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Circular 03/2013/tt-Bnnptnt: On The Management Of Medicines And Plant Protection

Original Language Title: Thông tư 03/2013/TT-BNNPTNT: Về quản lý thuốc bảo vệ thực vật

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AGRICULTURE AND RURAL DEVELOPMENT
Numbers: 03 /2013/TT-BNPTNT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, January 11, 2013

IT ' S SMART

It's about drug management.

____________

Base of Protocol 01 /2008/NĐ-CP 03 January 2008 of the Government regulates the functions, duties, powers, and organizational structure of the Ministry of Agriculture and Rural Development and the United States Digital Protocol. 75 /2009/NĐ-CP 10 September 2009 of the Government on the revision of Article 3 of the Digital Protocol 01 /2008/NĐ-CP 03 January 2008 of the Government regulates the functions, duties, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

The French base for the Protection and Control of the plants July 25, 2001;

Base of Protocol 58 /2002/NĐ-CP June 03, 2002 of the Government enacted the Vegetation Protection Charter, the Plant Censorship and the Management of the Drug Protection Treatment;

Base of Protocol 104 /2009/NĐ-CP November 9, 2009 by the Government of the Government to rule out dangerous goods and transport of dangerous goods by road-road motor vehicles;

At the suggestion of the Bureau of Food Protection;

Minister. The Ministry of Agriculture and Rural Development issued the Information Management of Drug Protection.

Chapter I

GENERAL REGULATION

What? 1. The adjustment range

This information regulates the management of food protection including: registration; production, macho, to bottle, packaging; export, import; merchandising; preservation; use; consumption; label; packaging, packaging; workshop, advertising; survey; survey, censure; Quality, quality; contract certification, and public protection of plant protection in Vietnam.

What? 2. Subject applies

This information applies to organizations, domestic and foreign individuals whose activities are related to the protection of plants in Vietnam.

What? 3. Charge and fees

The organization, the individual whose activities are related to the food protection drug must pay the fee, the fee under the law of law on fees and fees.

Chapter II

REGISTER FOR PLANT PROTECTION

What? 4 General rule.

1. All the food protection drugs used to room, except for the pest or regulation of crop growth; antiseptic sterilization, marina; agricultural rangers not used as food and medicinal products; except for the construction of construction, dikes; the seed treatment must be found. Registered in Vietnam.

2. Organization, domestic personal or foreign (whose representative office, company, branch of the drug-protecting drug company that is being allowed to operate in Vietnam) is the manufacturer of active operations or technical medicine in the name of the registry. You know, sign up for one of your business, you know, business class, one of the things that you produce.

3. The organization, personally, is a manufacturer of operations or technical drugs if not directly in the name of the registry, which is authorized 1 times for organization, domestic or foreign individuals (whose representative office, the company, branch of the drug business business). While plants are being allowed to operate in Vietnam, they are registered to register one for 01 of their products or drugs.

4. Each organization, the authorized individual named registered only the sole authorization of 1 manufacturers for 01 activities (not receiving any other manufacturer's authorship for the authorized activity) to register 1 of the business names.

5. Every organization, personally, is a manufacturer of active or licensed or licensed or licensed or licensed to register 1 for 1 active or technical medicine for a room, except for the harm or regulation of crop growth. If these practices or techniques are used to disinfect the treasure, the marina; the agricultural rangers are not used as food and pharmaceutical products, processed agricultural products after harvesting; except for the construction of construction work, dikes; seed processing must register for an additional 1. The other brand name.

6. Organization, individual named regioners changed the manufacturer's name, transfer the brand name and change the name of the brand.

The organization, the individual is only allowed to receive a transfer of the name of the registered plant protection drug, which has not yet been registered as registered.

After the transfer, the unit was named registered and the unit transferred to the registration name was not used in the same type as the other brand name registration.

The drug protection drug after registration is only renamed to the product name if there is a written conclusion of the state agency that has jurisdiction over the intellectual property or of the court on the breach of the brand label. The old brand name was canceled and was not used again.

The change of the manufacturer, the transfer of the brand name and the renaming of the drug protection drug to the relevant legal procedures stipulated at Article 11, Article 12 and Article 13 of this Information.

7. The organization, the individual is only filed with the additional registration name of the product. The drug protection drug is the new activity that has been organized, the other individual (registration of this new activity first in Vietnam) is the official registration name of the year (05) years from the date of the Certificate of Drug Protection.

What? 5 Drug protection drugs are allowed to register in Vietnam.

1. Drug protection drug containing untitled activity in the Catalogue of Vegetation Protection Drugs is allowed to use in Vietnam.

2. Drug protection drug containing the name in the category of Vegetation Protection Drugs is allowed to use in Vietnam but bears other brand names.

3. Drug protection for a product name in the category is allowed to be used in Vietnam but adds a range of use, dose of use, usage, form of medication, active content or mixed together into a new drug.

4. Drug protection drugs contain name in the category of limited food protection drugs used in Vietnam to disinfect the museum, marina; forestry preservation is not used as food and pharmaceutical products; except for the construction of construction works, dikes.

What? 6 The drug protection drugs are not allowed to register in Vietnam.

1. Drug in the category of banned food protection drugs in Vietnam; drugs in the category of limited food protection drugs used in Vietnam to subtract the plague on the field.

2. Drug protection is either a compound or a mixture of overseas patents but has not yet been registered for use abroad.

3. Drug protection with a brand name that coincides with the active name or product name of the registered drug.

4. Vegetation Protection is a mixture of the activities of the same organization, the individual when the additional registration changes the rate of the active ingredient that the total content of the activity is not changed compared to the registered drug.

5. Drug protection drugs that have a Category I class toxicity or drug-grade toxin II but have an inactivated group I, according to the WHO classification; except for the medications used in antiseptic sterilization, marina; forestry prescriptions. does not use as food and medicinal products; the pesticide of building works, dikes; and insecticides.

6. Activity or food protection products included in Annex III of the Rotterdam Convention; activity or food protection for food protection warned by the United Nations Food and Agriculture Organization (FAO), the Environment Programme of the United Nations (FAO). (UNEP) or the Ministry of Agriculture and Rural Development Council proposed the prohibition on use in Vietnam.

7. Chemical plant protection drugs with acute toxicity of the group I, II, according to the WHO classification; are active in organic chor group; there is a time quarantine in Vietnam over 07 (seven) days that are not registered except for pest control, birth control. head for the fruit tree, the tea tree and the vegetable tree or to preserve the crops after the harvest.

8. The drug contains methyl bromide.

What? 7 Register for the protection of the plant.

1. Sign up for the Food Protection Drug Survey license

a) All medications that protect registered plants in Vietnam have to register for the license of the Food Protection Drug Survey in Vietnam.

b) Official chemical plant protection drugs, named for a narrow, narrow-area biological effect.

c) The protection of biological plants for formal registration, brand name; medications that protect the plant to supplement their range of use, dose of use, use of the use, form of medication, and the amount of activity that has to be performed on a broad field of biological efficacy.

d) Chemical plant protection for the first time in the plant, the tea tree, the vegetable tree, and the vegetable tree must be conducted in Vietnam (except for the herbicides used for the fruit tree).

2. Official registration

The official registered plant protection drugs in the Catalogue of Vegetation Protection Drugs are allowed to use, restricted use in Vietnam:

a) Drug protection containing the activity for the first time registered in Vietnam or the mixture of activities already in the category of new products due to the organization, the individual patent abroad and has been registered for use abroad;

b) Food protection drugs containing the activity for the first time registered in Vietnam or the mixture of activities already in the Catalogue to a new product due to the organization, domestic patent, and recognized by the Bureau of Food Protection as a food protection drug. animal.

3. Additional registration

Additional drug protection drugs supplement the Catalogue of Vegetation Protection for use, restriction used in Vietnam include:

a) Place a different product name with a plant protection drug that has the same type of activity in the Category;

b) Additional use of the range of use, dose of use, usage, form of medication, the function of the activities of the drug protection drug already in the Catalogue.

4. Renewal of the Certificate of Drug Protection Drug Registry.

a) The registration limit is applied to the drugs included in the category of Usable Plant Protection for use, restriction used in Vietnam (for antiseptic disinfection, marina; agricultural rangers do not use as food and pharmaceutical products; except for the harm). Construction of the building, the conforma, when the Certificate of Pesticide Registration Expired.

b) The time for filing a term extension of registration 3 (three) months before the Certificate of Pesticide Registration Expired.

c) Food protection drugs that do not renew the registration extension by regulation will be excluded from the category of Vegetation Protection for use, restricted use in Vietnam.

What? 8 . Sequencing, the registration procedure for the Food Protection Drug Survey

1. File

a) The organization, the individual file the filing directly or sent through the postal route to the Department of Food Protection.

b) The number of records: 02 (two) copies 1 (a) hard copy (paper profile) and 01 (one) PDF format software.

c) Check the full calculation of the profile during the time of 3 (three) working days. If the full profile is prescribed, then take the file, if not full, return the profile to the organization, the individual, and the additional requirements, complete the profile.

2. File

a) For an official subscription, the additional registration is named a brand name.

The application to register for the license to examine the Food Protection Drug on the prescribed form at Annex I issued with this Information;

The copyright paper itself of the manufacturer is active or applied for registration (for the case of the manufacturer's authority for the organization, the other individual);

The main copy or copy of the certificate is that the manufacturer is an active or technical manufacturer due to the jurisdiction of the governing body of the country at the level;

The main version or copy of the Certificate of Registered Medicine in foreign countries for the official registration drugs being patented abroad or the Decision of the Bureau of Food Protection is recognized as a drug protection drug for registered drugs. the official invention in the country;

Detailed technical documentation in Vietnamese or English, which is copied, translated from the original, marked by the manufacturer's validation of the material or the prescribed technique at Annex IV issued by this message;

The prescribed drug pattern at Chapter IX of this Smart;

A diploma in industrial ownership protection issued by the Bureau of Intellectual Property issued by the Bureau of Intellectual Property or proxy paper, the transfer paper uses the copyright protection of the holders of the products in Vietnam owned by the owner of those products (if any).

b) For the application to supplement the use of use, dose, usage,

The application to register for the license to examine the Food Protection Drug on the prescribed form at Annex I issued with this Information;

The copy of the Certificate of Drug Protection Certificate has been issued;

The prescribed medicine for Chapter IX of this information.

c) For the application of the addition of the drug, the active content

The application to register for the license to examine the Food Protection Drug on the prescribed form at Annex I issued with this Information;

The copy of the Certificate of Drug Protection Certificate has been issued;

The prescribed drug pattern at Chapter IX of this Smart;

Technical documentation in Vietnamese or English, which is copied, translated from the original, marked by the manufacturer's validation of the material or the prescribed technique in section II, Annex IV issued by this message.

d) Register for testing (for new activities not included in the category of Plant Protection Medicines allowed to use, restrict use in Vietnam)

The application to register for the license to examine the Food Protection Drug on the prescribed form at Annex I issued with this Information;

Material safety data sheet.

3. Profile appraisework and Plant Protection Drug license level

The Bureau of Vegetation Appraisal in the 15 (fifteen) day of work since the complete filing date of the specified file (For specified cases at d d, Clause 2, This is the case appraisal in the period 05 (year) day of work):

a) If the valid case, the response is required by the prescribed specifications at Annex IV issued by this message, the Order of the Drug Protection Test is issued in accordance with the provisions of the XIII Appendix attached to this message.

b) If the profile is not yet valid, the specified specification is required by the Appendix IV issued by this message, and the information for the organization, the individual of the content needs to be added, complete the prescribed profile.

c) The case does not issue a Vegetation Protection survey, the Food Protection Bureau informs the organization, the individual in writing and stating the reason.

What? 9 . The procedure, the official registration procedure and the addition of the plant protection medicine

1. File

a) In accordance with regulation at Point a, c, paragraph 1, Article 8 of this Information.

b) The number of records: 01 (a) hard copy (paper profile), 01 (a) the word format or excel format for the label.

2. File

a) The application of the registration of the drug protection medicine by the prescribed pattern at Annex II issued by this message;

b) The copy of the Certificate of Food Protection Drug Survey provided by the Department of Food Protection;

c) The prescribed drug pattern at Chapter IX of this Information;

d) The results of the results of the biological effect, the results of the testing of the quarantine period in accordance with the prescribed form in Annex XVII and XVIII were issued with this message.

3. Profile appraisework and Certificate of Drug Protection Certificate

a) The Bureau of Vegetation Protection records in the period 05 (year) day of work since the complete adoption date of the filing.

If the case is valid, the response is specified in Chapter IX, Chapter XII, and other provisions of this Smart, as the procedure as specified at point b, c, d, e, paragraph 3, This Article.

If the profile is not yet valid, the provisions specified in Chapter IX, Chapter XII, and other provisions of this Smart are notified to the organization, which individuals to add, complete the prescribed profile.

b) The Food Protection Bureau organizes the Food Protection Advisory Council for evaluation and review of the food protection drugs recommended for formal registration and registration of the addition of a year 03 (three).

c) Shortly after the outcome of the Advisory Council meeting, for a maximum of 10 days as the Bureau of Food Protection informed the organization, the individual by text of the consultation council concluded:

The registered food protection drug is accepted and issued a Certificate of Drug Protection in accordance with the prescribed form at Appendix XIV issued by this message and it is allowed to circulate.

The food protection drug recommended registration is accepted but needs additional, complete profile.

The food protection drug offers to register not to accept and specify the reason.

d) The Bureau of Food Protection of drugs is reviewed by the Council of Consultative Affairs and recommended for the recognition of the Ministry of Agriculture and Rural Development.

In time of no more than 15 (fifteen) days of work since the registry, the Minister of Agriculture and Rural Development issued the Private Protection of the Protection of Food Protection, restricted use, and prohibition of use in Vietnam.

What? 10. The procedure, the procedure to renew the Certificate of Plant Protection Medication

1. File

a) In accordance with regulation at Point a, c, paragraph 1, Article 8 of this Information.

b) The number of records: 01 (a) hard copy (paper profile), 01 (a) the word format or excel format for the label.

2. File

a) The proposed extension of the Certificate of Registration of the Drug Protection in accordance with the prescribed form at Annex II issued by this Information;

b) The Certificate of Registration for the Protection of the plant has been issued;

c) A drug label or a sample label if there is a change in the specified content at Chapter IX of this Information.

3. Profile appraisework and Certificate of Drug Protection Certificate

The Bureau of Vegetation Appraisal in the period 05 (year) day of work since the full filing date is specified:

a) If case valid, the response is specified in Chapter IX and other provisions of this message, the Certificate of Subscriptions for the Protection of the Protection of the plant in Appendix XIV issued to this message.

b) If the profile is not yet valid, the specified application is specified at Chapter IX and the other provisions of this Smart, the individual needs additional content, complete the prescribed profile.

c) The case does not grant a plant protection drug registration certification, the Bureau of Food Protection informs the organization, the individual in writing and stating the reason.

What? 1 1 . sequencing, the procedure to change the manufacturer of plant protection.

1. File

It is in accordance with Article 1, Article 8 of this Information.

2. File

a) The application to change the manufacturer by the prescribed template at Annex III issued by this message;

b) The copyright paper itself of the manufacturer of the active or technical drug (For the case of the manufacturer's authority for the organization, the other individual);

c) The main version or copy of the Certificate of Confirmation Certificate is the manufacturer of the activity or the technical drug administered by the governing body of the country at the level;

d) detailed technical documentation in Vietnamese or English, which is copied, translated from the original, which has a confirmation stamp of the manufacturer of the activity or the prescribed technique at Annex IV issued by this message;

The self-release of the Food Protection Drug, the Certificate of Plant Protection Medicine has been issued;

e) The prescribed drug pattern at Chapter IX of this Smart.

3. Profile appraisitology and licensing of the plant protection drug, the Certificate of Food Protection Drug Registration.

The Bureau of Vegetation Appraisal records in the 15 (fifteen) days of work since the complete adoption date of the filing.

a) If the valid case, the response is required by the prescribed specifications at Annex IV, issued by this message, the Ministry of Drug Protection (Certificate of Vegetation Protection) licenses, the Certificate of Drug Subscriptions for the Protection of the plant in accordance with Appendix XIII, XIV. This is a private practice. The validity of the license for the Food Protection Drug Examination Permit, the new plant protection drug registration certificate holds the deadline of the issued paper.

b) If the profile is not yet valid, the specified specification is required by the Appendix IV issued by this message, and the information for the organization, the individual of the content needs to be added, complete the prescribed profile.

c) The case does not issue a Vegetation Protection Drug (C) Pesticide Application certification, the Vegetation Protection Certification for the organization, the individual in writing and stating the reason.

What? 1 2 The order, the procedure of transferring the name of the drug protection drug.

1. File

a) In accordance with regulation at Point a, c, paragraph 1, Article 8 of this Information.

b) The number of records: 01 (a) hard copy (paper profile), 01 (a) the word format or excel format for the label.

2. File

a) The application for the transfer of the product name by the prescribed pattern at Annex III issued by this message;

b) The main copy or copy of the transfer contract or the product transfer agreement;

c) The main license of the Drug Protection Drug, Certificate of Plant Protection Medicine has been issued;

d) The government authorized the manufacturer's authority or medicine for the organization, the individual to receive the transfer;

The prescribed medication for Chapter IX of this information.

3. Examine and grant of the Vegetation Protection Drug examination, Food Protection Certificate of Drug Protection:

a) The Bureau of Vegetation Protection records in the period 05 (year) day of work since the complete adoption date of the filing.

If the case is valid, it is possible to meet the provisions in this message granting the Food Protection Drug Application to the prescribed pattern at Annex XIII issued by this message.

If the profile is not valid, inform the organization, the contents of the contents need to be added, complete the prescribed profile.

In the absence of a licensed plant protection drug, the Certificate of Drug Protection of the plant, the Department of Food Protection informs the organization, the individual with zebras and explicitly states the reason.

b) For the name of the drug protection drug that is already in the category of Usable Plant Protection for use, restriction used in Vietnam: if valid records, meet the regulations in this Privacy, the Food Protection Bureau of the Ministry of Agriculture and Agriculture. Rural development. In time of no more than 15 (fifteen) days of work since the agency ' s registration, the Minister of Agriculture and Rural Development issued the Portfolio Of Portfolio or Revised Investments, supplematment of the Catalogue of the Licensed Plant Protection. It ' s not used in Vietnam.

During the 10 (ten) days of work since the issued date of the law, the Department of Food Protection has certified the registration of the prescribed food protection drug in Appendix XIV, issued by this Privacy.

c) The validity of the validity of the Food Protection Drug Examination Permit, the new plant protection drug registration certificate holds the deadline of the issued papers.

What? 1 3 The procedure, the procedure of changing the name of the drug protection drug.

1. File

a) In accordance with regulation at Point a, c, paragraph 1, Article 8 of this Information.

b) The number of records: 01 (a) hard copy (paper profile), 01 (a) the word format or excel format for the label.

2. File

a) The application to change the name of the merchant by the prescribed template at Annex III issued by this message;

b) The main license of the Drug Protection Drug, Certificate of Plant Protection Medicine has been issued;

c) The prescribed drug pattern at Chapter IX of this Information;

d) The main version or copy of the State Agency's text of intellectual property authority or of the court on the breach of the label for the protection of the drug for plant protection has been issued a Certificate of Plant Protection Certificate of Plant Protection.

3. Profile appraisitology and licensing of the plant protection drug, the Certificate of Food Protection Drug Registration.

It is in accordance with Article 3, Article 12 of this Information.

What? 1 4 . The procedure, the procedure of granting the Plant Protection Drug research license, the Certificate of Food Protection Drug Registration

1. Level cases

a) Food protection drug testing permit, the original plant protection drug registration certificate remains in effect but lost, lost;

b) Food protection drug testing, the original plant protection drug registration certificate remains in effect but is damaged, cannot continue to use;

c) When there is a discovery or change of information on the Vegetation Protection Drug survey, the Certificate of Drug Protection;

d) Change the organization, the individual registered;

p) In exchange for the license to examine the chemical plant protection drug already in the category to register to supplement the range of use, dose of use, how to use, form of medication, active content;

e) Gfiled the registration certificate at the request of the organization, the individual registered.

2. File

a) In accordance with regulation at Point a, c, paragraph 1, Article 8 of this Information.

b) The number of records: 01 (a) hard copy (paper file).

3. File

a) The application to re-issue the prescribed pattern at Annex III issued with this message;

b) The main permit for the Vegetation Protection for plant protection, the Certificate of Vegetation Protection (for specified cases at Point b, c, d, e, e, Clap 1, This);

c) A copy of the new business registration certificate (for the specified case at Point d, Clause 1, This Article);

d) The prescribed drug pattern at Chapter IX of this message (for the specified case at Point c, d, Clap 1, This).

3. Profile appraisor

a) The Bureau of Vegetation Protection records in the period 05 (year) day of work since the complete adoption date of the filing:

If the valid case is licensed for a plant protection drug, the Certificate of Subscriptions for the Protection of the Food in accordance with the prescribed form at Appendix XIII, XIV, issued this.

If the profile is not valid, inform the organization, the contents of the contents need to be added, complete the prescribed profile.

In the absence of a licensed plant protection drug, the Certificate of Drug Protection of the plant, the Department of Food Protection informs the organization, the individual in writing and stating the reason.

b) For the specified case at Point d, Clause 1, This is in accordance with regulation at Point b, Clause 3, Article 12.

c) The validity of the validity of the Food Protection Drug Survey, the Certificate of Food Protection for the Acute Food Protection for the duration of the issued paper. For cases of regulation at Point e, Clause 1, this time the validity of the Certificate of Pesticide Registration certification is the statute of limitations of the shortest-preserved plant protection application.

What? 1 5 Recovery of the Food Protection Drug Survey, Certified plant protection drug registration certificate

The case must be revoked:

1. The experimental drug protection drug, the Certificate of Drug Protection of the Food Protection, content repair;

2. Use false paper, the information provides not to be honest in the registration records;

3. There are other violations that the law rules must recall.

What? 1 6 -The standard.

1. Organization, individuals with chemical plant protection drugs (formal registration, name of the brand name) must submit 2 (two) grams (g) of the standard for each activity of the registered drug for the registry when receiving the Vegetation Protection Drug examination.

2. The standard must have a test certificate of the test room that reaches the ISO standard or equivalent and has a shelf life of 2 (two) years or more.

What? 1 7 . The registry and the responsibility of the registry.

1. The Bureau of Food Protection is the registered drug registry in Vietnam.

2. The registration agency ' s responsibility:

a) Continue registration and standard profile;

b) appraisor, save and secure the profile;

c) Answer the results of the appraisal, grant and revoking the Certificate of Food Protection Drug Registration, Food Protection Drug Survey;

d) Organization of Consultative Council meetings for review of formal registration medicines, take the opinion of the members of the Consultative Council on the additional types of registration medicines and set up the Department of Agriculture and Rural Development ' s Minister of Agriculture and Rural Development The category of drug protection is allowed to use, restrict use, prohibition of use in Vietnam after having been reviewed by the Council of Consultative Affairs and recommended;

e) Toll Fees, charge fees, and resupply of the Food Protection Drug Examination Permit; Certificate of Registration for Vegetation Protection; renew the Certificate of Vegetation Protection Drug certification according to the current regulation.

What? 18. The validity of the Certificate of Certificates, License

1. The certification certificate for the Protection of the plant is valid during the time of 05 (year) years.

03 (three) months before the Certificate of Pesticide Registration Expired, the organization, the individual must file a proposal to renew the Registration Certificate in the event of a limited need for the Food Protection Bureau. The profile, sequence, procedure extension of the Certificate of the Protection of the plant protection is carried out in accordance with Article 10 of this Information.

2. The plant protection permit is in effect during the period 05 (year) years.

The license for the experimental drug protection is not renewed. In the event of an organization, the individual has not yet performed the expiration of the expiration of the expat license, the individual must register for a licensed plant protection for the prescribed plant in accordance with Article 8 of this information.

What? 1 9 Time of file storage time

1. Case storage time: 05 (five) years for the hard copy, 10 (ten) years for the floppy.

2. At the end of the storage period, the profile is culled by the current regulation.

Chapter III

PRODUCTION, MACHO, TO BOTTLE, PACKAGING PLANT PROTECTION MEDICINE

What? 20. Common Principles

1. Only manufactured, macho-to-bottle, packaging drugs in the category of drug protection drugs allowed to use, restricted use in Vietnam and drugs that have been allowed to be imported for macho, to bottle, packaging aims to reappear in the future. The contract signed with foreign countries.

2. Organization, individual production, macho, to bottle, packaging of the food protection drug must have sufficient conditions prescribed at Article 7 of the Executive Order of the Protection of Botany in accordance with the Digital Protocol. 58 /2002/NĐ-CP June 3, 2002, Decree No. 59 /2006/NĐ-CP June 12, 2006 of the Government Regulation the implementation of the Commercial Law on Goods, Business Prohibition Services, Business Restrictions and conditional business and Article 12 of the Digital Decree. 108 /2008/NĐ-CP October 7, 2008 of the Government on the Regulation of Regulation and Guide to some of the provisions of the Law of Chemicals.

3. The person who runs the production, macho, to the bottle, packaging the food protection drug must have a certificate of practice due to the Department of Provincial Food Protection.

What? 21. Register for production, macho, to bottle packaging plant protection drugs

1. The state agency has the authority to grant only business registration in terms of production, macho, to bottle, packaging for food protection as the person directly manages, operating this operation with a certificate of practice due to the state governing body of food protection. It's a local thing.

2. The person offering a certificate of conduct of production, macho, to bottle, packing the food protection drug must have sufficient conditions stipulated at Article 8 of the Executive Protection of Botany Rules issued with the Digital Protocol. 58 /2002/NĐ-CP June 3, 2002.

The procedure for the certification of manufacturing, macho, to bottle, the packaging of plant protection is carried out by the regulation of the Minister of Agriculture and Rural Development.

3. The manufacturing facility, macho, to bottle and packaging plant protection drugs has only been allowed to operate since being granted a certificate of qualified production, macho, to bottle, packaging for food protection under the provisions of the No. 1 Protocol. 59 /2006/NĐ-CP June 12, 2006, the Government regulates the implementation of the Commercial Law on goods, business prohibition, business restrictions and conditional business.

The procedure, the procedure of granting the Certificate of Certificate of Manufacturing, to the public, to the bottle, the packaging of the food protection drug was carried out by the provisions of the Minister of Agriculture and Rural Development.

What? 22. The organization ' s responsibility, personal production, macho, to bottle and packaging of food protection drugs.

1. Manufacturing, macho, to bottle and packaging must follow the process of production, technical and quality standards registered.

2. Take responsibility before the law if the production, macho, to the bottle and the packaging of its plant protection adversely affects people, livestock and the environment.

3. Take responsibility for the quality and other laws of law on the drugs produced by the manufacturing facility, medication in the shelf life of the market.

4. Text-to-text report for the Department of Botany and Food Protection on the site of the production situation, macho, to the bottle, packaging the food protection drug at the fourth quarter of the year.

5. Text-written notice for the Department of Plant Protection when changing the location of the factory, the workshop; production capacity, operational form, the type of drug produced, the macho, the bottle, the packaging; the non-continuing production, the macho, the bottle, the packaging.

What? 23. The responsibility of the Department of Food Protection

1. Take on the reports of manufacturing activity, macho, to bottle, packaging; announcements about not continuing to operate production, macho, to bottle, packaging for the food protection of organizations, individuals and aggregation of the Ministry of Agriculture and Agriculture Report. Rural development.

2. Inspector, annual periodic examination; inspectors, inspection of the production of production facilities, macho, to bottle, packaging plant protection drugs when required.

Chapter IV

EXPORT, IMPORT DRUG PROTECTION

What? 24. Common Principles

1. organizations, individuals with a Certificate in Registration Of Food Protection Drugs or agricultural supplies are allowed to export the drug protection drug.

2. Only importing drugs, the material protection drug in the Department of Vegetation Protection allowed to use in Vietnam by the Minister of Agriculture and Rural Development, when imports are not required, only to be the only importers of imports. at the customs office.

3. For the imported plant protection drugs, imported, the export-export authorization unit must export the authorization letter (the producer of the manufacturer to the export unit); the order of the registration unit for the unit. The name of the porter) at the Customs office.

4. Import of the drug, the raw material protection drug in the following cases must be licensed by the Department of Food Protection. :

a) Drug, material protection drug in the category of limited food protection drugs used in Vietnam;

b) The drug, material protection of plants in addition to the Catalogue of Vegetation Protection Drugs is allowed to use in Vietnam: drugs used for scientific research, testing; use in foreign projects in Vietnam; to be machinable, to bottles, packaging, and more. Re-export under contract signed with foreign countries; drug-making drugs, exhibitions of exhibition, fair market and drug use in other special cases;

c) The preparation of plant protection in addition to the Catalogue of Vegetation Protection Drugs is allowed to use in Vietnam to serve for testing, research.

5. Drug protection in the Catalogue of Vegetation Protection allowed or restricted use in Vietnam to be imported must meet the following requirements:

a) Drug protection drugs must have the right amount of activity, drug form, and manufacturer with the Certificate of Drug Protection in Vietnam.

b) The raw materials or techniques must have a minimum amount of activity by the active content of the raw materials or drugs in the Usable Plant Protection Drug Category, which is restricted use in Vietnam and must import from the manufacturers. There are origins, clear origin.

6. Do not import the type of activity or food protection products in Annex III of the Rotterdam Convention.

7. Prototype that imports the drug and the raw material protection of the plant in Annex VII, issued by this message.

What? 25. Level the drug import license and plant protection material

The procedure, the procedure of granting the import of drugs and the raw material protection of plants by regulation at the Digital Information 88 /2011/TT-BNPTNT November 28, 2011 of the Minister of Agriculture and Rural Development on the guidelines for the implementation of the Digital Protocol. 12 /2006/NĐ-CP rules for the implementation of the Commercial Law of Trade, Purchase, sale, public and transit of goods to foreign countries, forestry and fisheries.

Second 6. Report Mode

At the end of the fourth quarter of the year, organizations, individuals exported, importing plant protection drugs must report written statistics on the export situation, importing plant protection drugs to the Bureau of Food Protection.

What? 2 7 Export, importing plant protection drugs containing methyl bromide activity.

1. export conditions, import of methyl bromide.

a) It is only imported, exporting plant protection drugs containing methyl bromide activity from or to the countries participating in the Montreal Protocol.

b) Subscription with the Department of Methyl Bromide volume of mass imports for use for various uses: plant testing; export disinfection (QPS) and other purposes (non-QPS) of the next year before December 15 of the previous year.

c) The plant protection department allocated the amount of methyl bromide imported in the prior year of 30 January of the next year based on the registration, the scale of operation of the organization of the operation of disinfection and the gradual elimination of methyl bromide that Vietnam had signed. To international.

d) The license to import the methyl bromide prescribed at Annex VIII issued this message. The validity term of the import permit is December 31 of the licensing year and is not allowed to renew in any case.

There is a certificate of registration of the drug-protective drug industry or agricultural supplies that are allowed to export the drug protection drug.

2. The procedure, the procedure of granting a License to import methyl bromide in accordance with regulation at No. 88 /2011/TT-BNPTNT November 28, 2011 of the Minister of Agriculture and Rural Development on the guidelines for the implementation of the Digital Protocol. 12 /2006/NĐ-CP rules for the implementation of the Commercial Law of Trade, Purchase, sale, public and transit of goods to foreign countries, forestry and fisheries.

3. The responsibility of the export organization, importing plant protection drugs containing methyl bromide activity.

a) Only allowed the use of methyl bromide in accordance with the Department of Food Protection and subject to inspection, inspection of the state governing body in the use of methyl bromide;

b) Only the sale of methyl bromide active drugs to organizations with sufficient disinfection of sterilization in accordance with the rule of law;

c) Every year must report the Bureau of Vegetation Protection in the prescribed pattern of regulations at Annex 7 regulations governing the state of the operation of an animal disinfection operation accompanied by a numerical decision. 89 /2007/QĐ-BNN November 1, 2007, of the Minister of Agriculture and Rural Development and the trade of methyl bromide in accordance with the prescribed form of Annex IX. The deadline was reported 6 months earlier in the year before July 15 and reported the year before 15 January next year.

4. The organizations are not importing methyl bromide if violating one of the following cases:

a) Do not comply with a specified report mode or a non-honest report on the import situation, use, purchase of methyl bromide.

b) Use the registered target error methyl bromide or the purpose of converting the use of an export disinfection in plant testing (QPS) to other purposes (non-QPS).

c) The additional import for external operations for the purposes of testing and disinfection of exports (non-QPS).

Chapter V.

DRUG TRAFFICKING

What? 28. Common Principles

1. Organization, the individual trafficking of the drug protection drug must have sufficient conditions stipulated at Article 16 of the Executive Order of Drug Protection issued with the United States Census Protocol. 58 /2002/NĐ-CP June 3, 2002 of the Government and Article 7 of the Digital Protocol 59 /2006/NĐ-CP June 12, 2006, the Government regulates the implementation of the Commercial Law on goods, business prohibition, business restrictions and conditional business.

2. Only the trafficking of plant protection drugs included in the category of protected plant protection drugs, restricted use in Vietnam by the Minister of Agriculture and Rural Development.

3. Only the trade of food-based food protection medications that are available, originating in the original, originating in the country, have the correct goods label prescribed at Chapter IX of this and other provisions of the law of goods labels.

4. The direct seller of the drug protection drug and the administrator of the drug-protection drug business must have a certificate of practice due to the Department of Provincial Food Protection.

5. Organization, domestic or foreign, registered, distributing food protection in Vietnam is responsible for the quality of food protection in the market.

What? 29. Register of drug protection

1. The State Agency has the authority to grant only business registration to drug trafficking activity when the drug-protection drug dealer has a certificate of practice due to the Department of Provincial Food Protection.

2. The person offering the certificate of conduct of the drug protection trade must be eligible for regulation at Article 17 of the Charter of the Management of the Department of Food Protection issued with the Digital Protocol. 58 /2002/NĐ-CP June 3, 2002 of the Government and Article 3 Decree No. 98 /2011/ND-CP October 26, 2011 of the Government on the Amendment, complements some of the provisions of the Convisions of Agriculture.

3. The organization, the individual who trafficking the drug protection drug only is allowed to operate since being granted a certificate of qualified plant protection drug business according to the regulation of the Digital Protocol. 59 /2006/NĐ-CP June 12, 2006, the Government regulates the implementation of the Commercial Law on goods, business prohibition, business restrictions and conditional business.

4. The procedure, procedures for the Certificate of Vegetation Protection, the Certificate of Occupational Protection of the Vegetation is carried out by the regulation of the Minister of Agriculture and Rural Development.

What? 30. Drug protection site

The site of the drug protection trade must be agreed by the administration of the township; it must be far from schools, hospitals, markets, and water resources; to ensure the safety of people, pets and the environment; not submerged in all situations; there is full media. prevention of fire prevention and response to regulation requirement at paragraph 2, Article 19 of the Charter of the Management of the Protection of plants attached to the Digital Protocol 58 /2002/NĐ-CP June 3, 2002 of the Government.

Chapter VI

TRANSPORT, DRUG PRESERVATION, RAW MATERIALS PLANT PROTECTION MEDICINE

What? 31. Common Principles

1. The transport of the drug, the material protection material must follow the provisions of the Digital Protocol. 104 /2009/NĐ-CP November 9, 2009 by the Government of the Government to rule out dangerous goods and transport of dangerous goods by road-road motor vehicles, law on the safety of road traffic, rail, inland waterways and the provisions of the law. The rules are relevant.

The food protection drugs are regulated at the Annex I issued by the Protocol. 104 /2009/NĐ-CP January 9, 2009, the government must be granted a transfer license.

2. The transportation of the drug, the material protection material must follow the schedule of the record in the contract or other paper involved in transporting the drug protection between the media owner and the owner of the goods.

3. The transportation of the drug, the raw material protecting the plant must ensure the safety of the person, the environment. Do not stop the car in the east, near schools, hospitals, markets, water supplies.

4. Drug protection materials are transported only when packaged, labeled, and authorized by the authority to grant the license to transport the drug, the material protection of the plant according to regulation at Article 33 of this Information.

5. Food protection drugs are likely to react to each other not being carried on the same vehicle.

6. No drug transport, material protection materials on the same means of passenger, pet, food, food, flammable substances, explosions and other goods, except for fertilizer.

What? 32. Drug transport, food protection.

1. The transporer of the drug, the material protection of the plant

a) The driver of the vehicle, the oppressants must understand the dangerous nature of the drug, the material protection material such as: toxic, flammable, flammable, corrodiated, and having to know the preliminary processing when the incident occurs during the transport process, raw materials. It protects plants and practices in accordance with laws of dangerous shipping.

b) The operator of the drug delivery vehicle, the material protection material other than the evidence of vehicle controls in accordance with the existing state regulations, has to obtain a training certificate in the safety of the labor. Transport, drug protection, plant protection.

c) The opprescierer is the drug, the material that protects the plant must be trained in the safety of labor in the transport, the protection of the drug, the material protection of the plant.

2. The packaging, container or container containing the drug, the material protection material in the transport process.

a) Must be made with persistent, durable, waterproof materials;

b) Must paste a dangerous symbol with a long head, the black cross bone on the white background in the deflated square. The size of the risk manifold sticker on each drug barrel, the plant protection material is 100 mi-li-meter (mm) x 100 mi-li-metre (mm) and paste on the container is 250 mi-li-metres (mm) x 250 mi-li-metre (mm) in prescribed form at Annex VI. It ' s an attachment to this.

c) There must be a dangerous rectangular signal, yellow orange, in the middle of the United Nations Code (UN), the dangerous signal size is 300 mi-li-meter (mm) x 500 mi-li-metre (mm) in the prescribed form at Appendix VI accompanied by this message, location below. It's a dangerous symbol. For packaging and containers, the risk signal is a smaller size consistent with the ratio with the packaging and containers but must be able to clear the danger signal.

3. Drug delivery vehicle, plant protection material

a) The conventional means of transport are authorized by authorities to transport goods that are loaded with medication, the material protection of the plant.

b) The means of carrying the drug, the material protection material must ensure the following technical conditions:

There are tools, fire-room equipment, firefighting in accordance with the drug, the material protection of plants when shipping;

There's a convertible, the canopy covers the entire cargo bay, ensuring that the cargo hold is not waterproof in the transport.

You don't use a car to carry a drug protection.

c) The transportation of the drug, the last known plant protection material of each ferry, if the ferry terminal does not have a specialized ferry for dangerous goods.

d) The means of carrying the containers of the drug, the material protection material must be labeled the danger of the shipping group. The size of the hazard symbol on the vehicle is 500 mi-li-metre (mm) x 500 mi-li-metre (mm). The sticker position is dangerous on both sides and behind the vehicle.

4. Processing of incident

When the incident is caused by the crash, traffic accidents during the transport process, the material protection of the plant, the driver, the oppresor, or the owner of the goods must handle the incident and simultaneously inform the local government or the state agency. The nearest authority to have a deterred, in time for the resulting drug to be caused by the leaking drug. The offender is subject to all the remediation costs.

What? 33. Drug delivery permit, plant protection.

1. Organization, the individual who transport the volume of drugs, the material protection material from 1000kg/car has to have a drug delivery permit, the material protection of plants due to the Department of Provincial Food Protection.

2. Drug delivery permits, plant protection materials with value in circulation across the country.

3. The duration of the drug delivery permit, the material protection of the food issued by every single trip or period but not more than 12 months, since the date of the grant.

4. Drug transport license, food-protection materials prescribed at Annex XI issued by this message.

What? 34. The procedure, the procedure of issuing a drug transport license, the material protection of the plant

1. File

The organization, which is personally recommended to grant a licensed drug transport license, the material protection of plants directly or sent via postal mail one (01) a case for the authorities under regulation at paragraph 1 of Article 33 of this Information.

2. File

a) The application for the granting of the Medication Transport License, the raw materials protection of plants according to the prescribed pattern at the Appendix X attached to this message;

b) The copy of the Certificate of Labor Safety Certificate in Transport, Protection of the Drug, Materials Protection Materials of the Vehicle Operator or the oppreser (when submitting a major version to the passport);

c) One of the following papers (copy certificate):

Supply contract;

Drug delivery contract, plant protection material;

The financial bill of publishing, importing plant protection medicine;

The company ' s cargo transport manifold (validation and stamp of the company)

d) The schedule of transporting goods, addresses and phones of the owner (have confirmation and sign of the company).

3. Profile appraisitation and delivery of drug transport licenses, food protection materials

In the time of 3 (three) days of work since the full profile is in accordance with the prescribed procedure, the authorities have the authority to degrade the case, if the valid case is issued a license for the transfer of the drug, the material protection of the plant.

Case case is not valid, within 1 (a) working date from the full profile, the authority has the authority to notify the organization, the individual the contents need to add, complete the filing accordingly.

The case does not grant a permit to transport the drug protection drug, within 1 (one) of working days, the authorities have the authority to inform the organization, the individual in writing, and specify the reason.

What? 35. The training content of labor safety in transport, drug preservation, food protection materials, and food protection.

The driver of the transportation vehicle, the delivery man, the trained treasurer, the training of the following content:

1. The coaching content on the labor safety is regulated at the Digital Information. 37 /2005/TT-BLTBXH December 29, 2005, of the Ministry of Labor-Trade and Social Affairs on the guidance of working safety training, labor hygiene;

2. Text-related texts, which preserve dangerous chemicals;

3. The properties of plant protection drugs;

4. The signs, symbols and signs of danger of the goods;

5. Safe safeguards when transporting the drug, the material protection of plants (emergency, safety on the road, basic knowledge of the use of protective instruments); and so on.

6. The prevention and disposal measures for each drug protection drug.

What? 36. Responsible for training and grade training certification

1. The Department of Food Protection in the Ministry of Agriculture and Rural Development is responsible for building content, training programs for the treasurer, the oppresso, and the operator of the vehicle to transport the drug protection.

2. The Provincial Museum of Food Protection in collaboration with training facilities, vocational training, business organization holding training in accordance with the provisions of the regulatory program at Article 35 of this Privacy and granting a Certificate of Training in accordance with the prescribed form at Appendix XII. This is a private practice.

3. The organizations, individuals involved in the transport of the drug, the raw material protection material must ensure the vehicle operator, the oppreser, the keeper of the drug protection drug trained according to regulatory content at Article 35 of the United States. This is private.

What? 37. Drug store, food protection.

1. The location of the drug store, the raw material protection of plants outside the industrial zone must be granted the consent of the township authorities.

2. The depot must be firmly built, by fire that is difficult to burn, unabated, secure, convenient for operational fire vehicles; ensure the requirements of TCVN 5507:2002 Chemical chemicals-safety regulations in production, business, and security. business, use, preserve and transport.

3. The warehouse must have fire extinguiers, poison rooms, emergency and sea signs that represent a long-standing, black cross in a white background in a deflated square such as the dangerous row symbol of the vehicle or container prescribed at the site. Appendix VI issued this message.

4. The Treasury must meet the regulations of the law on environmental protection.

What? 38. Food Protection Drug Administration

1. The preservation of the drug protection drug must ensure the safety of the person, livestock and the environment in the surrounding area.

2. The treasurer must be trained in the labor safety in the preservation of the plant protection drug.

3. In the case of a leaked drug, diffuse causes harm to the environment, the owner of the drug must be responsible for remediation under the guidance or examination of the plant protection agency, the environmental regulator, the department government and is subject to everything. The cost of remediation.

Chapter VII.

USE OF PLANT PROTECTION

What? 39. Common Principles

1. Only used as a plant protection drug in the category of Vegetation Protection permitted use or List of restrictions used in Vietnam by the Minister of Agriculture and Rural Development.

2. Use the right plant protection medication with the manual that has been written on the drug label.

3. The use of a plant protection drug must ensure the right principle of four true: correct medicine, at the right time, correct doable and concentration, in the right way; to comply with the time quarantine has been inscribed on the label.

4. Strict the use of plant protection drugs in the category of prohibited food protection drugs used in Vietnam; external medicines are allowed to use, in addition to the restricted category used in Vietnam; the drugs that are unknown to the origin, origin; and other types of drugs. The drug is not labeled or labeled in foreign language.

What? 40. The person ' s responsibility to protect plant protection

1. Use the right plant protection medicine and ensure the safety of the self, community and environment.

2. The person who uses the drug protection drug must be held accountable to the law on the following acts:

a) Use arbitrary, non-technical medications recommended, do not guarantee quarantine time;

b) Use of a banned drug, using a drug in the name of the Usable Plant Protection Medication, the restricted category used in Vietnam, the use of an unknown source of medicine, origin;

c) Throw away the packaging that has taken the drugs, the drugs, the non-regulatory drugs that adversely affect people ' s health, livestock and the environment.

3. If the use of food protection for other people is required to compensate or damage the health, the lives of others outside of compensation must be processed under the rule of law.

What? 41. The responsibility of the management agencies and the drug-protection drug business unit

1. The state governing body for the protection and epidemics of the province, the Central City of China in coordination with the organizational functions examining the use of plant protection drugs in the productive areas, in particular in the specialty areas of the country ' s manufacturing sector. Vegetables, tea, fruit trees; detection and processing cases in violation of common principles for the use of food protection drugs prescribed at Article 39 of this message. The guide collects drug protection drugs after use to destroy according to regulation.

2. The Social People ' s Committee is responsible for the management of the trade, which uses local plant protection drugs; in coordination with the specialist body of protection and animal control of the propaganda organization, instructs the use of effective plant protection drugs, the rule of law. the location of the following drug packaging collection and disposal of violations.

3. Organization, business individual, drug-protecting drug trafficking must be specific, clear to the drug buyer, and must be held accountable to the law and must pay for economic damage due to the propaganda, advertising, guidelines for use of the drug. The drug protection drug is not enough, not correct, improperly, makes the buyer and uses the drugs to be confused, which is detrimental to the health of the person, the livestock, the environment, and the damage to production.

Chapter VIII

DRUG CONSUMPTION, DRUG PROTECTION

What? 42. Common Principles

The consumption of drugs, the packaging of the plant protection medicine must ensure that the requirements be prescribed at Article 22 of the Executive Protection of the Department of Food Protection issued with the Digital Protocol. 58 /2002/NĐ-CP June 3, 2002 of the Government and the provisions of the law on the destruction of hazardous waste.

What? 43.

1. The process of collecting, consuming drugs, the packaging of plants that protect plants is not spilt, dispersable or increases the hazardous waste of the environment; it has to be safe for people, pets and the environment.

2. The destruction of the drug, the packaging of food protection carried out by law on environmental protection.

3. Organization, individuals with the drug, the packaging that protects the food that charges the destruction of all costs for the destruction. If the drug, the packaging of the food protection agent, is forced to destroy without any local owners, the People's Committee governs the budget to carry out the correct destruction.

Chapter IX

PLANT PROTECTION MEDICINE

What? 44. Common Principles

1. All plant protection drugs when trafficking and use must be labeled in Vietnamese, the label content must be true to the contents of the label in the label that has been agreed upon by the Department of Food Protection when the register is registered, in accordance with the regulations at the Digital Protocol. 89 /2006/NĐ-CP August 30, 2006 of the Government on the label of the goods and guidelines of the Global harmonization System on the classification and labeling of goods .

2. The main label and sub-label are printed in the usual size, a minimum of 8 (the Times New Roman or equivalent), which is clear, easy to read, not blurred or prone to tear in the course of circulation, preservation, transport and use.

The main label does not record the required information, which must have an attached label for each drug package.

Content names; organized names, individuals responsible for medicines; export of goods; quantitative; date of production; the use of the medication must be inscribed on the main label.

3. The label must be attached to or printed on the packaging of the drug.

4. The label is not used in color with the toxic color of the plant protection medication.

5. The active ingredient or raw material (technical medication) is only inscribed on the label in the "component" section.

6. All changes to the label content compared to the label pattern have been approved when the registration review must be approved by the Food Protection Bureau.

7. The restricted plant protection medication used to write "shelf-use drugs" on the label (e.g., the limited-store disinfection uses Alumifos 56% TB).

8. For some medicines at the request of the agency ' s protection for the protection of plants required to warn the user, it must be written in accordance with the required warning (e.g., no medication in the wheat after the injection; not used). It ' s medicine in the aquacosphere.

What? 45. The contents of the contents of the drug protection.

1.

a) Information about products

The name of the merchant.

The form of a form is signed by the International Sign System for the Material and Formulated Pesticide (Croplife International Codes for Technical and Formulated Pesticides). according to this message;

The name, component, active content: identity records of g/kg (for solid, viscous, aerosol, aerosols or volatile liquids); the unit is equal to g/l (for other liquid form) or a percentage of mass (%w/w);

Solvent (if changing the toxicity of the drug): the name and function of the solvent. Unit and usage as for the activity;

Positive, unit is l or ml (for liquid form); the density is a kilogram or g (for powder, seed); the number of units, the unit diameters are kilogram or g (for the pill).

b) Information on safety

The information about the toxicity is consistent with the regulation at section 1 and section 7, Annex V issued with this message;

The symbol, the color line denoking the toxicity, the poison group of the drug is consistent with the regulation at Annex VI issued with this message;

Measures are safe to use, after the use and method of poisoning in accordance with regulation in section 5 and section 6, Appendix V issued with this message.

c) Information about use

The manual for use in accordance with the content was registered;

The shape guide to the preservation, preparation, use (if any);

Quarantine time (day);

The ability to mix with other drugs (if any).

d) Other information

Registration Number It protects plants.

Organization name, individual registration k I do

The name, address of the final responsibility for the product in Vietnam;

Exporting the goods.

Public day or to bottle, packaging; shelf life (writing the same location, which can be abbreviated);

The preservation condition.

2. Technical Drugs

a) The active name;

b) The name, component, active content: the unit record is of g/kg, g/l or the percentage of volume (% w/w);

c) A volume, a volume of rest;

d) Name, import unit address;

The name of the manufacturer, the place where the production is;

e) The date of production; the shelf life (writing the same position, can be abbreviated).

Chapter X

THE PACKAGING, THE PACKAGING OF THE FOOD PROTECTION

What? 46. Common Principles

The packaging of the food protection drug must comply with the requirements of TCVN 5507:2002 Chemical hazard-the safety of safety in manufacturing, business, use, preservation and transportation and the following requirements:

1. Food protection drugs must be packaged in the packaging of good quality; applied to all types of packaging that protects the plants, including all the packaging that is recycled or reused. The package must ensure:

a) Good quality can withstand normal impacts and tremor during transport, transfer of goods between the vehicles and the unloading of the treasure house or mechanized equipment;

b) It must be closed to ensure that no chemicals fail in the process of preparing to transport or when shipping with effects such as shaking, increased temperature, humidity and pressure;

c) The exterior of the package must be sure to be clean and not to stick to any dangerous chemicals.

2. The sections of the package that are exposed to the food protection medicine must ensure:

a) Not affected or impaired in quality due to the effects of internal packaging chemicals;

b) There are no dangerous effects, the impact of catalytiship or response to the drug protection drug in packaging;

c) Used to use the appropriate inert lining to make the protective lining, insulated the packaging with the protective plant inside.

3. When packing the plant protection medication in the liquid form, it is necessary to leave the space necessary to ensure that the package is not leaked or deformed because of the increased volume of the liquid that is covered when the temperature increases during the transport process.

4. Layer envelopes inside when the plant protection is packed with two classes to ensure that in normal transport conditions, they cannot be broken, punctated, or leakage of substances that are wrapping up outside packaging.

5. The types of internal packaging in either a broken or punctated form such as glass, connoisor, or certain types of plastics need to be inserted fixed with an outer layer of packaging with the inserts of the inserts, the adaptive concussion cushion.

6. The plant protection drugs are not covered together in the same layer of outer packaging or in a large transit compartment, when these chemicals can react together and cause:

a) A fire or a great heat.

b) heat up or burn gas, oxygen, or gas;

c) Creating a strong corrodiant substance;

d) Create unsustainable substances.

7. The packaging of the package for the volatile substances must be tight enough to ensure during the transport of the non-downgrade fluid level below the limit.

8. The liquid must be packed with the appropriate packaging that is suitable for the pressure from the inside of the delivery in the transport process.

9. Drug protection packages produced or recycled, reused to ensure regulatory requirements.

10. The containers of containers, empty packaging that have contained plant protection drugs that need to be managed as packaging are containing plant protection drugs.

11. All the packaging used to contain the plant protection medication in the liquid form must try the leak before use.

12. The packaging of plant protection in the form of a grain or powder needs to be closed enough to avoid the fall or need of enclosed underwear classes.

Chapter XI

INFORMATION, WORKSHOPS, DRUG PROTECTION

What? 47. Common Principles

1. Only information, seminars, advertising of drugs in the Catalogue of Vegetation Protection Drugs are allowed to use in Vietnam.

For medications in the category of limited food protection drugs used in Vietnam are only recommended for safe use.

2. The content of the workshop, the drug-protecting drug, must be true to the contents of the certificate in the Certificate of Drug Protection of the Drug.

3. All trade seminars on the food protection of organizations, business individuals must have an introduction program on "Safety in the Use of Food Protection". The program follows Decision No. 779 /QĐ-BVTV on May 22, 2011, of the Department of Food Protection enacted the TCCS 20 :2010/BVTV Guide to the Use of Safe, effective plant protection.

4. No information, seminars, advertising, recommended use of the non-correct plant protection drug at Article 48, is not the right purpose of the use of the drug that has been registered; the recommended use of the drug with the technical process has been granted jurisdiction. issued.

What? 48. Information, workshop, drug protection drug advertisement

1. Food protection pills must guarantee:

a) Middle-, clear, objectiative objectiation, effect, cognitive traits and usage of the drug as well as the adverse effects of drugs on humans, organisms and the environment;

b) The guide uses full, understandable, misunderstanding, misunderstandable and wrong medications; true to the content of registration, ensuring that the drug is legally used, safe and effective.

2. The workshop, the drug protection drug ad:

a) Food protection drug advertising must comply with the laws of advertising law;

b) The advertising of the drug protection drug must accompany a warning of hazardous, toxic, and preventative properties of drug protection.

3. The conference information, conference, event organization, exhibition, promoter of advertising products, advertising objects and other promotional vehicles have introduced the product protection drug marketing drug marketing drug protection, the scientific program due to the public ' s public health care program. The drug-sponsored drug company in local media must have a written approval of the contents of the Department of Provincial Food Protection.

4. The sequence, the way to implement and component of the ad registration profile performs under the law of advertising.

Chapter XII

EXPERIMENTAL DRUG PROTECTION

What? 49. Common Principles

1. Only performed on a field of food protection in Vietnam when there was a study permit in Vietnam. For an experimental drug that aims to register, the testing must be done by the organizations that are eligible to perform.

The organization, the individual directly carrying out the experimental drug protection drug test, is not known as an experimental drug to ensure its objectiation.

2. Bioperformance testing to determine effective prevention or regulation of growth for crops (including safety for crops) in the cultivation conditions of the major production regions of Vietnam.

3. The experiment determines the time of quarantine to determine the time since the use of a plant protection drug last time until the product harvesting in the cultivation conditions of the major production regions on the territory of Vietnam.

4. The Food Protection Drug Survey aims to register on the Catalogue of Pesticide Protection Drugs in Vietnam including:

a) Bioeffects testing;

b) The time defining the quarantine period;

c) For plant growth medicine in addition to the study of biological efficacy, the duration of the quarantine must evaluate the effect of the drug to some indicator of the quality of the product corresponding to each crop type.

What? 50. Survey scale and scale aim to register

The forms, the scale of the survey for a plant object and a type of pest:

1. Bioforce Performance Survey

a) The narrow-size survey is a small scale survey. Survey area from 25-50 square meters (d 2 )/cell, repeat 3-4 times; must proceed at least 2 (two) of production (north and south), each area of the 2 (two) locations and must proceed in 2 (two) different production. For crops or services only at 1 (one) of the production area only conducted an experiment at 3 (three) different locations in 2 (two) of that production area.

b) The extensive survey is a large scale progress survey, which has an area of 300-500 sq. m. 2 ); having to proceed at 2 (two) of the production zone (north and south), each region at 01 (one) location and conduct in 01 (one) production. For crop or pest control only at 1 (one) of the production area only conducted an experiment at 2 (two) different locations in that production area.

c) For perennial plants and special examination subjects (agricultural pest pest damage, post-harvest agricultural processing, forest pest pest, crop pest, rats in warehouses and populations, construction), the size of the field is required. It ' s on a specialized scale.

2. A quarantine time trial

a) The experimental time determining the quarantine of the plant protection for crops is conducted on a large scale, which has an area of 300-500 square meters (m). 2 ), do not reiterate, at 02 (two) the production area (north and south) in the 2 (two) production cases.

b) For crops that are only 1 cases per year, the tests are conducted at 2 (two) different locations in 01 (one) of that production.

c) For plants that are only available at 1 (one) of the production area, the course determines the quarantine time at 2 (two) locations in 2 (two) of the region's production. For plants that are only available in 01 (one) of production and have 1 per year per year, the tests are conducted at 4 (four) different locations in that production area.

What? 51. Conditions for the organization carrying out plant protection drugs.

1. The head of the organization must have a degree from the university to become a specialist in plant protection or specialization in cultivation, biology, chemistry with a certificate of training in plant protection.

2. There is a cadet team that is working as a plant protection and has been trained on the experimental drug protection drug.

3. Have the basis of the technical material at the request of the experimental drug protection drug.

4. Do not directly examine the food protection drugs due to the organization ' s registration of registration or given the name of the registration of food protection drugs in Vietnam.

What? 52. organization Plant protection for plant protection.

1. Register to join the network of food protection drug testing with the Department of Food Protection.

2. Full implementation of the examination process and the requirements of the examination.

3. Not organized, guidelines for the field of animal protection for plant protection without the consent of the Department of Food Protection.

4. Accountable to the law on the accuracy of the results of the experiment.

5. Report results report in prescribed form at Subside The XVII and the XVIII Appendix were issued.

6. Save all the raw data of the minimum examination of 05 (five) years from the date of the end of the examination.

What? 53. The responsibility of the organization, the individual with the food protection drug needed.

1. Organization, individuals with food protection drugs that need to be sent directly or sent through postal mail 01 (one) a case for the organization of the food protection drug that includes:

-A copy of the Food Protection Drug Survey by the Department of Food Protection;

-The prescription.

2. The test sample ensures the following request:

a) True strain, quality such as the examination request and written in the Food Protection Drug Survey;

b) Enough numbers;

c) Close the packaging carefully, which is sealed or intact in the packaging of the manufacturer.

3. Provide the Food Protection Bureau full of information about the products required by regulation at Article 8, Article 16 of this Privacy and the recommended dose, the concentration of the examination. Responsible for the accuracy of those information. In the case of food products that cause damage to humans, crops, animals and the environment are organized, individuals whose products are responsible for damages in accordance with Vietnamese law.

What? 54. The responsibility of the Food Protection Agency

1. Manage, organize activities on the experimental drug protection of plants that guarantee the objective, correct.

2. Specify the organizations to carry out plant protection drugs.

3. The cadre manager is a drug-protection drug experiment.

4. The organization tests, evaluate the results of the experimental drug protection.

5. Use the results of the evaluation to organize the evaluation of the registration of drugs and guidelines used when the drug has been allowed to use in Vietnam.

Chapter XIII.

QUALITY CONTROL, BALANCE, CERTIFICATION AND QUALITY

A DRUG-PROTECTING DRUG.

What? 5 5 General rule.

1. The quality of the quality of the drug protection is to determine the amount of activity, the form of medication, the amount of impushable impurity to the plant, for humans or to pollate the environment (if any), the additive content that increases the safety of the plant. product for people, crops (if present); the chemical properties are related to biological activity and the safety of the drug in the preservation and use.

2. The quality control of plant protection in agricultural products, food and the environment (for example) is to determine the amount of activity and the metabolized products of the toxic plant protection drug that remains in the item.

3. Drug protection drugs must measure quality including a drug and food protection drug into imported plants; food protection products in warehouses, manufacturing, macho, to bottles, packaging, trafficking.

4. Medication and materials protection for imported plants must be given the quality test sample before importing and implemented according to regulation at the U.S. Census. 77 /2009/TT-BNN PTNT on December 10, 2009, of the Minister of Agriculture and Rural Development regulations on the state inspection of the quality of imported plants.

5. The state inspection of the residue of pesticide protection in agricultural products derived from imported plant origin is done according to the Digital Information Information. 13 /2011/TT-BNPTNT March 16, 2011 by the Minister of Agriculture and Rural Development on the guidelines for the safety of food safety inspections of imported plant origin and existing law texts.

6. The state inspection of the quality of food protection and the balance of drug protection in agricultural products originating in the market is carried out under the Law Quality Law, commodity, and digital media, according to the report. 16 /2009/TT-BKHCN June 2, 2009, of the Minister of Science and Technology on the guidance of the state examination of the quality of goods in circulation on the market.

7. The state governing body for protection and testing of plants conducts a sample of the quality of food protection for food products at manufacturing facilities, macho, to bottle, packaging periodically to 1 time/year for the licensed facilities GMP (Good News). Manufacturing Practices), ISO (Intenational Standards Organization) or the equivalent quality management system; no more than 02 times per year for the remaining facilities without the detection of a breach. When the breach is detected, the frequency of the test may be higher.

8. The state examination of the quality of food protection and the balance of drug protection in agricultural products is made at organized entities due to the Ministry of Agriculture and Rural Development or the body of the Ministry of Agriculture in the Ministry of Agriculture. and rural development assigned to the designation.

The designation of testing organizations is done according to the Digital Information. 16 /2011/TT-BNPTNT April 01, 2011 of the Minister of Agriculture and Rural Development regulates the assessment, designation, and management of the laboratory of agriculture and rural development and the Digital Development of the Ministry of Agriculture. 52 /2012/TT-BNPTNT October 22, 2012 amendment, adds some of the provisions of the Digital Information 16 /2011/TT-BNPTNT April 01, 2011 and Digital News 54 /2011/TT-BNPTNT August 3, 2011.

9. A contract certification, a contract publication is a mandatory activity for the organization, the individual produces, the drug-protecting drug business.

What? 5 6 -Quality control base, pesticide residuation, compound certification, contract publication.

1. sampling the quality and quality control sample must follow the National Standard TCVN 8143: 2009: Food protection agents-Identitiate the concentration of cypermethrin, Annex A, the sampling method; TCVN 5139:2008: The recommended method. sample to determine the quality of the drug protection in accordance with the maximum residue limit (MRL).

The sampling of the quality and quality of the food protection is prescribed in Appendix XV and Annex XVI attached to this.

2. Quality Control, Quality of Drug Protection under the National Technical Regulation (QCVN), National Standards (TCVN); Facilities Standards (TC) of the Food Protection Bureau (if there is no national technical standard, national standard). In the absence of the above bases, it applies to international, regional, and drug manufacturers.

3. Base for a valid certification, a contract publication on the drug protection drug is regulated in the National Technical Regulation (QCVN), National Standards (TCVN); Facility Standards (TC) of the Food Protection Bureau by the Department of Food Protection annually.

4. The quality and quality control sample must be preserved in time 03 (three) months from the date of the sampling date.

5. The quality of the quality control, the quality of the drug protection must be stored in time 3 (three) years from the date of the results of the results.

What? 5 7 The sequence and the way it works.

1. Quality Control, Quality of Drug Protection

a) Submit

The organization, the individual who has a food protection drug that needs to test the quality or the farmer wants to test the residue of food protection drugs (collectively known as the sample) directly sent or sent via a postal line a sample prescribed by the sampling criteria for testing, The request for the checklist is specified by the specified organization and the sampling of the template (if any).

The recipient views the required vote, check out the sample status and date the results in the specified results.

b) Control and level the test results

In no more than 15 (fifteen) days of work since receiving the sample, the organization controls the test results.

2. The certification and the publication of the procedure for the protection of plants by regulations at the Digital Information 55 /2012/TT-BNPTNT October 31, 2012 of the Minister of Agriculture and Rural Development guidelines for the procedure to specify a contract certification and the publication of the state management of the state department of the Ministry of Agriculture and Rural Development.

What? 5 8 The responsibility of the Department of Food Protection.

1. Manage operations on quality control, quality of food protection;

2. Training training as quality control, quality of food protection;

3. designation of the Certification Organizations, the Laboratory for Vegetation Protection in accordance with the Digital Information Regulation. 55 /2012/TT-BNPTNT, Digital 16 /2011/TT-BNPTNT and Digital News 52 /2012/TT-BNPTNT . List of contract certification organizations, testing departments, National Technical Standards (QCVN), National Standards (TCVN), Agency Standards (TC) announced publicly on the Bureau of Food Protection.

Chapter XIV.

EXECUTION CLAUSE

What? 59 The transition rule.

1. Drug protection prescribed at Clause 7, Article 6 of this Notice is only allowed to import, produce, trade, use the maximum 2 (two) years from this date of the Notice effective; if the Certificate of Registration Food Protection Expired, only the same is available. to be renewed for enough 02 (two) five counts from the date of the Fourth Effective date.

2. Drug protection is regulated at Clause 5, Article 6 of this is only traded, using a maximum of 6 (six) months from the date of this date effective.

In case, new plant protection drugs were added to Appendix III of the Rotterdam Convention, the Drug Protection Agency warned by the United Nations Food and Agriculture Organization (FAO), the United Nations Environment Programme (UNEP) or the National Council of Science. The Ministry of Agriculture and Rural Development proposed banning the use in Vietnam is excluded from the category of Vegetation Protection for use, restriction of use and only imported, manufactured, trading and using a maximum of 2 (two) years from the date of their decision. The authorities have the authority to take effect.

3. Chemical plant protection drugs registered on vegetable trees, fruit trees and tea trees that have been granted an experimental license without regulating the time of quarantine before the time of this Smart.

4. Drug protection labels have rules in accordance with the Digital Information 38 /2010/TT-BNPTNT June 28, 2010 by the Minister of Agriculture and Rural Development regulations on the management of the plant protection drug that continues to use the maximum 2 (two) years from the date of this date valid.

5. Organization, the foreign individual who is directly in the name of the registry without responding to a regulation at Clause 2, 3, Article 4 of this Private Information must be executed on the right of term 1 (one) of the year since the date of this date is valid.

What? 6 0 The effect of execution.

This message has been in effect since 25 February 2013.

This information replaces the Digital. 38 /2010/TT-BNPTNT June 28, 2010 by the Minister of Agriculture and Rural Development regulates the management of plant protection drugs and Article 1 Digital Information on the Ministry of Agriculture. 18 /2011/TT-BNPTNT April 6, 2011, of the Minister of Agriculture and Rural Development on the amendment, complements some provisions for administrative procedures in the field of protection and animal testing under Resolution No. 57 /NQ-CP on December 15, 2010.

What? 6 1 Responsibility for execution.

The units of the Ministry of Agriculture and Rural Development, the Department of Agriculture and Rural Development of the provinces, the Central City of Central, the organizations and individuals involved have the responsibility for carrying out this Information;

In the course of implementation if there are difficulties, entanging organizations, individuals reflect on the Ministry of Agriculture and Rural Development (Department of the Food Protection) to promptly resolve the ./.

KT. MINISTER.
Chief.

(signed)

I'm sorry.