REGISTRATION PROCEDURES FOR CIRCULATION OF BACTERICIDAL PREPARATIONS IN 2021 IN VIETNAM

Despite the fact that the current situation of COVID-19 infection has been well avoided by the Vietnamese government and citizens, the possible danger from this epidemic remains very high. In such a scenario, disinfectants are an emerging product that is being increasingly sought after to meet customer needs. Many countries already have the world's largest biocides industry. This is also the preferred method of importation for companies. The following article will include details on " Registration procedures for circulation of bactericidal preparations in 2021 in Vietnam" to readers and businesses.

I. Legal basis

- Law on Commerce dated June 14, 2005;

- Law on Technical regulations and standards dated June 29, 2006;

- Law on Product and goods quality dated November 21, 2007;

- Law on Chemicals dated November 21, 2007;

- Law on Investment dated November 26, 2014.

II. Conditions of preparation registration

Preparations must meet the following conditions to be circulated in Vietnam according to Article 19 of Decree No. 91/2016/ND-CP:

- Toxicity of preparations not in group 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 chemicals - GHS;

- Does not contain active ingredients on the list of prohibited substances from use in preparations;

- Preparations containing active ingredients on the list of the limited scope of use in preparations may only register for import with the prescribed scope of use;

- Produced at an establishment that has imported fully qualified production conditions (for domestically produced preparations) or has a certificate of free import (for imported preparations).

In addition, imported inoculants also need to be tested and tested as stipulated in Article 9 and Article 13 of Decree 91/2016/ND-CP respectively. Accordingly, testing is the determination of the composition and active ingredient content in insecticidal and germicidal preparations according to import and export registration dossiers. The cases to be tested are: Preparations in the manufacturing process; Preparations before new import registration; Preparations imported in Vietnam in accordance with the Law on Product and Goods Quality.

III. Registration procedures

1. Dossier

- Application for registration of circulation

- A document on the legal status of the registration establishment or manufacturer.

- A power of attorney for import registration, unless the establishment is the owner of the preparation or the representative office of a foreign trader in Vietnam in which such trader is the owner of the preparation;

- The technical document of the preparation for registration

- Results of testing for ingredients and active ingredient content in the preparation (to be added with the answer sheet of testing results).

- Answer report of testing results (to be supplemented after the Health Ministry has issued written permission for testing).

- Sample label of preparations.

- Certificate of free import (for imported preparations).

- Documents, research results on safety and efficacy or recommendations of the World Health Organization or equivalent international organizations on the use of inoculants in the domestic and medical sectors (for products containing active ingredients or in the form of products registered in Vietnam for the first time).

2. Procedures

Step 1: The applicant shall, by hand or by post, submit the application for registration of new preparations to the Ministry of Health. If the Ministry of Health adopts the method of online registration, the application shall be submitted online.

Step 2: Ministry of Health shall issue a Receipt note to the applicant upon the receipt of the application and fees for appraising the application for registration of new preparations.

Step 3: Within 30 days from the date stated in the Receipt note mentioned above, the Ministry of Health shall make a written notice to the applicant for registration of new preparations of request for supplement or modification of the application dossiers, or approval or refusal to give approval for the experiment. In case of supplement or modification of the application, contents requiring supplement or modification must be specified in writing. In case of refusal to give approval for the experiment, reasons must be specified in writing.

Step 4: Within 90 days from the date stated on the written request for supplement or modification of the application by the Ministry of Health, the applicant must complete and send a written explanation about supplemented or modified contents to the Ministry of Health. The time limit for making supplements or modifications is specified in the Receipt note of the application. Over the said time limit, if the application for registration of new preparations shall be canceled.

Step 5: If the application is valid, the Ministry of Health shall give a written notice of approval or refusal to give approval for the experiment to the applicant for registration of new preparations. In case of refusal to give approval for the experiment, reasons thereof must be specified in writing.

Step 6: Within 12 months from the date stated in the written approval for the experiment, the applicant shall be responsible for completing the testing and/or experiment as referred to in Chapter III herein and supplementing the application with testing and/or experiment results. The time limit for receiving the testing/experiment results is specified in the Receipt note of the application. Over the said time limit, if the application for registration of new preparations shall be canceled.

Step 7: Within 30 days from the date stated in the Receipt note mentioned in Step 6, the Ministry of Health shall make a written notice to the applicant for registration of new preparations of request for supplement or modification of the application dossiers, or issuance or refusal to issue the registration number. In case of supplement or modification of the application, contents requiring supplement or modification must be specified in writing. In case of refusal to issue the registration number, reasons thereof must be specified in writing.

Step 8: Within 03 working days from the issued date of the new registration number, the Ministry of Health shall publish the following information on its website:

a) The name of preparations;

b) The registration number;

c) The full text of the sale registration certificate.

The above information is about the "Registration procedures for circulation of bacterial preparations in 2021 in Vietnam". For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

Hotline: (+84) 911.233.955 - (024) 6293 8326

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