific criterion and percentage difference.

Violation of regulations on purchasing, selling, and importing expired animal feed

A fine of up to VND 40 million (USD 1,730) depending on the value of the violating goods will be imposed for the act of purchasing, selling, or importing animal feed products whose labels or enclosed documents state that the product has expired.

A fine of up to VND 10 million (USD 430) will be imposed for the act of not presenting or incorrectly presenting the manufacturing date on the product label or documents accompanying the product.

Violations of regulations on purchasing, selling, and importing animal feeds containing antibiotics

A fine of up to VND 15 million (USD 650) will be imposed for each acts of purchasing, selling, or importing an animal feed product having antibiotic content different from the content presented on the product label or in the documents accompanying the product, depending on the difference.

A fine of up to VND 15 million (USD 650) will be imposed for each act of (i) purchasing or importing an animal feed product containing antibiotics in which the information about the name and content of antibiotics, instruction for use, or time to ease using is not presented on the product labels or accompanying documents; or (ii) importing an animal feed product containing antibiotics without a prescription or not according to the prescription of a person having a practice certificate of prevention and treatment of animal diseases.

A fine of up to VND 20 million (USD 860) will be imposed for the each act of (i) importing an animal feed product containing antibiotics that is not a complete mixed feed for livestock or poultry, or pure feed for grass-fed cattle; (ii) purchasing, selling, or importing an animal feed product containing antibiotics to prevent disease for pets that are not in the immature stage; and (iii) purchasing, selling, or importing an animal feed product containing antibiotics for the purpose of growth stimulation.

A fine of up to VND 30 million (USD 1,300) will be imposed for the acts of purchasing, selling, or importing each animal feed product containing antibiotics that is not a veterinary drug approved for circulation in Vietnam or has not been approved by the relevant authority.

Violations of regulations on using animal feed material

A fine of up to VND 20 million (USD 860) will be imposed for each act of using an animal feed material which is not listed in the list of materials permitted to use in animal feed, depending on the value of the violating batch or the amount of illicit profits.

Remedial measures

In addition to the fines above, some remedial measures below are applied, depending on the case:

  • Being forced to repeal the published animal feed product information, or correct the false information published on the Portal of the MARD;
  • Being forced to recall, recycle, transform the use purpose, re-export or destroy the violating products; and
  • Being forced to re-submit the illicit profits gained from the violations.

Transitional provisions

For administrative violations that occurred before the effective date of Decree 14 (April 20, 2021) but were detected later, or are being considered and resolved, regulations that are beneficial to the violators will be applied.

For decisions on sanctioning of administrative violations that were issued or completely implemented before the effective date of Decree 14, but for which the violators can still appeal the decision, the previous legal document (Decree No. 64/2018/ND-CP) is applied.

For violations detected after the effective date of Decree 14 that are effective in transitional provisions in the Law on Animal Husbandry and documents detailing the implementation of the Law on Animal Husbandry, Decree No. 64/2018/ND-CP is still applied until the transition period expires.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

February 14, 2024
Thailand is preparing to implement new rules on drug importation for clinical studies. The Medicines Regulation Department of Thailand’s Food and Drug Administration (Thai FDA) first issued the Notification Re. Detailed Requirements for Drug Importation into Thailand for Clinical Studies almost a year ago, and the notification is expected to come into effect on March 1, 2024. Key Provisions The notification aims at enhancing the efficiency of conducting clinical studies while ensuring the protection of human subjects participating in such studies within Thailand. Some of its key provisions include: Definition of Clinical Study. The notification defines a “clinical study” as a study of a medicine involving human subjects, conducted to provide supporting evidence for the registration of a medicinal product in Thailand or other countries, including for additional indications or variations of a registration dossier. Compliance with ICH GCP. Clinical studies conducted in Thailand must adhere to the current edition of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. Clinical Trial Application. Sponsors are required to submit a clinical trial application along with supporting documents to the Thai FDA for approval before commencing a clinical study. The permit remains valid for five years and is renewable. Supply of Investigational Drugs. Sponsors must obtain investigational drugs from manufacturers compliant with Good Manufacturing Practice (GMP) standards as recognized by the Thai FDA. Postapproval Obligations. The secretary-general of the Thai FDA may impose postapproval conditions or order investigators to conduct or suspend certain activities to ensure human subject protection and regulatory compliance. Regulatory Oversight. The Thai FDA is responsible for inspecting and overseeing the regulatory compliance of clinical studies, including during prestudy, ongoing, and poststudy phases. The Thai FDA may also conduct inspections of clinical studies conducted overseas. The Thai FDA
Read More
December 15, 2023
As part of its membership in Lex Mundi, Tilleke & Gibbins has published an updated edition of its Guide to Doing Business in Thailand for 2023. This guide outlines the key factors for starting and operating a business in the Thai market. Issues covered include: Investment incentives Financial facilities Exchange controls Import and export regulations Structures for doing business Requirements for the Establishment of a Business Operation of the Business Cessation or Termination of the Business Labor legislation, relations, and supply Tax Immigration requirements This publication is part of Lex Mundi’s Country Guides series prepared by member firms in more than 100 jurisdictions worldwide. The guides serve as a useful resource for planning international business strategy and researching new markets. The full Guide to Doing Business in Thailand is available through the button below.
Read More
December 6, 2023
New regulatory requirements for medical device registration and notification in Laos are set to enter into force in the coming weeks under the plan found in Notification No. 9606 to implement Decision No. 1470/MOH on Registration and Notification of Medical Devices (Decision 1470). The notification, issued on October 25, 2023, by the Food and Drug Department (FDD) under the Ministry of Health (MOH), outlines the FDD’s strategic plan for phased-in registration and notification requirements for medical devices. In the first phase, starting January 1, 2024, the FDD will initiate the registration process for class C (moderate-high risk) and D (high risk) medical devices. Meanwhile, operators dealing with class A (low risk) and B (low-moderate risk) devices can continue applying for import permits without having to register the devices or notify the FDD. In the subsequent phase, starting January 1, 2025, operators will have to notify the FDD about class A devices and complete the registration process for class B devices. To prepare for these requirements, import-export companies in the pharmaceutical and medical products sector must submit a list of medical devices, including their classification based on the country of manufacture, to the FDD by December 15, 2023. This measure is aimed at enabling the FDD to streamline the collection, guidance, and preparation processes to ensure efficient registration within the set time frame. While import-export companies can still submit their lists after either December 15, 2023, or January 1, 2024 (the registration commencement date), registration may be delayed since the FDD will prioritize those who submit their lists by the December 15 deadline. The list of medical devices should encompass medical devices imported in the past as well as those intended for future import permission applications. During the initial registration stage (i.e., from January 1, 2024), import-export companies that are
Read More
October 25, 2023
Cambodia’s Ministry of Health (MOH) continues to increase awareness among the public and private sector of the need for strict healthcare regulations and strict enforcement to advance the quality of the country’s healthcare sector. In April 2023, the MOH issued a notification letter reminding advertisers of health products that they need to obtain a permit before advertising their products in Cambodia. On October 12, 2023, the MOH issued two press releases on continued noncompliance in the healthcare sector. The two press releases address the illegal advertising of both healthcare products and private healthcare services. The releases also address unlicensed healthcare professionals and general noncompliance by private healthcare services. These releases indicate that the MOH, in cooperation with local authorities, will substantially increase its enforcement efforts across Cambodia. Since October 12, several private healthcare clinics have had their operations closed and licenses suspended or revoked, signaling the ministry’s intent to enforce the legal framework. Noncompliant Advertising of Health Products The first press release focuses on the continued illegal advertising of health products and the advertising of unregistered health products. Health products include modern medicines, traditional medicines, health supplements, medical devices, cosmetics, and other products that prevent or treat diseases. The release highlights that the MOH has noticed ongoing unauthorized and illegal advertising, commenting that these are often found online and on social media. The noncompliant advertising referenced in the release includes advertising of health products without the required advertising permit, advertising products that are not properly registered with the MOH, and advertising by unlicensed companies and individuals. The MOH also states in the release that some advertisements are using inappropriate and noncompliant content that is not based on medical science and exaggerates the qualities of the health products—specifically mentioning skin-whitening cosmetics. The ministry’s press release also informs the public of
Read More