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REGISTRATION FOR CIRCULATION OF IMPORTED SURFACE DISINFECTANT PREPARATIONS 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 for circulation of imported surface disinfectant preparations 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 for circulation of imported surface disinfectant preparations in Vietnam

Article 50 of Decree 91/2016/ND-CP of the Government has clearly provided for the procedure for licensing the import of biocidal products. Based on this regulation, organizations, businesses, and individuals follow the steps below:

Step 1: Organizations, enterprises, and individuals that wish to import inoculants shall submit their dossiers directly or by post to the Health Environment Management Department of the Ministry of Health.

Step 2: After receiving the dossier, the Ministry of Health shall send it to the importing organization, enterprise or individual for the receipt of the application for import. The Form of Receipt of Application for Import Application.

* If the application does not require any additional documents, the Ministry of Health is responsible for issuing the import license.

* In case the dossier of application for import is incomplete, the Ministry of Health shall notify the applicant in writing to amend and supplement the dossier within 15 days. The written notice must clearly state the content to be modified.

* If the Ministry of Health sends a written request for supplementation within 60 days, the applicant must complete the dossier, clearly explain the additional contents, and send it to the Ministry of Health in writing.

Step 3: Within 03 working days from the date of issuance of the license, the Ministry of Health is responsible for publishing it on the website of the Ministry of Health:

+ Name of the preparation;

+ Import license number;

+ Full text of import license.

IV. Dossier

* Dossier includes:

- 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).

* Requirements for import registration documents

- The original authorization letter to carry out the import registration.

- The original or valid copy of the Certificate of Free Sale, for imported preparations. Certificate of free sale must meet the following requirements:

+ The CFS issuing country must be the inoculant producing country or one of the member countries of the World Trade Organization.

+ CFS must be issued within a period of no more than 12 months from the date of submission of the import registration dossier.

+ The CFS must remain valid for at least 6 months from the date of submission of the import registration dossier to the dossier-receiving agency in case the CFS has a date of expiration.

+ CFS must be consular legalized as prescribed, except for cases exempted from consular legalization under international treaties to which Vietnam is a member.

- Original or valid copy of the answer sheet of testing results by an independent establishment (other than the manufacturer or registration establishment of preparations) and eligible for testing.

- The original or a valid copy of the results of testing the ingredients and active ingredient content of the preparation. Test results must be performed by an establishment qualified for testing as prescribed in Article 10 of this Decree. In case the testing establishments in Vietnam are not qualified for testing, they can use the testing results of the manufacturer or an independent laboratory that has achieved ISO 17025: 2005 or ISO standards. 15189: 2012 or the updated version and the registrant must take legal responsibility for the legality of the test results provided by them.

- Label samples of all packing specifications according to actual size certified by the applicant. In case many packaging specifications have the same label design, the applicant shall submit the label of the smallest packaging specification. If the label sample of imported preparations is written in a foreign language, the contents of the supplementary label in Vietnamese must be attached. The sample label and sub-label content of preparations must meet the requirements in Appendix IX issued together with Decree 91/2016/ND-CP;

- Valid copies of papers on the legal status of the registration establishment or manufacturer;

- The original or valid copy of the written notice of change of name, address, location, or consular legalized change of the foreign establishment's production facility as prescribed.

- Other papers in the import registration dossier must be affixed with a seal or stamp on each page of the document by the registration establishment.

The above information is about the "Registration for circulation of imported surface disinfectant preparations 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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