Under Circular No. 21/2015/TT-BNNPTNT - Pesticide Administration in Vietnam, any pesticides must be registered before they can be produced, imported, distributed and used in Vietnam. This Circular stipulates pesticide administration measures, including registration; testing; manufacturing; export, import; quality control; certificate of conformity and declaration of conformity; storage, transportation; application; labeling; packaging; advertising; recall or eradication of pesticide products in Vietnam.
Definition of Pesticide
In Vietnam, pesticides are defined as those used for deterring or killing organisms harmful to plants, regulating the growth of plants, storing plants, disinfecting warehouses, killing termites causing damage to architectural structures, dykes or embankments; killing weeds on uncultivated lands; or increasing their safe and effective use.
Main Regulations
- Circular No. 21/2015/TT-BNNPTNT - Pesticide Administration, June 8, 2015
- Law on Plant Protection and Quarantine
Who Shall Register?
- Domestic or foreign organizations or individuals (including their representative offices, companies, branches licensed to carry out pesticide product business operations in Vietnam)
- Organizations or individuals manufacturing active ingredients, technical pesticides or formulated pesticide products that do not directly use their names to apply for such registration shall be permitted to authorize only one eligible organization or individual stipulated in Clause 3 Article 50 of the Law on Plant Protection and Quarantine to bear its name on the registration of each of their own pesticide products.
Authorities
- The Ministry of Agriculture and Rural Development (MARD) in Vietnam
- The plant Protection Department (PPD) of MARD
Pesticide Registration Constraints in Vietnam
1. The authorized organization or individual shall be allowed to act on behalf of only one manufacturer of active ingredients, technical pesticides or Formulated pesticide products to apply for the registration of specific active ingredients, technical pesticides or formulated pesticide products.
2. Registration certificate holder be entitled to register 01 commercial name for each active ingredient, technical pesticide or Formulated pesticide product used for deterring or killing harmful organisms or regulating the growth of plants. If these active ingredients, technical pesticides or Formulated pesticide products are used to disinfect warehouses or storage facilities, store plants, kill termites causing damage to buildings, dykes or embankments, or treat seeds, they are subject to another commercial name registration;
3. Registration certificate holder can only register 01 specified content of active ingredient used for each formulation of a pesticide product;
4. Registration certificate holder should avoid any change made to commercial names of pesticide products defined in the List, except when a competent intellectual property authority or a court judge in writing that such names have breached regulations on commodity labels;
5. Registration certificate holder is allowed to change the manufacturer’s name written on the registration certificate of pesticide products if that manufacturer ceases to provide products, or the manufacturer and the authorized organization or individual give the written mutual consent to authorization termination.
6. Plant protection drugs containing active ingredients being mixtures of chemicals and biologicals shall be managed like chemical drugs.
List of Approved and Banned Pesticides in Vietnam
Vietnam’s Ministry of Agriculture and Rural Development (MARD) maintains the List of Pesticides Approved for Use and the List of Pesticides Banned from Use in Vietnam. The lists are reviewed annually and regulates all pesticides, including active ingredients and commercial products, allowed for use or banned from use in Vietnam.
The list can be accessed here.
Pesticide Registration Types and Validity
There are two types of registration: official registration and supplemental registration.
1. The official registration shall be applicable to the followings:
a) Pesticide products containing active ingredients which have not been already specified in the List, or those with the new combination in terms of the ratio and composition of ingredients that already exist in the List invented by organizations or individuals and registered for use in overseas countries;
b) Pesticide products containing active ingredients which have not been already specified in the List, or those with the new combination in terms of the ratio and composition of ingredients that already exist in the List domestically invented by organizations or individuals, and recognized as a class of pesticide product by the Plant Protection Department upon the request of the Science Council established by this Department.
2. The supplemental registration shall be applicable to the followings:
a) Pesticide products with commercial names specified in the List but supplemented with the scope of application, dosage change, application method, formulation type and change of active ingredient content;
b) Pesticide products containing active ingredients specified in the list but registered with different commercial names
The validity of pesticide registration certificate is 5 years from the official issue date of the initial registration certificate.
Registration Data Requirements
Applicants for pesticide registration must submit the necessary registration data to the plant protection department (PPD). This typically includes an application form, lable, sample and test reports on product chemistry, toxicology, environmental impact, efficacy, and residue, among other required documents. The laboratories conducting the toxicology studies must operate in accordance with the principles of Good Laboratory Practice (GLP) or in conformity with the ISO 17025:2005 standard.
Thailand accepts GLP study reports issued by overseas laboratories, with lower registration data requirements and costs compared to Europe and America, as well as shorter review periods, allowing pesticide companies to enter this market more quickly, particularly new active ingredients and biopesticides.
Estimated Registration Costs and Timelines
It typically takes more than 3 years to register a pesticide in Vietnam. Registration costs depend on product types and test data requirements.
Our Services
CIRS Group offers a comprehensive suite of services covering every aspect of pesticide registration in Southeast Asia. Our services include:
- Regulatory Consulting: We provide up-to-date insights on regulatory trends and changes, helping you stay ahead in the market.
- Dossier Preparation and Submission: Our team of experts prepares and submits your registration dossiers, ensuring they meet the specific requirements of each country's regulatory body.
- Efficacy and Safety Testing: We facilitate and manage all required local testing, including efficacy, toxicology, and environmental impact studies, through our network of accredited laboratories.
- Local Representation: For clients without a local presence, CIRS Group can act as your local agent, representing your interests and liaising with regulatory authorities.
For more information on how we can assist with your pesticide registration needs in Southeast Asia, contact us today via service@cirs-group.com.