Decree No. 91/2016/ND-CP dated July 01, 2016 of the Government on management of insecticidal and germicidal chemicals and preparations for household and medical use

DECREE

On management of insecticidal or germicidal chemicals and preparations for household and medical use[1]

Pursuant to the June 19, 2015 Law on Organization of the Government;

Pursuant to the November 21, 2007 Law on Chemicals;

Pursuant to the November 26, 2014 Law on Investment;

Pursuant to the November 21, 2007 Law on Product and Goods Quality;

Pursuant to the November 26, 2014 Law on Enterprises;

Pursuant to the June 14, 2005 Commercial Law;

Pursuant to the June 29, 2006 Law on Standards and Technical Regulations;

At the proposal of the Minister of Health;

The Government promulgates the Decree on management of insecticidal or germicidal chemicals and preparations for household and medical use.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Decree prescribes the production, bottling and packing (below referred to as production), testing, assay, circulation, trading, transport, import and export of insecticidal or germicidal chemicals and preparations for household and medical use.

Germicidal chemicals and preparations for food and chemicals and preparations used for the sole purpose of sterilizing medical equipment and devices are not regulated by this Decree.

Article 2. Interpretation of terms

In this Decree, the terms below are construed as follows:

1. Active ingredient means an active agent with insecticidal or germicidal properties.

2. Insecticidal or germicidal chemical means a chemical that contains insecticidal or germicidal active ingredients in technical form and is used for processing into insecticidal or germicidal preparations for household and medical use (below referred to as chemical).

3. Insecticidal or germicidal preparation means a product that contains insecticidal or germicidal active ingredients, has its own trade name and is directly used for killing insects or germs in household and medical fields (below referred to as preparation).

4. Preparation owner means an organization or individual that:

a/ Supplies a preparation under its/his/her own name or with any label, design, trade name or another name or another code under its/his/her ownership or control;

b/ Assumes responsibility for the production, labeling and packaging or assigns a use purpose for a preparation.

5. Circulation registration number owner means an organization or individual that has registered for circulation of a preparation and is granted a circulation registration certificate.

6. Legal person status paper means a paper granted by a competent agency to an organization or individual upon registration in accordance with the Law on Enterprises, the Law on Investment, the Commercial Law or the Law on Cooperatives.

7. Valid copy means a copy granted from the master register or a copy granted from the original by a competent agency or organization.

Article 3. Lists of active ingredients

1. Lists of active ingredients include:

a/ List of active ingredients banned from use in preparations;

b/ List of active ingredients restricted from use in preparations.

2. The Minister of Health shall promulgate the list of active ingredients banned from use or restricted from use referred to in Clause 1 of this Article based on either or both of the following information sources:

a/ International organizations’ warnings and the usage in other countries in the world;

b/ Chemical and preparation safety data.

Chapter II

PRODUCTION OF PREPARATIONS

Article 4. Conditions on a preparation production establishment

1. Being an enterprise, a cooperative or a business household established in accordance with law.

2. Satisfying requirements on staff, physical foundations and equipment prescribed in Articles 5 and 6 of this Decree.

3. Having performed the announcement of eligibility to produce preparations as prescribed in Article 8 of this Decree.

Article 5. Conditions on staff

1. Having at least one person in charge of chemical safety who satisfies the following requirements:

a/ Possessing an intermediate or higher degree in chemistry;

b/ Working on a full time basis at the production establishment;

c/ Having a written assignment to take charge of chemical safety.

2. For an establishment producing preparations on the list of dangerous chemicals as prescribed by the law on chemicals, the person directly administering production activities must satisfy the conditions prescribed at Points b and c, Clause 1 of this Article, and possess a university or higher degree in chemistry.   

Article 6. Conditions on physical foundations and equipment

1. Having physical foundations and equipment satisfying requirements of chemical storage and preservation; disposal and discard of chemical residues, wastes and chemical containers, and prevention of chemical incidents; possessing chemical incident response equipment, devices and manpower as prescribed by the law on chemicals.

b/ Having a testing laboratory capable of testing the composition and contents of active ingredients in preparations produced by the establishment. If having no testing laboratory, a production establishment must have a contract to hire a capable testing laboratory as prescribed in Article 10 of this Decree.

Article 7. Dossier of announcement of eligibility to produce preparations

1. A dossier of announcement of eligibility to produce preparations must comprise:

a/ A written announcement of eligibility to produce preparations, made according to Form No. 1 in Appendix I to this Decree;

b/ A staff declaration, made according to the form provided in Appendix II to this Decree;

c/ A written assignment of a person in charge of chemical safety issued by the establishment’s at-law representative. An establishment that produces chemicals on the list of dangerous chemicals prescribed by the law on chemicals must have a written assignment of a person to manage production activities. In case a person managing production activities also works as a person in charge of chemical safety, the written assignment must clearly state this detail;

d/ A workshop and storehouse plan. In case an establishment produces chemicals on the list of dangerous chemicals prescribed by the law on chemicals, papers proving the compliance with the Ministry of Industry and Trade’s technical regulations on safety distance are also required;

dd/ A list of equipment and facilities for chemical and preparation production and chemical incident response;

e/ Internal rules on chemical safety;

g/ A list of chemical incident prevention and response measures or a chemical incident prevention and response plan.

2. Requirements on a dossier of announcement of eligibility for production:

a/ A dossier of announcement of eligibility for production shall be made in one paper set and one electronic file in PDF;

b/ Documents in a dossier must be legibly printed and arranged in the order prescribed in Clause 1 of this Article. A dossier must have separating space between its parts, cover pages and an index of documents;

c/ The papers prescribed at Points b and c, Clause 1 of this Article may be originals or valid copies;

d/ The papers prescribed at Points d, dd, e and g, Clause 1 of this Article must be certified by the production establishment.

Article 8. Announcement of eligibility to produce preparations

1. A production establishment shall send directly or by post a dossier to the provincial-level Health Department of the locality where its production workshop is located. In case the provincial-level Health Department has applied online announcement, a production establishment shall file its dossier online.

2. Procedures for direct announcement:

a/ Before producing preparations, a production establishment’s at-law representative shall send its dossier of announcement of eligibility to produce preparations  prescribed in Clause 1, Article 7 of this Decree to the provincial-level Health Department of the locality where its production workshop is located;

b/ After receiving a complete dossier, the provincial-level Health Department shall issue to the establishment a dossier receipt, made according to Form No. 01 in Appendix III to this Decree.

3. The procedures for online announcement are prescribed in Chapter VIII of this Decree.

4. Within 3 working days from the date indicated on the dossier receipt, the provincial-level Health Department shall post on its website the  name, address and telephone number of the production establishment; name of the person in charge of chemical safety; and name of the person managing production activities (for dangerous chemical production establishments).

5. During operation, a production establishment shall update the information in its dossier of announcement of eligibility for production within 15 days after having one of the following changes in:

a/ Staff: A written request for update of information relating to the announcement of eligibility accompanied by papers prescribed at Point b, Clause 1, Article 7 of this Decree. In case of replacing the person in charge of chemical safety or the person administering production activities, a production establishment shall add the paper prescribed at Point c, Clause 1, Article 7 of this Decree;

b/ Workshop and storehouse area: A written request for update of information relating to the announcement of eligibility, accompanied by papers prescribed at Point d, Clause 1, Article 7 of this Decree;

c/ Equipment and facilities for chemical and preparation production and chemical and preparation incident response: A written request for update of information relating to the announcement of eligibility, accompanied by the paper prescribed at Point dd, Clause 1, Article 7 of this Decree;

d/ Name, address and telephone number: A written request for update of information relating to the announcement of eligibility.

6. Within three working days after receiving a written request for update of information relating to the announcement of eligibility as prescribed in Clause 5 of this Article (the time of receiving the updated document is the date on the stamp of receipt of incoming official letter of the provincial-level Heath Department), the provincial-level Heath Department shall update the information on its website.

7. In case an establishment changes its location or opens another production workshop in the same province, it shall carry out again the procedures for announcement of eligibility for production in accordance to this Decree.

8. In case a production establishment relocates its production place from one province to another, within 15 days after relocating its production place, it shall inform the provincial-level Heath Department of the locality where it has announced its eligibility for production.

Within three working days after receiving a notice of the relocation of production place to another province from a production establishment (the time of receipt of the written notice is the date on the stamp of receipt of incoming official letter of the provincial-level Heath Department), the provincial-level Heath Department that has received the dossier of announcement of eligibility for production shall stop posting information on such establishment.

Chapter III

TESTING AND ASSAY OF PREPARATIONS

Section 1

TESTING OF PREPARATIONS

Article 9. Contents of and cases subject to testing

1. Contents of testing: Determining the composition and contents of active ingredients in insecticidal and germicidal preparations according to circulation or import registration dossiers.

2. Cases subject to testing:

a/ Preparations in the course of production;

b/ Preparations prior to new circulation registration;

c/ Preparations currently in circulation in Vietnam in accordance with the Law on Product and Goods Quality.

Article 10. Conditions on a testing establishment

1. Being established lawfully.

2. Satisfying ISO 17025:2005 standard or its new versions.

3. Having performed the announcement of eligibility for testing under Article 12 of this Decree.

Article 11. Dossier of announcement of eligibility for testing

1. A written announcement of eligibility for testing, made according to Form No. 02 in Appendix I to this Decree.

2. A list of names of active ingredients that the establishment is capable of testing, certified by the testing establishment.

3. A valid copy of the certificate of satisfaction of ISO 17025:2005 standard or its new version.

Article 12. Announcement of eligibility for testing

1. A testing establishment shall send directly or by post a dossier to the Ministry of Health. In case the Ministry of Health has applied online announcement, the establishment shall file its dossier online.

2. Procedures for direct announcement:

a/ Before conducting testing activities, a testing establishment’s at-law representative shall send a dossier of announcement of eligibility for testing prescribed in Article 11 of this Decree to the Ministry of Health;

b/ After receiving a complete dossier, the Ministry of Health shall issue to the testing establishment a dossier receipt, made according to Form No. 02 in Appendix III to this Decree.

3. The procedures for online announcement are prescribed in Chapter VIII of this Decree.

4. Within three working days from the date indicated on the dossier receipt, the Ministry of Health shall post on its website the name, address and telephone number of the testing establishment; and the list of chemicals that the establishment is capable of testing.

5. In case there is any change in its dossier of announcement of eligibility for testing, within five working days from the date of the change, the testing establishment shall carry out the procedures for re-announcement as prescribed in Clauses 1, 2 and 3 of this Article.

Section 2

ASSAY OF PREPARATIONS

Article 13. Cases subject to assay

1. New circulation registration of preparations.

2. Additional circulation registration of preparations as prescribed at Points c and dd, Clause 2, Article 21 of this Decree.

Article 14. Conditions on an assaying establishment

1. Being a health establishment.

2. Requirements on staff:

a/ The person in charge of assay must possess a university or higher degree in medicine or biology and have at least three years’ experience in assay of preparations;

b/ Having at least five employees possessing an intermediate or higher degree in medicine, biology or chemistry, of whom at least two have two years’ experience in assay of preparations.

3. Requirements on physical foundations:

a/ Having an assay lab and supporting labs, a lab for raising insects, germs and viruses for assay that satisfies technical requirements of the assay process issued by the Ministry of Health and is operated according to ISO 17025:2005 or ISO 15189:2012 standard or its new version;

b/ Having a testing and assay lab that is granted a biosafety certificate suitable to each type of insect, germ or virus subject to assay as prescribed in the Law on Prevention and Control of Infectious Diseases and detailing documents;

c/ Having sufficient species of insects, germs and viruses for the assay process;

d/ Having sufficient facilities and equipment as required by the assay process;

dd/ In case an assaying establishment conducts a field assay, it must have a location to conduct the assay in conformity with the assay process;

e/ Satisfying the conditions in Clauses 2, 3 and 4, Article 33 of the Law on Chemicals.

4. Having performed the announcement of eligibility for assay as prescribed in Article 16 of this Decree.

Article 15. Dossier of announcement of eligibility for assay

1. A written announcement of eligibility for assay, made according to Form No. 03 in Appendix I to this Decree.

2. A list of names of assay processes that the establishment is capable of undertaking, certified by the assaying establishment.

3.  A staff declaration, made according to the form in Appendix II to this Decree.

4. A valid copy of the certificate of satisfaction of ISO 17025:2005 or ISO 15189:2012 standard or its new version.

5. A valid copy of the biosafety certificate.

6. A list of facilities and equipment for assay, certified by the assaying establishment.

Article 16. Announcement of eligibility for assay

1. An assaying establishment shall send directly or by post a dossier to the Ministry of Health. In case the Ministry of Health has applied online announcement, the establishment shall file its dossier online.

2. Procedures for direct announcement:

a/ Before conducting assays, an assaying establishment’s at-law representative shall send a dossier for announcement of eligibility for assay prescribed in Article 15 of this Decree to the Ministry of Health;

b/ After receiving a complete dossier, the Ministry of Health shall issue to the assaying establishment a dossier receipt, made according to Form No. 3 in Appendix III to this Decree.

3. The procedures for online announcement are prescribed Chapter VIII of this Decree.

4. Within three working days from the date indicated on the dossier receipt, the Ministry of Health shall post on its website the name, address and telephone number of the assaying establishment; and the list of assay processes that the assaying establishment announces its eligibility to undertake.

5. During operation, an assaying establishment shall update the information in the dossier of eligibility for assay within 15 days after having one of the following changes in:

a/ Staff: A written request for update of information relating to the announcement of eligibility, accompanied by papers prescribed in Clause 3, Article 15 of this Decree;

b/ The certificate of satisfaction of ISO 17025:2005 or ISO 15189:2012 standard or its new version:  A written request for update of information relating to the announcement of eligibility, accompanied by papers prescribed in Clause 4, Article 15 of this Decree;

c/ The biosafety certificate:  A written request for update of information relating to the announcement of eligibility, accompanied by papers prescribed in Clause 5, Article 15 of this Decree;

d/ Facilities and equipment for assay: A written request for update of information relating to the announcement of eligibility, accompanied by papers prescribed in Clause 6, Article 15 of this Decree;

dd/ Name, address and telephone number: A written request for update of information relating to the announcement of eligibility.

6. Within three working days after receiving a written request for update of information relating to the announcement of eligibility under Clause 5 of this Article (the time of receiving the updated document is the date on the stamp of receipt of incoming official letter of the Health Ministry), the Health Ministry shall update the information on its website.

7. In case of changes in the information in the dossier not mentioned in Clause 5 of this Article, an assaying establishment shall carry out again the procedures for announcement of eligibility as prescribed by this Decree.

Chapter IV

CIRCULATION OF PREPARATIONS

Section 1

CIRCULATION CONDITIONS, CIRCULATION REGISTRATION NUMBERS, ORGANIZATIONS ELIGIBLE TO CARRY OUT CIRCULATION REGISTRATION

Article 17. Conditions for preparations to be circulated

1. Having a circulation registration number.

2. Being labeled or having an attached additional label as prescribed by this Decree.

3. For a preparation that has a circulation registration number and is produced before the expiry date of its circulation registration number, if the establishment that has registered such preparation does not register for extension of such number, the preparation may be circulated on the market after the expiration of its registration number until the expiry date of the preparation indicated on its label.

Article 18. Circulation registration numbers of preparations

1. Each preparation may be granted only one circulation registration number.

2. The circulation registration number of a preparation is valid for five years from the date of grant. In case the preparation has its circulation registration number extended, its granted circulation registration number shall be kept unchanged.

3. The circulation registration number shall be granted in the form of circulation registration certificate, made according to the form in Appendix IV to this Decree.

Article 19. Conditions for preparations to be registered for circulation

1. The toxicity of preparations is outside class Ia or Ib according to the World Health Organization’s classification for insecticidal preparations or class I or II according to the globally-harmonized system of classification and labeling of chemicals.

2. Preparations do not contain active ingredients on the list of active ingredients banned from use in preparations.

3. Preparations containing active ingredients on the list of active ingredients restricted from use in preparations may be registered for circulation within the prescribed scope of use.

4. Preparations are produced at establishments that have announced eligibility for production (for locally made products) or having a free sale certificate (for imported products).

Article 20. Organizations eligible to register circulation

1. Establishments eligible to register circulation of preparations include:

a/ Domestic enterprises, cooperatives and business households being owners of preparations or Vietnam-based representative offices of foreign traders who are owners of preparations;

b/ Domestic enterprises, cooperatives and business households which are authorized by owners of preparations to carry out registration;

c/ Vietnam-based representative offices of foreign traders that are authorized by owners of preparations to carry out registration.

2. In case of additional circulation registration, extension of circulation registration number or re-grant of circulation registration certificate, an establishment eligible to register circulation must be the owner of the circulation registration number.

3. In case the owner of a preparation permits the establishment he/she/it has authorized to register the preparation to grant the authorization to another establishment, he/she/it shall clearly indicate such permission in the authorization paper.

4. In case the owner of a preparation authorizes two or more establishments in Vietnam to register the same preparation, the Ministry of Health shall only accept and settle the registration for the establishment that registers first and has a valid authorization paper.

Section 2

CIRCULATION REGISTRATION

Article 21. Forms of circulation registration

1. New circulation registration applies to:

a/ Preparations which are newly produced in Vietnam, except those which are produced only for export;

b/ Preparations which have been permitted for use in foreign countries but are imported for the first time for use in Vietnam;

c/ Preparations which have been granted a circulation registration number but no registration for extension of such number is made within the time limit prescribed in Clause 2, Article 24 of this Decree.

2. Additional circulation registration applies to preparations which have a still valid circulation registration number in Vietnam but see one of the following changes:

a/ Transfer of the right to own the circulation registration number;

b/ Change of the trade name of the preparation;

c/ Relocation of the production establishment or change of the production establishment;

d/ Change of the name and address of the registering establishment, name of the production establishment or address of the production place;

dd/ Change of effects, quality criteria or use method of the preparation.

3. Registration for extension of circulation registration number applies to preparations which already have a circulation registration number but are subject to registration extension as prescribed in Clause 2, Article 24 of this Decree.

4. Registration for re-grant of circulation registration certificate applies to registration certificates that are lost or damaged.

Article 22. Dossier for new circulation registration

1. A written request for new circulation registration, made according to Form No. 04 in Appendix I to this Decree.

2. Papers on the legal entity status of the registering establishment or production establishment.

3. A paper of authorization to register circulation, except for the case prescribed at Point a, Clause 1, Article 20 of this Decree.

4. Technical documents of the preparation registered for circulation with the contents prescribed in Appendix V to this Decree.

5. Results of testing of the composition and contents of active ingredients of the preparation (to be added with the assay result slip).

6. The assay result slip (to be added after the Ministry of Health issues a written permission for assay).

7. The specimen label of the preparation.

8. The free sale certificate (for imported products).

9. Research documents and results on safety and efficacy or warnings of the World Health Organization or equivalent international organizations on the use of preparations in household and medical fields (for preparations containing active ingredient or with a formulation registered for the first time in Vietnam).

Article 23. Dossier for additional circulation registration

1. In case of change in the right to own the circulation registration number:

a/ A written request for additional circulation registration, made according to Form No. 05 in Appendix I to this Decree;

b/ A paper of authorization to register circulation, except for the case prescribed at Point a, Clause 1, Article 20 of this Decree;

c/ The document on transfer of the right to own the circulation registration number, made by the circulation registration number owner;

d/ The document on receipt of the right to own the circulation registration number and the commitment to continued trading in the preparation in conformity with the dossier approved by the Ministry of Health;

dd/ The legal person status paper of the establishment acquiring the circulation registration number;

 e/ The new specimen label of the preparation.

2. In case of change in the trade name of a preparation:

a/ A written request for additional circulation registration, made according to Form No. 05 in Appendix I to this Decree;

b/ A paper of authorization to register circulation for the preparation with its new trade name, except for the case prescribed at Point a, Clause 1, Article 20 of this Decree;

c/ The free sale certificate of the preparation with its new trade name (for imported preparations);

d/ The new specimen label of the preparation.

3. In case of relocation of the production place or change of the production establishment:

a/ A written request for additional circulation registration, made according to Form No. 05 in Appendix I to this Decree;

b/ The legal person status paper of the production establishment indicating the new address (for establishments in Vietnam), or a written notice of the new address of the production establishment (for overseas establishments);

c/ The assay result slip of the preparation produced at the new establishment;

d/ A paper of authorization to register circulation, except for the case prescribed at Point a, Clause 1, Article 20 of this Decree;

dd/ The free sale certificate, except for additional registration for an overseas production establishment for a preparation that has been granted a circulation registration number for production in Vietnam;

e/ The new specimen label of the preparation.

4. In case of changing the name or contact address of the registering establishment, name of the production establishment or address of the production place:

a/ A written request for additional circulation registration, made according to Form No. 05 in Appendix I to this Decree;

b/ The legal person status paper of the registering establishment or production establishment indicating the changed details (for establishments in Vietnam), or a written notice of the changed name and address (for overseas establishments);

c/ The new specimen label of the preparation.

5. In case of changing the effects, quality criteria or use method:

a/ A written request for additional circulation registration, made according to Form No. 05 in Appendix I to this Decree;

b/ The assay result slip for the preparation after its effects, quality criteria or use methods are changed (except for change of the expiry date of a preparation);

c/ Research documents on stability (for change of the expiry date of a preparation);

d/ Results of testing of the composition and contents of active ingredients (for change of the composition and contents of active ingredients);

dd/ The new specimen label of the preparation.

Article 24. Dossier for registration of extension of circulation registration number

1. A dossier for registration of extension of circulation registration number must comprise:

a/ A written request for registration of extension of circulation registration number, made according to Form No. 06 in Appendix I to this Decree;

b/ The legal person status paper of the registering establishment or production establishment;

c/ A paper of authorization to register circulation, except the case prescribed at Point a, Clause 1, Article 20 of this Decree;

d/ A report on the preparation circulation process, made according to the form in Appendix VI to this Decree.

2. The line limit for submission of a dossier for registration of extension of circulation registration number is three months at least and 12 months at most before the expiry date of circulation registration numbers.

Article 25. Dossier of request for re-grant of circulation registration certificate

1. A written request for re-grant of circulation registration certificate, made according to Form No. 07 in Appendix 1 to this Decree.

2. The damaged circulation registration certificate.

Article 26. Requirements on circulation registration dossiers

1. A dossier for new registration, additional registration or registration for extension of the circulation registration number of a preparation shall be made in one paper set accompanied by one electronic file in PDF.

2. Documents in a dossier must be legibly printed and arranged in an order as required for each form of registration prescribed in Article 22, 23 or 24 of this Decree. A dossier must have separating space between its parts, cover pages and an index of documents.

3. For documents in English, their Vietnamese translations are required together with their originals. For documents in a foreign language other than English, their Vietnamese versions must be notarized in accordance with law.

4. Requirements on papers in a circulation registration dossier:   

a/ The original paper of authorization to register circulation, which must satisfy the requirements set in Appendix VII to this Decree;

b/ The original or a valid copy of the free sale certificate for an imported preparation, which must satisfy the requirements set in Appendix VIII to this Decree;

c/ The original or a valid copy of the slip of the result of the assay performed by an independent establishment (rather than the preparation production establishment or the registering establishment) that is eligible to carry out assays as prescribed in Article 14 of this Decree;

d/ The original or a valid copy of the notice of the result of testing of the composition and contents of active ingredients of the preparation performed by an establishment eligible to carry out testing as prescribed in Article 10 of this Decree;

dd/ The specimen labels for all packaging specifications of actual sizes, certified by the registering establishment. In case many packaging specifications have the same label design, the registering establishment shall submit the label of the package with the smallest specifications. For a foreign-language specimen label of an imported preparation, it shall be accompanied by an additional label in Vietnamese. The specimen and content of this additional label must satisfy the requirements set in Appendix IX to this Decree;

e/ Valid copies of papers on the legal entity status of the registering establishment or production establishment;

g/ The original or a valid copy of a written notice of the change in the name, address, location or production establishment of the foreign establishment, which must be consularly legalized under regulations.

5. Other papers in a circulation registration dossier must bear a seal of the registering establishment appended on every two adjoining pages or on every page.

Article 27. Receipt and appraisal of new circulation registration dossiers

1. Dossiers shall be sent directly or by post to the Ministry of Health. In case the Ministry of Health has applied online registration, dossiers shall be submitted online. Online registration must comply with Chapter VIII of this Decree.

2. Upon receiving a dossier for new circulation registration and a charge for its appraisal, the Ministry of Health shall issue to the registering establishment a dossier receipt, made according to Form No. 04 in Appendix III to this Decree.

3. Within 30 days from the date indicated on the dossier receipt referred to in Clause 2 of this Article, the Ministry of Health shall notify in writing the registering establishment of its request for supplementation and modification of the dossier or of its permission or non-permission for conducting assays.

If requesting supplementation and modification of the dossier, the notice must clearly indicate the contents to be supplemented and modified.

If refusing to permit an assay, the Ministry shall clearly state the reason.

4. In case the Ministry of Health issues a written request for supplementation and modification of the dossier, within 90 days from the date indicated on the request, the registering establishment shall complete the dossier, prepare written explanations on the supplemented and modified contents and send them to the Ministry of Health. The date of receipt of the supplemented and modified dossier shall be recorded on the dossier receipt. Past this time limit, the new circulation registration dossier shall become invalid.

The supplemented and modified dossier shall be received and appraised under Clause 3 of this Article.

5. In case no supplementation and modification is needed, the Ministry of Health shall notify in writing the registering establishment of its permission or non-permission for conducting assays. If refusing to permit an assay, the Ministry shall clearly state the reason.

6. After obtaining a written assay permission from the Ministry of Health, the registering establishment shall carry out the testing or assay as prescribed in Chapter III of this Decree and submit the testing or assay result for addition to the dossier within 12 months from the date indicated on the assay permission document. The date of receipt of the testing or assay result shall be recorded on the dossier receipt. Past this time limit, the new circulation registration dossier shall become invalid.

7. Within 30 days from the date indicated on the dossier receipt as prescribed in Clause 6 of this Article, the Ministry of Health shall notify in writing to the registering establishment of its request for supplementation and modification of the dossier or of the grant of, or refusal to grant, a circulation registration number.

If requesting supplementation and modification of the dossier, the notice must clearly indicate the contents to be supplemented and modified.

If refusing to grant a circulation registration number, the Ministry shall clearly state the reason.

In case the registering establishment uses imported materials for production of preparations, the circulation registration certificate must clearly state the permission for importing materials, made according to the form in Appendix IV to this Decree.

8. Within three working days after granting a new circulation registration number, the Ministry of Health shall publicly post the following information on its website:

a/ Name of the preparation;

b/ The circulation registration number;

c/ The full text of the circulation registration certificate.

9. The Ministry of Health shall neither receive circulation registration dossiers from nor issue circulation registration numbers for the submitted dossiers within two years to registering establishments and production establishments which have preparations with circulation numbers revoked in any of the cases prescribed in Clause 1, 4 or 9, Article 38 of this Decree.

Article 28. Receipt and appraisal of additional circulation registration dossiers

1. Dossiers shall be sent directly or by post to the Ministry of Health. In case the Ministry of Health has applied online registration, dossiers may be submitted online. Online registration must comply with Chapter VIII of this Decree.

2. Upon receiving a dossier for registration of additional circulation and a charge for its appraisal, the Ministry of Health shall issue to the registering establishment a dossier receipt, made according to Form No. 05 in Appendix III to this Decree.

3. Within 30 days from the date indicated on the dossier receipt, the Ministry of Health shall notify in writing to the registering establishment of:

a/ The request for supplementation and modification of the dossier or its agreement or disagreement with the content of registration and the reason (for dossiers of registration for additional circulation not involving assay);

b/ The request for supplementation and modification of the dossier or permission or non-permission for assay and the reason (for dossiers of registration for additional circulation involving assay).

4. In case the Ministry of Health issues an assay permission document, within 12 months from the date indicated on such document, the registering establishment shall submit an assay result slip for addition to the additional circulation registration dossier. Past this time limit, the submitted dossier shall become invalid.

5. In case the Ministry of Health issues a written request for supplementation and modification of the dossier, within 90 days from the date indicated on the request, the registering establishment shall complete the dossier and prepare written explanations and send them to the Ministry of Health. The date of receipt of the supplemented and modified dossier shall be recorded on the dossier receipt. Past this time limit, the additional circulation registration dossier shall become invalid.

6. In case no supplementation and modification is required, the Ministry of Health shall supplement the circulation registration certificate.

7. Within three working days after supplementing the circulation registration certificate, the Ministry of Health shall post on its website the full text of the supplemented circulation registration certificate.

Article 29. Receipt and appraisal of dossiers for registration of extension of circulation registration number

1. Dossiers shall be sent directly or by post to the Ministry of Health. In case the Ministry of Health has applied online registration, dossiers may be submitted online. Online registration must comply with Chapter VIII of this Decree.

2. Upon receiving a dossier for registration for extension of circulation registration number and a charge for its appraisal, the Ministry of Health shall issue to the registering establishment a dossier receipt, made according to Form No. 06 in Appendix III to this Decree.

3. Within 30 days from the date indicated on the dossier receipt referred to in Clause 2 of this Article, the Ministry of Health shall notify in writing the registering establishment of its request for supplementation and modification of the dossier or its permission or non-permission for extension of the circulation registration number.

If requesting supplementation and modification of the dossier, the notice must clearly state the details to be supplemented and modified.

If refusing to grant permission for extension of the circulation registration number, the Ministry of Health shall clearly state the reason.

4. After receiving a written request for supplementation and modification of the dossier, the registering establishment shall supplement and modify the dossier and prepare written explanations and send them to the Ministry of Health within 30 days from the date indicated on the written request and at least 10 days before the expiry date of the circulation registration number. The date of receipt of the supplemented and modified dossier shall be recorded on the dossier receipt. Past this time limit, the dossier of registration for extension of the circulation registration number shall become invalid.

The supplemented and modified dossier shall be appraised under Clause 3 of this Article.

5. In case no supplementation and modification is required, the Ministry of Health shall extend the circulation registration number.

6. Within three working days after the circulation registration number is extended, the Ministry of Health shall post on its website the full text of the circulation registration certificate to replace the information prescribed at Point c, Clause 8, Article 27 of this Decree.

Article 30. Receipt and appraisal of dossiers for re-grant of circulation registration certificates

1. Dossiers shall be submitted to the Ministry of Health.

2. Upon receiving a dossier for re-grant of the circulation registration certificate, the Ministry of Health shall issue to the registering establishment a dossier receipt, made according to Form No. 07 in Appendix III to this Decree.

3. Within 10 days from the date indicated on the dossier receipt, the Ministry of Health shall re-grant the circulation registration certificate. In case of refusal, it shall issue a written reply clearly stating the reason.

Section 3

TRADE NAMES, LABELS, PACKAGING, PRESERVATION AND DESTRUCTION OF CHEMICALS AND PREPARATIONS

Article 31. Trade names of preparations

1. For each preparation of one producer only one trade name may be registered in Vietnam.

2. One trade name may not be used for two or more preparations of one producer.

3. The trade name of a preparation must not be identical with that of another preparation whose granted circulation registration number remains valid.

4. The trade name of a preparation must not be identical with the name of an active ingredient or the name of an active ingredient and content or the name of an active ingredient and formulation of the preparation.

5. It is prohibited to give a preparation a trade name with the meaning inappropriate for its efficacy and safety.

Article 32. Labels of chemicals and preparations

1. Labeling of chemicals and preparations must comply with Appendix IX to this Decree.

2. When there are any changes in the content and form of the label of a preparation other than those prescribed in Clause 2, Article 21 of this Decree, at least 15 days before the circulation of the new label, the circulation registration number owner shall issue a notice of the changed content enclosed with the new specimen label (including specimen labels of all packaging specifications of real sizes; if many packaging specifications share the same label design, the circulation registration number owner shall send the label of the package with the smallest packaging specifications) to the Ministry of Health for addition to the dossier. In case the Ministry of Health has applied online registration, the circulation registration number owner shall send a notice of the changed content or form of the label online. The sending of notices online must comply with Chapter VIII of this Decree.

3. Within 5 working days after receiving a written notice of the changed label content (the time of receipt of the written notice is the date indicated on the receipt stamp of incoming official letter of the Ministry of Health), if the Ministry of Health does request supplementation and modification:

a/ The circulation registration number owner may circulate the new label;

b/ The Ministry of Health shall add the new specimen label of the preparation to the circulation registration dossier.

Article 33. Packaging of chemicals and preparations

1. When circulated in Vietnam, preparations shall be contained in packages that satisfy the following requirements:

a/ Being firm and durable enough to stand normal impacts and shocks during transportation, transshipment and handling by manual or mechanical methods;

b/ Being tight to prevent leakage of preparations during transportation or when being transported under impacts of vibration or changes in temperature, moisture or pressure;

c/ The outer surface of packages is clean and free of any dangerous chemicals.

2. Packaging parts in direct contact with preparations must meet the following requirements:

a/ Being neither affected nor deteriorated in quality due to impacts of the packaged preparation;

b/ Not affecting the composition, properties or uses of the packaged preparation.

3. For a liquid preparation, a necessary space must be left inside its package to prevent leakage or deformation when the volume of the packaged liquid increases as a result of temperature changes.

4. Inner packages which are breakable or easily pierceable, such as those made of glass, glazed terracotta, porcelain and some kinds of plastic, must be insulated with appropriate shock-absorbing materials from the outer packaging layer.

5. Packages of volatile substances must be tight enough to ensure the volume of liquids will not decrease below the set limit during transportation.

6. Packages of liquids must stand the inside pressure built up during transportation.

7. Packages of liquid preparations must be tested for leakage before delivery.

8. Packages of granule or powdery preparations must be tight enough to prevent leakage or have tight lining layers.

Article 34. Preservation of chemicals and preparations

The preservation of chemicals and preparations must observe producers’ instructions indicated on the product labels.

Article 35. Destruction of chemicals and preparations

1. Cases subject to destruction:

a/ Chemicals and preparations which have expired and cannot be recycled or have unsatisfactory quality and cannot be improved;

b/ Containers and packages of chemicals and preparations which are not re-used; discarded wastes or chemicals and preparations left over from the production, trading or use.

2. Chemicals and preparations for household or personal use shall be discarded according to producers’ recommendations and the environmental protection law.

3. Organizations and persons having chemicals and preparations or chemical and preparation packages subject to destruction shall bear all destruction costs.

4. In the process of collecting and destroying chemicals and preparations and chemical and preparation packages, it is prohibited to scatter, disperse or increase hazardous wastes into the environment and appropriate treatment technologies shall be used in accordance with the environmental protection law.

Section 4

SUSPENSION OF CIRCULATION OF PREPARATIONS

Article 36. Procedures for suspension of circulation of preparations under warnings of owners of preparations or circulation registration numbers

1. In case of identifying a preparation that has defects or potential adverse effects on human health or the environment, the owner of its circulation registration number shall:

a/ Suspend the circulation of the preparation;

b/ Send a written notice to the Ministry of Health and organizations and individuals that are distributing the preparation; concurrently make public in the mass media the suspension of the circulation and use of the preparation. The notice must clearly state the batch of products, defects or potential adverse effects on human health or the environment as well as the possibility or impossibility to remedy such defects.

2. In case the preparation’s defects or its potential adverse effects on human health or the environment may be remedied:

a/ Within 5 working days after receiving the notice from the owner of the preparation or circulation registration number, the Ministry of Health shall issue a decision to suspend the circulation of the preparation;

b/ Within 90 days after the issuance of the decision, the registration number owner shall finish the remediation of the preparation’s defects or potential adverse effects on human health or the environment;

c/ After finishing the remediation, the registration number owner shall send a written report together with documents proving the finished remediation to the Ministry of Health;

d/ Within 30 days after receiving the registration number owner’s report, the Ministry of Health shall issue a decision to terminate the suspension of the circulation of the preparation. In case of refusal, it shall issue a written reply clearly stating the reason.

3. In case the defects or potential adverse effects of the preparation on human health or the environment cannot be remedied or past the time limit for remediation as prescribed in the decision on circulation suspension but the establishment fails to finish the remediation, the Ministry of Health shall issue a decision on recall of the preparation concerned and post it on its website.

4. Details of a decision on suspension of the circulation of a preparation or recall of a suspended preparation:

a/ Name of the suspended or recalled preparation;

b/ The number of the batch of the suspended or recalled preparation;

c/ The circulation registration number of the suspended or recalled preparation;

d/ The suspension time limit;

dd/ Requirements on disposal of the recalled preparation.

Article 37. Procedures for suspension of circulation of preparations under warnings of competent agencies in charge of preparations

1. Within 5 working days after receiving a notice of potential adverse impacts of an active ingredient or a preparation on human health and the environment from countries where the preparation is being circulated or from the World Health Organization, the Ministry of Health shall issue a decision on suspension of circulation of the preparation and send a written request for explanation to the circulation registration number owner.

2. Within 5 working days after receiving the Ministry of Health’s document, the registration number owner shall send a written report to the Ministry.

3. Within 5 working days after receiving the registration number owner’s report, the Ministry of Health shall assess potential adverse effects of the active ingredient or preparation on human health and the environment.

4. In case the active ingredient or preparation is identified to pose no potential risks, within 5 working days after the issuance of the assessment result, the Ministry of Health shall issue a decision on termination of the suspension of the circulation.

5. In case the active ingredient or preparation is identified to pose potential risks to human health or the environment and such risks can be remedied, the Ministry of Health shall issue a written notice to the circulation registration number owner for the latter to take remedies as prescribed in Clause 2, Article 36 of this Decree.

6. In case the active ingredient or preparation is identified to pose potential risks  to human health or the environment and such risks cannot be remedied, the Ministry of Health shall, depending on the nature and severity of the potential risks, issue a decision on recall of batches or all of products.

Section 5

REVOCATION OF CIRCULATION
REGISTRATION NUMBERS

Article 38. Cases subject to revocation of circulation registration number

1. A registering establishment has forged the circulation registration dossier.

2.  A preparation is produced at an establishment that lacks prescribed production conditions.

3. Technical criteria of a produced preparation fail to conform with the circulation registration dossier.

4. Three or more batches of a preparation are suspended from circulation within the validity period of its circulation registration number.

5. An imported preparation has its circulation registration number revoked in the exporting country.

6. A preparation with potential adverse effects on human health or the environment is recalled under Clause 6, Article 37 of this Decree.

7. The owner of a preparation or circulation registration number requests revocation of the circulation registration number in Vietnam.

8. A preparation infringes upon intellectual property rights under written conclusions of a competent agency.

9. A circulation registration number owner leases or lends his/her/its circulation registration certificate or modifies his/her/its circulation registration certificate without permission.

10. A circulation registration number owner terminates operation or no longer satisfies the conditions for registration for circulation of preparations.

Article 39. Procedures for revocation of circulation registration numbers

1. Within 15 days from the date of identifying a case prescribed in Article 38 of this Decree, the Ministry of Health shall consider and decide on revocation of the circulation registration number.

2. A decision on revocation of a circulation registration number shall be sent to the registration number owner, the Ministry of Finance (the General Department of Customs) and provincial-level People’s Committee, and posted on the website of the Ministry of Health.

Chapter V

TRADING IN PREPARATIONS

Article 40. Conditions for traders in preparations

1. Staff:

a/ The person in charge of chemical safety must possess an intermediate or higher degree in chemistry;

b/ Persons directly selling preparations must have knowledge about preparations.

2. Material and physical foundations:

a/ The place for display of insecticidal and germicidal preparations on sale must be isolated from those for food;

b/ The conditions for preservation of preparations satisfy preservation requirements indicated on their label;

3. Traders in common insecticidal and germicidal preparations including mosquito repellent sticks (incense); mosquito repellent tablets for household and medical use; insecticidal sprays; bug baits; insect repellent cream, patches and bands for human use; mosquito repellent liquids; nets, curtains and papers absorbed with mosquito repellents; germicidal preparations for household use, are not required to satisfy the requirements prescribed in Clause 1 of this Article.

Article 41. Conditions for insecticidal and germicidal service providers using preparations

1. The service provider must be an enterprise, a cooperative or a business household established in accordance with law.

2. Persons who directly performing insecticidal and germicidal work must have knowledge on using insecticidal and germicidal preparations as guided by the Minister of Health.

3. Having appropriate equipment required for each technique used by the service provider.

4. Having performed the announcement of eligibility to provide insecticidal and germicidal services using preparations as prescribed in Article 43 of this Decree.

Article 42. Dossier of announcement of eligibility to provide insecticidal and germicidal services using preparations

1. A written announcement of eligibility to provide insecticidal and germicidal services using preparations, made according to Form No. 08 in Appendix I to this Decree.

2. A personnel declaration, made according to the form in Appendix II to this Decree.

3. A list of insecticidal and germicidal equipment certified by the announcement-making establishment.

Article 43. Announcement of eligibility to provide insecticidal and germicidal services using preparations

1. A service provider shall send directly or by post a dossier to the provincial-level Heath Department of the locality where its head office is located. In case the provincial-level Heath Department has applied online announcement, the provider shall file its dossier online.

2. Procedures for direct announcement:

a/ Before providing insecticidal and germicidal services using preparations, the provider’s at-law representative shall send a dossier of announcement of eligibility to provide insecticidal and germicidal services using preparations as prescribed in Article 42 of this Decree to the provincial-level Heath Department of the locality where its head office is located;

b/ After receiving a complete dossier, the provincial-level Heath Department shall issue to the provider a dossier receipt, made according to Form. 08 in Appendix III to this Decree.

3. The procedures for online announcement are prescribed in Chapter VIII of this Decree.

4. Within 3 working days from the date indicated on the dossier receipt, the provincial-level Heath Department shall post on its website the name, address and  telephone number of the provider of insecticidal and germicidal services using preparations.

5. During operation, the service provider shall update information in the dossier within 15 days after the occurrence of one of the following changes in:

a/ Staff: A written request for update of information relating to the announcement of eligibility, accompanied by the papers specified in Clause 2, Article 42 of this Decree;

b/ Insecticidal and germicidal equipment and facilities:  A written request for update of information relating to the announcement of eligibility, accompanied by the papers specified in Clause 3, Article 42 of this Decree;

c/ Name, address and telephone number: A written request for update of information relating to the announcement of eligibility.

6. Within 3 working days after receiving a written request for update of information relating to the announcement of eligibility prescribed in Clause 5 of this Article (the time of receipt of the update document is the date on the stamp of receipt of incoming official letter of the provincial-level Heath Department), the provincial-level Heath Department shall update the information on its website.

7. In case the service provider changes its location or opens a service provision branch in the same locality, it shall carry out again the procedures for announcement of eligibility prescribed in this Decree.

8. In case the service provider changes its location from one province to another, within 15 days after changing its location, it shall notify the provincial-level Heath Department of the locality where it has announced its eligibility for service provision.

Within 3 working days after receiving a written notice of the change in location from a service provider (the time of receipt of the written notice is the date on the stamp of receipt of incoming official letter of the provincial-level Heath Department), the provincial-level Heath Department that received the dossier shall stop posting information on such establishment.

Chapter VI

TRANSPORTATION OF CHEMICALS AND
PREPARATIONS

Article 44. Principles of transportation of chemicals and preparations

1. Transportation of chemicals and preparations on the list of dangerous chemicals  as prescribed by the law on chemicals must comply with the provisions of not only this Decree but also of the law on transportation of dangerous goods.

2. Chemicals and preparations that are capable of reacting with one another may not be transported in the same vehicle.

Article 45. Requirements on packages, casks and containers during transportation 

1. Each type of chemical or preparation shall be properly packaged under Article 33 of this Decree.

2. Packages, casks or containers shall be affixed with symbols displaying the physical properties of contained chemicals or preparations. The size of such symbol must be 100 mm x 100 mm for each chemical or preparation tank and 250 mm x 250 mm for containers.

3. Packages, casks or containers containing chemicals and preparations on the list of dangerous chemicals as prescribed by the law on chemicals must be affixed with dangerous goods symbols. The size of such symbol must be 100 mm x 100 mm for each chemical or preparation cask and 250 mm x 250 mm for containers. Danger signals shall be affixed below the dangerous goods symbols. The size of danger signals must be 300 mm x 500 mm.

Article 46. Requirements for vehicles

1. Having fire prevention and fighting equipment and devices suitable for chemicals and preparations transported.

2. Having a cover to protect chemicals and preparations against water during transport.

3. The size of a dangerous goods symbol affixed to the vehicles must be 500 mm x 500 mm.

Article 47. Provisions on the chemical and preparation transport process

1. During transport of chemicals or preparations, vehicle drivers must follow the route and schedule stated in the contracts or other papers on transport between vehicle owners and goods owners.

2. If a chemical incident occurs en route, the vehicle driver, goods owner and vehicle owner shall take prompt measures to minimize consequences and remedy the incident, at the same time, notify the incident to the nearest fire brigade, related agencies and establishments and local administration for help in responding to and remedying the incident.

Chapter VII

IMPORT AND EXPORT OF CHEMICALS AND
PREPARATIONS

Article 48. Principles of import and export of chemicals and preparations

1. The import and export of chemicals and preparations must comply with the law on goods import and export.

2. Preparations with unexpired circulation registration certificates may be imported as demanded in unlimited quantity or value. Import procedures shall be carried out at customs offices without requiring the Ministry of Health’s approval. Importers shall assume responsibility before law for their operations.

3. For materials for production of preparations with granted circulation registration numbers, production establishments may import these materials as demanded by their production. Import procedures shall be carried out at customs offices without requiring the Ministry of Health’s approval. Importers shall assume responsibility before law for their operations.

4. In case an importing country requires certification of free sale of preparations in Vietnam, circulation registration number owners shall provide such certification under regulations on certificates of free sale for imported and exported products and goods.

Article 49. Import license

1. Chemicals and preparations requiring an import license:

a/ Chemicals and preparations imported for research;

b/ Preparations imported for use as aid or other particular purposes (which are being used as gifts or donations or in case products or use methods needed by organizations and individuals applying for an import license are unavailable on the market).

2. A dossier of application for an import license must comprise:

a/ A written request for import permission, made according to form No. 09 in Appendix I to this Decree;

b/ Technical documents of chemicals or preparations that contain the contents prescribed in Appendix V of this Decree;

c/ For chemicals and preparations imported for research: The research outline certified by an at-law representative of the research institute or producer that has announced its eligibility for production;

d/ For aid: A valid copy of a competent agency’s decision on approval of the aid receipt and documents on the batch of imported goods;

dd/ For gifts or presents: A letter notifying the presentation and papers proving that products for which an import license is applied are permitted for use by the exporting country’s competent agency;

e/ For products and use methods needed by the organization or individual applying for an import license which are unavailable on the market: Documents proving that products and use methods needed by the organization or individual applying for an import license are unavailable on the market and documents proving that such products have been permitted for use by the exporting country’s competent agency;

g/ In case of importing preparations for another particular purpose in a total weight of 50 kilograms upon each importation: A valid copy of the GMP certificate or ISO accreditation of the manufacturer and the free sale certificate of the preparations.

Article 50. Procedures for grant of an import license

1. Organizations and individuals applying for an import license (below referred to as importers) shall submit directly or by post a dossier to the Ministry of Health (the Health Environment Management Agency). In case the Ministry of Health grants import licenses online, the importer shall send its dossier online. The procedures for online application for an import license are prescribed in Chapter VIII of this Decree.

2. After receiving a dossier of application for an import license, the Ministry of Health shall issue to the importer a dossier receipt, made according to form No. 09 in Appendix III to this Decree.

3. In case no supplementation and modification of the dossier is required, the Ministry of Health shall grant an import license. In case of refusal, it shall issue a written reply clearly stating the reason.

4. In case the dossier of application for an import license is incomplete, the Ministry of Health shall issue a written notice of the supplementation and modification of the dossier to the importer within 15 days from the date indicated on the dossier receipt. The notice must clearly state the contents to be supplemented and modified.

5. In case the Ministry of Health issues a written request for supplementation and modification of the dossier, within 60 days from the date indicated on the request, the importer shall complete the dossier and prepare written explanations on the supplemented and modified contents and sent them to the Ministry of Health. The date of receipt of the supplemented and modified dossier shall be recorded on the dossier receipt. Past this time limit, the dossier of application for an import license shall become invalid.

6. In case no further supplementation and modification is required, the Ministry of Health shall issue an import license as prescribed in Clause 3 of this Article.

7. Within 3 working days after the issuance of an import license, the Ministry of Health shall post the following information on its website:

a/ Name of the preparation;

b/ The import license number;

c/ The full text of the import license.

Chapter VIII

ONLINE ANNOUNCEMENT AND REGISTRATION

Article 51. Cases of online announcement, registration or application for import licenses

1. Announcement of eligibility to produce preparations.

2. Announcement of eligibility to test preparations.

3. Announcement of eligibility to assay preparations.

4. Circulation registration.

5. Notice of addition of label content or form as prescribed in Clause 2, Article 32 of this Decree.

6. Announcement of eligibility to provide insecticidal and germicidal services using preparations.

7. Application for import license.

Article 52. Requirements on dossiers of online announcement, registration, or application for import license

A dossier of online announcement, registration, or application for import license, or online notice of supplementation of label content or form (below referred to as registration dossier) shall be considered valid when fully satisfying the following requirements:

1. Having sufficient papers with contents fully filled in as prescribed for the paper dossier which are converted into electronic files. The names of electronic files must correspond to those of papers in the paper dossier.

2. Information of online announcement, registration, or application for import license shall be fully and accurately input according to information in electronic files.

Article 53. Procedures for online registration

1. The at-law representative shall declare information, download electronic files and put digital signatures in the online registration dossier and pay online charges and fees according to the process on the website of the Ministry of Health or the provincial-level Heath Department.

2. After having sent the online registration dossier, the at-law representative shall receive an online dossier receipt.

3. The online registration dossier-receiving agency shall perform administrative procedures corresponding to the registration dossier as prescribed in this Decree.

4.   The result of online administrative procedures is an electronic file bearing the digital signature of the dossier-receiving agency and having the same legal validity as the result of administrative procedures settled by the ordinary method.

Article 54. Archives of online registration dossiers

1. In case online registration is performed, a registering organization or individual (below referred to as registering establishment) shall preserve the dossier in paper.

2. If a paper in a registration dossier prescribed in Clause 1 of this Article is lost or damaged, the registering establishment shall notify such in writing to the dossier-receiving agency and complete the dossier within 60 days from the date the paper in the registration dossier is lost or damaged.

3. Within 5 working days after the expiration of the time limit prescribed in Clause 2 of this Article, if the registering establishment fails to complete its dossier, the dossier-receiving agency shall:

a/ Stop uploading on the website information relating to the preparation production establishment, the preparation testing establishment, the preparation assaying establishment,  the provider of insecticidal and germicidal services using preparations;

b/ Revoke the circulation registration number and the import license of preparations and stop uploading on the website information relating to the circulation registration number and import license.

4. A registering establishment shall terminate its operation from the time the dossier-receiving agency removes information prescribed at Point a, Clause 3 of this Article. The preparation concerned may not be circulated from the time the dossier-receiving agency removes information prescribed at Point b, Clause 3 of this Article.

Chapter IX

ORGANIZATION OF IMPLEMENTATION

Article 55. Responsibilities of the Ministry of Health

The Ministry of Health shall take responsibility before the Government for performing the state management of chemicals and preparations and have the following tasks and powers:

1. To submit to the Government and the Prime Minister for promulgation, and promulgate according to its competence, legal documents on chemicals and preparations.

2. To organize the implementation of legal documents, strategies, policies and plans on chemicals and preparations.

3. To organize information, education and communication about chemicals and preparations.

4. To publicly post information prescribed in this Decree on the website of the Ministry of Health.

5. To inspect, examine and settle complaints and denunciations and handle  violations of regulations on chemicals and preparations.

6. To organize international cooperation on chemicals and preparations.

Article 56. Responsibilities of the Ministry of Industry and Trade

1. To assume the prime responsibility for, and coordinate with the Ministry of Health in, promulgating regulations on safety distance for preparation production establishments and on labeling of chemicals and preparations according to the globally harmonized system of classification and labeling of chemicals (GHS).

2. To inspect and examine chemicals and preparations circulated on the market in accordance with law.

Article 57. Responsibilities of a provincial-level People’s Committee

1. To manage chemicals and preparations in its locality.

2. To publicly post on the website of the provincial-level People’s Committee (the provincial-level Heath Department) and send to the Ministry of Health information on chemical and preparation production establishments and providers of insecticidal and germicidal services using preparations in its locality.

3. To inspect, examine and settle complaints and denunciations and handle violations of law on chemicals and preparations in its locality.

Article 58. Responsibilities of a circulation registration number owner

1. To ensure the sufficiency and lawfulness of documents in the circulation registration dossiers filed with the Ministry of Health or provide them upon request (for preserved paper dossiers in case of online registration).

2. To provide complete and accurate information on preparations on their labels, packages and in documents accompanying chemicals and preparations in accordance with the law on goods label and this Decree.

3. To give timely, complete and accurate warnings about potential adverse effects on human health and the environment; to inform preventive measures to sellers and consumers and requirements on the transportation, storage, preservation and use of chemicals and preparations.

4. To promptly suspend circulation, notify related parties of and take measures to dispose of or remedy or recall, preparations that fall in the cases prescribed in Articles 36 and 37 of this Decree.

5. To recall or dispose of chemicals and preparations that fall in the cases prescribed in Articles 36 and 37 of this Decree. In case the method of destruction is applied, the registration number owner shall comply with the law on environmental protection and other relevant laws and bear all destruction expenses.

6. To comply with the law and competent state agencies’ decisions on inspection and examination.

7. Other obligations as prescribed by law.

Article 59. Users of preparations

1. Importers or users of preparations which are permitted by the Ministry of Health to be imported as aid or for use for a particular purpose shall take full responsibility for the use of these preparations.

2. To request suppliers of preparations to provide sufficient information on dangerous properties of preparations and requirements for ensuring their efficacy and safety; to be entitled to compensation as prescribed by law from suppliers for damage they suffer when using preparations due to untruthful  information provided by suppliers.

3. To strictly follow use instructions shown on labels of preparations or attached to preparations and take full responsibility for using preparations improperly; to ensure safety for themselves, the environment and community; if using chemicals and preparations in a way causing damage to the health, life or property of others, to pay compensation in accordance with law.

4. If detecting a chemical or preparation that fails to produce the effect according to the producer’s instructions shown on the product label, or that information on the preparation is inconsistent with the granted circulation registration certificate, to stop using such chemical or preparation and notify such in writing to the Ministry of Health or the provincial-level Heath Department of the locality where the head office of the circulation registration number owner is located or where the individual user resides for handling in accordance with law.

Article 60. Responsibilities of a production establishment

1. To ensure the production conditions prescribed in this Decree and declared in the establishment’s dossier of announcement of eligibility for production.

2. To preserve the results of testing of the composition and contents of active ingredients of the preparations produced in each batch of products before delivery and the preservation period must be at least equal to the shelf life of the batch.

3. When an establishment no longer satisfies the production conditions, it shall notify such in writing to the provincial-level Heath Department of the locality where its production workshop is located.

Article 61. Responsibilities of an assaying establishment

1. To ensure the conditions prescribed in this Decree and declared in the establishment’s announcement of eligibility for assay.

2. To conduct assays according to effects, methods and dosage indicated on the labels of preparations and follow the assay process issued by the Ministry of Health and give the assay results according to Appendix X to this Decree.

3. In case a preparation is permitted for assay but no relevant assay process has been issued by the Ministry of Health, the assaying establishment shall propose the Ministry to issue such process.

4. To take responsibility before law for the results of its assays.

5. To make biannual reports on assays before July 15 of the year and before January 15 of the subsequent year to the Ministry of Health. When detecting any differences in the actual dosage and the dosage recommended by the producer indicated on the label of a preparation or having evidence of chemical or reparation resistance, the assaying establishment shall report such in writing to the Ministry of Health for consideration and settlement.

6. When an establishment no longer satisfies the conditions for conducting assays, to notify such in writing to the Ministry of Health.

Article 62. Responsibilities of a testing establishment

1. To ensure the conditions prescribed for a testing establishment in this Decree and described in the establishment’s announcement of eligibility for testing.

2. To take responsibility before law for the results of its testing of preparations.

3. When an establishment no longer satisfies the conditions for conducting testing, to notify such in writing to the Ministry of Health.

Article 63. Responsibilities of a provider of insecticidal and germicidal services using preparations

1. To ensure the conditions for the provision of insecticidal and germicidal services using preparations prescribed in this Decree and described in the dossier of announcement of eligibility for service provision.

2. When an establishment no longer satisfies the conditions for service provision, to notify such in writing to the provincial-level Heath Department of the locality where its head office is located.

Chapter X

IMPLEMENTATION PROVISIONS

Article 64. Effect

1. This Decree takes effect on July 1, 2016.

2. Clause 12, Article 12 of the Government’s Decree No. 89/2006/ND-CP of August 30, 2006 on labeling of goods; Clauses 2 and 3, Article 8 of Decree No. 108/2008/ND-CP which have been amended and supplemented under Clause 8, Article 1 of Decree No. 26/2011/ND-CP of April 8, 2011, detailing and guiding a number of articles of the Law on Chemicals; and Clause 3, Article 18 of the Government’s Decree No. 104/2009/ND-CP of November 9, 2009, providing the list of dangerous goods and the transport of dangerous goods by road motor vehicles cease to be effective on the effective date of this Decree.

Article 65. Transitional provisions

1. Chemical and preparation production establishments that have operated before the effective date of this Decree may continue their production activities but shall finish the announcement of eligibility for production before July 1, 2017.

2. Chemical and preparation testing and assaying establishments that have operated in accordance with law before the effective date of this Decree may continue their testing and assaying activities but shall finish their request for announcement of eligibility for testing and assaying activities before July 1, 2017.

3. Dossiers of registration for circulation and application for import licenses received before the effective date of this Decree continue to be settled under regulations applicable at the time of their receipt.

4. Material chemicals which have been received before the effective date of this Decree and granted circulation registration numbers may be further circulated until the expiry date of the granted registration numbers.

5. Chemicals and preparations which have been received before the effective date of this Decree and granted circulation registration numbers may be further circulated but their labeling shall be completed in accordance with this Decree before July 1, 2018.

6. Providers of insecticidal and germicidal services using preparations which have operated before the effective date of this Decree may continue providing the services but shall finish the announcement of eligibility for service provision before July 1, 2018.

Article 66. Guidance and implementation responsibilities

1. The Minister of Health shall guide, organize and examine the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government-attached agencies and chairpersons of provincial-level People’s Committees and related agencies, organizations and individuals shall implement this Decree.-

On behalf of the Government
Prime Minister
NGUYEN XUAN PHUC

* All appendices to this Decree are not translated.