Rights of foreign enterprises in importing veterinary medicines and equipment and distributing them in Vietnam

Due to the background of the rapidly developing livestock and veterinary sectors in Vietnam, the demand for veterinary medicines, vaccines, and diagnostic and treatment support tools is steadily increasing. This market represents not only a significant opportunity for domestic enterprises but also an attractive destination for foreign corporations with established brands and advanced technologies.

However, the right of foreign-invested enterprises (FDI) to participate in the importation and distribution (wholesale and retail) of veterinary medicines and equipment in Vietnam is not absolute. It is regulated by a comprehensive legal framework, including the 2015 Law on Veterinary Medicine, relevant decrees on veterinary drug management, as well as investment and trade regulations specifically applicable to foreign investors. This article will provide a detailed analysis of the legal framework, as well as the rights and obligations of foreign enterprises in the importation and business of veterinary medicines and equipment in Vietnam.

1. Legal framework governing the trade of veterinary medicines

For veterinary drugs, the condition for importation into Vietnam is to obtain a Test permit in accordance with Decree No. 69/2018/ND-CP. Pursuant to Article 94 of the 2015 Law on Veterinary Medicine and guided by Article 18 of Decree No. 35/2016/ND-CP, the conditions that organizations or individuals must satisfy to import veterinary drugs are as follows:

Have Enterprise Registration Certificate;

Have a suitable location and adequate facilities and technical equipment, specifically:

• Have sufficient counters, cabinets, and shelves for storing and displaying products, which must be sturdy, easy to clean, and protected from adverse effects of light, temperature, humidity, mold, rodents, and harmful insects;
• Have equipment to ensure the storage conditions indicated on the product label, including thermometers and hygrometers to monitor storage conditions. For establishments trading vaccines and biological products, there must be refrigerators, cool cabinets, or cold storage facilities; thermometers to check storage conditions; backup generators; and tools or transportation means that ensure vaccines are distributed under the storage conditions specified on the product label;
  • (pursuant to Article 17 of Decree No. 35/2016/ND-CP)
• Have ventilation fans and air conditioning systems to ensure the storage conditions indicated on the product label, with thermometers and hygrometers to monitor storage conditions. For establishments importing vaccines and biological products, there must be a separate storage warehouse, backup generators, and equipment or transportation means that ensure the storage conditions specified on the product label during transportation and distribution; (Clause 2, Article 18 of Decree No. 35/2016/ND-CP, amended and supplemented by Decree No. 123/2018/ND-CP)

The manager and personnel directly engaged in the sale of veterinary drugs shall hold a valid veterinary practice certificate;

Have a storage facility meeting the required conditions for preserving drugs, specifically:

• Have separate storage for raw materials, excipients, and finished drugs;
• Have a separate external warehouse for the storage of solvents and flammable or explosive materials;
• Prevent the intrusion of insects and other animals;
• Have floors that are water-resistant, easy to clean, disinfect, and decontaminate; walls and ceilings made of durable, sturdy, and easy-to-clean materials;
• Provide shelves and racks for raw materials, excipients, packaging, and finished drugs; have equipment and means to ensure proper storage conditions. (Article 17 of Decree No. 35/2016/ND-CP, amended and supplemented by Decree No. 123/2018/ND-CP)

Have a Certificate of sale of veterinary drugs in Vietnam or an Import License for veterinary drugs (applicable only when importing vaccines or microorganisms used in veterinary medicine, pursuant to Clause 1, Article 100 of the 2015 Law on Veterinary Medicine);

Maintain quality control records and import-export tracking for each type of veterinary drug;

Hold a Certificate of Eligibility for Importing Veterinary Drugs. It should be noted that if the enterprise already possesses a valid Good Manufacturing Practice (GMP) certificate or a valid Certificate of Eligibility for producing veterinary drugs issued by the Department of Animal Health for the same type of veterinary drugs, it is not required to apply for a separate Certificate of Eligibility for Importing Veterinary Drugs.

2. Regarding the procedure and implementation process

For veterinary drugs being imported into Vietnam for the first time, and currently without a circulation sample in Vietnam, except for products that already have a registration number in Vietnam, including: Cefalexin 250mg Tablets; Catch One (Selamectin 60mg/ml) 6% Spot On in 2ml, 0.75ml, 0.5ml, and 0.25ml, this process shall be carried out in two stages:

Stage 1:

Step 1: Register for the issuance of the Certificate of Eligibility for Importation of Veterinary Drugs (this step may be omitted if the applicant already possesses a Good Manufacturing Practice (GMP) Certificate or a Certificate of Eligibility for producing veterinary drugs issued by the Department of Animal Health) (pursuant to Article 98 of the Law on Animal Health 2015 and Article 21 of Circular No. 13/2016/TT-BNNPTNT). The documentation required for this procedure includes:

• Application form for the Certificate, in accordance with the template in Appendix XX attached to Circular No. 13/2016/TT-BNNPTNT;
• Detailed explanatory report on the facilities and technical conditions for importing veterinary drugs, in accordance with the template in Appendix XXII attached to Circular No. 13/2016/TT-BNNPTNT;
• Enterprise Registration Certificate or Business Registration Certificate
• Veterinary Practice Certificate;

Step 2: Apply for the issuance of the License for Importation of Veterinary Drugs and Raw Materials for the Manufacture of Veterinary Drugs for the purposes of testing, trial use, and registration for circulation (pursuant to Clause 2, Article 22 of Circular No. 13/2016/TT-BNNPTNT). (This requirement shall not apply to products already registered for circulation in Vietnam).

Exemptions from testing shall apply to the following cases: Veterinary drugs manufactured based on original drugs; Generic drugs in respect of pharmaceuticals, chemicals, and biological products; imported veterinary drugs, excluding vaccines and antibodies, that have been authorized for circulation in the United States, Japan, Australia, Canada, and Europe (pursuant to Clause 1, Article 11 of Circular No. 13/2016/TT-BNNPTNT

The application dossier for the issuance of an import license for veterinary drugs and raw materials for the production of veterinary drugs for the purposes of testing, clinical trials, and registration for circulation shall comprise:

• An application form for the importation of veterinary drugs, using the template prescribed in Appendix XXXII issued together with this Circular, which shall also be submitted via email (in Word or Excel format);
• A copy of the Certificate of Business Registration, the Enterprise Registration Certificate, or the Investment License of the organization or individual applying for the import license, applicable to entities importing veterinary drugs for the first time;
• A Certificate of Good Manufacturing Practice (GMP), a Certificate of Quality Management System (ISO), or another equivalent certificate, in respect of certain commonly used chemicals;
• A Certificate of Free Sale (CFS), a Certificate of Pharmaceutical Product (CPP), or a Marketing Authorization (MA), issued by the competent state authority of the exporting country;
• A Certificate of Analysis (CoA) issued by the manufacturer;
• A summary of product characteristics, in the form prescribed in Appendix VIII issued together with Circular No. 13/2016/TT-BNNPTNT.

Step 3: Application for the issuance of a license for veterinary drug testing (this requirement shall not apply to products already registered for circulation in Viet Nam).

Veterinary drug testing must be conducted for all veterinary drugs prior to their registration for circulation in Viet Nam, except for the cases exempted from testing as provided above (Clause 1, Article 84 of the Law on Veterinary Medicine 2015).

Application dossier for the issuance of a license for veterinary drug testing (pursuant to Article 18 of Circular No. 13/2016/TT-BNNPTNT).”

• An application form for the issuance of a license for veterinary drug testing, using the template prescribed in Appendix XV issued together with Circular No. 13/2016/TT-BNNPTNT;
• A report on the assessment results of the facility’s eligibility for drug testing;
• Technical documents for each type of veterinary drug to be tested shall include: a summary of product characteristics, using the template prescribed in Appendix VIII issued together with Circular No. 13/2016/TT-BNNPTNT; technical information on product quality; technical information on product safety and efficacy; a certificate of analysis issued by the manufacturer (original or a copy certified by the applicant); a certificate of analysis issued by the veterinary drug testing authority designated in Viet Nam (original or a copy certified by the applicant); a testing protocol; and a testing contract between the applicant and the testing facility (original or a copy certified by the applicant).

After 15 days from the completion of the testing process, the applicant for veterinary drug testing shall submit the testing results to the Department of Animal Health, in the form set forth in Appendix XVIII issued together with Circular No. 13/2016/TT-BNNPTNT, with confirmation by the testing supervision entity.

Step 4: Register for the issuance of a Certificate of sale of veterinary drugs (this requirement shall not apply to products already registered for circulation in Viet Nam);

Carry out procedures for the issuance of a Certificate of sale of veterinary drugs in Viet Nam, with the application dossier comprising:

• Application form for circulation, using the template prescribed in Appendix I issued together with Circular No. 13/2016/TT-BNNPTNT;
• Summary of product characteristics, using the template prescribed in Appendix VIII issued together with Circular No. 13/2016/TT-BNNPTNT;
• Product label sample and package insert. The mandatory contents of the product label shall include (Article 27 of Circular No. 13/2016/TT-BNNPTNT): the name of the veterinary drug; the composition of active substances and quantitative composition of active substances (dosage or concentration); packaging specifications; indications, directions for use, and contraindications; withdrawal periods for eggs, meat, and milk for each indicated animal species; dosage form, circulation registration number, batch number, date of manufacture, expiry date, and the phrase “For veterinary use only.”
• Certificate of Good Manufacturing Practice (GMP) or certificate of quality management system (ISO) for certain common chemicals, and a certificate of circulation issued by the competent state authority of the manufacturing country for imported drugs;
• Manufacturing process;
• Quality standards and testing methods;
• Report on safety data, including research materials on toxicity (acute toxicity, sub-chronic toxicity, chronic toxicity, cytotoxicity, and carcinogenic potential);
• Report on efficacy data of the product, including research materials on experimental pharmacology, pharmacodynamics, pharmacokinetics, and bioavailability of the product;
• Studies on residues in all animal species indicated for drug administration, for the purpose of determining the withdrawal period;
• Research materials on the stability and shelf life of the drug;
• Research materials on dosage and treatment regimens for each indicated animal species;
• Certificate of analysis issued by the manufacturer and certificate of analysis issued by the veterinary drug testing authority designated in Viet Nam.
• Testing results;
• Undertaking of compliance with intellectual property regulations, using the template prescribed in Appendix VII issued together with this Circular;
• Other technical information (if any).

Upon receipt of the complete application dossier, the Department of Animal Health shall conduct an appraisal, convene the Scientific Council on veterinary drugs, and subsequently issue the Certificate of Circulation for veterinary drugs. The total time limit shall be six (06) months for application dossiers concerning new drugs, vaccines, antibodies, and herbal medicines (Point a, Clause 1 and Clause 3, Article 8 of Circular No. 13/2016/TT-BNNPTNT).

It is noteworthy that, in the case of application dossiers exempted from testing, the prescribed time limit is forty (40) days.

Stage 2:

Step 1: Importation of the Goods Consignment into Vietnam (upon completion of the dossier under Stage 1 and the import–export documents as prescribed by law)

The importer shall declare the import dossier on the Vietnam Automated Cargo and Port Consolidated System (VNACCS/VCIS).

Step 2: Conduct State Inspection of the Quality of Imported Goods

The importer shall register for state inspection with the Department of Animal Health. The registration dossier shall include:

• Registration form in accordance with Form No. 01 issued together with Decree No. 74/2018/ND-CP;
• Certified copy of the contract and list of goods;
• Certified copy of the bill of lading, invoice, and import declaration form;
• Quality certificate issued by the exporting country (certificate of quality or testing results), if any;
• Certificate of origin (if any);
• Photograph or description of the goods showing all mandatory information required to be presented on the product label and supplementary label (in case the main label does not contain sufficient information);
• Certificate of Free Sale (CFS), if any.

Within one (01) working day, the Department of Animal Health shall certify on the importer’s registration form that the importer has duly registered for the quality inspection of imported goods. The importer shall then submit the registration form, duly certified by the Department of Animal Health, to the customs authority in order to obtain customs clearance of the goods.

Thereafter, within (15) working days from the date of customs clearance of the goods, the importer shall submit to the Department of Animal Health a duly certified true copy (bearing the signature and seal of the importer) of the certificate of quality (Certificate of conformity with technical regulations issued by a certification body or Certificate of inspection of conformity with technical regulations issued by an inspection body). (Official Dispatch No. 196/TY-QLT of the Department of Animal Health – Ministry of Agriculture and Rural Development regarding the declaration of conformity of veterinary drugs).

Step 3: Implementation of the Declaration of Conformity

In cases of self-assessment:

• Declaration of conformity (using Form 2.CBHC/HQ as prescribed in Appendix III to Circular No. 28/2012/TT-BKHCN);
• Report on self-assessment results, including the following information: name of the organization or individual; address; telephone, fax; name of the product or goods, manufacturer; reference number of the applicable national technical regulation; testing results demonstrating conformity with the national technical regulation conducted by a product quality testing body for group-2 goods as prescribed in the corresponding national technical regulation; conclusion confirming that the product or goods conform to the applicable national technical regulation; commitment that the product or goods conform to the national technical regulation and the declared applicable standard, and that the organization or individual shall bear full legal responsibility for the product quality and the self-assessment results.

In cases where a third party is engaged for certification:

• A declaration of conformity (using Form 2.CBHC/HQ as prescribed in Appendix III to Circular No. 28/2012/TT-BKHCN);
• A certified true copy of the Certificate of Conformity with the relevant technical regulation, together with the conformity mark specimen, issued to the organization or individual by a registered certification body or a designated certification body.

Regarding the procedure for dossier receipt: For a conformity announcement dossier that is complete in accordance with Article 14 of Circular No. 28/2012/TT-BKHCN, within five (05) working days from the date of receipt of the conformity announcement dossier, the Department of Animal Health shall examine the validity of the dossier. In the event that the conformity announcement dossier is complete and valid, the Department of Animal Health shall issue a Notification of Receipt of the Conformity Announcement Dossier to the organization or individual making the announcement. (Articles 13, 14, 15 of Circular No. 28/2012/TT-BKHCN; Official Letter No. 196/TY-QLT of the Department of Animal Health – Ministry of Agriculture and Rural Development regarding the conformity announcement of veterinary drugs).

Step 4: Release the goods into market circulation

Currently, pursuant to Decree No. 69/2018/ND-CP, there is no requirement for any license with respect to the importation of veterinary surgical instruments. Furthermore, in the annexes attached to Circular No. 01/2024/TT-BNNPTNT, there is no provision stipulating that pet surgical instruments are subject to specialized inspection. Accordingly, such goods are only required to be imported under ordinary import procedures. A standard import dossier shall comprise: the customs declaration, commercial invoice, bill of lading, packing list, certificate of origin, technical documents (if any), and certificate of free sale (CFS) (if any).

It should be noted that imported goods must bear clear labels in Vietnamese, which shall include: the product name, manufacturer, product code, country of origin, user instructions,…

Time of writing: 19/08/2025

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