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HOW TO REGISTER ANTIBACTERIAL PRODUCTS IN VIETNAM?

For an agricultural country in a hot and humid tropical monsoon climate like Vietnam. The need to kill insects and bacteria is extremely necessary. Therefore, antibacterial products are "a farmer's friend" as well as the daily life of everyone. However, registration of marketing of antibacterial is mandatory for products to be circulated on the market. In this article, Doanh Tri Law Firm shall provide the process of antibacterial product registration.
I. Legal basis
- Law on standards and technical regulations 2006;
- Law on chemicals 2007;
- Law on product and goods quality 2007;
- Decree 91/2016/ND-CP on the management of insecticidal and germicidal chemicals and preparations for household and medical use.


II. Conditions for registration of marketing of antibacterial product
- Toxicity of preparations not in groups Ia, Ib according to the classification of the World Health Organization for insecticidal preparations or groups I, II according to the classification of the globally harmonized system of classification and labeling of chemicals substance – GHS.
- Must not contain active ingredients named in the list of prohibited use in the preparation.
- Preparations containing active ingredients on the list of restricted use in the preparation may only be registered for circulation with the prescribed scope of use.
- Produced at an establishment that has announced production conditions (for domestically produced preparations) or has a Certificate of free sale (for imported preparations).


III. Procedure for registration of marketing of antibacterial products
1. Dossiers for registration of marketing of antibacterial products:
- A written request for registration of marketing, made according to Form No. 04 in Appendix I issued together with Decree No. 91/2016/ND-CP;
- Papers on the legal status of the registrant or production establishment;
- Power of attorney for circulation registration, except for the case specified at Point a, Clause 1, Article 20 of Decree No. 91/2016/ND-CP, as following: 
+ Domestic enterprises, cooperatives, and business households being the owners of preparations or representative offices of foreign traders in Vietnam of which such traders are owners of preparations;
+ Domestic enterprises, cooperatives, and business households authorized by the owner of the preparation to register;
+ Representative offices of foreign traders in Vietnam are authorized by the owner of the preparation for registration.
- Technical documents of the product to be registered;
- Results of testing of ingredients and content of active ingredients in the preparation;
- Answer sheet for testing results (added after the Ministry of Health has written permission for testing);
- Sample label of the product;
- Certificate of free sale (for imported preparations);
- Documents, results of studies on safety and efficacy, or recommendations of the World Health Organization or equivalent international organizations on the use of the preparation in the household and medical fields (for pharmaceutical preparations). containing active ingredients or in the form of products registered in Vietnam for the first time)


2. Procedure for registration of marketing of antibacterial preparations
Step 1: Submit the application to the Department of Health Environmental Management, Ministry of Health
Step 2: After receiving the application for registration of circulation and the fee for assessment of the application for permission for testing, the Department of Health Environmental Management will send the customer a receipt for the application.
Step 3: Within 30 days from the date on which the application is received, the Department of Health Environmental Management shall notify in writing the customer of the request to amend or supplement the dossier or permit the application. or disallow testing
Step 4: If no amendment or supplement is required, the Department of Health Environmental Management must notify in writing the customer of the permission or disallowance of the test.
Step 5: After obtaining the written permission for testing, the customer is responsible for:
- Complete the testing and testing as prescribed
- Submit test results to add to the dossier together with the fee for appraisal of the application for registration of circulation within 12 months from the date written on the official letter of permission for testing.
Step 6: Within 30 days from the date on which the application is received, the Department of Health Environmental Management shall notify in writing the customer of the request to amend or supplement the dossier, or not grant the application. circulation registration number or issue a circulation registration number and clearly state the reason.

The above information is about the "How to register antibacterial products in Vietnam?" For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

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