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CONSULTING REGISTRATION OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS FOR HOUSEHOLD AND MEDICAL USE IN VIETNAM

In the face of the stressful situation of the COVID-19 pandemic in 2021, the demand for goods related to disinfection, sterilization, and disease prevention becomes necessary, especially antibacterial preparations using in household and medical use. Like other products in the medical industry, chemicals, and antibacterial preparations must be registered for circulation before being circulated on the market. In this article, Doanh Tri will make an attempt to shed more light on this issue.

I. Legal basis

- Law on standards and technical regulations 2006;

- Law on Chemicals 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 circulation

Conditions for preparations for circulation registration:

- 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 chemicals - GHS.

- Does not contain active ingredients on the list of banned substances used in the preparation.

- Preparations containing active ingredients on the list of restricted use in preparations 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).

Establishments entitled to register for circulation of new insecticidal and germicidal preparations include:

- 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.

III. Procedures for registration of insecticidal and germicidal products for household and medical use

Dossiers for registration of insecticidal and germicidal products for household and medical use

- A written request for new circulation registration

- Papers on the legal status of the registration establishment, the production establishment.

- Power of attorney to carry out the registration

- Technical documents of the product to be registered

- Results of testing of ingredients and content of active ingredients in preparations (added with the answer sheet of testing results)

- Answer sheet of 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 preparations in the household and medical fields.

The order of carrying out the registration procedure

Step 1: Submit the dossiers to the Department of Health Environment Management, Ministry of Health.

Step 2: After receiving the new dossiers for registration of circulation and the fee for assessment of the application for testing permission.

Step 3: Within 30 days from the date on which the application is received, the Department of Health Environmental Management and the Ministry of Health shall notify in writing the new circulation registration establishment of the request for amendment. additional records or allow or disallow testing.

In case there is a request to supplement or amend the dossier, within 90 days from the date written on the registration document, the registration establishment must complete the dossier, clearly explain the additional and revised contents in writing and send it to the Department of Health Environmental Management, Ministry of Health.

If no amendment or supplement is required, the Medical Environmental Management Department, the Ministry of Health must notify in writing the registration establishment of the permitting or disallowing the testing.

Step 4: After obtaining written permission for testing, the registration establishment is responsible for completing the testing.

Step 5: Within 30 days from the date on which the application is received, the Department of Health Environmental Management and the Ministry of Health shall notify in writing the registration establishment of the request to amend and supplement the application. preliminary, no circulation registration number or circulation registration number.

The above information is about the "Consulting registration of insecticidal and germicidal chemicals and preparations for household and medical use 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

Email: contact@luatdoanhtri.vn

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