Nghị định 91/2016/ND-CP

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

Nội dung toàn văn Decree 91/2016/ND-CP management insecticidal germicidal chemicals preparations household medical use


GOVERNMENT
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.: 91/2016/ND-CP

Hanoi, July 01, 2016.

 

DECREE

ON MANAGEMENT OF INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS FOR HOUSEHOLD AND MEDICAL USE 

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

Pursuant to the Law on chemicals dated November 21, 2007;

Pursuant to the Law on Investment dated November 26, 2014;

Pursuant to the Law on quality of goods and products dated November 21, 2007;

Pursuant to the Law on Enterprises dated November 26, 2014;

Pursuant to the Commercial Law dated June 14, 2005;

Pursuant to the Law on technical regulations and standards dated June 29, 2006;

At the request of Minister of Health;

The Government promulgates a Decree to provide for the management of insecticidal and germicidal chemicals and preparations for household and medical use.

Chaprter I

GENERAL PROVISIONS

Article 1. Scope

This Decree provides for the production and packaging (hereinafter referred to as the production), testing, experiment, sale registration, trading, transportation and export/import of insecticidal and germicidal chemicals and preparations for household and medical use.

Chemicals and preparations for the sterilization of foods and those only used in the sterilization of medical equipment are not governed by this Decree.

Article 2. Interpretation of terms

In this Decree, these terms shall be construed as follows:

1. Active ingredient is an active substance with insecticidal and germicidal properties.

2. Insecticidal and germicidal chemical refers to a type of chemical which contains insecticidal and germicidal active ingredients in the form of technical grade and is used to produce insecticidal and germicidal preparations for household and medical use (hereinafter referred to as chemical).

3. Insecticidal and germicidal preparation is a product that contains insecticidal and germicidal active ingredients, has specific trade name and is directly used to sterilize and kill pests in the household and medical fields (hereinafter referred to as preparation).

4. Owner of preparations refers to an organization or individual that:

a) Provides that type of preparations by using a specific name of that organization or individual, or any brand, design and trade name, or other name or code which belongs to the ownership or management of that organization or individual; and

b) Takes charge of the production, labeling, packaging or determination of effects of that type of preparations.

5. Registration number holder refers to an organization or individual that has a Sale Registration Certificate granted in the name of that organization or individual.

6. Proof of legal status is a document which is issued by a competent authority to an organization or individual when that organization or individual carries out procedures for registration of legal entity as referred to by the Law on enterprises, the Investment Law, the Commercial Law and the Law on co-operatives.

7. Valid copy is issued from the master register or the original by a competent authority or organization.

Article 3. Lists of active ingredients

1. Lists of active ingredients consist of:

a) The list of active ingredients banned from use in preparations;

b) The list of active ingredients with restricted use in preparations.

2. Minister of Health shall promulgate lists of active ingredients banned from use or with restricted use as mentioned in Clause 1 of this Article on the basis of one or several sources of information as below:

a) Warnings from international organizations about the use of a given ingredient in foreign countries;

b) Safety data for chemicals and preparations.

Chaprter II

PRODUCTION OF PREPARATIONS

Article 4. Requirements for manufacturers of preparations

1. A manufacturer of preparations must be an enterprise, or a co-operative, or a business household that is established under the law.

2. A manufacturer of preparations must satisfy requirements on personnel, facilities and equipment as referred to in Article 5 and Article 6 of this Decree.

3. Declaration of eligibility to produce preparations must be made in compliance with regulations in Article 8 of this Decree.

Article 5. Requirements on personnel

1. At least 01 person in charge of chemical safety (hereinafter referred to as chemical safety manager) meets all of the following conditions:

a) Possess a two-year associate degree in Chemistry or higher level;

b) Enter into full time employment contract with the manufacturer of preparations;

c) Have letter of appointment that implies that he/she is assigned to take charge of chemical safety.

2. With regard to manufacturers of preparations in the list of hazardous chemicals as referred to by the law on chemicals, persons directly managing the production process (hereinafter referred to as production manager) must satisfy all of conditions in Point b and Point c Clause 1 of this Article, and possess bachelor's degrees in chemistry or higher.

Article 6. Requirements on facilities and equipment

1. Technical and materials facilities must be available and meet requirements for storing and preserving chemicals, handling and discharging residual chemicals, waste and chemical containers, and preventing event of chemical hazards. Equipment and personnel must be available for dealing with event of chemical hazards in compliance with regulations of the law on chemicals.

2. A manufacturer of preparations must have testing laboratories to test ingredients and content of active ingredients of produced preparations. A manufacturer of preparations that does not construct testing laboratories must enter into contracts with testing establishments that are competent as referred to as in Article 10 of this Decree.

Article 7. Application for declaration of eligibility to produce preparations

1. The application for the declaration of eligibility to produce preparations consists of:

a) The written declaration of eligibility to produce preparations, using the Form No. 01 in Annex I herein;

b) The declaration on personnel of the manufacturer of preparations, using the form stated in Annex II herein;

c) Letter of appointment of chemical safety manager, made by the legal representative of the manufacturer of preparations. With regard to manufacturers of chemicals which are in the list of hazardous chemicals as referred to by the law on chemicals, the letter of appointment of production manager must be supplemented. If the production manager is also the chemical safety manager, the letter of appointment must clarify this content.

d) The site plans of workshop and warehouse. With regard to manufacturers of chemicals which are in the list of hazardous chemicals as referred to by the law on chemicals, documents proving the compliance with technical regulations on safe distance by Ministry of Industry and Trade must be supplemented.

dd) The list of equipment and facilities for production and dealing with event of chemical hazards;

e) Table of internal regulations on chemical safety;

g) The list of measures or plans for preventing and dealing with event of chemical hazards.

2. Requirements on the application for declaration of eligibility to produce preparations:

a) The application for the declaration of eligibility to produce preparations includes 01 set in paper form, enclosed with PDF form files;

b) Documents in the application must be clearly printed and arranged in the order as prescribed in Clause 1 of this Article; it must have space between parts in a document with cover page and the list of documents must be included in the application;

c) Originals or valid copies of types of documents mentioned in point b and point c Clause 1 of this Article are submitted;

d) Other documents mentioned in Points d, dd, e and g Clause 1 of this Article must be certified by the relevant manufacturer of preparations.

Article 8. Declaration of eligibility to produce preparations

1. The manufacturer of preparations shall, by hand or by post, submit the application for declaration of eligibility to produce preparations to the Department of Health where the workshop is located. If the Department of Health adopts the method of online declaration, the manufacturer must submit online application.

2. Procedures for direct declaration:

a) Before starting the production of preparations, the legal representative of the manufacturer of preparations must submit the application for declaration of eligibility to produce preparations as prescribed in Clause 1 Article 7 of this Decree to the Department of Health where its workshop is located;

b) Department of Health shall issue a Receipt note of the application for declaration of eligibility to produce preparations to the applicant upon the receipt of valid application. The Receipt note of the application for declaration of eligibility to produce preparations shall follow the Form No. 01 in Annex III herein.

3. Procedures for online declaration shall comply with regulations in Chapter VIII of this Decree.

4. Within 03 working days from the date stated in the Receipt note, Department of Health shall be responsible for publish the eligibility to produce preparations of the applicant on its website, including the following information: Name, address and telephone number of the manufacturer of preparations, name of the chemical safety manager and name of production manager (if produced chemicals are hazardous types).

5. During its operation, the manufacturer must update information relating to the application for declaration of eligibility to produce preparations within 15 days from the date on which any of the following changes occurs:

a) Change of its personnel: The written request for change of information relating to the declaration of eligibility to produce preparations shall be submitted, enclosed with the documents mentioned in Point b Clause 1 Article 7 of this Decree. Documents mentioned in Point c Clause 1 Article 7 of this Decree must be supplemented if there is any change of the chemical safety manager or production manager;

b) Change of area of workshop or warehouse: The written request for change of information relating to the declaration of eligibility to produce preparations shall be submitted, enclosed with the documents mentioned in Point d Clause 1 Article 7 of this Decree;

c) Change of facilities and equipment for production and dealing with event of chemical hazards or accidents relating to preparations: The written request for change of information relating to the declaration of eligibility to produce preparations shall be submitted, enclosed with the documents mentioned in Point dd Clause 1 Article 7 of this Decree;

d) Change of name, address or telephone number: The written request for change of information relating to the declaration of eligibility to produce preparations shall be submitted.

6. Within 03 working days from the receipt of the written request for change of information relating to the declaration of eligibility to produce preparations as referred to in Clause 5 of this Article (time of receipt shall follow the date stated in the Department of Health's seal of receiving incoming document), Department of Health shall update information posted on its website.

7. All procedures for the application for declaration of eligibility to produce preparations as referred to in this Decree must be repeated if the manufacturer of preparations moves to another location or constructs additional workshops in the same province.

8. If a manufacturer of preparations moves its production location to another province, it must, within 15 days from the date on which the production location is moved, inform the Department of Health that has handled the manufacturer's application for declaration of eligibility to produce preparations.

Within 03 working days from the receipt of the notice of moving the production location to another province by the manufacturer (time of receipt of the notice shall follow the date stated in the Department of Health's seal of receiving incoming document), Department of Health that has received that manufacturer's application for declaration of eligibility to produce preparations shall terminate the declaration of information relating to that manufacturer.

Chaprter III

TESTING AND EXPERIMENT OF PREPRATIONS

Section 1. TESTING OF PREPRATIONS

Article 9. Testing contents and cases undergoing the testing

1. Testing contents: Determine ingredients and the content of active ingredients in insecticidal and germicidal preparations in conformity with requirements on the application dossiers for sale registration or import.

2. The following cases must undergo the testing:

a) Preparations in progress;

b) New preparations before the registration of which is carried out;

c) Preparations sold in Vietnam in accordance with regulations of the Law on quality of goods and products.

Article 10. Requirements for testing establishments

1. A testing establishment must be established under the law.

2. Testing establishments must meet requirements defined in ISO 17025:2005 or its editions.

3. The application for declaration of eligibility to conduct testing must be carried out in compliance with regulations in Article 12 of this Decree.

Article 11. Application for declaration of eligibility to conduct testing

1. The written declaration of eligibility to conduct testing, using the Form No. 02 in Annex I herein.

2. The list of chemicals for which the testing establishment is capable to conduct the testing with that testing establishment's certification.

3. The valid copy of Certificate of conformity to ISO 17025:2005 or its editions.

Article 12. Declaration of eligibility to conduct testing

1. The testing establishment shall, by hand or by post, submit the application for declaration of eligibility to conduct testing to Ministry of Health. If Ministry of Health adopts the method of online declaration, the said application shall be submitted online.

2. Procedures for direct declaration:

a) Before conducting testing activities, the legal representative of the testing establishment must submit the application for declaration of eligibility to conduct testing as prescribed in Article 11 of this Decree to Ministry of Health;

b) Ministry of Health shall issue a Receipt note of the application for declaration of eligibility to conduct testing to the applicant upon the receipt of valid application. The Receipt note of the application for declaration of eligibility to conduct testing shall follow the Form No. 02 in Annex III herein.

3. Procedures for online declaration shall comply with regulations in Chapter VIII of this Decree.

4. Within 03 working days from the date stated in the Receipt note, Ministry of Health shall be responsible for publishing the eligibility to conduct the testing of the applicant on its website, including the following information: Name, address and telephone number of the testing establishment, and list of testable chemicals.

5. If there is any change of information relating to the application for declaration of eligibility to conduct testing, the testing establishment must, within 05 working days from the date on which the change occurs, carry out procedures for re-declaration as referred to in Clauses 1, 2 and 3 of this Article.

Section 2. EXPERIMENT ON PREPRATIONS

Article 13. Cases subject to the experiment

1. New preparations of which the application for sale registration is carried out.

2. Preparations of which the additional registration is carried out as referred to in Point c and Point dd Clause 2 Article 21 of this Decree.

Article 14. Requirements for experiment establishments

1. An establishment carrying out experiments on preparations must be a health facility.

2. Requirements on personnel:

a) The person in charge of managing the experiment division must possess a bachelor’s degree or higher level in medical or biological fields, and have at least 03 years of experience in the experiment on preparations;

b) The experiment establishment must contract at least 05 employees who possess two-year associate degree, or higher level, in medical or biological or chemical fields, among which at least 02 employees have 02 years, or more, of experience in the experiment on preparations.

3. Requirements on facilities:

a) Have experimental lab and support labs, and labs for raising insects, germs and viruses for experiment which must be designed in conformity with technical requirements on experimental process adopted by Ministry of Health and managed and operated under ISO 17025:2005 or ISO 15189:2012 or their editions;

b) Have testing or experimental labs which have Biosafety Certificates awarded and are suitable for each species of insects, germs or viruses for experiment as referred to in the Law on control and prevention of infectious diseases and relevant legislative documents;

c) Have species of insects, germs or viruses available and sufficient for experiment;

d) Have facilities and equipment sufficient and conformable to requirements on experiment process;

dd) In case of field experiment, the location for carrying out that field experiment must be available in conformity with the experiment process;

e) Meet requirements in Clauses 2, 3 and 4 Article 33 of the Law on chemicals.

4. Perform the declaration of eligibility to conduct experiment activities as referred to in Article 16 of this Decree.

Article 15. Application for declaration of eligibility to conduct experiment activities

1. The written declaration of eligibility to conduct experiment activities, using the Form No. 03 in Annex I herein.

2. The list of names of experiments which the experiment establishment is capable to conduct with its certification.

3. The declaration on personnel, using the form stated in Annex II herein.

4. The valid copy of Certificate of conformity to ISO 17025:2005 or ISO 15189:2012 or their editions.

5. The valid copy of Biosafety Certificate.

6. The list of facilities and equipment serving experiment activities with the experiment establishment’s certification.

Article 16. Declaration of eligibility to conduct experiment activities

1. The experiment establishment shall, by hand or by post, submit the application for declaration of eligibility to conduct experiment activities to Ministry of Health. If Ministry of Health adopts the method of online declaration, the application must be submitted online.

2. Procedures for direct declaration:

a) Before conducting experiment activities, the legal representative of the experiment establishment must submit the application for declaration of eligibility to conduct experiment activities as prescribed in Article 15 of this Decree to Ministry of Health;

b) Ministry of Health shall issue a Receipt note of the application for declaration of eligibility to conduct experiment activities to the applicant upon the receipt of valid application. The Receipt note of the application for declaration of eligibility to conduct experiment activities shall follow the Form No. 03 in Annex III herein.

3. Procedures for online declaration shall comply with regulations in Chapter VIII of this Decree.

4. Within 03 working days from the date stated in the Receipt note, Ministry of Health shall be responsible for publishing the eligibility to conduct experiment activities of the applicant on its website, including the following information: Name, address and telephone number of the experiment establishment, and list of types of experiments which the experiment establishment are capable to conduct as declared.

5. During its operation, the experiment establishment must update information relating to the application for declaration of eligibility to conduct experiment activities within 15 days from the date on which any of the following changes occurs:

a) Change of its personnel: The written request for change of information relating to the declaration of eligibility to conduct experiment activities shall be submitted, enclosed with the documents mentioned in Clause 3 Article 15 of this Decree;

b) Change of Certificate of conformity to ISO 17025:2005 or ISO 15189:2012 or their editions: The written request for change of information relating to the declaration of eligibility to conduct experiment activities shall be submitted, enclosed with the documents mentioned in Clause 4 Article 15 of this Decree;

c) Change of Biosafety Certificate: The written request for change of information relating to the declaration of eligibility to conduct experiment activities shall be submitted, enclosed with the documents mentioned in Clause 5 Article 15 of this Decree;

d) Change of facilities and equipment serving experiment activities: The written request for change of information relating to the declaration of eligibility to conduct experiment activities shall be submitted, enclosed with the documents mentioned in Clause 6 Article 15 of this Decree;

dd) Change of name, address or telephone number of the experiment establishment: The written request for change of information relating to the declaration of eligibility to conduct experiment activities shall be submitted.

6. Within 03 working days from the receipt of the written request for change of information relating to the declaration of eligibility to conduct experiment activities as referred to in Clause 5 of this Article (time of receipt shall follow the date stated in the Ministry of Health's seal of receiving incoming document), Ministry of Health shall update information posted on its website.

7. The experiment establishment must re-carry out procedures for the declaration of eligibility to conduct experiment activities as referred to in this Decree if having any changes other than those specified in Clause 5 of this Article.

Chaprter IV

SALE OF PREPARATIONS

Section 1. REQUIREMENTS ON SALE OF PREPARATIONS, REGISTRATION NUMBER AND HOLDERS OF SALE REGISTRATION CERTIFICATES

Article 17. Requirements for sale of preparations

1. A preparation is allowed to be freely sold if having a registration number. And

2. It must have a label or supplementary label containing sufficient information as referred to in this Decree.

3. If the duration of registration number issued to a type of preparations expires but the registration number holder fails to apply for extension of that registration number, the preparations which are produced before the expiration date of that registration number are still freely sold on the market until the expiry date stated in their label is over.

Article 18. Registration number for preparations

1. One type of preparations shall be issued with a registration number.

2. Each registration number shall be valid within 05 years from its issued date. In case of extension of registration number of a type of preparations, the issued registration number shall be maintained.

3. Registration number is issued under a Sale Registration Certificate. The form of Sale Registration Certificate shall comply with regulations in Annex IV herein.

Article 19. Requirements for registered preparations

1. The toxicity of preparations of which the registration is carried out is not classified in Class Ia or Ib according to WHO’s classification system for pesticides (or insecticidal preparations), or in Heading I or II according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

2. Preparations must not contain any of active ingredients in the list of active ingredients banned from use in preparations.

3. The registration of preparations which contain any of active ingredients in the list of active ingredients with restricted use in preparations shall be made within the regulated scope of use only.

4. Registered preparations must be made by a manufacturer that has declared its eligibility to produce preparations as regulated (domestic preparations) or attached with Certificate of Free Sale (for imported preparations).

Article 20. Holders of sale registration certificates

1. The following entities may be holders of sale registration certificates:

a) A domestic enterprise, or co-operative, or business household that is the owner of preparations of which the registration is made or a representative office in Vietnam of a foreign trader who is the owner of relevant preparations;

b) A domestic enterprise, or a co-operative, or a business household that applies for the registration of preparations under the authorization of the owner of such preparations;

c) A representative office of foreign trader in Vietnam that applies for the registration of preparations under the authorization of the owner of such preparations.

2. In case of additional registration of preparations, or extension of registration number, or re-issuance of Sale Registration Certificate, the holder of sale registration certificate is also the registration number holder.

3. If the owner of preparations gives permission to its authorized entity to re-authorize another entity to apply for the registration of preparations, the permitted reauthorization must be clarified in the Letter of Authorization.

4. If there are two or several entities in Vietnam apply for the registration of the same type of preparations under the authorization of the owner of that type of preparations, Ministry of Health shall only receive and settle the application submitted by the entity that comes first with a valid letter of authorization.

Section 2. REGISTRATION OF SALE OF PREPARATIONS

Article 21. Forms of registration

1. The registration of new preparations shall be carried out in the following cases:

a) New preparations which are produced domestically, except for those for export purpose;

b) Preparations which are permitted to use abroad but imported to use in Vietnam for the first time;

c) Preparations being issued with registration number but the extension of that registration number is not carried out within the period prescribed in Clause 2 Article 24 of this Decree.

2. Additional registration of preparations shall apply to preparations whose registration number has been issued in Vietnam and is still in effect but there is one of the following changes occurs:

a) Change of the ownership of the registration number;

b) Change of the trade name of relevant type of preparations;

c) Change of manufacturer’s location or change of manufacturer;

d) Change of name or contact address of the entity carrying out the registration, or change of name of manufacturer or production location;

dd) Change of effects, quality criteria or method of using preparations.

3. The registration for extension of registration number shall apply to preparations which have been issued with the registration number but it reaches the period for carrying out the registration for extension as prescribed in Clause 2 Article 24 of this Decree.

4. The registration for re-issuance of Sale Registration Certificate shall be carried out if the issued Sale Registration Certificate is lost or damaged.

Article 22. Application for registration of new preparations

1. The application form for registration of new preparations using the Form No. 04 stated in Annex I enclosed with this Decree.

2. Documents proving legal status of the applicant or the manufacturer.

3. Letter of authorization for registration of preparations, except for the cases stated in Point a Clause 1 Article 20 of this Decree.

4. Technical documents of the type of preparations which applies for registration, including contents as prescribed in Annex V enclosed with this Decree.

5. Testing results for ingredients and the content of active ingredients in preparations (the written notice of testing results must be supplemented).

6. The written notice of experiment results (which is supplemented upon the written approval for experiment by Ministry of Health).

7. Label sample of preparations.

8. Certificate of Free Sale (for imported preparations).

9. Documents and/or written results of the research on the safety and effects of preparations, or warnings by WHO or other international organizations about the use of relevant preparations in household and medical sectors (if the type of preparations that applies for registration contains active ingredients or this is the first application for registration of that type of preparations in Vietnam).

Article 23. Application for additional registration of preparations

1. Change of the ownership of the registration number:

a) The application form for additional registration of preparations using the form No. 05 stated in Annex I enclosed with this Decree;

b) Letter of authorization for registration of preparations, except for the cases stated in Point a Clause 1 Article 20 of this Decree;

c) Document for transfer of the registration number ownership, which is made by the registration number holder;

d) Document relating to the receipt of registration number ownership and written commitment on the continuation of trading of preparations as approved by Ministry of Health upon the receipt of the registration number thereof;

dd) Documents proving legal status of the receiver of registration number;

e) New label sample of preparations.

2. Change of the trade name of relevant type of preparations:

a) The application form for additional registration of preparations using the form No. 05 stated in Annex I enclosed with this Decree;

b) Letter of authorization for registration of preparations under the new trade name, except for the cases stated in Point a Clause 1 Article 20 of this Decree;

c) Certificate of Free Sale of relevant preparations under new trade name (for imported preparations);

d) New label sample of preparations.

3. Change of production location or change of manufacturer:

a) The application form for additional registration of preparations using the form No. 05 stated in Annex I enclosed with this Decree;

b) Documents proving legal status of the manufacturer, including information about the new production location (if the manufacturer is in Vietnam), or written notice of production location or manufacturer (if the manufacturer is abroad);

c) Written notice of experiment results on preparations which are produced at new location;

d) Letter of authorization for registration of preparations, except for the cases stated in Point a Clause 1 Article 20 of this Decree;

dd) Certificate of Free Sale, except for the cases where the applicant has been issued with registration number to produce preparations in Vietnam and carries out the additional registration for manufacturer in a foreign country;

e) New label sample of preparations.

4. Change of name or contact address of the entity carrying out the registration, or change of name of manufacturer or production location:

a) The application form for additional registration of preparations using the form No. 05 stated in Annex I enclosed with this Decree;

b) Documents proving legal status of the applicant or the manufacturer, including the changed content (if the applicant or the manufacturer is in Vietnam), or written notice of change of name or address (if the manufacturer is abroad);

c) New label sample of preparations.

5. Change of effects, quality criteria or method of using preprations:

a) The application form for additional registration of preparations using the form No. 05 stated in Annex I enclosed with this Decree;

b) Written notice of experiment results on preparations after the change (except for the change of the expiry date of preparations);

c) Research documents on the stability (if the expiry date of preparations is changed);

d) Testing results for ingredients and the content of active ingredients (if the ingredients and the content of active ingredients of preparations are changed);

dd) New label sample of preparations.

Article 24. Application for extension of registration number

1. The application for extension of registration number shall consist of the following documents:

a) The application form for extension of registration number using the form No. 06 stated in Annex I enclosed with this Decree;

b) Documents proving the legal status of the applicant or the manufacturer;

c) Letter of authorization for registration of preparations, except for the cases stated in Point a Clause 1 Article 20 of this Decree;

d) The report of the selling process of preparations using the form stated in Annex VI enclosed with this Decree.

2. The application for extension of the registration number must be submitted within 03 to 12 months before it expires.

Article 25. Application for re-issuance of sale registration certificate

1. The application form for re-reissuance of sale registration certificate using the form No. 07 stated in Annex I enclosed with this Decree.

2. The damaged sale registration certificate.

Article 26. Requirements for application dossiers for registration

1. The application dossiers for registration of new preparations, or additional registration, or extension of registration number shall include 01 set in paper form, enclosed with PDF form files.

2. Documents included in the application dossiers must be clearly printed and arranged in the order for each form of registration as prescribed in Articles 22, 23 and 24 of this Decree; it must have space between content parts in a document with cover page and list of documents.

3. English documents must be translated into Vietnamese and enclosed with the originals thereof. Documents in a foreign language other than English must be translated into Vietnamese and notarized in accordance with the law.

4. Requirements for documents in a set of application dossiers for registration:

a) The original letter of authorization for registration of preparations. The letter of authorization must meet requirements in Annex VII enclosed with this Decree;

b) The original or valid copy of Certificate of Free Sale (for imported preparations). Certificate of Free Sale must meet requirements in Annex VIII enclosed with this Decree;

c) The original or valid copy of the written notice of experiment results made by an entity that is independent (that is not the manufacturer or the applicant for registration of preparations) and qualified to conduct experiment activities as referred to in Article 14 of this Decree;

d) The original or valid copy of the written notice of testing results for ingredients and the content of active ingredients in preparations, which is made by an entity that is qualified to conduct testing as referred to in Article 10 of this Decree;

dd) Label samples of all packaging specifications according to real package size with certification of the applicant. If several packaging specifications have the same label design, the applicant shall only submit the label sample of the packaging specification with the smallest package size. If the label sample of imported preparations uses a foreign language, it must be attached with a secondary label with contents in Vietnamese. The sample and contents of the secondary label of preparations must meet requirements in Annex IX enclosed with this Decree.

e) Valid copies of documents proving the legal status of the applicant or the manufacturer;

g) The original or valid copy of the written notice of change of name, or address, or location, or change of manufacturer of a foreign manufacturer, which must be legalized by consular bodies in accordance with the law.

5. Other documents in the application dossiers for registration must be fan-stamped or stamped on each page of a document by the applicant.

Article 27. Receipt and appraisal of application for registration of new preparations

1. The applicant shall, by hand or by post, submit the application for registration of new preparations to Ministry of Health. If Ministry of Health adopts the method of online registration, the application shall be submitted online. The online registration shall comply with regulations in Chapter VIII of this Decree.

2. Ministry of Health shall issue a Receipt note to the applicant upon the receipt of the application and fees for appraising the application for registration of new preparations. The Receipt note of the application for registration of new preparations shall follow the Form No. 04 in Annex III enclosed with this Decree.

3. Within 30 days from the date stated in the Receipt note mentioned in Clause 2 of this Article, Ministry of Health shall make a written notice to the applicant for registration of new preparations of request for supplement or modification of the application dossiers, or approval or refusal to give approval for the experiment.

In case of supplement or modification of the application, contents requiring supplement or modification must be specified in writing.

In case of refusal to give approval for the experiment, reasons must be specified in writing.

4. Within 90 days from the date stated on the written request for supplement or modification of the application by Ministry of Health, the applicant must complete and send written explanation about supplemented or modified contents to Ministry of Health. The time limit for making supplement or modification is specified in the Receipt note of the application. Over the said time limit, if the application for registration of new preparations shall be cancelled.

Supplemented or modified application shall be received and appraised in conformity with regulations in Clause 3 of this Article.

5. If the application is valid, Ministry of Health shall give a written notice of approval or refusal to give approval for the experiment to the applicant for registration of new preparations. In case of refusal to give approval for the experiment, reasons thereof must be specified in writing.

6. Within 12 months from the date stated in the written approval for the experiment, the applicant shall be responsible for completing the testing and/or experiment as referred to in Chapter III herein and supplementing the application with testing and/or experiment results. The time limit for receiving the testing/experiment results is specified in the Receipt note of the application. Over the said time limit, if the application for registration of new preparations shall be cancelled.

7. Within 30 days from the date stated in the Receipt note mentioned in Clause 6 of this Article, Ministry of Health shall make a written notice to the applicant for registration of new preparations of request for supplement or modification of the application dossiers, or issuance or refusal to issue the registration number.

In case of supplement or modification of the application, contents requiring supplement or modification must be specified in writing.

In case of refusal to issue the registration number, reasons thereof must be specified in writing.

If the applicant uses imported materials to produce preparations, the sale registration certificate must include the approval for imported materials using the form stated in Annex IV enclosed with this Decree.

8. Within 03 working days from the issued date of the new registration number, Ministry of Health shall publish the following information on its website:

a) The name of preparations;

b) The registration number;

c) The full text of the sale registration certificate.

9. Ministry of Health shall neither receive the application for registration nor issue a registration number to the applicant that has the registration number of his/her preparations revoked under any of the cases mentioned in Clauses 1, 4 and 9 Article 38 of this Decree within 02 years from the date of revocation.

Article 28. Receipt and appraisal of application for additional registration of preparations

1. The applicant shall, by hand or by post, submit the application for additional registration of preparations to Ministry of Health. If Ministry of Health adopts the method of online registration, the application shall be submitted online. The online registration shall comply with regulations in Chapter VIII of this Decree.

2. Ministry of Health shall issue a Receipt note to the applicant upon the receipt of the application and fees for appraising the application for additional registration of preparations. The Receipt note shall follow the Form No. 05 in Annex III enclosed with this Decree.

3. Within 30 days from the date stated in the Receipt note, Ministry of Health shall make a written notice to the applicant for additional registration of preparations of the following issues:

a) Request for supplement or modification of the application, or approve or refuse to approve the contents of additional registration and specify reasons thereof (if the application for additional registration of preparations does not require the experiment);

b) Request for supplement or modification of the application, or approve or refuse to approve experiment activities and specify reasons thereof (if the application for additional registration of preparations requires the experiment).

4. Within 12 months from the date stated in the written approval for the experiment by Ministry of Health, the applicant must supplement the application with experiment results. Over the said period, the application for additional registration of preparations shall be cancelled.

5. Within 90 days from the date stated on the written request for supplement or modification of the application by Ministry of Health, the applicant must complete and send written explanation about supplemented or modified contents to Ministry of Health. The time limit for receiving supplemented or modified documents is specified in the Receipt note. Over the said time limit, the application for additional registration of preparations shall be cancelled.

6. If the application is valid, Ministry of Health shall amend the sale registration certificate.

7. Within 03 working days from the date on which the sale registration certificate is amended, Ministry of Health shall publish the full text of the amended sale registration certificate on its website.

Article 29. Receipt and appraisal of application for extension of registration number

1. The applicant shall, by hand or by post, submit the application for extension of registration number to Ministry of Health. If Ministry of Health adopts the method of online registration, the application shall be submitted online. The online registration shall comply with regulations in Chapter VIII of this Decree.

2. Ministry of Health shall issue a Receipt note to the applicant upon the receipt of the application and fees for appraising the application for extension of registration number. The Receipt note shall follow the Form No. 06 in Annex III enclosed with this Decree.

3. Within 30 days from the date stated in the Receipt note mentioned in Clause 2 of this Article, Ministry of Health shall make a written notice to the applicant of request for supplement or modification of the application dossiers, or approval or refusal to give approval for the extension of registration number.

The written request for supplement or modification of the application for extension of registration number must clarify the contents requiring supplement or modification.

In case of refusal to give approval for extension of the registration number, reasons thereof must be specified in writing.

4. Within 30 days from the date stated in the written request for supplement or modification but at least 10 days before the registration number expires, the applicant must send the valid application, enclosed with written explanation about supplemented or modified contents, to Ministry of Health. The time limit for receiving supplemented or modified documents is specified in the Receipt note. Over the said time limit, the application for extension of registration number shall be cancelled.

Supplemented or modified documents shall be received and appraised in conformity with regulations in Clause 3 of this Article.

5. If the application is valid, Ministry of Health shall grant an extension of registration number to the applicant.

6. Within 03 working days from the date on which the extension of registration number is granted, Ministry of Health shall publish the full text of the sale registration certificate instead of the information referred to in Point c Clause 8 Article 27 of this Decree on its website.

Article 30. Receipt and appraisal of application for re-issuance of sale registration certificate

1. The applicant must submit the application for re-issuance of sale registration certificate at Ministry of Health.

2. Ministry of Health shall issue a Receipt note to the applicant upon the receipt of the application for re-issuance of sale registration certificate. The Receipt note shall follow the Form No. 07 in Annex III enclosed with this Decree.

3. Within 10 days from the date stated in the Receipt note, Ministry of Health shall re-issue a sale registration certificate to the applicant. In case of refusal to re-issue the sale registration certificate, reasons thereof must be specified in writing.

Section 3. TRADE NAME, LABELING, PACKAGING, PRESERVATION AND DESTRUCTION OF CHEMICALS AND PREPARATIONS

Article 31. Trade name of preparations

1. One trade name shall be registered in Vietnam for one type of preparations produced by a manufacturer;

2. Two or more types of preparations of the same manufacturer cannot bear the same trade name;

3. A type of preparations cannot have the same trade name as that of another type of preparations which has a registration number in effect;

4. A trade name of preparations must be different from the name of active ingredients, or the name of active ingredients and their content, or the name of active ingredients and their content and the form of such preparations;

5. It is not allowed to use a trade name of preparations with a meaning inconsistent with effects and safety property of such preparations.

Article 32. Labeling of chemicals and preparations

1. The labeling of chemicals and preparations shall comply with regulations in Annex IX enclosed with this Decree.

2. If any change of the contents or the form of the label of preparations other than the contents mentioned in Clause 2 Article 21 of this Decree occurs, the registration number holder must, at least 15 days before the new label is used, send a written notice of changed contents enclosed with samples of new labels (including label samples of all packaging specifications according to real package sizes; if several packaging specifications have the same label design, the applicant shall submit the label sample of the packaging specification with smallest package size) to Ministry of Health. If Ministry of Health adopts the method of online registration, the registration number holder shall send the notice of change of the contents or the form of the label of preparations online. The online notice shall comply with regulations in Chapter VIII of this Decree.

3. Within 05 working days from the receipt of the written notice of changed contents of the label (time of receipt shall follow the date stated in the Ministry of Health's seal of receiving incoming document), if Ministry of Health does not make written request for modification:

a) The registration number holder may use the new label;

b) Ministry of Health shall add the new label sample of preparations to the application for registration of such preparations.

Article 33. Packaging of chemicals and preparations

1. Preparations sold in Vietnam must be packaged in conformity with the following requirements:

a) Packages must be strong enough to stand normal impacts and shocks during transportation, transshipment and handling by manual or mechanical methods;

b) Packages must be tight to prevent leakage of preparations during transportation or being transported under impacts of vibration or change of temperature, moisture or pressure;

c) The outer surface of packages must be clean and free of any hazardous chemicals.

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

a) Neither being affected nor deteriorated in quality due to impacts of packaged preparations;

b) Not affecting the ingredients, properties or effects of or preparations.

3. When packaging liquid preparations, a necessary space must be left to ensure packages will not be leaked or deformed due to an increase in volume of packaged liquids when temperature changes.

4. Inner packages which are breakable or easily holed such as those made of glass, porcelain or certain kinds of plastics must be insulated with appropriate shock-absorbing materials from the outer packaging layers.

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 liquid preparations must stand the inside pressure built up during the transportation.

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

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

Article 34. Preservation of chemicals and preparations

The preservation of chemicals and preparations must comply with the manufacturer’s instructions specified in the labels.

Article 35. Destruction of chemicals and preparations

1. Cases subject to destruction:

a) Chemicals and preparations which have expired shelf life and are non-recyclable, or chemicals and preparations whose quality is not ensured and cannot be improved;

b) Containers and packages of chemicals and preparations which are not permitted for re-use; non-recyclable wastes, or chemicals or preparations left from the production or trading or use.

2. Chemicals and preparations for household or personal use only must be discarded according to manufacturers' recommendations and regulations of the law on environmental protection.

3. Entities having chemicals and preparations or chemical and preparation packages subject to destruction shall bear all destruction expenses.

4. In the process of collecting and destroying chemicals and preparations and chemical and preparation packages, the hazardous waste must not be scattered, dispersed or increased in the environment and must be treated with appropriate technologies in accordance with regulations of the law on environmental protection.

Section 4. SUSPENSION OF SALE OF PREPARATIONS

Article 36. Procedures for suspension of sale of preparations with warnings from the owner of preparations or registration number holder

1. If it is determined those preparations are defective or may cause adverse impacts on users’ health or the environment, the registration number holder shall:

a) Suspend the sale of preparations;

b) Send written notice to Ministry of Health and entities in charge of distributing such preparations; at the same time, publish on the mass media the suspension of sale and use of such preparations. The written notice must include the number of lot of suspended preparations, defective elements or risks that cause adverse impacts on users’ health or the environment as well as the fact that such defective elements may or may not be remedied.

2. If it is able to remedy defective elements or factors causing adverse impacts on users’ health or the environment:

a) Within 05 days from the receipt of the written notice sent by the owner of preparations or the registration number holder, Ministry of Health shall make a decision on the suspension of sale of preparations;

b) Within 90 days from the date on which a decision on the suspension of sale of preparations is made, the registration number holder shall be responsible for completing the remedy of defective elements or factors that cause adverse impacts on users’ health or the environment;

c) Upon the completion of the remedial measures, the registration number holder shall send a written report to Ministry of Health, enclosed with documents proving its completion of remedy of defective elements or risks.

d) Within 30 days from the receipt of the written report submitted by the registration number holder, Ministry of Health shall make a decision on the termination of suspension of sale of preparations. If Ministry of Health refuses to terminate the suspension of sale of preparations, it must specify reasons thereof in writing.

3. If it is unable to remedy defective elements or factors causing adverse impacts on users’ health or the environment, or over the period for remedy which is stated in the decision on suspension of sale of preparations but the manufacturer fails to complete remedial measures, Ministry of Health shall make a decision on recalling of suspended preparations. Decision on the recalling of suspended preparations must be published on the website of Ministry of Health.

4. A decision on suspension of sale of preparations or a decision on the recalling of suspended preparations must include the following contents:

a) Name of type of preparations subject to the suspension or recalling;

b) The lot number of preparations subject to the suspension or recalling;

c) The registration number of preparations subject to the suspension or recalling;

d) Suspension period;

dd) Requirements for settlement of recalled preparations.

Article 37. Procedures for suspension of sale of preparations with warnings from preparations competent authorities

1. Within 05 working days from the receipt of the notice of active ingredients’ or preparations’ factors causing adverse impacts on users’ health or the environment from countries where such preparations are sold or from WHO, Ministry of Health shall make decision on suspension of sale of such preparations and send a written request to the registration number holder for explanation

2. Within 05 working days from the receipt of the written request from Ministry of Health, the registration number holder shall send explanation report to Ministry of Health.

3. Within 05 working days from the receipt of the report submitted by the registration number holder, Ministry of Health shall carry out the assessment of factors causing adverse impacts on human health and the environment contained in active ingredients or preparations.

4. Within 05 working days from the date on which assessment results are given, if it was determined that active ingredients or preparations do not pose risks, Ministry of Health shall make decision on termination of suspension of sale of such preparations.

5. If it was determined that active ingredients or preparations contain factors causing adverse impacts on human health or the environment and it is able to remedy such mistakes, Ministry of Health shall send a written notice to the registration number holder to carry out remedial measures as referred to in Clause 2 Article 36 of this Decree.

6. If it was determined that active ingredients or preparations contain factors causing adverse impacts on human health or the environment but it is unable to remedy such mistakes, Ministry of Health shall, on the basis of features and level of such factors, make decision on recalling of lot(s) or entire preparations.

Section 5. REVOCATION OF REGISTRATION NUMBER

Article 38. Cases subject to revocation of registration number

1. The application for registration of preparations was forged.

2. Preparations are produced at an unqualified manufacturer.

3. Produced preparations have technical criteria inconsistent with the application dossiers for registration of such preparations.

4. There are 03 lots, or above, of preparations subject to the suspension of sale within the effective period of the registration number.

5. Imported preparations have their registration number revoked in the exporting country.

6. Preparations contain factors causing adverse impacts on human health or the environment resulting in entire preparations are revoked as referred to in Clause 6 Article 37 of this Decree.

7. The owner of preparations or the registration number holder requests for the revocation of the registration number of such preparations in Vietnam.

8. Preparations infringe the intellectual property right upon the written conclusion made by a competent authority.

9. The registration number holder lets out or lends the sale registration certificate or itself alters contents in the sale registration certificate.

10. The registration number holder terminates its operations or is unqualified to apply for registration of preparations.

Article 39. Procedures for revocation of registration number

1. Within 15 working days from the date on which any of the cases mentioned in Article 38 herein is verified, Ministry of Health shall consider and make decision on the revocation of registration number.

2. The decision on the revocation of registration number must be sent to the registration number holder, Ministry of Finance (General Department of Vietnam Customs) and provincial people’s committee, and be published on Ministry of Health’s website.

Chaprter V

TRADING OF PREPARATIONS

Article 40. Conditions for traders in preparations

A trader in preparations must satisfy the following conditions

1. Personnel:

a) The chemical safety manager must possess two-year associate degree in chemistry or higher;

b) Sales staff must have knowledge about sold preparations.

2. Technical facilities and materials:

a) The areas displaying insecticidal and germicidal chemicals and preparations for sale must be separated from those for foods;

b) Facilities for preserving preparations must meet requirements on preservation specified in the preparations’ labels;

c) The first aid kit must be available to meet requirements on first aid specified in the preparations’ labels.

3. Traders in common insecticidal and germicidal preparations, consisting of: mosquito coil and mosquito repellent tablets for household and medical use; insecticidal sprays; insect poisons; insect repelling cream, patch and band for human use; liquid mosquito repellents and killers; mosquito nets with mosquito repellents and killers; and germicidal preparations for household use must not meet requirements in Clause 1 of this Article.

Article 41. Requirements for preparations-used insecticidal and germicidal service providers

1. A preparations-used insecticidal and germicidal service provider must be an enterprise, or a co-operative, or a business household that is established under the law.

2. The person directly performing insecticidal and germicidal works must have knowledge about the insecticidal and germicidal preparations as instructed by Minister of Health.

3. Equipment must be available and suitable for each technique adopted by the service provider.

4. The declaration of eligibility to provide preparations-used insecticidal and germicidal service must be made in compliance with regulations in Article 43 of this Decree.

Article 42. Application for declaration of eligibility to provide preparations-used insecticidal and germicidal service

1. The written declaration of eligibility to provide preparations-used insecticidal and germicidal service using the Form No. 08 in Annex I herein.

2. The declaration of personnel using the form stated in Annex II herein.

3. The list of insecticidal and germicidal equipment with the provider’s certification.

Article 43. Declaration of eligibility to provide preparations-used insecticidal and germicidal service

1. The preparations-used insecticidal and germicidal service provider shall, by hand or by post, submit the application to Department of Health where its head office is located. If Department of Health adopts the method of online declaration, the application must be submitted online.

2. Procedures for direct declaration:

a) Before providing preparations-used insecticidal and germicidal service, the legal representative of the service provider must submit the application for declaration of eligibility to provide preparations-used insecticidal and germicidal service as prescribed in Article 42 of this Decree to the Department of Health where its head office is located;

b) After receiving the valid application, Department of Health shall grant a Receipt note of the application for declaration of eligibility to provide preparations-used insecticidal and germicidal service to the applicant, using the Form No. 08 in Annex III herein.

3. Procedures for online declaration shall comply with regulations in Chapter VIII of this Decree.

4. Within 03 working days from the date stated in the Receipt note, Department of Health shall be responsible for publishing on its website the following information: Name, address and telephone number of the preparations-used insecticidal and germicidal service provider.

5. During its operation, the preparations-used insecticidal and germicidal service provider must update information relating to the application for declaration of eligibility to provide preparations-used insecticidal and germicidal service within 15 days from the date on which any of the following changes occurs:

a) Change of its personnel: The written request for change of information relating to the application for declaration of eligibility to provide preparations-used insecticidal and germicidal service shall be submitted, enclosed with the documents mentioned in Clause 2 Article 42 of this Decree;

b) Change of insecticidal and germicidal facilities and equipment: The written request for change of information relating to the application for declaration of eligibility to provide preparations-used insecticidal and germicidal service shall be submitted, enclosed with the documents mentioned in Clause 3 Article 42 of this Decree;

c) Change of name, address or telephone number: The written request for change of information relating to the application for declaration of eligibility to provide preparations-used insecticidal and germicidal service shall be submitted.

6. Within 03 working days from the receipt of the written request for change of information relating to the application for declaration of eligibility to provide preparations-used insecticidal and germicidal service as referred to in Clause 5 of this Article (time of receipt shall follow the date stated in the Department of Health's seal of receiving incoming document), Department of Health shall update the information posted on its website.

7. All procedures for the application for declaration of eligibility to provide preparations-used insecticidal and germicidal service as referred to in this Decree must be repeated if the service provider moves to another location or constructs additional establishments in the same province.

8. If a service provider moves to another province, it must, within 15 days from the date of relocation, report that relocation to the Department of Health that has declared the eligibility to provide preparations-used insecticidal and germicidal service of that provider.

Within 03 working days from the receipt of the notice of moving to another province by the preparations-used insecticidal and germicidal service provider (time of receipt of the notice shall follow the date stated in the Department of Health's seal of receiving incoming document), Department of Health that has received that provider’s application for declaration of eligibility to provide preparations-used insecticidal and germicidal service shall stop publishing information relating to that provider.

Chaprter VI

TRANSPORTATION OF CHEMICALS AND PREPARATIONS

Article 44. Rules for transportation of chemicals and preparations

1. Other than the compliance with regulations in this Decree, the transportation of chemicals and preparations in the list of hazardous chemicals as referred to by the law on chemicals must also comply with regulations of the law on transportation of dangerous goods.

2. Chemicals and preparations which may react with each other must not be transported on the same vehicle.

Article 45. Requirements for packages, casks or containers for transportation of chemicals and preparations

1. Each type of chemicals or preparations must be packaged in a proper way as referred to in Article 33 of this Decree.

2. Chemicals and preparations must be marked with symbols showing their physical properties. The dimension of a symbol showing physical properties stuck on each cask and container of chemicals or preparations shall be 100 mm x 100 mm and 250 mm x 250 mm respectively.

3. Dangerous goods symbols must be displayed if chemicals or preparations in the list of hazardous chemicals as referred to by the law on chemicals are transported. The dimension of a dangerous goods symbol sticked on each cask and container of chemicals or preparations shall be 100 mm x 100 mm and 250 mm x 250 mm respectively. A dangerous warning sign must be placed under each dangerous goods symbol. The dimension of a dangerous warning sign shall be 300 mm x 500 mm.

Article 46. Requirements for vehicles

1. Must be equipped with fire fighting and prevention equipment suitable for each type of transported chemicals or preparations.

2. Transported chemicals and preparations must be carefully covered to avoid the water permeation during the transportation.

3. The dimension of a dangerous goods symbol displayed on the vehicle shall be 500 mm x 500 mm.

Article 47. Requirements for transportation of chemicals and preparations

1. During transport of chemicals and/or preprations, a driver must run the vehicle according to the schedule indicated in the contract or another paper relating to transport of chemicals and/or preprations made by and between the vehicle owner and goods owner.

2. If any event of chemical hazards occurs during the transportation, the driver, the goods owner and the vehicle owner must implement measures for minimizing effects and dealing with that event in an appropriate and timely manner, and inform the fire force, relevant entities and local government to cooperate in responding and dealing with such event.

Chaprter VII

EXPORT/IMPORT OF CHEMICALS AND PREPARATIONS

Article 48. Rules for export/import of chemicals and preparations

1. The export/import of chemicals and preparations shall be conducted in accordance with regulations of the law on export/import of goods.

2. Preparations with valid sale registration certificates may be imported on demand in unlimited quantity or value. Import procedures shall be carried out at customs agencies without requiring the Ministry of Health's approval. Importers shall take responsibility before law for their operations.

3. Manufacturers may import materials for production of preparations which have been issued with registration number on their demand. Import procedures shall be carried out at customs agencies without requiring the Ministry of Health's approval. Importers of materials shall take responsibility before law for their operations.

4. In case importing countries require certification of free sale of preparations in Vietnam, the registration number holder shall comply with the law on certificates of free sale for imported/exported products and goods.

Article 49. Import licenses

1. The following chemicals and preparations require import licenses:

a) Chemicals and preparations imported for research purpose;

b) Preparations imported for aid or other particular purposes (which are used as gifts or presents or in case similar products or methods are unavailable in the market);

2. The application for import license consists of:

a) The application form for import license using the form No. 09 stated in Annex I enclosed with this Decree;

b) Technical documents of chemicals or preparations, including contents as prescribed in Annex V enclosed with this Decree;

c) With regard to chemicals or preparations imported for research purpose: The research outline with certification of the legal representative of the research establishment or the manufacturer that has declared its eligibility for production;

d) With regard to chemicals or preparations imported for aid: The valid copies of decisions on approval for receipt of aids granted by competent authorities and documents relating to the imported shipment;

dd) With regard to chemicals or preparations imported for using as gifts or presents: The written notice of such gifts or presents and documents proving that imported preparations are permitted by competent bodies to use in exporting countries.

e) In case similar products or methods are unavailable in the market: Documents proving that products or methods in need of the importer are not available on Vietnamese market, and documents proving that imported preparations are permitted by competent bodies to use in exporting country;

g) The valid copies of GMP (Good Manufacturing Practices) or ISO certificate of manufacturer and Certificate of Free Sale must be submitted if preparations are imported to use for other particular purposes with a total weight of 50 kilograms, or above, upon each importation.

Article 50. Procedures for issuance of import license

1. The applicant for import license (hereinafter referred to as the importer) shall, by hand or by post, submit the application for import license to Ministry of Health (via Health Environment Management Agency). If Ministry of Health adopts the method of online issuance of import license, the importer must submit the application for import license online. Procedures for online issuance of import license shall comply with regulations in Chapter VIII of this Decree.

2. After receiving the application for import license, Ministry of Health shall give a Receipt note to the importer. The Receipt note of the application for import license shall follow the Form No. 09 in Annex III enclosed with this Decree.

3. Ministry of Health shall issue an import license to the importer if the application is valid. In case of refusal to issue the import license, Ministry of Health shall specify its reasons in writing.

4. In case of invalid application, Ministry of Health must give a written request for supplement or modification of the application to the importer within 15 days from the date stated in the Receipt note. The written request for supplement or modification of the application must specify contents requiring supplement or modification.

5. Within 60 days from the date stated in the written request for supplement or modification of the application granted by Ministry of Health, the importer must send the complete application, enclosed with written explanation about supplemented or modified contents to Ministry of Health. The time limit for receiving supplemented or modified documents is specified in the Receipt note. Over the said time limit, if the application for import license shall be cancelled.

6. Ministry of Health shall issue the import license as referred to as Clause 3 of this Article if the application is valid.

7. Within 03 working days from the issued date of the import license, Ministry of Health shall publish the following information on its website:

a) Name of preparation;

b) The number of import license;

c) The full text of the import license.

Chaprter VIII

ONLINE DELCARATION AND REGISTRATION

Article 51. Cases subject to online declaration, registration or application

1. Declaration of eligibility to produce preparations.

2. Declaration of eligibility to conduct testing for preparations.

3. Declaration of eligibility to conduct experiment on preparations.

4. Registration of sale of preparations.

5. Notice of additional change of contents or the form of labels as referred to Clause 2 Article 32 of this Decree.

6. Declaration of eligibility to provide preparations-used insecticidal and germicidal service.

7. The application for issuance of import license.

Article 52. Online application for declaration, registration or issuance of import license

A valid online application for declaration, registration, issuance of import license, or notice of change of the contents or the form of label (hereinafter referred to as the online registration application) must satisfy the following requirements:

1. It contains sufficient documents according to regulations applicable to written application which are transformed into electronic documents.

Such electronic documents shall be named according to the name of the form in the written application.

2. Information about the declaration, registration or licensing must be announced sufficiently and accurately according to the information provided in the electronic documents.

Article 53. Procedures for online application

1. The legal representative shall make declaration, download electronic documents, confirm the online registration application and pay charges according to procedures specified on the website of Ministry of Health or Department of Health.

2. When the online application has been completed, the legal representative shall receive a receipt note online.

3. The online application receiving body shall carry out the same administrative procedures with the application for registration referred to in this Decree.

4. The result of the online administrative procedures is an electronic document with the digital signature of the receiving body and shall have legal effect like the one of the normal administrative procedures.

Article 54. Retention of online applications

1. In case of online registration application, the entity carrying out the online application (hereinafter referred to as the applicant) shall retain the written documents of the application.

2. If any document of the registration dossier specified in clause 1 of this Article is lost or damaged, the applicant shall send a written notification to the receiving body and recomplete the registration dossier within 60 days from the date on which such registration dossier is lost or damaged. 

3. Within 05 working days from the date on which the period specific in Clause 2 of this Article is over, if the applicant fails to recomplete the registration dossier, the application receiving body shall:

a) Stop publishing on its website the information relating to the manufacturer of preparations, testing establishment, experiment establishment or preparations-based insecticidal and germicidal service provider;

b) Revoke the registration number or import license and stop publishing on its website the information relating to that registration number or import license.

4. The applicant is not allowed to continue its operations from the date on which the application receiving body cancels relevant information as referred to as in Point a Clause 3 of this Article. It is not allowed to sell preparations from the date on which the application receiving body cancels relevant information as referred to as in Point b Clause 3 of this Article.

Chaprter IX

IMPLEMENTATION

Article 55. Responsibilities of Ministry of Health

Ministry of Health shall bear responsibility before the Government for state management of chemicals and preparations, and have the following rights and duties:

1. Request the Government and/or the Prime Minister to promulgate and promulgate by itself within its competence legislative documents on chemicals and preparations.

2. Organize the implementation of legislative documents, strategies, policies and plans on chemicals and preparations.

3. Education and disseminate information about chemicals and preparations.

4. Publish on the website of Ministry of Health the information as referred to in this Decree.

5. Conduct inspection, resolve complaints/denunciations and impose penalties for violations against regulations on chemicals and preparations.

6. Promote the international cooperation in chemicals and preparations.

Article 56. Responsibilities of Ministry of Industry and Trade

1. Preside over or cooperate with the Ministry of Health in formulating technical regulations on safe distance for manufacturers of preparations and labeling of chemicals and preparations in conformity with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

2. Conduct the inspection of chemicals and preparations sold on the market in accordance with applicable laws.

Article 57. Responsibilities of Provincial People’s Committees

1. Assume responsibility for managing chemicals and preparations in provincial areas.

2. Publish on the website of provincial people’s committee (Department of Health) the information about manufacturers of chemicals and preparations, and preparations-based insecticidal and germicidal service providers in that province, and send such information to Ministry of Health.

3. Conduct inspection, resolve complaints/denunciations and impose penalties for violations against regulations on chemicals and preparations in provincial area.

Article 58. Responsibilities of registration number holders

1. Ensure the sufficiency and legality of documents in the application dossier submitted to Ministry of Health or provide such documents as requested (for documents retained in case of the online application).

2. Provide sufficient and accurate information about the preparations on their labels, packages, documents enclosed to those chemicals or preparations in accordance with regulations of the law on labeling of goods and regulations herein.

3. Promptly give sufficient and accurate warning about the risks of causing adverse impacts on users’ health or on the environment; guide the sellers and the consumers to prevent such risks; provide information about requirements applicable to transport, storage and use of chemicals and preparations.

4. Promptly terminate the sale of preparations, notify relevant parties and take measures to handle or eliminate the issues or recall the defective preparations as provided for in Articles 36 and 37 of this Decree.

5. Recall and handle chemicals and preparations in the cases referred to in Articles 36 and 37 of this Decree. In cases where preparations must be destroyed, such destruction must comply with the law on environmental protection and relevant law provisions. And the relevant registration number holder shall pay fully the cost of such destruction activity.

6. Comply with laws and decisions on inspection issued by regulatory bodies.

7. Fulfill other obligations as referred to by law.

Article 59. Users of preparations

1. With regard to preparations which are imported upon the permission of Ministry of Health and used for aid or other particular purposes, importers and users must bear responsibility for the use of imported preparations.

2. Request the providers of preparations to provide sufficient information about hazardous properties of such preparations and requirements on guarantee of effects and safety of such preparations; receive compensate by relevant providers for damage during the use of preparations suffered from the provider’s provision of false information in accordance with applicable laws.

3. Comply with instructions specified in the preparations’ labels or enclosed with the preparations, and bear responsibility for using preparations inconsistent with provided instructions; ensure personal safety, the safety of environment and community; make compensate in accordance with applicable laws if causing damage to the health, life or property of other person by using chemicals or preparations.

4. In case of realizing that the chemical or preparation fails to achieve effects as the manufacturer’s instructions specified in its label or the information about the preparations is not conformable to the issued sale registration certificate, the user must suspend the use of such chemical or preparation and send a written notice to Ministry of Health or Department of Health where the registration number holder locates its head office or where the user resides in to take actions in compliance with applicable laws.

Article 60. Responsibilities of manufacturers

A manufacturer must discharge the following duties:

1. Ensure production conditions as referred to in this Decree and in conformity with tits application dossier for declaration of eligibility for production.

2. Retain testing results for the ingredients and the content of active ingredients of its preparations for each lot of preparations before providing for sale on the market. Minimum period of retention shall be equal to the expiry date of that lot of preparations.

3. Send a written notice to Department of Health where its head office is located when it fails to meet production conditions.

Article 61. Responsibilities of experiment establishments

An experiment establishment shall have the following responsibilities:

1. Ensure experiment conditions as referred to in this Decree and in conformity with its application dossier for declaration of eligibility to conduct experiment activities.

2. Carry out the experiment activities according to effects, methods and dosage specified in the preparation's label, and comply with experiment process adopted by Ministry of Health and provide experiment results in writing by using the form stated in Annex X enclosed to this Decree.

3. The experiment establishment must request the Ministry of Health to promulgate the experiment process to a type of preparations which are given with approval for experiment but the experiment process on which is not available.

4. Take responsibility before law for its experiment results on relevant preparations.

5. Every 6 months, submit reports on experiment activities to Ministry of Health before July 15th annually, and before January 15th of the following year. If discovering that there is a difference between the real dosage and that instructed by the manufacturer on the label of preparations, or there is evidence about the preparation or chemical resistance, the experiment establishment must send a written report to Ministry of Health for consideration.

6. Send a written notice to Ministry of Health when it fails to meet conditions for conducting experiment activities.

Article 62. Responsibilities of testing establishments

A testing establishment shall have the following responsibilities:

1. Ensure testing conditions as referred to in this Decree and in conformity with its application dossier for declaration of eligibility for testing.

2. Take responsibility before law for its testing results for relevant preparations.

3. Send a written notice to Ministry of Health when it cannot meet conditions for conducting testing.

Article 63. Responsibilities of preparations-used insecticidal and germicidal service providers

1. Ensure conditions for providing preparations-used insecticidal and germicidal service as referred to in this Decree and in conformity with the application dossier for declaration of eligibility to provide preparations-used insecticidal and germicidal service.

2. Send a written notice to Department of Health where its head office is located when it cannot meet conditions for providing preparations-used insecticidal and germicidal service.

Chaprter X

IMPLEMENTATION PROVISION

Article 64. Effect

1. This Decree takes effect as of July 01, 2016.

2. Clause 12 Article 12 of the Government’s Decree No. 89/2006/ND-CP dated August 30, 2006 on labeling of chemicals; Clauses 2 and 3 Article 8 of the Government’s Decree No. 108/2008/ND-CP, amended at Clause 8 Article 1 of the Government’s Decree No. 26/2011/ND-CP dated April 08, 2011 detailing and guiding the implementation of certain articles of the Law on chemicals; Clause 3 Article 18 of the Government’s Decree No. 104/2009/ND-CP dated November 09, 2009 promulgating the list of dangerous goods and transportation of dangerous goods by motor vehicles shall be invalid from the effective of this Decree.

Article 65. Transitional provision

1. Manufacturers of chemicals and/or preparations which have operated before the effective date of this Decree may continue their operation provided that the declaration of eligibility for production must be made before July 01, 2017.

2. Testing or experiment establishments for chemicals and/or preparations which have operated before the effective date of this Decree may continue their operation provided that the declaration of eligibility to conduct testing or experiment activities must be made before July 01, 2017.

3. Applications for registration of sale of preparations or issuance of import licenses which have been received before the effective date of this Decree shall be handed in compliance with the laws applicable at time of receipt.

4. Chemicals or preparations which have been issued with registration numbers before the effective date of this Decree shall be sold until the issued registration numbers expire.

5. Chemicals or preparations which have been issued with registration numbers before the effective date of this Decree shall be sold provided that the labeling of chemicals must be made as referred to in this Decree before July 01, 2018.

6. Preparations-used insecticidal and germicidal service providers which have operated before the effective date of this Decree may continue their operation provided that the declaration of eligibility to provide preparations-used insecticidal and germicidal service must be made before July 01, 2018.

Article 66. Responsibilities for guiding and implementing

1. Minister of Health shall be responsible for guiding, organizing and inspecting the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of affiliates of the Government, chairpersons of people’s committees at all levels and relevant entities shall be responsible for implementing this Decree./.

 

 

ON BEHALF OF THE GOVERNMENT
PRIME MINISTER




Nguyen Xuan Phuc

 

ANNEX V

TECHNICAL DOCUMENTS
(Enclosed to the Government’s Decree No. 91/2016/ND-CP dated July 01, 2016)

I. PREPARATION OF TECHNICAL DOCUMENTS

1. With regard to preparations containing active ingredients which are registered in Vietnam for the first time, technical documents must include all of items specified in Section II.

2. With regard to preparations containing active ingredients which have been registered in Vietnam, technical documents must include items specified in Part 1, Part 3 (preparation documents) and Part 4 of Section II.

II. REQUIREMENTS FOR TECHNICAL DOCUMENTS:

Part 1
QUALITY CRITERIA

1

Active ingredients and concentrations thereof

2

Adjuvants and concentrations thereof

3

Type of preparations

4

Form of preparations

5

Shelf life

6

Origin of active ingredients (name of active ingredient, concentration, manufacturer)

Part 2
ACTIVE INGREDIENT

1

Appearance

2

Minimum and maximum concentrations of active ingredient

3

Identification and concentrations of isomers and impurities

4

Shelf life

5

Methods and process of analysis to determine concentration of active ingredient

6

CAS number

7

Common name

8

IUPAC name

9

Structural formula

10

Molecular formula

11

Molecular weight

12

Chemical family

13

Melting point, boiling point, breaking down point

14

Vapor pressure

15

Density (for liquid only)

16

Solubility in water and organic solvent

17

Acute toxicity

17.1

Acute oral toxicity (LD50)

17.2

Acute dermal toxicity (LD50)

17.3

Acute inhalation toxicity (LC50)

17.4

Eye irritation

17.5

Skin irritation

17.6

 Allergy/ sensitization test

18

Sub-chronic toxicity

19

Chronic toxicity

20

Carcinogenicity

21

Mutagenicity

22

Reproductive and developmental toxicity (including teratogenicity)

23

Other toxicity studies, if any

24

Medical data, poisoning symptom, antidote, if any

25

Environmental fate

25.1

In soil

25.2

In water

25.3

In air

26

Ecotoxicity

26.1

Bird

26.2

Fish and aquatic organisms

26.3

 Bee

26.4

Non-target organisms

Part 3
PREPARATIONS

I

PHYSIO-CHEMICAL DATA

1

Preparation identity

1.1

Trade name of preparation

1.2

Name and address of manufacturer

1.3

Name and address of packaging establishment (if any)

1.4

GHS acute toxicity hazard category:

2

Composition

2.1

Concentration of active ingredient

2.2

Concentration of adjuvant (including solvent and carrier)

3

Physical and chemical properties of the preparation

3.1

Appearance

3.2

Density (for liquid only)

3.3

Flammability, flash point

3.4

Corrosiveness (if any)

3.5

Storage stability

3.6

Acidity, alkalinity or pH

3.7

Compatibility with other preparations

4

Analytical methods and process

5

Process of formulation of the preparation

II

TOXICITY

1

Acute oral toxicity (LD50)

2

Acute dermal toxicity (LD50)

3

Acute inhalation toxicity (LC50)

4

Eye irritation

5

Skin irritation

6

Allergy/ sensitization test

III

ECOTOXICITY

1

Bird

2

Fish and aquatic organisms

3

 Bee

4

Non-target organisms

IV

BIO-EFFICACY

1

Mode of action of the insecticidal and germicidal preparation

2

Insecticidal and germicidal ability (types of germs and insects)

3

Fields of application (for household or medical use, etc.)

4

Dosage

5

Interval between times of application (for long-lasting preparations)

6

Dilution medium, if any (water, oil, etc.)

7

Application method (spray, spread, etc.)

V

OTHER INFORMATION

1

Instructions for use

2

Instructions for storage

3

Notes of safety when using the preparation

4

Adverse effects on the user of preparation and handling methods

5

Methods for destructing expired or unused preparations

6

Methods for destructing preparation containers

7

HS code: apply to imported preparations

8

UN numbers

Part 4
MATERIAL SAFETY DATA SHEET (MSDS)

For preparations of which MSDS must be prepared as regulated by the Law on chemicals.

 


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