Plant protection drug trial permits in Vietnam

Plant protection drug trial permits in Vietnam

I. Interpretation of terms on plant protection drug trial permits

In this text, the terms and phrases below are construed as follows:

1.Bio-efficacy trial means the determination of the efficacy of prevention and control of pests or regulation of crop growth (including also safety for crops).
2.Trial for determination of pre-harvest interval means the determination of the period of time (in day) from the last use of a plant protection drug to the harvest of products, which drug users are required to observe to ensure food safety.
3.Biological plant protection drug means a plant protection drug having efficacious constituents being live microorganisms or substances of microorganism, plant or animal origin.
4.Chemical plant protection drug means a plant protection drug having active ingredients being synthetic inorganic or organic chemicals.

II. General principles of grant of plant protection drug trial permits in Vietnam

1.Plant protection drugs registered on the list must have plant protection drug trial permits (below referred to as trial permits) granted by the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam under Articles 10 and 11 of Circular 21, and undergo trial under Chapter III of Circular 21.

2.Grant of trial permits for biological plant protection drugs

a/ Biological plant protection drugs require only large-scale biological efficacy trial, not trial for determination of pre-harvest interval, except the case specified at Point b of this Clause;
b/ Biological plant protection drugs containing pyrethrins, rotenone or avermectin products and subject to full registration or supplementary registration of trade names must undergo smallscale and large-scale biological efficacy trials. If they are first registered for use on fruit trees, tea and vegetables and for post-harvest preservation of farm produce, trial for determination of pre-harvest interval in Vietnam is required.

3.Grant of trial permits for chemical plant protection drugs

a/Chemical plant protection drugs subject to full registration or supplementary registration of trade names must undergo small-scale and large-scale biological efficacy trials;

b/Chemical plant protection drugs subject to registration of broadened use scope or changed dosage, usage, formulation type or active ingredient content must undergo large-scale biological efficacy trial;

c/Chemical plant protection drugs first registered for use on fruit trees, tea and vegetables and for post-harvest preservation of farm produce must undergo trial for determination of preharvest interval in Vietnam (except herbicide used for perennial fruit trees, insect attractants, drugs for pre-cultivation soil treatment, drugs for prevention and control of sapling wilt, and drugs for treatment of seeds and grafts).

4.Both Vietnamese and scientific names of pests shall be written on trial permits.

III.Dossiers, order and procedures for grant of trial permits for full registration of plant protection drugs in Vietnam.

1.Submission of dossiers for grant of trial permits of plant protection drugs in Vietnam.

a/ A dossier may be submitted directly, by post or online to the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam;

b/ Number of dossiers: One paper dossier and its electronic file (PDF format).

c/ The dossier shall be checked within 2 working days. If the dossier is valid as prescribed, it shall be accepted. If the dossier is invalid, it shall be returned together with a request for supplementation and completion;

2.A dossier for grant of trial permits for full registration of plant protection drugs in Vietnam:

a/ An application for plant protection drug trial permit, made according to the form provided in Appendix I to Circular 21;

b/ Papers proving the applicant’s eligibility to register plant protection drugs in Vietnam:

The original or an authenticated copy of the document certifying the manufacturer of drugs, including the plant protection drug for which the trial permit is applied, granted by a competent agency of the country of origin (for foreign manufacturers);

An authenticated copy or a photocopy together with the original (for comparison) of the establishment license of the company, company branch or representative office in Vietnam (for foreign manufacturers that register drugs for the first time);

The original power of attorney of the manufacturer for the registrant (in case of authorized registration). The power of attorney of a foreign manufacturer shall be consularly legalized in accordance with Vietnamese law, unless it is exempted from legalization under a treaty to which Vietnam is a contracting party;

A copy of the certificate of eligibility for plant protection drug trading (for domestic entities authorized to make first-time registration under their names);

c/ Technical documents of the plant protection drug specified in Appendix III to Circular 21.

3.Appraisal of dossiers and grant of trial permits plant protection drugs in Vietnam

a/ the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam shall appraise the dossier within 10 working days after receiving the complete dossier as prescribed in Clause 2 of this Article. For a dossier of application for trial permit for more than three crops or three pests, the time limit for dossier appraisal is 15 working days;
In case the dossier satisfies the requirements prescribed in Circular 21, the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam shall submit it to the Minister of Agriculture and Rural Development;
In case the dossier fails to satisfy the requirements prescribed in Circular 21, the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam shall notify contents to be supplemented to the applicant for dossier completion;

b/ The Ministry of Agriculture and Rural Development (the Department of Science, Technology and Environment) shall appraise the dossier under regulations within 5 working days after receiving it from the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam;

c/ Within 2 working days after receiving the approval of the Minister of Agriculture and Rural Development, the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam shall grant a plant protection drug trial permit, made according to the form provided in Appendix IV to Circular 21;
d/ In case of refusal to grant a trial permit, the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam shall notify such in writing to the applicant clearly stating the reason.

IV. Dossiers, order and procedures for grant of trial permits for supplementary registration of plant protection drugs.

1. Submission of dossiers for grant of trial permits

a/ A dossier may be submitted directly, by post or online to the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam;

b/ Number of dossiers: One paper dossier and its electronic file (PDF format).

c/ The dossier shall be checked within 2 working days. If the dossier is valid as prescribed, it shall be accepted. If the dossier is invalid, it shall be returned together with a request for supplementation and completion;

2.A dossier for grant of trial permits must comprise:

a/ An application for plant protection drug trial permit, made according to the form provided in Appendix I to Circular 21;

b/ A copy of the granted plant protection drug registration certificate (in case of broadened scope of use or changed formulation type, active ingredient content, dosage or usage);

c/ Technical documents on the finished product specified in Appendix III to Circular 21 (in case of changed formulation type or active ingredient content);

d/ Papers specified at Points b and c, Clause 2, Article 10 of Circular 21 (in case of addition of other trade names);

3.Appraisal of dossiers and grant of trial permits of plant protection drugs in Vietnam

a/ The Plant Protection Department Minister of Agriculture and Rural Development of Vietnam shall appraise the dossier within 10 working days after receiving the complete dossier as prescribed in Clause 2 of this Article. For a dossier of application for trial permit for more than three crops or three pests, the time limit for dossier appraisal is 15 working days;
In case the dossier satisfies the requirements prescribed in this Circular, the Plant Protection Department Minister of Agriculture and Rural Development of Vietnam shall submit it to the Minister of Agriculture and Rural Development;
In case the dossier fails to satisfy the requirements prescribed in this Circular, the Plant Protection Department Minister of Agriculture and Rural Development of Vietnam shall notify contents to be supplemented to the applicant for dossier completion;

b/ The Ministry of Agriculture and Rural Development (the Department of Science, Technology and Environment) shall appraise the dossier under regulations within 5 working days after receiving it from the Plant Protection Department;

c/ Within 2 working days after receiving the approval of the Minister of Agriculture and Rural Development, the Plant Protection Department shall grant a plant protection drug trial permit, made according to the form provided in Appendix IV to this Circular;

d/ In case of refusal to grant a trial permit, the Plant Protection Department - Minister of Agriculture and Rural Development of Vietnam  shall notify such in writing to the applicant clearly stating the reason.

V. Dossiers, order and procedures for re-grant of trial permits of plant protection drugs

1. Submission of dossiers for re-grant of trial permits

a/ A dossier may be submitted directly, by post or online to the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam;

b/ Number of dossiers: One paper dossier.

c/ The dossier shall be checked within 2 working days. If the dossier is valid as prescribed, it shall be accepted. If the dossier is invalid, it shall be returned together with a request for supplementation and completion;

2.A dossier for re-grant of trial permits must comprise:

a/ An application for re-grant of plant protection drug trial permit, made according to the form provided in Appendix I to Circular 21;

b/ The original trial permit already granted (unless it is lost).

3.Appraisal of dossiers and re-grant of trial permits of plant protection drugs in Vietnam.

Within 5 working days after receiving a complete dossier as prescribed, the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam shall appraise it:
a/ If the dossier is valid, the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam shall re-grant the plant protection drug trial permit according to the form provided in Appendix IV to Circular 21. The new trial permit must have the same validity duration as that of the granted permit;
b/ In case the dossier is invalid, the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam shall notify the contents which need to be supplemented to the applicant for dossier completion; c/ In case of refusal to re-grant the trial permit, the Plant Protection Department - Ministry of Agricultural and Rural Development of Vietnam shall notify such in writing clearly stating the reason to the applicant.

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