Decision 5083/QD-BYT in 2019 announcing administrative procedures to be amended and supplemented in the field of health environment management under the management of the Ministry of Health as prescribed in Decree 155/2018/ND-CP

THE MINISTRY OF HEALTH
-------

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------

No. 5083/QD-BYT

Hanoi, October 29, 2019

PP. THE MINISTER
THE DEPUTY MINISTER




Nguyen Truong Son

No.

Number of administrative procedure document

Name of administrative procedure

Name of legislative document providing for amendments and replacement

Field

Responsible agency

A. Administrative procedures of central authorities

A. Administrative procedures of central authorities

A. Administrative procedures of central authorities

A. Administrative procedures of central authorities

A. Administrative procedures of central authorities

A. Administrative procedures of central authorities

1

B-BYT-286739-TT

Declaration of eligibility to test insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Health Environment Management Agency

2

B-BYT-286740-TT

Declaration of eligibility to conduct trial of insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Health Environment Management Agency

3

B-BYT-286741-TT

Registration of new insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Health Environment Management Agency

4

B-BYT-286742-TT

Extension of registration number of insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Health Environment Management Agency

5

B-BYT-286743-TT

Additional registration in case of change of the ownership of the registration number of insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Health Environment Management Agency

6

B-BYT-286744-TT

Additional registration in case of change of the trade name of insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Health Environment Management Agency

7

B-BYT-286745-TT

Additional registration in case of change of manufacturing site or change of manufacturer of insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Health Environment Management Agency

8

B-BYT-286746-TT

Additional registration in case of change of name or contact address of applicant for registration or manufacturer of insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Health Environment Management Agency

9

B-BYT-286748-TT

Additional registration in case of change of effects, quality criteria or method of application of insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Health Environment Management Agency

B. Administrative procedures of provincial authorities

B. Administrative procedures of provincial authorities

B. Administrative procedures of provincial authorities

B. Administrative procedures of provincial authorities

B. Administrative procedures of provincial authorities

B. Administrative procedures of provincial authorities

1

B-BYT-286756-TT

Declaration of eligibility to produce insecticidal and germicidal preparations for domestic and medical use

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Department of Health

2

B-BYT-286757-TT

Declaration of eligibility to provide preparation-based insect and germ control services in household and medical fields

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018

Health environment management

Department of Health

1-Procedure

Declaration of eligibility to test insecticidal and germicidal preparations for domestic and medical use

Sequence

Sequence

Step 1: Before conduct testing for the first time, the testing facility shall submit an application including the documents specified in Article 11 of the Government’s Decree No. 91/2016/ND-CP to the Health Environment Management Agency.

Step 2: Within 03 working days from the receipt of the application, the Health Environment Management Agency shall publish the following information on the website of the Ministry of Health: name, address and phone number of the testing facility; list of testable chemicals.

Method of submission

Method of submission

By post or in person at the Health Environment Management Agency affiliated to the Ministry of Health (hereinafter referred to as “the Health Environment Management Agency”). If the Health Environment Management Agency adopts the method of online declaration, the aforesaid application shall be submitted online.

Composition and number of application

Composition and number of application

I. Composition of the application:

1. A declaration of eligibility to conduct testing, which is made using the Form No. 02 in the Appendix I enclosed with the Decree No. 91/2016/ND-CP;

2. A list of active ingredients for which the testing facility is capable to conduct the testing, which is certified by the testing facility;

3. A legitimate copy of the certificate of conformity with ISO 17025:2005 or its editions.

II. Number of application: 01 set of physical application (not applicable to the case of online declaration).

Time limit for processing the application

Time limit for processing the application

Within 03 days.

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Facility testing insecticidal and germicidal preparations for domestic and medical use.

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

The Health Environment Management Agency

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

Publish the following information on the website of the Ministry of Health: name, address and phone number of the testing facility; list of testable chemicals.

Fees and charges

 Free

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

A declaration of eligibility to conduct testing, which is made using the Form No. 02 provided in the Decree No. 91/2016/ND-CP.

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Clause 5 Article 9 of the Decree No. 155/2018/ND-CP:

Conform to ISO 17025:2005 or its editions certified by the certification body which has registered in accordance with regulations of law on conditions for provision of conformity assessment services.

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018.

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

1

A declaration of eligibility to conduct testing

□

2

A list of active ingredients for which the testing facility is capable to conduct the testing

□

3

Certificate of conformity with ISO 17025:2005 or its editions

□

LEGAL REPRESENTATIVE
(Signature, full name and seal)

2-Procedure

Declaration of eligibility to conduct trial of insecticidal and germicidal preparations for domestic and medical use

Sequence

Sequence

Step 1: Before conduct trial for the first time, the trial facility shall submit an application including the documents specified in Article 15 of the Government’s Decree No. 91/2016/ND-CP and Decree No. 155/2018/ND-CP to the Health Environment Management Agency. If the Health Environment Management Agency adopts the method of online declaration, the aforesaid application shall be submitted online.

Step 2: Within 03 working days from the receipt of the notification, the Health Environment Management Agency shall publish the following information on the website of the Ministry of Health: name, address and phone number of the trial facility; list of available trials.

Method of submission

Method of submission

By post or in person at the Health Environment Management Agency. If the Health Environment Management Agency adopts the method of online declaration, the application shall be submitted online.

Composition and number of application

Composition and number of application

I. Composition of the application:

1. A declaration of eligibility to conduct trial, which is made using the Form No. 03 in the Appendix I enclosed with the Decree No. 155/2018/ND-CP;

2. A list of available trials, which is certified by the trial facility.

3. A list of personnel, which is made using Form in the Appendix II enclosed with the Decree No. 91/2016/ND-CP.

4. A legitimate copy of the certificate of conformity with ISO 17025:2005 or ISO 15189: 2012 or their editions.

5. A list of facilities and equipment serving trial, which is certified by the trial facility.

II. Number of application: 01 set of physical application (not applicable to the case of online declaration)

Time limit for processing the application

Time limit for processing the application

On the date on which the application is received

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Facility conducting trial of insecticidal and germicidal preparations for domestic and medical use.

Agency carrying out the administrative procedures

Agency carrying out the administrative procedures

The Health Environment Management Agency

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

Publish the following information on the website of the Ministry of Health: name, address and phone number of the trial facility; list of available trials.

Fees and charges

 Free

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

Appendix I: A declaration of eligibility to conduct trial, which is made using the Form No. 03 provided in the Decree No. 155/2018/ND-CP;

Appendix II: A list of personnel.

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Clause 1 and Point c Clause 3 Article 14 of the Decree No. 91/2016/ND-CP and Clauses 7 and 8 Article 9 of the Decree No. 155/2018/ND-CP

1. A trial facility must be a health facility.

2. Personnel requirements:

The person in charge of the trial division must have at least 03 years of experience in trial of preparations;

3. Infrastructure requirements:

a) Have a trial laboratory managed and operated under ISO 17025:2005 or ISO 15189:2012 or their editions. If testing services are available, such services must be registered in accordance with regulations of law on conditions for provision of conformity assessment services;

b) Have species of insects, germs or viruses sufficient for trials.

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018.

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

1

A declaration of eligibility to conduct trial

□

2

A list of available trials

□

3

A list of personnel

□

4

Certificate of conformity with ISO 17025:2005 or ISO 15189:2012 or its editions

□

LEGAL REPRESENTATIVE
(Signature, full name and seal)

No.

Full name

Professional qualification

Degree/diploma and certificate

Number of years of experience 2

Position

1

Nguyen Van A

…………..

…………..

…………..

…………..

2

3

LEGAL REPRESENTATIVE
(Signature, full name and seal)

3-Procedure

Registration of new insecticidal and germicidal chemicals and preparations for household and medical use

Sequence

Sequence

Step 1: The applicant for registration of insecticidal and germicidal preparations for household and medical use shall submit an application to the Health Environment Management Agency affiliated to the Ministry of Health (hereinafter referred to as “the Health Environment Management Agency”).

Step 2: After receiving the application and fees for appraising the application for permission for trial, the Health Environment Management Agency shall send the applicant an application receipt form made using the Form No. 04 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.

Step 3: Within 30 days from the date specified in the application receipt form, the Health Environment Management Agency shall send a written notice to the applicant for registration of new preparations of request for supplement or modification of the application or permission or refusal to grant permission for trial.

In case of supplement or modification of the application, within 90 days from the date specified in the written request, the applicant must complete the application and provide written explanation for supplemented or modified contents to Health Environment Management Agency. The date of receiving the supplemented or modified application is specified in the application receipt form. After the aforementioned deadline, the application shall be rejected.

Step 4: If the application is valid, the Health Environment Management Agency shall give a written notice of permission or refusal to grant permission for trial to the applicant.

Step 5: After obtaining the written permission for trial, the applicant shall complete the testing and/or trial in accordance with Chapter II of the Decree No. 91/2016/ND-CP, supplement the application with testing and/or trial results and pay fees for application appraisal within 12 months from the date specified in the written permission for trial.

Step 6: Within 30 daysfrom the date specified in the application receipt form, the Health Environment Management Agency shall send a written notice to the applicant of the request for supplement or modification of the application or refusal to issue the registration number.

Method of submission

Method of submission

By post or in person at the Health Environment Management Agency. If the Health Environment Management Agency adopts the method of online declaration, the application shall be submitted online.

Composition and number of application

Composition and number of application

I. Composition of the application:

1. An application form, which is made using the Form No. 04 in the Appendix I enclosed with the Circular No. 155/2018/ND-CP.

2. A document proving legal status of the applicant or the manufacturer.

3. Letter of authorization for registration, except for the case stated in Point a Clause 1 Article 20 of the Decree No. 91/2016/ND-CP.

4. Technical documents of the preparations covered by the sale registration certificate applied for, including the contents prescribed in the Appendix V enclosed with the Decree No. 91/2016/ND-CP.

5. Results of testing for ingredients and concentration of active ingredients in preparations (supplemented together with the written notice of trial results).

6. The written notice of trial results (which is supplemented after the Ministry of Health grants written permission for trial).

7. Label sample of preparations.

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

9. Documents and/or results of the research on the safety and effects of preparations, or recommendations given by WHO or other international organizations about the use of preparations in household and medical sectors (for the preparations that have an active ingredient or form that is registered in Vietnam for the first time).

 (Requirements for an application for registration)

1. Documents included in the application must be clearly printed and arranged in the order prescribed in Article 22 of the Decree No. 91/2016/ND-CP. Space must be provided between content parts in a document and each document and a cover page and list of documents must be available.

2. 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 Vietnamese translations must be notarized in accordance with the law.

3. Requirements for documents in an application for registration:

a) The original letter of authorization for registration of preparations. The letter of authorization must meet the requirements in the Appendix VII enclosed with the Decree No. 155/2018/ND-CP;

b) The original or legitimate copy of the Certificate of Free Sale (for imported preparations). The Certificate of Free Sale must meet the requirements in the Appendix VIII enclosed with the Decree No. 91/2016/ND-CP;

c) The original or legitimate copy of the written notice of trial results made by an entity that is independent (that is not the manufacturer or the applicant for registration of preparations) and eligible to conduct trial as prescribed in Article 14 of the Decree No. 91/2016/ND-CP;

d) The original or legitimate copy of the written notice of results of testing for ingredients and concentration of active ingredients in preparations. The testing results must be given by an entity that is eligible to conduct testing prescribed in Article 10 of this Decree. If testing facilities in Vietnam are not sufficiently competent to conduct testing, the applicant may use the testing results given by the manufacturer or an independent laboratory that meets ISO 17025:2005 or ISO 15189:2012 or its editions and the applicant shall take legal responsibility for the legitimacy of the testing results which such applicant gives.

dd) Label samples of all packaging specifications according to real package size with certification of the applicant. If multiple 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 is written in a foreign language, it must be attached with a secondary label written in Vietnamese. The sample and contents of the secondary label of preparations must meet the requirements in the Appendix IX enclosed with the Decree No. 155/2018/ND-CP.

e) Legitimate copy of the document proving the legal status of the applicant or the manufacturer;

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

II. Number of application: 01 set of physical application enclosed with a PDF file (not applicable to the case of submission of the online application)

Time limit for processing the application

Time limit for processing the application

1. Within 30 days from receipt of a sufficient application, the Health Environment Management Agency shall send a written notice to the applicant for registration of new preparations of the request for supplement or modification of the application or permission or refusal to grant permission for trial.

2. Within 30 days from receipt of the written notice of trial results and results of testing for ingredients given by the applicant to be supplemented with the application, the Health Environment Management Agency shall send a written notice to the applicant of the request for supplement or modification of the application or refusal to issue the registration number.

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Owner of the insecticidal and germicidal chemicals and preparations for household and medical use or the organization authorized by the owner to apply for registration

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

The Health Environment Management Agency

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

The sale registration certificate or written notice of refusal to issue registration number specifying reasons thereof

Fees and charges

Fees and charges

Fees for appraising an application for permission for trial (paid upon submitting the application for registration of new preparations for the first time): VND 2,000,000/application.Fees for appraising the application for registration of new preparations (paid upon supplementing the written notice of trial results and results of testing for active ingredients): VND 8,000,000/application

Name of forms and declarations (attached below)

Name of forms and declarations (attached below)

Appendix I: Application form for registration of new insecticidal and germicidal chemicals and preparations for household and medical use - Form No. 04 (enclosed with the Decree No. 155/2018/ND-CP);

Appendix V: Technical documents of preparations covered by the sale registration certificate applied for (enclosed with the Decree No. 91/2016/ND-CP);

Appendix VII: Requirements for letter of authorization (enclosed with the Decree No. 155/2018/ND-CP);

Appendix VIII: Requirements for Certificate of Free Sale (enclosed with the Decree No. 91/2016/ND-CP).

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Article 19 of the Decree No. 91/2016/ND-CP: Requirements for registered preparations

1. The toxicity of preparations is not classified into 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 on the list of active ingredients banned from use in preparations.

3. The registration of preparations which contain any of active ingredients on 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 manufactured by a manufacturer that has declared its eligibility to produce preparations (for domestic preparations) or attached with Certificate of Free Sale (for imported preparations).

Article 20 of Decree No. 91/2016/ND-CP: 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 the preparations 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 specified in the Letter of Authorization.

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016.

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018;

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

LEGAL REPRESENTATIVE
(Signature, full name and seal)

No.

Trade name

Concentration of active ingredients

Unit

Quantity

Name and address of manufacturer

Part 1

QUALITY CRITERIA

Part 1

QUALITY CRITERIA

Part 1

QUALITY CRITERIA

1

Active ingredients and concentration thereof

Active ingredients and concentration thereof

2

Adjuvants and concentration thereof

Adjuvants and concentration thereof

3

Type of preparations

Type of preparations

4

Form of preparations

Form of preparations

5

Shelf life

Shelf life

6

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

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

Part 2

ACTIVE INGREDIENT

Part 2

ACTIVE INGREDIENT

Part 2

ACTIVE INGREDIENT

1

Appearance

Appearance

2

Minimum and maximum concentrations of active ingredient

Minimum and maximum concentrations of active ingredient

3

Identification and concentrations of isomers and impurities

Identification and concentrations of isomers and impurities

4

Shelf life

Shelf life

5

Methods and process of analysis to determine concentration of active ingredient

Methods and process of analysis to determine concentration of active ingredient

6

CAS number

CAS number

7

Common name

Common name

8

IUPAC name

IUPAC name

9

Structural formula

Structural formula

10

Molecular formula

Molecular formula

11

Molecular mass

Molecular mass

12

Chemical family

Chemical family

13

Melting point, boiling point, breaking down point

Melting point, boiling point, breaking down point

14

Vapor pressure

Vapor pressure

15

Density (for liquid only)

Density (for liquid only)

16

Solubility in water and organic solvent

Solubility in water and organic solvent

17

Acute toxicity

Acute toxicity

17.1

Acute oral toxicity (LD50)

Acute oral toxicity (LD50)

17.2

Acute dermal toxicity (LD50)

Acute dermal toxicity (LD50)

17.3

Acute inhalation toxicity (LC50)

Acute inhalation toxicity (LC50)

17.4

Eye irritation

Eye irritation

17.5

Skin irritation

Skin irritation

17.6

Allergy/sensitization test

Allergy/sensitization test

18

Sub-chronic toxicity

Sub-chronic toxicity

19

Chronic toxicity

Chronic toxicity

20

Carcinogenicity

Carcinogenicity

21

Mutagenicity

Mutagenicity

22

Reproductive and developmental toxicity (including teratogenicity)

Reproductive and developmental toxicity (including teratogenicity)

23

Other toxicity studies, if any

Other toxicity studies, if any

24

Medical data, poisoning symptom, antidote, if any

Medical data, poisoning symptom, antidote, if any

25

Environmental fate

Environmental fate

25.1

In soil

In soil

25.2

In water

In water

25.3

In air

In air

26

Ecotoxicity

Ecotoxicity

26.1

Bird

Bird

26.2

Fish and aquatic organisms

Fish and aquatic organisms

26.3

Bee

Bee

26.4

Non-target organisms

Non-target organisms

Part 3

PREPARATIONS

Part 3

PREPARATIONS

Part 3

PREPARATIONS

I

PHYSIO-CHEMICAL DATA

PHYSIO-CHEMICAL DATA

1

Preparation identity

Preparation identity

1.1

Trade name of preparation

Trade name of preparation

1.2

Name and address of manufacturer

Name and address of manufacturer

1.3

Name and address of packaging establishment (if any)

Name and address of packaging establishment (if any)

1.4

GHS acute toxicity hazard category

GHS acute toxicity hazard category

2

Composition

Composition

2.1

Concentration of active ingredient

Concentration of active ingredient

2.2

Concentration of adjuvant (including solvent and carrier)

Concentration of adjuvant (including solvent and carrier)

3

Physical and chemical properties of the preparation

Physical and chemical properties of the preparation

3.1

Appearance

Appearance

3.2

Density (for liquid only)

Density (for liquid only)

3.3

Flammability, flash point

Flammability, flash point

3.4

Corrosiveness (if any)

Corrosiveness (if any)

3.5

Storage stability

Storage stability

3.6

Acidity, alkalinity or pH

Acidity, alkalinity or pH

3.7

Compatibility with other preparations

Compatibility with other preparations

4

Analytical methods and process

Analytical methods and process

5

Process of formulation of the preparation

Process of formulation of the preparation

II

TOXICITY

TOXICITY

1

Acute oral toxicity (LD50)

Acute oral toxicity (LD50)

2

Acute dermal toxicity (LD50)

Acute dermal toxicity (LD50)

3

Acute inhalation toxicity (LC50)

Acute inhalation toxicity (LC50)

4

Eye irritation

Eye irritation

5

Skin irritation

Skin irritation

6

Allergy/sensitization test

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)

Part 4

MATERIAL SAFETY DATA SHEET (MSDS)

For preparations of which MSDS must be prepared as prescribed by the Law on Chemicals.

For preparations of which MSDS must be prepared as prescribed by the Law on Chemicals.

4-Procedure

Extension of registration number of insecticidal and germicidal preparations for domestic and medical use

Sequence

Sequence

Step 1: The applicant for extension of registration number shall submit an application to the Health Environment Management Agency.

Step 2: After receiving a sufficient application and fees for application appraisal, theHealth Environment Management Agency shall send an application receipt form according to the Form No. 06 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.

Step 3: Within 30 days from the date specified in the application receipt form, the Health Environment Management Agency shall send a written notice to the applicant of request for supplement or modification of the application or permission or refusal to grant permission for extension of the registration number.

Step 4: Upon receipt of the written request, within 30 days from the date specified in the written request and within 10 days before the expiry of the registration number, the applicant shall supplement or modify the application and provide written explanation for supplemented or modified contents to the Health Environment Management Agency. The date of receiving the supplemented or modified application is specified in the application receipt form. After the aforementioned deadline, the application shall be rejected.

Step 5: If the application is valid, the Health Environment Management Agency shall extend the registration number.

Method of submission

Method of submission

By post or in person at the Health Environment Management Agency. If the Health Environment Management Agency adopts the method of online declaration, the application shall be submitted online.

Composition and number of application

Composition and number of application

I. Composition of the application:

1. An application form, which is made using the Form No. 06 in the Appendix I provided in the Decree No. 155/2018/ND-CP;

2. A document proving legal status of the applicant or the manufacturer;

3. A letter of authorization for registration, except for the case stated in Point a Clause 1 Article 20 of the Decree No. 91/2016/ND-CP;

4. A report on preparation sale, which is prepared using the form stated in Appendix VI enclosed with the Decree No. 155/2018/ND-CP.

 (Requirements for the application for registration):

1. Documents included in the application must be clearly printed and arranged in the order prescribed in Article 24 of the Decree No. 91/2016/ND-CP. Space must be provided between content parts in a document and each document and a cover page and list of documents must be available.

2. 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 Vietnamese translations must be notarized in accordance with the law.

3. Requirements for documents in an application for registration:

a) The original letter of authorization for registration. The letter of authorization must meet the requirements in the Appendix VII enclosed with the Decree No. 155/2018/ND-CP;

b) A legitimate copy of the document proving legal status of the applicant or the manufacturer;

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

II. Number of application: 01 set of physical application enclosed with a PDF file (not applicable to the case of submission of the online application).

Time limit for processing the application

Time limit for processing the application

Within 30 days from the date specified in the application receipt form, the Health Environment Management Agency shall send a written notice to the applicant of request for supplement or modification of the application or permission or refusal to grant permission for extension of the registration number.

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Owner of the registration number

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

The Health Environment Management Agency.

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

The sale registration certificate or written notice of refusal to extend registration number specifying reasons therefor.

Fees and charges

Fees and charges

VND 1,000,000/application

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

Appendix I: Application form for extension of registration number of insecticidal and germicidal chemicals and preparations for household and medical use - Form No. 06 (provided in the Decree No. 155/2018/ND-CP);

Appendix VI: A report on preparation sale (provided in the Decree No. 155/2018/ND-CP);

Appendix VII: Requirements for letter of authorization (provided in the Decree No. 155/2018/ND-CP).

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

The application for extension of registration number must be submitted to the Health Environment Management Agency for at least 03 months and up to 12 months before the expiry of the registration number.

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

8. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018;

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

LEGAL REPRESENTATIVE
(Signature, full name and seal)

Year of manufacturing/import

Unit

Quantity manufactured/imported

Quantity sold

Violations against law on chemicals and preparations and penalties

20…..

20…..

20…..

20…..

20…..

Total

LEGAL REPRESENTATIVE
(Signature, full name and seal)

5-Procedure

Additional registration in case of change of the ownership of the registration number of insecticidal and germicidal preparations for domestic and medical use

Sequence

Sequence

Step 1: The applicant for additional registration shall submit an application to the Health Environment Management Agency.

Step 2: After receiving a sufficient application and fees for application appraisal, the Health Environment Management Agency shall send an application receipt form according to the Form No. 05 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.

Step 3: Within 30 days from the date specified in the application receipt form, the Ministry of Health shall send a written notice to the applicant of request for supplement or modification of the application or approval or refusal to grant approval for additional registration and reasons therefor.

Step 4: Within 90 days from the date stated on the written request for supplement or modification of the application, the applicant must complete the application and provide written explanation for supplemented or modified contents to the Health Environment Management Agency. The date of receiving the supplemented or modified application is specified in the application receipt form. After the aforementioned deadline, the application shall be rejected.

Step 5: If the application is valid, the Health Environment Management Agency shall make an addition to the sale registration certificate.

Method of submission

Method of submission

By post or in person at the Health Environment Management Agency. If the Health Environment Management Agency adopts the method of online declaration, the application shall be submitted online.

Composition and number of application

Composition and number of application

I. Composition of the application:

1. An application form, which is made using the Form No. 05 in the Appendix I in the Decree No. 155/2018/ND-CP;

2. A letter of authorization for registration, except for the case stated in Point a Clause 1 Article 20 of the Decree No. 91/2016/ND-CP;

3. A document concerning the transfer of the registration number ownership, which is made by the registration number holder;

4. A document concerning the receipt of registration number ownership and written commitment on the continuation of trading in preparations in line with the application approved by the Health Environment Management Agency;

5. A document proving legal status of the receiver of registration number;

6. New label sample of the preparation.

 (Requirements for the application for registration):

1. Documents included in the application must be clearly printed and arranged in the order prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be provided between content parts in a document and each document and a cover page and list of documents must be available.

2. 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 Vietnamese translations must be notarized in accordance with the law.

3. Requirements for documents in an application for registration:

a) The original letter of authorization for registration. The letter of authorization must meet the requirements in the Appendix VII enclosed with the Decree No. 155/2018/ND-CP;

b) 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 the requirements in the Appendix IX enclosed with the Decree No. 155/2018/ND-CP.

c) A legitimate copy of the document proving legal status of the applicant or the manufacturer;

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

II. Number of application:01 set of physical application enclosed with a PDF file (not applicable to the case of submission of the online application).

Time limit for processing the application

Time limit for processing the application

30 days from the date specified in the application receipt form

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Owner of the registration number

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

The Health Environment Management Agency

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

A document concerning approval or refusal to grant approval for addition to the sale registration certificate

Fees and charges

Fees and charges

VND 1,000,000/application

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

Appendix I: Application form for additional registration of insecticidal and germicidal chemicals and preparations for household and medical use - Form No. 05 (provided in the Decree No. 155/2018/ND-CP);

Appendix VII: Requirements for letter of authorization (provided in the Decree No. 155/2018/ND-CP).

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Not required

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018.

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

LEGAL REPRESENTATIVE
(Signature, full name and seal)

6-Procedure

Additional registration in case of change of the trade name of insecticidal and germicidal preparations for domestic and medical use

Sequence

Sequence

Step 1: The applicant shall submit an application to the Health Environment Management Agency.

Step 2: After receiving a sufficient application and fees for application appraisal, the Health Environment Management Agency shall send an application receipt form according to the Form No. 05 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.

Step 3: Within 30 days from the date specified in the application receipt form, the Health Environment Management Agency shall send a written notice to the applicant of request for supplement or modification of the application or approval for or refusal to grant approval for additional registration and reasons therefor.

Step 4: Within 90 days from the date stated on the written request for supplement or modification of the application, the applicant must complete the application and provide written explanation for supplemented or modified contents to the Health Environment Management Agency. The date of receiving the supplemented or modified application is specified in the application receipt form. After the aforementioned deadline, the application shall be rejected.

Step 5: If the application is valid, the Health Environment Management Agency shall make an addition to the sale registration certificate.

Method of submission

Method of submission

By post or in person at the Health Environment Management Agency. If the Health Environment Management Agency adopts the method of online declaration, the application shall be submitted online.

Composition and number of application

Composition and number of application

I. Composition of the application:

1. An application form, which is made using the Form No. 05 in the Appendix I in the Decree No. 155/2018/ND-CP;

2. A letter of authorization for registration of preparations under the new trade name,, except for the case stated in Point a Clause 1 Article 20 of the Decree No. 91/2016/ND-CP;

3. A Certificate of Free Sale of preparations under new trade name (for the imported preparations).

4. New label sample of the preparation.

 (Requirements for the application for registration:

1. Documents included in the application must be clearly printed and arranged in the order prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be provided between content parts in a document and each document and a cover page and list of documents must be available.

2. 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 Vietnamese translations must be notarized in accordance with the law.

3. Requirements for documents in an application for registration:

a) The original letter of authorization for registration. The letter of authorization must meet the requirements in the Appendix VII enclosed with the Decree No. 155/2018/ND-CP;

b) An original or legitimate copy of Certificate of Free Sale (for imported preparations). The letter of authorization must meet the requirements in the Appendix VIII enclosed with the Decree No. 91/2016/ND-CP;

c) 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 the requirements in the Appendix IX enclosed with the Decree No. 155/2018/ND-CP.

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

II. Number of application: 01 set of physical application enclosed with a PDF file (not applicable to the case of submission of the online application).

Time limit for processing the application

Time limit for processing the application

30 days from the date specified in the application receipt form

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Owner of the registration number

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

The Health Environment Management Agency

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

A document concerning approval or refusal to grant approval for addition to the sale registration certificate

Fees and charges

Fees and charges

VND 5,000,000/application

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

Appendix I: Application form for additional registration of insecticidal and germicidal chemicals and preparations for household and medical use - Form No. 05 (enclosed with the Decree No. 155/2018/ND-CP);

Appendix VII: Requirements for letter of authorization (provided in the Decree No. 155/2018/ND-CP);

Appendix VIII: Requirements for Certificate of Free Sale (provided in the Decree No. 91/2016/ND-CP).

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Not required

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018;

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

LEGAL REPRESENTATIVE
(Signature, full name and seal)

7-Procedure

Additional registration in case of change of manufacturing site or change of manufacturer of insecticidal and germicidal preparations for domestic and medical use

Sequence

Sequence

Step 1: The applicant shall submit an application to the Health Environment Management Agency.

Step 2: After receiving a sufficient application and fees for application appraisal, the Health Environment Management Agency shall send an application receipt form according to the Form No. 05 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.

Step 3: Within 30 days from the date specified in the application receipt form, the Health Environment Management Agency shall send a written notice to the applicant of request for supplement or modification of the application or permission or refusal to grant permission for trial and reasons therefor.

Step 4: Within 90 days from the date stated on the written request for supplement or modification of the application, the applicant must complete the application and provide written explanation for supplemented or modified contents to the Health Environment Management Agency. The date of receiving the supplemented or modified application is specified in the application receipt form. After the aforementioned deadline, the application shall be rejected.

Within 12 months from the date stated in the written permission for trial granted by the Health Environment Management Agency, the applicant must supplement the application with trial results.

Step 5: Within 30 days from the receipt of thewritten notice of trial results and fees for application appraisal, the Health Environment Management Agency shall send a written notice to the applicant of request for supplement or modification of the application or permission or refusal to grant permission for addition to the sale registration certificate and reasons therefor.

Method of submission

Method of submission

By post or in person at the Health Environment Management Agency. If the Health Environment Management Agency adopts the method of online declaration, the application shall be submitted online.

Composition and number of application

Composition and number of application

I. Composition of the application:

1. An application form, which is made using the Form No. 05 in the Appendix I in the Decree No. 91/2016/ND-CP;

2. A document proving legal status of the manufacturer, including information about the new manufacturing site (if the manufacturer is in Vietnam) or written notice of change of the manufacturing site or manufacturer (if the manufacturer is in a foreign country);

3. A written notice of results of trial of preparations which are manufactured at the new site;

4. A letter of authorization for registration, except for the case stated in Point a Clause 1 Article 20 of the Decree No. 91/2016/ND-CP;

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

6. New label sample of the preparation.

 (Requirements for the application for registration):

1. Documents included in the application must be clearly printed and arranged in the order prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be provided between content parts in a document and each document and a cover page and list of documents must be available.

2. 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 Vietnamese translations must be notarized in accordance with the law.

3. Requirements for documents in an application for registration:

a) The original letter of authorization for registration. The letter of authorization must meet the requirements in the Appendix VII enclosed with the Decree No. 155/2018/ND-CP;

b) An original or legitimate copy of Certificate of Free Sale (for imported preparations). The letter of authorization must meet the requirements in the Appendix VIII enclosed with the Decree No. 91/2016/ND-CP;

c) The original or legitimate copy of the written notice of results of testing for ingredients and concentration of active ingredients in preparations; The testing results must be given by an entity that is eligible to conduct testing prescribed in Article 10 of this Decree. If testing facilities in Vietnam are not sufficiently competent to conduct testing, the applicant may use the testing results given by the manufacturer or an independent laboratory that meets ISO 17025:2005 or ISO 15189:2012 or its editions and the applicant shall take legal responsibility for the legitimacy of the testing results which such applicant gives;

d) 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 the requirements in the Appendix IX enclosed with the Decree No. 155/2018/ND-CP;

e) A legitimate copy of the document proving legal status of the applicant or the manufacturer;

g) The original or legitimate copy of the written notice of change of manufacturing site or change of manufacturer of a foreign manufacturer, which must be consularly legalized in accordance with the law.

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

II. Number of application: 01 set of physical application enclosed with a PDF file (not applicable to the case of submission of the online application).

Time limit for processing the application

Time limit for processing the application

30 days from the date specified in the application receipt form or the date of receiving the written notice of trial results and fees for appraising the application for additional registration

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Owner of the registration number

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

The Health Environment Management Agency

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

A document concerning approval or refusal to grant approval for addition to the sale registration certificate

Fees and charges

Fees and charges

- Fees for appraising an application for permission for trial (submitted together with the application for registration): VND 2,000,000 per application

- Fees for appraising an application for additional registration (submitted together with the written notice of trial results): VND 2,000,000 per application.

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

Appendix I: Application form for additional registration of insecticidal and germicidal chemicals and preparations for household and medical use - Form No. 05 (provided in the Decree No. 155/2018/ND-CP);

Appendix VII: Requirements for letter of authorization (provided in the Decree No. 155/2018/ND-CP);

Appendix VIII: Requirements for Certificate of Free Sale (provided in the Decree No. 91/2016/ND-CP).

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Not required

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

9. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

LEGAL REPRESENTATIVE
(Signature, full name and seal)

8-Procedure

Additional registration in case of change of name or contact address of applicant for registration or manufacturer of insecticidal and germicidal preparations for domestic and medical use

Sequence

Sequence

Step 1: The applicant shall submit an application and pay fees for application appraisal to the Health Environment Management Agency.

Step 2: After receiving a sufficient application and fees for application appraisal, the Health Environment Management Agency shall send an application receipt form according to the Form No. 05 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.

Step 3: Within 30 days from the date specified in the application receipt form, the Health Environment Management Agency shall send a written notice to the applicant of request for supplement or modification of the application or approval or refusal to grant approval for additional registration.

Step 4: Within 90 days from the date stated on the written request for supplement or modification of the application, the applicant must complete the application and provide written explanation for supplemented or modified contents to the Ministry of Health. The date of receiving the supplemented or modified application is specified in the application receipt form. After the aforementioned deadline, the application shall be rejected.

Method of submission

Method of submission

By post or in person at the Health Environment Management Agency. If the Health Environment Management Agency adopts the method of online declaration, the application shall be submitted online.

Composition and number of application

Composition and number of application

I. Composition of the application:

1. An application form, which is made using the Form No. 05 in the Appendix I in the Decree No. 155/2018/ND-CP;

2. A document proving legal status of the manufacturer, including information about the new manufacturing site (if the manufacturer is in Vietnam) or written notice of change of the manufacturing site or manufacturer (if the manufacturer is in a foreign country);

3. New label sample of the preparation.

 (Requirements for the application for registration):

1. Documents included in the application must be clearly printed and arranged in the order prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be provided between content parts in a document and each document and a cover page and list of documents must be available.

2. 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 Vietnamese translations must be notarized in accordance with the law.

3. Requirements for documents in an application for registration:

a) 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 the requirements in the Appendix IX enclosed with the Decree No. 155/2018/ND-CP.

b) A legitimate copy of the document proving legal status of the applicant or the manufacturer;

g) The original or legitimate copy of the written notice of change of manufacturing site or change of manufacturer of a foreign manufacturer, which must be consularly legalized in accordance with the law.

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

II. Number of application:01 set of physical application enclosed with a PDF file (not applicable to the case of submission of the online application).

Time limit for processing the application

Time limit for processing the application

30 days from the date specified in the application receipt form

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Owner of the registration number

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

The Health Environment Management Agency

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

A document concerning approval or refusal to grant approval for addition to the sale registration certificate

Fees and charges

Fees and charges

VND 1,000,000/application

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

Appendix I: Application form for additional registration of insecticidal and germicidal chemicals and preparations for household and medical use - Form No. 05 (provided in the Decree No. 155/2018/ND-CP);

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Not required

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018;

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

LEGAL REPRESENTATIVE
(Signature, full name and seal)

9-Procedure

Additional registration in case of change of effects, quality criteria or method of application of insecticidal and germicidal preparations for domestic and medical use

Sequence

Sequence

Step 1: The applicant shall submit an application and pay fees for application appraisal to the Health Environment Management Agency.

Step 2: After receiving a sufficient application and fees for application appraisal, the Health Environment Management Agency shall send an application receipt form according to the Form No. 05 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.

Step 3: In the case of change of shelf life of the preparations, within 30 days from the date specified in the application receipt form, the Health Environment Management Agency shall send a written notice to the applicant of request for supplement or modification of the application or permission or refusal to grant permission for addition to the Certificate of Free Sale and reasons therefor.

In other cases, within 30 days from the date specified in the application receipt form, the Health Environment Management Agency shall send a written notice to the applicant of request for supplement or modification of the application or permission or refusal to grant permission for trial and reasons therefor.

Step 4: Within 90 days from the date stated on the written request for supplement or modification of the application, the applicant must complete the application and provide written explanation for supplemented or modified contents to the Health Environment Management Agency. The date of receiving the supplemented or modified application is specified in the application receipt form. After the aforementioned deadline, the application shall be rejected.

Within 12 months from the date stated in the written permission for trial granted by the Health Environment Management Agency, the applicant must supplement the application with trial results.

Step 5: Within 30 days from the receipt of the written notice of trial results and fees for application appraisal, the Health Environment Management Agency shall send a written notice to the applicant of request for supplement or modification of the application or permission or refusal to grant permission for addition to the Certificate of Free Sale and reasons therefor.

Method of submission

Method of submission

By post or in person at the Health Environment Management Agency. If the Health Environment Management Agency adopts the method of online declaration, the application shall be submitted online.

Composition and number of application

Composition and number of application

I. Composition of the application:

1. An application form, which is made using the Form No. 05 in the Appendix I in the Decree No. 155/2018/ND-CP;

2. A written notice of trial results (except for the change of shelf life of preparations);

3. A document concerning stability research (in case of change of shelf life of preparations);

4. Results of testing for ingredients and concentration of active ingredients in preparations (in case of change of ingredients and concentration of active ingredients);

5. New label sample of the preparation.

 (Requirements for the application for registration):

1. Documents included in the application must be clearly printed and arranged in the order prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be provided between content parts in a document and each document and a cover page and list of documents must be available.

2. 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 Vietnamese translations must be notarized in accordance with the law.

3. Requirements for documents in an application for registration:

a) The original or legitimate copy of the written notice of trial results made by an entity that is independent (that is not the manufacturer or the applicant for registration of preparations) and eligible to conduct trial as prescribed in Article 14 of the Decree No. 91/2016/ND-CP;

b) The original or legitimate copy of the written notice of results of testing for ingredients and concentration of active ingredients in preparations; The testing results must be given by an entity that is eligible to conduct testing prescribed in Article 10 of this Decree. If testing facilities in Vietnam are not sufficiently competent to conduct testing, the applicant may use the testing results given by the manufacturer or an independent laboratory that meets ISO 17025:2005 or ISO 15189:2012 or its editions and the applicant shall take legal responsibility for the legitimacy of the testing results which such applicant gives;

c) 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 the requirements in the Appendix IX enclosed with the Decree No. 155/2018/ND-CP.

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

II. Number of application: 01 set of physical application enclosed with a PDF file (not applicable to the case of submission of the online application).

Time limit for processing the application

Time limit for processing the application

30 days from the date specified in the application receipt form or the date of receiving the written notice of trial results and fees for application appraisal

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Owner of the registration number

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

The Health Environment Management Agency

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

A document concerning approval or refusal to grant approval for addition to the sale registration certificate

Fees and charges

Fees and charges

- Fees for appraising an application for permission for trial: VND 2,000,000 per application

- Fees for appraising an application for additional registration: VND 2,000,000 per application.

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

Appendix I: Application form for additional registration of insecticidal and germicidal chemicals and preparations for household and medical use - Form No. 05 (provided in the Decree No. 155/2018/ND-CP);

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Not required

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018;

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

LEGAL REPRESENTATIVE
(Signature, full name and seal)

10-Procedure

Declaration of eligibility to produce insecticidal and germicidal preparations for domestic and medical use

Sequence

Sequence

Step 1: Before producing preparations,the legal representative of the manufacturer shall submit documents about declaration of eligibility to the Department of Health of the province where the factory is located.

Step 2: Upon the receipt of sufficient documents, the Department of Health shall issue a document receipt form to the declarant according to the Form No. 01 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.

Step 3: Within 03 working days from the date stated in the document receipt form, the Department of Health shall publish the following information on its website: Name, address and phone number of the manufacturer.

Method of submission

Method of submission

In person or by post to the Department of Health of the province where the factory is located. If the Department of Health adopts the method of online declaration, the documents shall be submitted online.

Documents and number of documents

Documents and number of documents

I. Documents:

1. A declaration of eligibility to produce preparations, which is made using the Form No. 01 in the Appendix I enclosed with the Decree No. 155/2018/ND-CP;

2. A list of personnel, which is made using the Form in the Appendix II enclosed with the Decree No. 91/2016/ND-CP;

3. Site plans of the factory and warehouse.

4. A list of facilities and equipment for production and response to event of chemical hazards.

 (Requirements for the documents about declaration of eligibility to produce preparations):

a) Documents must be clearly printed and arranged in the order prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be provided between content parts in a document and each document and a cover page and list of documents must be available.

b) The documents mentioned in Points d and dd Clause 1 Article 7 of the Decree No. 91/2016/ND-CP must be certified by the manufacturer.)

II. Number of documents: 01 set of physical documents enclosed with a PDF file (not applicable to the case of submission of the online documents).

Time limit for processing the documents

Time limit for processing the documents

On the date on which the documents are received.

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

The manufacturer of insecticidal and germicidal preparations for domestic and medical use in Vietnam

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

Department of Health

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

Document receipt form

Fees and charges

VND 300,000

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

Appendix I: A declaration of eligibility to produce preparations, which is made using the Form No. 01

Appendix II: A list of personnel

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Points a and b Clause 1 Article 5 of the Decree No. 91/2016/ND-CP: Personnel requirements

At least 01 person in charge of chemical safety meets all of the following conditions:

a) Possess at least an intermediate professional education diploma in chemistry;

b) Work on a full time basis at the manufacturing facility;

Clause 2 Article 6 of the Decree No. 91/2016/ND-CP and Clause 1 Article 9 of the Decree No. 155/2018/ND-CP: Requirements for infrastructure and equipment

1. Meet the requirements specified in Section 1 Chapter II of the Government’s Decree No. 113/2017/ND-CP dated October 09, 2017.

2. Have a testing laboratory that is capable to test ingredients and concentration of active ingredients in preparations. If the manufacturer does not have a testing laboratory, it must enter into contracts with testing facilities that are sufficiently competent as prescribed in Article 10 of the Decree No. 91/2016/ND-CP.

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018;

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

No.

Name of preparation

Form of preparation

Capacity
(…....7……./year)

Note

1

2

1

A declaration of eligibility to produce preparations

□

2

A list of personnel

□

3

A letter of appointment of production manager (for the manufacturer of hazardous chemicals)

□

4

Site plans of the factory and warehouse

□

5

A list of facilities and equipment for production and response to event of chemical hazards.

□

LEGAL REPRESENTATIVE
(Signature, full name and seal)

No.

Full name

Professional qualification

Degree/diploma and certificate

Number of years of experience
2

Position

1

Nguyen Van A

.....................

.........................

........................

...................

2

3

LEGAL REPRESENTATIVE
(Signature, full name and seal)

11-Procedure

Declaration of eligibility to provide preparation-based insect and germ control services in household and medical fields

Sequence

Sequence

Step 1: The service provider shall submit documents about declaration of eligibility to the Department of Health of the province where the service provider is located.

Step 2: Upon the receipt of sufficient documents, the Department of Health shall issue a document receipt form to the service provider according to the Form No. 08 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.

Step 3: Within 03 working days from the date stated in the document receipt form, the Department of Health shall publish the following information on its website: Name, address and phone number of the service provider.

Method of submission

Method of submission

In person or by post to the Department of Health of the province where the service provider is located. If the Department of Health adopts the method of online declaration, the documents shall be submitted online.

Documents and number of documents

Documents and number of documents

I. Documents:

1. A declaration of eligibility to provide preparation-based insect and germ control services in household and medical fields, which is made using the Form No. 08 in the Appendix I enclosed with the Decree No. 155/2018/ND-CP.

2. A list of trainees, which is certified by the declarant.

II. Number of documents: 01 set of physical application (not applicable to the case of submission of online documents)

Time limit for processing the documents

Time limit for processing the documents

On the date on which the documents are received.

Entity carrying out the administrative procedure

Entity carrying out the administrative procedure

Providers of preparation-based insect and germ control services in household and medical fields in Vietnam

Agency carrying out the administrative procedure

Agency carrying out the administrative procedure

Department of Health

Result of implementation of the administrative procedure

Result of implementation of the administrative procedure

Document receipt form

Fees and charges

VND 300,000

Not required

Name of forms and declarations (Attached below)

Name of forms and declarations (Attached below)

Appendix I: A declaration of eligibility to provide preparation-based insect and germ control services in household and medical fields, which is made using the Form No. 08 provided in the Decree No. 155/2018/ND-CP.

Requirements and conditions for following the administrative procedure

Requirements and conditions for following the administrative procedure

Clause 12 Article 9 of the Decree No. 155/2018/ND-CP

The person directly performing insecticidal and germicidal works must be trained in the following knowledge and confirmed by the provider that he/she has been trained in:

a) How to read information on the label of the preparation;

b) Techniques for killing insects and germs in a manner that is relevant to the services provided;

c) Use and safe disposal of insecticidal and germicidal preparations.

Legal bases of the administrative procedure

Legal bases of the administrative procedure

1. Law on Chemicals dated November 21, 2007;

2. Law on Investment dated November 26, 2014;

3. Law on Quality of Products and Goods dated November 21, 2007;

4. Law on Enterprises dated November 26, 2014;

5. Law on Commerce dated June 14, 2005;

6. Law on Standards and Technical Regulations dated June 29, 2006;

7. Law No. 28/2018/QH14 dated June 15, 2018 on amendments to some Articles concerning planning of 11 laws;

8. The Government’s Decree No. 91/2016/ND-CP dated July 01, 2016;

9. The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018;

10. The Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.

1

A declaration of eligibility to provide preparation-based insect and germ control services

□

2

A list of preparation-based insect and germ control services

□

3

A list of trainees, which is certified by the declarant.

□

LEGAL REPRESENTATIVE
(Signature, full name and seal)