Registration of plant protection drugs in Vietnam

Registration of plant protection drugs in Vietnam

I.General principles of registration of plant protection drugs in Vietnam.

1.All plant protection drugs used for preventing and controlling plant pests; regulating crop growth; preserving plants; disinfecting warehouses; killing termites harmful to construction works and dikes; killing weeds on uncultivated land; enhancing safety and effect when used (with particular trade names) shall be registered in the list of plant protection drugs permitted for use in Vietnam (below referred to as the list).

2. Domestic and foreign entities and individuals (with representative offices, companies, company branches trading in plant protection drugs licensed for operation in Vietnam) that manufacture plant protection drug active ingredients (below referred to as active ingredients), plant protection drugs of technical grade (below referred to as technical-grade drugs) or finished plant protection products from technical-grade drugs (below referred to as finished products) may register under their own names plant protection drugs which they manufacture.

3.A manufacturer of active ingredients, technical-grade drugs or finished products that does not register them under its/his/her own name may authorize only one organization or individual that fully satisfies the conditions prescribed in Clause 3, Article 50 of the Law on Plant Protection and Quarantine to register each plant protection drug under its/his/her name.

4.An entity or individual may be authorized by only one manufacturer of active ingredients, technical-grade drugs or finished products to register each of those active ingredients, technical-grade drugs or finished products.

5.A registrant may:
a/ Register one trade name for each active ingredient, technical-grade drug or finished product for pest prevention and control or crop growth regulation. In case such active ingredient, technical-grade drug or finished product is used for disinfection of warehouses; preservation of plants; killing of termites harmful to construction works or dikes; or treatment of seeds, one more trade name shall be registered;
b/ Register only one active ingredient content for each formulation of a plant protection drug; c/ Transfer trade names under Clauses 2, 3 and 4, and Points a and b, Clause 5, of this Article; d/ Not change trade names of plant protection drugs on the list, unless the state management agency in charge of intellectual property or a court makes written conclusions that they infringe upon trademarks of trade names on the list;
dd/ Change the manufacturer named in the plant protection drug registration certificate in case the manufacturer ceases supply of products or there is a written agreement on termination of authorization between the manufacturer and the authorized organization or individual.

6.Only five years after the organization or individual that first registers a plant protection drug containing active ingredients not yet on the list is granted a full registration certificate for such drug, may others file dossiers for supplementary registration of new trade names for plant protection drugs containing such active ingredients.

7. Plant protection drugs containing active ingredients being mixtures of chemicals and biologicals shall be managed like chemical drugs.

II. Plant protection drugs not permitted for registration in Vietnam

1. Plant protection drugs on the list of plant protection drugs banned from use in Vietnam (below referred to as banned list).

2. Finished products or active ingredients in finished products of class I or class II toxicity according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), except biological plant protection drugs and plant protection drugs used for fumigation, disinfection or as rodenticide; termiticide for construction works and dikes; and preservatives for forest products that are not used as food or pharmaceutical materials.

3. Plant protection drugs that are most likely to badly affect human health, livestock, the ecological system and environment, including:
a/ Plant protection drugs that are warned by the United Nations Food and Agriculture Organization (FAO), United Nations Environmental Program (UNEP) or World Health Organization (WHO); and those specified in Annex III to the Rotterdam Convention;
b/ Chemical plant protection drugs that are mixtures of plant protection drugs with different effects (insecticide, herbicide, pesticide, growth regulator), except seed treatment drugs;
c/ Plant protection drugs that contain microorganisms pathogenic to humans;
d/ Plant protection drugs that may cause genetic mutation, cancer or reproductive toxicity to humans;
dd/ Chemical plant protection drugs registered for prevention and control of plant pests or for growth regulation of fruit trees, tea and vegetables or post-harvest preservation of farm produce, with class III or class IV acute toxicity of active ingredients or finished products according to GHS; of the organic chlorine group; and with a pre-harvest interval of over 7 days in Vietnam.

4.Plant protection drugs with trade names identical to active ingredients or trade names of other plant protection drugs on the list.

5.Plant protection drugs that contain methyl bromide.

6.Plant protection drugs registered for prevention and control of living creatures other than microorganisms harmful to plants in Vietnam.

7.Plant protection drugs invented abroad but not yet permitted for use there.

II.Removal of plant protection drugs from the list

1.A plant protection drug shall be removed from the list in the following cases:
a/ It falls into one of the cases specified in Clause 2, Article 49; Points b and c, Clause 1, Article 54 of the Law on Plant Protection and Quarantine;
b/ It is specified in Annex III to the Rotterdam Convention or warned by the United Nations Food and Agriculture Organization (FAO), United Nations Environmental Program (UNEP) or World Health Organization (WHO).

2.Procedures for removing a plant protection drug from the list
a/ In the case specified at Point b, Clause 1 of this Article, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall report to and propose in writing the Minister of Agriculture and Rural Development to remove such plant protection drug from the list;
b/ In the case specified at Point a or b, Clause 2, Article 49 of the Law on Plant Protection and Quarantine, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall summarize information and form a scientific council to consider and advise on the removal of such plant protection drug from the list, and report to and propose the Minister of Agriculture and Rural Development to remove such plant protection drug from the list. The Minister of Agriculture and Rural Development shall decide on removal of such plant protection drug from the list;
c/ In the case specified at Point c, Clause 2, Article 49; Point b or c, Clause 1, Article 54 of the Law on Plant Protection and Quarantine, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall propose the Minister of Agriculture and Rural Development to remove such plant protection drug from the list.

3.A plant protection drug specified at Point b, Clause 1 of this Article; Point a or b, Clause 2, Article 49 of the Law on Plant Protection and Quarantine may only be manufactured or imported within one year, or traded and used within two years after the Ministry of Agriculture and Rural Development’s decision on removal of it from the list takes effect.

III.Forms of registration of plant protection drug in Vietnam

1.Full registration, covering:

a/ Plant protection drugs containing active ingredients not yet included in the list or plant protection drugs with new contents and compositions of active ingredients on the list which are invented and registered for use abroad;
b/ Plant protection drugs containing active ingredients not yet included in the list or plant protection drugs with new contents and compositions of active ingredients on the list which are invented at home and proposed by scientific councils formed by the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam to the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam for recognition as plant protection drugs.

2.Supplementary registration, covering:
a/ Plant protection drugs having their trade names on the list but having their use scope broadened, or their dosage, usage, formulation type or active ingredient content changed;
b/ Plant protection drugs containing active ingredients on the list but registered with other trade names.

IV.Dossiers, order and procedures for grant of plant protection drug registration certificates in Vietnam.

1.Submission of dossiers for grant of plant protection drug registration certificates in Vietnam
a/ A dossier may be submitted directly, by post or online to the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam;
b/ Number of dossier: One paper dossier and its electronic file in the word or excel format, or power point format for labels.
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 plant protection drug registration certificates in Vietnam must comprise:

a/ An application for a plant protection drug registration certificate, made according to the form provided in Appendix II to Circular 21;
b/ A copy of the granted trial permit;
c/ The drug label design as prescribed in Sections 1, 2 and 3, Chapter X of Circular 21;
d/ The original reports on results of biological efficacy trial and trial for determination of pre-harvest interval, and summary report on trial results, made according to the forms provided in Appendices VI, VII and XI to Circular 21.

3.Appraisal of dossiers and grant of plant protection drug registration certificates in Vietnam
Within 6 months after receiving a complete and valid dossier, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall appraise it and propose the Minister of Agriculture and Rural Development to include the plant protection drug in the list; and shall grant a plant protection drug registration certificate according to the form provided in Appendix V to Circular 21. In case of refusal to grant a certificate, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall reply in writing clearing stating the reason to the applicant. 

V.Dossiers, order and procedures for extension of plant protection drug registration certificates in Vietnam.

1.Three months before the expiration date of a plant protection drug registration certificate, its holder that wishes to have its/his/her certificate extended shall submit a dossier of request for certificate extension.

2.Submission of dossiers for extension of plant protection drug registration certificates in Vietnam.
a/ A dossier may be submitted directly, by post or online to the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam;
b/ The number of dossier is 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;

3.A dossier for extension of plant protection drug registration certificates in Vietnam must comprise:
a/ A written request for extension of a plant protection drug registration certificate, made according to the form provided in Appendix II to Circular 21;
b/ The original plant protection drug registration certificate already granted.

4.Appraisal of dossiers and extension of plant protection drug registration certificates in Vietnam
Within 10 working days after receiving a complete and valid dossier prescribed in Clause 3 of this Article, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall appraise it:
a/ In case the dossier is valid and satisfies the requirements prescribed in Circular 21, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall extend the plant protection drug registration certificate according to the form provided in Appendix V to Circular 21;
b/ In case the dossier is invalid and fails to satisfy the requirements prescribed in Circular 21, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall notify contents to be supplemented to the applicant for dossier completion;
c/ In case of refusal to extend the plant protection drug registration certificate, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall notify such in writing to the applicant clearly stating the reason.

VI. Re-grant of plant protection drug registration certificates in Vietnam:

A.Dossiers, order and procedures for re-grant of plant protection drug registration certificates in case of loss, error or damage

1.Submission of dossiers
a/ A dossier may be submitted directly, by post or online to the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam;
b/ The number of dossier is 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 plant protection drug registration certificates must comprise:
a/ An application for re-grant of a plant protection drug registration certificate, made according to the form provided in Appendix II to Circular 21;
b/ The original plant protection drug registration certificate, unless it is lost.

3.Order and procedures for re-grant of a plant protection drug registration certificate in Vietnam
A plant protection drug registration certificate shall be re-granted under Clause 4, Article 14 of Circular 21. The re-granted plant protection drug registration certificate must have the same validity duration as that of the original certificate.

B.Dossiers, order and procedures for re-grant of plant protection drug registration certificates in case of change of trade names or information about registrants

1.Submission of dossiers
a/ A dossier may be submitted directly, by post or online to the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam;
b/ The number of dossier is 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 must comprise:
a/ A written request for change of the trade name or information about the registrant, made according to the form provided in Appendix II to Circular 21;
b/ The original plant protection drug registration certificate;
c/ An authenticated copy or a photocopy with the original (for comparison) of the document of the competent state agency in charge of intellectual property or a court on trademark infringement (in case of change of trade name);
d/ An authenticated copy or a photocopy with the original (for comparison) of the new enterprise registration certificate (in case the registrant is renamed);
dd/ In case of transfer of trade name: The original or an authenticated copy of the contract or agreement of transfer of the plant protection drug; the original power of attorney of the manufacturer for registration by the transferee (in case of authorized registration).

3.Appraisal of dossiers and re-grant of plant protection drug registration certificates
a/ Within 10 working days after receiving a complete dossier prescribed in Clause 2 of this Article, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall appraise it: In case the dossier is valid, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall propose the Minister of Agriculture and Rural Development to include the drug in the list under Clause 3, Article 13 of Circular 21;
In case the dossier is invalid and fails to satisfy the requirements prescribed in Circular 21, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall notify contents to be supplemented to the applicant for dossier completion;
b/ In case of refusal to re-grant the plant protection drug registration certificate, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall notify such in writing clearly stating the reason to the applicant;

c/ The re-granted plant protection drug registration certificate must have the same validity term as that of the previously granted certificate.

C.Dossiers, order and procedures for re-grant of plant protection drug registration certificates in case of change of manufacturers

1.Submission of dossiers

a/ A dossier may be submitted directly, by post or online to the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam;
b/ 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;
c/ Number of dossiers: One paper dossier and its electronic file (PDF format).

2.A dossier must comprise:
a/ An application for re-grant of a plant protection drug registration certificate, made according to the form provided in Appendix II to Circular 21;
b/ The original or an authenticated copy of the agreement on termination of authorization between the manufacturer named in the plant protection drug registration certificate and the entity authorized to make registration;
c/ The original or an authenticated copy of the document certifying the new manufacturer as the plant protection drug manufacturer granted by a competent management agency of the country of origin (for foreign manufacturers);
d/ The original power of attorney of the new manufacturer for registration by the registrant (in case of authorized registration). The power of attorney of the 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;
dd/ Technical documents of the plant protection drug specified in Appendix III to Circular 21;
e/ The original plant protection drug registration certificate already granted.
3.Appraisal of dossiers and re-grant of plant protection drug registration certificates
a/ Dossiers shall be appraised and plant protection drug registration certificates shall be re-granted under Clause 4, Article 14 of Circular 21;
b/ The re-granted plant protection drug registration certificate must have the same validity duration as that of the previously granted certificate.

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