Legal framework as of 28 October 2026: Law on Animal Health No. 79/2015/QH13, as amended by Law No. 146/2025/QH15 (effective 1 January 2026); Circular No. 13/2016/TT-BNNPTNT on veterinary drug management, as consolidated in Consolidated Document No. 60/VBHN-BNNMT 2026 (including amendments up to Circular No. 22/2026/TT-BNNMT); Decree No. 35/2016/ND-CP on conditions for producing, trading and importing veterinary drugs; Decree No. 35/2025/ND-CP on the organisation of the Ministry of Agriculture and Environment. Important note: Law No. 146/2025 rewrote Articles 80, 81, 82, 85 and 86 of the Law on Animal Health, keeping only the legal framework and delegating detailed procedures to the Minister. The detailed time limits in this article therefore come from Circular No. 13/2016 as currently consolidated, not from the pre-amendment 2015 text of the Law.
1. Introduction — what certificate does a veterinary drug need before it can be sold in Vietnam?
A veterinary drug may be circulated in Vietnam only after it has been granted a certificate of veterinary drug circulation in Vietnam and that certificate is still valid. The certificate is valid for 05 years (Article 80 of the Law on Animal Health, as amended by Law No. 146/2025). A drug without such a certificate cannot lawfully be placed on the Vietnamese market, even if it is already sold abroad.
This is a separate track from human medicines. Do not confuse veterinary drug registration with human drug registration under the Law on Pharmacy: veterinary drugs follow the Law on Animal Health, with their own authority and their own dossier.
This article is written for domestic veterinary drug manufacturers, Vietnamese importers, and foreign manufacturers planning to enter Vietnam. It answers four questions: who must register, what the dossier contains, who decides and how long assessment takes, and how long the certificate lasts, including renewal, re-issuance and revocation.
2. What is a veterinary drug, which drugs must be registered, and which drugs cannot be registered?
Under Article 3, Clause 21 of the Law on Animal Health, veterinary drugs include pharmaceuticals, vaccines, biological products, microorganisms and chemicals used for animals. Any preparation intended for animals — an oral or injectable medicine, a vaccine, or a veterinary chemical — must first be checked against the registration requirement before it reaches the market.
Under Article 80, Clause 1 of the Law on Animal Health (as amended by Law No. 146/2025), an organisation or individual producing or importing veterinary drugs must register circulation with the Department of Livestock Production and Animal Health in two cases:
- A drug newly produced in Vietnam;
- A drug imported into Vietnam for the first time for trading or production.
Article 79 of the Law sets out five cases in which a veterinary drug cannot be registered. Applicants should screen for these before preparing a dossier:
- The drug is on the list of veterinary drugs prohibited for use in Vietnam;
- The drug poses a high risk of adverse effects on human health, animal health or the environment;
- A competent state authority has concluded that the drug infringes intellectual property rights;
- The applicant has altered, or used forged documents or papers in, the registration dossier;
- The applicant has used a forged seal or forged signatures or seals of related organisations or individuals in the dossier.
Falling into any one of these five cases blocks registration, however complete the technical dossier may be. Veterinary drugs containing narcotic substances or precursors follow a separate licensing track for narcotics and precursors; this article notes that boundary only and does not set out that track in detail.
This article covers only the drug registration track; feed issues — quality, antibiotics in feed and liability when animals consume substandard feed — are covered separately in Animal feed: quality, antibiotics and liability when animals consume substandard feed.
3. Before registration: field trials — a short background
Under Article 84 of the Law on Animal Health, field trials must be carried out for all veterinary drugs before registration for circulation in Vietnam, except where exemption from trials is provided under the regulations of the Minister of Agriculture and Environment. That is why the registration dossier contains trial results on efficacy and safety for drugs subject to trials.
A field trial licence is valid for 05 years (Article 85, as amended by Law No. 146/2025). It is re-issued where there is an error or a change in the drug name or in the information of the trial registrant (Article 86). A trial organisation must meet Article 88, including a technical lead holding a veterinary practice certificate, adequate facilities and technical capacity, and a prohibition on registering, or accepting authorisation to register, a drug in its own name.
Circular No. 13/2016 lists exempt cases, including generic drugs produced following an originator drug (for pharmaceuticals, chemicals and biological products) and imported veterinary drugs — other than vaccines and antibodies — already authorised in the United States, Japan, Australia, Canada or Europe. An applicant claiming exemption must still prove the basis for it; exemption is not self-declared.
This section is background only. Trials are not the core of this article, but no registration dossier can be understood without them.
4. The registration dossier — a checklist under Circular No. 13/2016
The detailed dossier is set out in Circular No. 13/2016, Article 3 (for new drugs in the form of pharmaceuticals, chemicals and biological products; vaccines, antibodies and diagnostic biological products have corresponding dossier components under the same article). The four groups below summarise that structure:
| Dossier group | Main components |
|---|---|
| 1. Application and product identification | Registration application (form in Appendix I); product characteristics summary (form in Appendix VIII); product label sample and instructions for use |
| 2. Technical documentation | Production process (accompanying technical documentation, not a separate item in Article 3, Clause 1); quality standards and testing methods; safety data reports (including toxicity studies); efficacy data reports (experimental pharmacology, pharmacodynamics, pharmacokinetics, bioavailability); residue studies to determine the withdrawal period; stability and shelf-life studies; dosage and treatment course for each target animal species |
| 3. Quality testing and trial results | Manufacturer's product quality analysis sheet and the analysis sheet of a testing laboratory designated in Vietnam; trial results on efficacy and safety for drugs subject to trials |
| 4. Capacity and legal standing documents | GMP certificate or quality management system (ISO) certificate for certain common chemicals; for imported drugs, additionally the certificate of circulation issued by the competent authority of the producing country; a commitment not to infringe intellectual property law, using the form in Appendix VII |
Three points commonly encountered when a dossier is returned for completion: a label that does not match the product characteristics summary, an analysis sheet missing one of the two sources (manufacturer or designated Vietnamese laboratory), and a GMP or eligibility certificate that has expired or covers the wrong activity (production versus import). This article gives no return rate, because no official figure has been published for it.
Domestic production versus import
| Item | Domestic production | Import |
|---|---|---|
| Registration case | A drug newly produced in Vietnam | A drug imported for the first time into Vietnam for trading or production |
| GMP / eligibility paper | GMP certificate or certificate of eligibility for production | GMP certificate or certificate of eligibility for import |
| Additional paper required | — | Certificate of circulation issued by the competent authority of the producing country |
| Basis for the GMP / eligibility paper | Production facility conditions in Articles 12 and 13 of Decree No. 35/2016 (pharmaceutical and vaccine facilities must apply GMP-ASEAN, GMP-WHO or an equivalent standard not lower than GMP-ASEAN) | Import conditions in Article 18 of Decree No. 35/2016 |
Each veterinary drug requires its own registration dossier. A dossier for a domestically produced drug must be in Vietnamese. A dossier for a foreign-produced drug must be in Vietnamese or English, but the instructions for use and the product characteristics summary must be in Vietnamese.
For a foreign manufacturer, the practical consequence is straightforward: appoint a Vietnamese registrant or importer early, because the dossier, the designated-laboratory testing in Vietnam and the Vietnamese-language product documents all run through the Vietnamese side. The foreign certificate of circulation from the producing country supports the dossier; it does not replace the Vietnamese certificate.
5. Where to file, how assessment works, and how long it takes
The authority that appraises and issues the certificate of veterinary drug circulation is the Department of Animal Health under the Law on Animal Health 2015; after the 2025 ministerial merger, this function belongs to the Department of Livestock Production and Animal Health, Ministry of Agriculture and Environment (Decree No. 35/2025/ND-CP). Law No. 146/2025 also replaced the phrase "Department of Animal Health" in the Law on Animal Health with "the central specialised animal health management agency", and the central agency today is the Department of Livestock Production and Animal Health. Under the published administrative procedure, dossiers are filed online, by post, or in person with the Department of Livestock Production and Animal Health.
Under Circular No. 13/2016 (Consolidated Document No. 60/VBHN-BNNMT 2026, including amendments by Circular No. 22/2026), the Department receives the dossier and, within 07 days of receiving the registration dossier, notifies the applicant to complete the dossier where it does not meet requirements. It then appraises the dossier and replies within the time limit for each dossier type; where it does not issue the certificate, it replies in writing stating the reasons. The appraisal council meets at least once every 03 months (original Circular No. 13/2016, Article 8, Clause 1, point a).
Current time limits
| Step | Current limit | Basis |
|---|---|---|
| Notice to complete an incomplete dossier | 07 days from receipt of the registration dossier | Circular No. 13/2016, time-limit clause (amended by Circular No. 22/2026) |
| Appraisal and reply: dossiers for production for export, contract production, splitting | 10 days from receipt of a valid dossier | As above |
| Appraisal and reply: trial-exempt drugs, diagnostic biological products | 30 days from receipt of a valid dossier | As above |
| Appraisal and reply: new drugs, vaccines, antibodies, herbal drugs | 75 days from receipt of a valid dossier | As above |
| Validity of a newly issued certificate | 05 years from the date of issue | Article 80, Law on Animal Health; Circular No. 13/2016 |
| Validity for contract-produced or split drugs | Contract period plus product shelf life, up to a maximum of 05 years | Circular No. 13/2016 |
Note: the older limits of 20 days, 40 days and 06 months in pre-2026 versions of Circular No. 13/2016, and the former 06-month appraisal period in the 2015 text of Article 80, no longer apply. Relying on an old version of the circular will misstate the waiting time.
6. Validity, renewal, re-issuance and revocation — the life cycle of a certificate
Validity
A certificate of veterinary drug circulation in Vietnam is valid for 05 years from the date of issue. A drug holding a still-valid certificate is exempt from conformity announcement (Article 78 of the Law on Animal Health, as amended by Law No. 146/2025). Once the certificate expires without renewal, the drug no longer has a lawful basis for circulation under that certificate.
Renewal
Before the 03-month period preceding the expiry date of the certificate, an organisation or individual wishing to renew must file a renewal dossier (Article 81, Clause 1, as amended by Law No. 146/2025). A renewed certificate is valid for 05 years (Article 81, Clause 2).
The renewal dossier under Article 10 of Circular No. 13/2016 comprises: the renewal application (form in Appendix V); a GMP certificate or a written confirmation from the competent authority of the producing country that GMP standards are met, or an ISO certificate for imported chemicals and biological products (other than vaccines, antibodies and test kits), or a certificate of eligibility for production (domestic drugs) or for import (imported drugs), together with the producing country's circulation certificate for imported drugs; product quality analysis sheets issued within 12 months before the filing date (for pharmaceuticals, chemicals and biological products: from the manufacturer or from a designated testing body in Vietnam; for vaccines and antibodies: from both); any contract-production or splitting contract; a product stability monitoring report; and a circulation history report (form in Appendix VI). Within 12 days of receiving a complete and valid dossier, the Department of Livestock Production and Animal Health appraises the dossier and renews the certificate where the dossier meets requirements; where it does not renew, it replies in writing stating the reasons (Article 10 of Circular No. 13/2016, amended by Circular No. 22/2026).
Re-issuance
Under Article 82 of the Law on Animal Health (as amended by Law No. 146/2025), a certificate is re-issued in two groups of cases:
- Substantive changes: changes to composition, formula, dosage form, route of administration, dosage, treatment indications; changes to the production method or process that alter product quality; re-evaluation of quality, efficacy or safety — re-issuance registration for this group is handled as a new registration (under the time limits in the time-limit clause of Circular No. 13/2016);
- Errors and information changes not affecting quality: errors; changes to product information or to information of the producing or registering organisation or individual — the dossier comprises the re-issuance application (form in Appendix IV), documents evidencing the change, old and new label samples, and the issued certificate; appraisal and re-issuance take 05 working days from receipt of a valid dossier (Article 9 of Circular No. 13/2016, amended by Circular No. 22/2026).
The practical dividing line: changing only the drug name or the company's information, without changing composition, dosage form or indications, falls in the fast re-issuance group; changing composition, strength, dosage form or indications requires the new-registration route.
Revocation
Under Article 83 of the Law on Animal Health, a certificate is revoked in 9 cases:
- The certificate has been erased or altered;
- Forged documents or papers, or untruthful information, are discovered in the approved registration dossier;
- The drug is prohibited from circulation in Vietnam;
- There is scientific evidence that the drug adversely affects human health, animal health or the environment;
- The drug has two consecutive production batches failing quality standards, or one serious quality-standard violation as concluded by the state quality management authority for veterinary drugs;
- The certificate holder requests withdrawal of the registration;
- The drug's circulation certificate is withdrawn in the producing or exporting country (a risk only importers face);
- A competent state authority concludes that the drug infringes intellectual property rights;
- The certificate holder commits another violation for which the law requires revocation.
The revoking authority is the central specialised animal health management agency, today the Department of Livestock Production and Animal Health. The two cases companies most often encounter in practice are two consecutive failing batches and withdrawal of the certificate in the producing country — both outside the company's control, but both ending the certificate in Vietnam.
Sanctions background — no specific fine stated
Violations of veterinary drug management rules are subject to administrative sanctions under the veterinary sanctions framework currently in force, Decree No. 204/2026/ND-CP (effective 1 August 2026). This article states no fine for any specific act, because a fine must be traced to the correct article and clause of the full text of the sanctions decree; the livestock sanctions framework in Decree No. 211/2026/ND-CP is not the framework for veterinary drug registration.
7. FAQ and practical conclusion
1. Must a drug already marketed abroad be registered again in Vietnam? Yes, if it is imported into Vietnam for the first time for trading or production (Article 80, Clause 1, point b). The import dossier must include the circulation certificate issued by the competent authority of the producing country. That foreign certificate is a dossier condition; it does not replace the Vietnamese certificate.
2. What happens if the certificate expires before renewal is completed? The renewal dossier must be filed before the 03-month period preceding expiry (Article 81, Clause 1). The Law provides no "automatic renewal" mechanism. Once the certificate has expired without renewal, the company may not continue circulating the drug under that certificate.
3. Does changing the drug name or company information require registration from scratch? No, if the change is only an error or an information change not affecting drug quality and does not change composition, dosage form or indications — that is the fast re-issuance group, 05 working days under Article 9 of Circular No. 13/2016. Changing composition, formula, dosage form, route, dosage or indications requires re-issuance registration as a new registration.
4. Can veterinary drugs use the human drug registration framework? No. Veterinary drugs are registered under the Law on Animal Health and Circular No. 13/2016, through the Department of Livestock Production and Animal Health, Ministry of Agriculture and Environment. The human drug framework is a different track and does not apply to veterinary drugs.
5. After registration, which list does the drug appear on? A drug granted a certificate of circulation is permitted for circulation in Vietnam (Article 80, Clause 2: the certificate is valid for 05 years). Conversely, a drug on the prohibited list cannot be registered in the first place (Article 79, Clause 1; the prohibited list is issued by the Minister under Article 78, Clause 4, point c).
Conclusion: a 5-step checklist
- Identify the registration case: a newly produced domestic drug or a first-time import;
- Determine the trial or trial-exemption position and complete trials before filing the registration dossier;
- Prepare all four dossier groups under Article 3 of Circular No. 13/2016, checking the GMP or eligibility paper separately and, for imported drugs, the producing country's circulation certificate;
- File with the Department of Livestock Production and Animal Health, Ministry of Agriculture and Environment (online, by post or in person) and track the reply deadline for the dossier type (10, 30 or 75 days);
- Track the certificate's 05-year validity, file for renewal before the final 03 months, and keep analysis sheets within 12 months for the renewal dossier.
Preparing the dossier correctly the first time is always cheaper than completing it after a notice: every round of completion extends the wait, while a drug without a certificate cannot yet reach the market.
