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Circulation registration of insecticidal and germicidal chemicals and preparations

Vietnam is a developed agricultural country leads to the huge demand of using chemicals, insecticides. Thus, enterprieses  manufacture and distribute many new products to markets. However, before that, insecticidal and germicidal chemicals and preparations must be registered for circulation. T2H Lawyers would like to provide you necessary information about this matter.

  1. Conditions for preparations to be registered for circulation:

– The toxicity of preparations is outside class Ia or Ib according to the World Health Organization’s classification for insecticidal preparations or class I or II according to the globally-harmonized system of classification and labeling of chemicals -GHS.

– Preparations do not contain active ingredients on the list of active ingredients banned from use in preparations.

– Preparations containing active ingredients on the list of active ingredients restricted from use in preparations may be registered for circulation within the prescribed scope of use.

– Preparations are having a Certificate of free sale (for imported products).

  1. Dossier for circulation registration:
  • A written request for new circulation registration;
  • Papers on the legal entity status of the registering establishment or production establishment;
  • A paper of authorization to register circulation in Vietnam;
  • Technical documents of the preparation registered for circulation;
  • Results of testing of the composition and contents of active ingredients of the preparation (to be added with the assay result slip);
  • The assay result slip (to be added after the Ministry of Health issues a written permission for assay);
  • The specimen label of the preparation;
  • The Certificate of free sale (for imported products);
  • Research documents and results on safety and efficacy or warnings of the World Health Organization or equivalent international organizations on the use of preparations in household and medical fields (for preparations containing active ingredient or with a formulation registered for the first time in Vietnam).
  1. The process of circulation registration:

Step 1: Submit dossier to the Department of Environmental Management under the Ministry of Health (directly or via post office or online).

Step 2: After receiving the dossier and a charge for its examination, the Department of Environmental Management shall issue a dossier receipt.

Step 3: Within 30 days from the date indicated on the dossier receipt, the Department of Environmental Management shall notify in writing the registering establishment of its request for supplementation and modification of the dossier or of its permission or non-permission for conducting assays.

If requesting supplementation and modification of the dossier, within 90 days from the date indicated on the request, the registering establishment shall complete the dossier, prepare written explanations on the supplemented and modified contents and send them to the Department of Environmental Management. The date of receipt of the supplemented and modified dossier shall be recorded on the dossier receipt. Past this time limit, the new circulation registration dossier shall become invalid.

Step 4: In case no supplementation and modification is needed, the Department of Environmental Management shall notify in writing the registering establishment of its permission or non-permission for conducting assays.

Step 5: After obtaining a written assay permission from the Department of Environmental Management, the registering establishment shall;

– Carrying out the testing or assay according to the law;

– Submitting the testing or assay result for addition to the dossier within 12 months from the date indicated on the assay permission document.

– The date of receipt of the testing or assay result shall be recorded on the dossier receipt. Past this time limit, the new circulation registration dossier shall become invalid.

Step 6: Within 30 days from the date indicated on the dossier receipt as prescribed in Step 5, the Department of Environmental Management shall notify in writing to the registering establishment of its request for supplementation and modification of the dossier or of the grant of, or refusal to grant, a circulation registration number.

  1. Charge for examination:

– Examination of dossier for granting the circulation registration certificate of insecticidal and germicidal chemicals and preparations for household and medical use: 11.000.000 VND/dossier.

– Examination for granting the assay result slip of insecticidal and germicidal chemicals and preparations for household and medical use: 3.500.000 VND/dossier.

– Examination for granting the circulation registration certificate of insecticidal and germicidal chemicals and preparations for household and medical use: 2.000.000 VND/time.

 

Contact T2H Lawyers for more information.

T2H Law Liability limited company

Head office: G4-4A, Dormitory 708, Lien Ninh, Thanh Tri, Hanoi

Branch office: 20N7A Nguyen Thi Thap, Nhan Chinh Ward, Thanh Xuan District, Hanoi.

Phone: 0242 242 9900 – 0989 656 682

Website: https://t2hlawyers.vn

Email: contact.t2h@t2hlawyers.vn – huong.le@t2hlawyers.vn

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