Procedures for new registration of insecticide and disinfectant preparations for use in the domestic and medical fields in Vietnam

Procedures for new registration of insecticide and disinfectant preparations for use in the domestic and medical fields in Vietnam​ (Image from the internet)

On November 30, 2024, the Minister of Health of Vietnam issued Decision 3613/QD-BYT announcing the amended and supplemented administrative procedures in the field of preventive health as stipulated in Decree 129/2024/ND-CP.

Procedures for new registration of insecticide and disinfectant preparations for use in the domestic and medical fields in Vietnam

Case 1: Procedure for new registration dossiers for household insecticidal products that have active ingredients, active ingredient concentrations, and product forms recommended by the World Health Organization and consistent with the Ministry of Health's regulations on the list of prohibited active ingredients, restriction of use scope in insecticidal and disinfectant products for household and medical fields; new registration dossiers for disinfectant products containing Ethanol or Isopropanol or a combination of Ethanol and Isopropanol with a total concentration of 60% to 90% and may contain no more than 0.5% Chlorhexidine:

Step 1: The entity registers the circulation of insecticidal and disinfectant products for use in household and medical fields by submitting the dossier to the Receipt and Result Delivery Department of the Ministry of Health.

Step 2: Upon receiving the new registration dossier and the dossier assessment fee, the Department of Health Environment Management, Ministry of Health issues the entity a Dossier Receipt Form according to Form No. 04 in Appendix III issued with Decree 91/2016/ND-CP.

Step 3:

- Within 30 days from the date on the Dossier Receipt Form, the Department of Health Environment Management, Ministry of Health shall notify the entity of any requests for amendments, supplements, or granting or not granting a registration number for circulation.

For dossiers with active ingredients, product forms, or usage scope or effects registered for the first time in Vietnam: Within 90 days from the date on the Dossier Receipt Form, the Department of Health Environment Management, Ministry of Health shall notify the entity of any requests for supplementing or amending the dossier or granting or not granting a registration number for circulation.

- If amendments or supplements to the dossier are requested, within 90 days from the date on the request, the registering entity must complete the dossier and provide a detailed explanation of the supplements or amendments by written document to the Ministry of Health. The date of receipt of the supplemented or amended dossier will be noted on the Dossier Receipt Form. If this period is exceeded, the new registration dossier will be nullified.

If the registering entity fails to submit the dossier within the prescribed time due to force majeure reasons such as natural disasters, catastrophes, epidemics, fires, etc., they may submit the dossier late, but not more than 12 months from the expiration date of the supplementation period, accompanied by an explanatory document.

Case 2: Procedure for new registration dossiers for insecticidal and disinfectant products for use in household and medical fields not covered in Case 1:

Step 1: The entity registers the circulation of insecticidal and disinfectant products for use in household and medical fields by submitting the dossier to the Receipt and Result Delivery Department of the Ministry of Health.

Step 2: Upon receiving the new registration dossier and the dossier assessment fee, the Department of Health Environment Management, Ministry of Health issues the entity a Dossier Receipt Form according to Form No. 04 in Appendix III issued with Decree 91/2016/ND-CP.

Step 3:

- Within 30 days from the date on the Dossier Receipt Form, the Department of Health Environment Management, Ministry of Health shall notify the entity of any requests for amendments, supplements, or approval or disapproval of the trial.

For dossiers with active ingredients, product forms, or usage scope or effects registered for the first time in Vietnam: Within 90 days from the date on the Dossier Receipt Form, the Department of Health Environment Management, Ministry of Health shall notify the entity of any requests for supplementing or amending the dossier; approving or disapproving the trial. In cases of disapproval of the trial, reasons must be clearly stated.

- If amendments or supplements to the dossier are requested, within 90 days from the date on the request, the registering entity must complete the dossier and provide a detailed explanation of the supplements or amendments by written document to the Ministry of Health. The date of receipt of the supplemented or amended dossier will be noted on the Dossier Receipt Form. If this period is exceeded, the new registration dossier will be nullified.

If the registering entity fails to submit the dossier within the prescribed time due to force majeure reasons such as natural disasters, catastrophes, epidemics, fires, etc., they may submit the dossier late, but not more than 12 months from the expiration date of the supplementation period, accompanied by an explanatory document.

Step 4: Following the approval for trial document, the registering entity is responsible for completing the trial and submitting the Trial Result Reply Sheet into the dossier within 36 months from the date on the trial approval document. The date of receipt of the Trial Result Reply Sheet is noted on the Dossier Receipt Form. If the 36-month limit is exceeded, the new registration dossier will be nullified.

Step 5: Within 30 days from the date on the Dossier Receipt Form, the Department of Health Environment Management, Ministry of Health shall notify the entity of any requests for amendments, supplements, or the granting or not granting of a registration number.

Refer to the detailed content at Decision 3613/QD-BYT effective from November 30, 2024.

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