Procedures for re-issuance of the Certificate of eligibility to manufacture plant protection drugs in Vietnam

Procedures for re-issuance of the Certificate of eligibility to manufacture plant protection drugs in Vietnam (Internet image)

Procedures for re-issuance of the Certificate of eligibility to manufacture plant protection drugs in Vietnam are specified in Decision 373/QD-BNN-BVTV in 2023.

1. Application for re-issuance of the Certificate of Eligibility to Manufacture plant protection drugs in Vietnam

An application for re-grant of the Certificate of Eligibility to Manufacture Pesticides includes the following:

- An application form for a Certificate of Eligibility to Manufacture Plant Protection Drugs (using the form specified in Appendix XIV, which was issued in conjunction with Circular 21/2015/TT-BNNPTNT).

Appendix XIV

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

Appendix XV

- A plan or measures to prevent and respond to chemical incidents in the form specified in Appendix XXI issued in conjunction with Circular 21/2015/TT-BNNPTNT; photocopies of documents proving that the production facility complies with environmental protection regulations issued by the competent environmental agency.

Appendix XXI

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

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

- If the establishment has been in operation for two years or more, include a certified true copy or a photocopy of the certificate (bring the original for comparison) or documents related to the accreditation of a quality management system in accordance with ISO 9001:2008 or its equivalent.

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

2. Procedures for re-issuance of the Certificate of eligibility to manufacture plant protection drugs in Vietnam

- Step 1: Organizations and individuals (plant protection drug production establishments) submit their dossiers to the Plant Protection Department (03 months before the date on which the Certificate of eligibility to manufacture pesticides expires)

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

Incomplete dossiers must be returned, supplemented, and completed.

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

In case 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 to manufacture plant protection drugs (under the form specified in Appendix XIX issued together with Circular 21/2015/TT-BNNPTNT).

Appendix XIX

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

+ In case the evaluation results are not satisfactory, the Plant Protection Department shall notify in writing the establishments of the unsatisfactory conditions and the time limit for remedial measures. The Plant Protection Department must issue a certificate of eligibility to manufacture pesticides to the establishment within five working days of receiving the remedial report or re-inspection results.

+ In the event of a refusal, the Plant Protection Department must notify the applicant in writing and state the reason in detail.

3. Time limit for processing the application for re-grant of the Certificate of eligibility to manufacture plant protection drugs in Vietnam

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

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

Nguyen Thi Diem My

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