What are the procedures for re-issuance of the Certificate of eligibility for production of pesticide in Vietnam?

What are the procedures for re-issuance of the Certificate of eligibility for production of pesticide in Vietnam? Question of Mr. Tri from Hue.

What is included in the application for re-issuance of the Certificate of eligibility for production of pesticide in Vietnam?

Pursuant to Section 3, Part II of the List of administrative procedures promulgated together with Decision 373/QD-BNN-BVTV of Vietnam in 2023, the application for re-issuance of the Certificate of eligibility for production of pesticide includes:

- An application form for the Certificate of eligibility for production of pesticide (under the form specified in Appendix XIV issued together with Circular 21/2015/TT-BNNPTNT of Vietnam).

- A written explanation of the conditions for the production of plant protection drugs (as specified in Appendix XV issued together with Circular 21/2015/TT-BNNPTNT of Vietnam).

- Plan or measures to prevent and respond to chemical incidents according to the form specified in Appendix XXI issued together with Circular 21/2015/TT-BNNPTNT of Vietnam; Photocopies of papers proving that the production facility meets the regulations on environmental protection issued by the competent environmental agency.

- If there is a laboratory, submit a photocopy of the Certificate or documents related to the accreditation of the quality management system in accordance with ISO 17025:2005 or equivalent.

- If there is no testing laboratory, submit a copy of the contract with a laboratory that has been accredited with ISO 17025:2005 or equivalent.

- In case the establishment has been in operation for 2 years or more, add a certified true copy or a photocopy (bring the original for comparison) of the certificate or documents related to the recognition of the management system. Quality conforming to ISO 9001:2008 or equivalent.

Number of documents: 01 paper copy and 01 electronic copy in PDF format.

What are the procedures for re-issuance of the Certificate of eligibility for production of pesticide in Vietnam?

What are the procedures for re-issuance of the Certificate of eligibility for production of pesticide in Vietnam?

What are the procedures of re-issuance of the Certificate of eligibility for production of pesticide in Vietnam?

Pursuant to Section 1, Part II of the List of administrative procedures promulgated together with Decision 373/QD-BNN-BVTV of Vietnam in 2023, the procedures of re-issuance of the Certificate of eligibility for production of pesticide as follows:

- Step 1: Organizations and individuals (plant protection drug production establishments) submit dossiers to the Plant Protection Department (03 months before the expiry date of the Certificate of eligibility for production of pesticide).

- Step 2: Receive and check the validity of the application within 02 working days.

Invalid dossiers shall be returned and requested to supplement and complete dossiers.

- Step 3: Appraise the dossier and set up the actual assessment team at the establishment within 05 working days.

If the application does not meet the requirements, the Plant Protection Department shall notify the organization or individual of the contents that need to be supplemented and completed.

- Step 4: Actual assessment at the facility

+ The audit team shall notify in writing the establishment 07 working days before the time of assessment, the assessment time at the establishment shall not exceed 01 working day.

- Step 5: Issue the Certificate of eligibility for production of pesticide (under the form specified in Appendix XIX issued together with Circular 21/2015/TT-BNNPTNT of Vietnam).

+ Within 15 working days in case an assessment team must be established.

+ In case the assessment results are not satisfactory, the Plant Protection Department shall notify in writing the establishments of unsatisfactory conditions and time limit for remedial measures. Within 05 working days from the date of receiving the remedial report of the establishment or the re-inspection result, the Plant Protection Department shall grant the Certificate of eligibility for production of pesticide to the establishment.

+ In case of refusal, the Plant Protection Department shall notify in writing and clearly state the reason.

The time limit for processing the application for re-issuance of the Certificate of eligibility for production of pesticide is:

- 30 working days excluding the time to supplement and complete the dossier.

- 35 working days after receiving the remedial report of the establishment with unsatisfactory conditions or re-inspection results, excluding the time for supplementing and completing the dossier and the time limit for remediation.

Application form for the Certificate of eligibility for production of pesticide in Vietnam?

The application form for the Certificate of eligibility for production of pesticide is specified in the Appendix issued together with Appendix XIV enclosed with Circular 21/2015/TT-BNNPTNT of Vietnam as follows:

Download the application form for the Certificate of eligibility for production of pesticide: here.

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