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Circular 13/2016/tt-Bnnptnt: Regulations On The Management Of Veterinary Drugs

Original Language Title: Thông tư 13/2016/TT-BNNPTNT: Quy định về quản lý thuốc thú y

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CIRCULAR rules on the management of veterinary medicines _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to the law of animal health by 2015;
 
Pursuant to the law of product quality, goods in 2007;
 
Pursuant to Decree No. 89/2006/ND-CP dated 30/8/2006 of government regulations about the labels of the goods;
 
Pursuant to Decree No. 132/2008/ND-CP dated 31/12/2008 detailing the Government's implementation of some articles of the law, quality goods and products;
 
Pursuant to Decree No. 181/2013/ND-CP dated 14/11/2013 details the Government's implementation of some articles of the law on advertising;
 
Pursuant to Decree No. 199/2013/ND-CP dated 26/11/2013 of government functions, tasks, powers and organizational structure of the Ministry of agriculture and rural development;
 
Pursuant to Decree No. 35/2016/ND-CP on 15/5/2016 the Government detailing a number of articles of the law on animal health;
 
At the suggestion of the Director of the Department of animal health, the Minister of agriculture and rural development issued a circular regulating the management of veterinary drugs.
 
Chapter I GENERAL PROVISIONS article 1. Scope and objects 1. Scope this circular regulates registration of circulation, assay, production, trade, export, import, testing, quality control, recovery, destruction, advertising veterinary drugs.
 
2. Subjects of application this circular apply to organizations, individuals, organizations, foreign individuals have activities related to the registration of circulation, assay, production, trade, export, import, testing, quality control, recovery, destruction, advertising veterinary drugs in Vietnam.
 
Article 2. Explanation of terms In this regulation, the terms below are interpreted as follows: 1. The production of veterinary drugs including the form of manufacturing, machining, san chia packaged veterinary medicine.
 
2. the new Drug is a medication with the formula containing new active substances, dosage medicines have new combination of active substances, medication dosage, new drugs have assigned new or have used drugs.
 
3. new active substances is first registered active circulating in Vietnam.
 
4. the original Drugs (drug discovery) is the drug was granted patent, to have a stable production process, have been licensed.
 
5. generic Drugs are drugs that are manufactured like the original formula of the drug, dosage, use, treatment, the dose used, the time to stop the use of drugs after patents or exclusive license expired.
 
6. Miscellaneous Name is the trade name due to drug manufacturing facility, the other with the original name or common name.
 
7. drug Label is printed, the drawing of text, drawings, photographs, printed signs, put directly on the packaging of medicinal products or tagged, attach, attached sure on commercial packaging of the drug.
 
8. drug labeling is expressing the basic content, and mainly about smoking up the medicine labels help users identify, select and use the correct medication and as a base to the relevant authorities make check, control, management.
 
9. the original Label of the drug is printed on labels or stickers, snap, sure on commercial packaging of the drug after completion of operation packed in the production line.
 
10. extra Label is the label of mandatory content translated from foreign origin label out Vietnamese and added the content required by Vietnamese as stipulated by law that the original drug's label is missing.
 
11. commercial packaging of drugs is the packaging containing the drug, along with the drug traffic, consisting of two types: a) direct packaging is the packaging contained in direct contact with the drug;
 
b) external packaging is the packaging used for the packing of one or several units are direct packaging.
 
12. Name and address of the Organization, the individual responsible is the name and address of the Organization, the individual production, export, import, import and export of drugs trust.
 
13. Packing of smoking is drug quantities are expressed in net weight, volume or number according to the number of counts in a packaged unit.
 
14. manufacturing batch number is denoted by the number or text, or a combination of both letters and numbers in order to get to know the plot and allowed considering the entire background of a batch of drugs including all stages of the production process, quality control and distribution of the drug batches.
 
15. Date of production is time finished production, processing, bottling, packaging or other forms to complete the final stages of the plot.
 
16. Expiry date (or expiration) of the drug is the timeline is assigned to a batch of the drug that after the deadline are not allowed to use the drug.
 
17. Origin of the drug as the country or territory where the entire production of drugs or where do the basic processing of end piece for the drug in the event of multiple countries or territories involved in the drug production process.
 
18. The manual is information related to the use, the necessary condition for use, storage of the goods; warning hazardous; How to handle hazardous incident occurring to the guidelines for the effective use of drugs users, reasonable.
 
Manual sheet is the document comes in commercial packaging of drugs including manual recording and other content under the rules.
 

19. the State inspection of the quality of veterinary medicine is the State agency review, evaluate the quality of veterinary medicine, manufacture, import, circulation has applied quality management measures of these organizations, individual manufacturing, business.
 
20. Smoking is drug quality standards registered quality standards of Pharmacopoeia, national technical regulation on veterinary medicine, national standards on veterinary standards or manufacturer's base and were competent authority approval.
 
21. Smoking quality is substandard quality medicines is registered with the competent authority.
 
22. the production Batch is a quantity of certain veterinary medicines, uniform in quality are produced in a single process or a series of processes and are indicated on the packing label with the same symbols of the batch.
 
23. The shipment is imported raw material amounts of veterinary drugs, veterinary drugs of one or more batches of production of a type of product by the same manufacturing base, the same organization that imports, imported the same shipment and have the same set of records imported.
 
Chapter II REGISTRATION of CIRCULATION, assay, the PRODUCTION, TRAFFICKING, importing veterinary category 1. REGISTER FLOATED veterinary medicine article 3. Registration documents circulating veterinary 1. For veterinary medicinal products, form new chemicals, biological preparations, registration documents include: a) application released under the form prescribed in annex I attached to this circular;
 
b) summarizes the characteristics of the products according to the form prescribed in annex VIII, attached to this circular;
 
c) form the product label, the directions for use;
 
d) GMP certificate or certificate of quality management system (ISO) for some common chemicals, the certificate issued by the competent State authorities of the country of origin for imported drugs;
 
DD) production process;
 
e) quality standards and testing methods;
 
g) reporting on the metrics to prove safety including material research on toxicity (acute toxicity, toxicity, field sales, field toxicity cells, the ability to cause cancer);
 
h) report on the figures prove the validity of the product including the documentary research on pharmacological experiments; about pharmacodynamics, pharmacokinetics and availability of products;
 
I) The study on the residual subsistence in all animal species indicated medication to determine the time to stop using drugs;
 
k) research on stability and expiry date of the drug;
 
l) document research on dosage and treatment data for each animal species is specified;
 
m) the votes of product quality analysis of manufacturer and product quality analysis of testing authority veterinary assigned in Vietnam;
 
n) assay results;
 
o) A commitment not to violate the provisions of intellectual property law according to the form prescribed in annex VII attached herewith;
 
p) other technical information (if available).
 
2. for medicinal pharmaceutical, chemical form, probiotics are free assay in article 11 of this circular, including registration records;
 
a) The content of the provisions in points a, b, c, d, e, e, k, m, o, p Item 1 of this article;
 
b) The information on the original drug, Generic Drug (product name, manufacturer name, formula, dosage, use, treatment, contraindications, dosage, use the time to stop using the drug, the note for specified animals, with users and other technical characteristics of the product).
 
3. for vaccines, antibodies, registration documents include: a) application released under the form prescribed in annex II, attachment to this circular;
 
b) summarizes the characteristics of the products according to the form prescribed in annex VIII, attached to this circular;
 
c) form the product label, the directions for use;
 
d) GMP certificate, license product circulation due to the competent State authorities of the country of origin for imported products;
 
DD) production process;
 
e) quality standards, methods of testing of vaccines, monoclonal antibodies;
 
g) report on the figures prove the safety, the effect of the product, including documentary research on antibody concentration and the length of immunity to vaccines, antibodies;
 
h) The study on the residual subsistence in all animal species are assigned to determine the time to stop the use of vaccines, monoclonal antibodies;
 
I) study materials on stability, the summary records of each batch produced 3 consecutive batches and proposed shelf life;
 
k) method of determining dosage and whether the process used for each species of animals are specified;
 
l) product quality analysis of Votes of the manufacturer, the product quality analysis of testing authority veterinary assigned in Vietnam;
 
m) report results assay on the effect and safety of the product;
 
n) The relevant documents include: origin, history, and the stability of the original micro-organism strain used for vaccines, antibodies; the documents related to copyright and the application of the certified production of vaccines, antibodies (if available);
 
o) other technical information such as results the assay laboratory in scope, data on the product has been released in other countries in the world (if available);
 

p) The epidemiological data demonstrate the presence of pathogens in Vietnam (applicable to new antibodies, vaccines).
 
4. for biological preparations for diagnosis (test KIT), registration documents include: a) application released under the form prescribed in annex III attached to this circular;
 
b) summarizes the characteristics of the products according to the form prescribed in annex VIII, attached to this circular;
 
c) form the product label; Manual sheet;
 
d) GMP certificate or certificate of quality management system (ISO) or other equivalent certificates, permits the circulation of products due to the competent State authorities of the country of origin for imported products;
 
quality analysis of Votes) probiotics of production base, slip the quality analysis of biological preparations by the Agency tested veterinary assigned in Vietnam;
 
e) report on the figures demonstrate the sensitivity analysis;
 
g) report on the figures prove the product's specific properties;
 
h) production process;
 
I) quality standards, methods of testing biological products;
 
k) study materials on stability, the summary records of each batch produced 3 consecutive batches and proposed shelf life;
 
l) report results assay, including the contents of assay sensitivity analysis, specific properties of the product;
 
m) The relevant documents include: origin, history of original microbial strains used for production of Biologicals; the documents related to copyright and the application of production certificate (if available);
 
n) other technical information (if available).
 
5. for veterinary medicines from medicinal herbs, registration documents include: a) application released under the form prescribed in annex I attached to this circular;
 
b) summarizes the characteristics of the products according to the form prescribed in annex VIII, attached to this circular;
 
c) form the product label, the directions for use;
 
d) GMP certificate, a certificate issued by the competent State authorities of the country of origin for imported drugs;
 
DD) production process;
 
e) quality standards and testing methods;
 
g) report on the figures demonstrate the safety and efficacy of the product;
 
h) The study on the residual subsistence in all animal species indicated medication to determine the time to stop using drugs;
 
I) research on stability and expiry date of the drug;
 
k) document research on dosage and treatment data for each animal species is specified;
 
l) Vote of product quality analysis of manufacturer and product quality analysis of testing authority veterinary assigned in Vietnam;
 
m) A commitment not to violate the provisions of intellectual property law according to the form prescribed in annex VII attached herewith;
 
n) other technical information (if available).
 
6. for veterinary certificates had circulated in Vietnam production, san chia, registration documents include: a) production application, form prescribed in divided san annex X attached herewith;
 
b) the summary of product information (name, ingredients, dosage, packing, uses, dosages, expiry date);
 
c) form the product label, the directions for use (registered label, label, san chia);
 
d) GMP certificate or certificate of eligibility of producers receiving production facility, san chia;
 
DD) certificate of circulation of the products set machining, san chia due to animal health;
 
e) contract machining, san chia veterinary between campus, san chia and get base, san chia;
 
g) the manufacturing process of the party place, san chia;
 
h) quality standards and testing methods for raw, original material, semi-finished and finished products of the parties placed, san chia;
 
I) product quality analysis of Votes of the receiving facility, san chia;
 
7. for veterinary medicine has no certificate of circulation in Vietnam to export production, registration documents include: a) sign the manufacture for export according to the form prescribed in annex XI attached herewith;
 
b) summarizes the characteristics of the products according to the form prescribed in annex VIII, attached to this circular;
 
c) form the product label, the directions for use;
 
d) GMP certificate of production facilities;
 
DD) production process;
 
e) quality standards and testing methods;
 
g) Votes of product quality analysis of production facilities, product quality analysis of testing authority veterinary assigned in Vietnam;
 
h) A commitment not to export the production of drugs consumed in Vietnam;
 
I) A commitment not to violate the provisions of intellectual property law according to the form prescribed in annex XII attached to this circular.
 
Article 4. Asked about outsourcing production, san chia veterinary 1. Only be machined, san chia veterinary certified circulation in Vietnam is still in force or veterinary certificate yet circulating in Vietnam to export.
 
2. the receiving facility, san chia's production facilities are animal health certification of good manufacturing practices (GMP) or the certificate of eligible production line with veterinary register production, san chia.
 
Article 5. Contract machining, san chia veterinary
 

Contract machining, san chia smoking must do the text and are consistent with the current rules of the law of Vietnam, there is has the following contents: 1. the agreement on supply of raw material, the supply of production processes, technical standards and testing methods resources the original material, semi-finished products, finished products and other papers relating to the production, san chia.
 
2. Rights and responsibilities of each party regarding the quality control of raw material, semi-finished products, finished products, packing process, the label of the product and specify signing the slip testing each batch of finished products and marketed products.
 
3. Powers and responsibilities of each party regarding the retention of records records of production, quality control, distribution, circulation, saving the form, solve the problems related to the quality, appeal, revoke the product on the market.
 
Article 6. Rules of language, forms of records 1. The language used in a registration profile) a profile registered veterinary drug production in the country are written in Vietnamese;
 
b) registration documents veterinary drugs manufactured abroad must be written in Vietnamese or English. Case records are written in English, the information in the manual sheet, summary of product characteristics required to be written in Vietnamese.
 
2. Form a record) registration documents veterinary drugs must be drafted on paper size A4, closed the for sure. The profile must have a cover page and table of contents, are arranged in the correct sequence of contents, there are separate between sections. The separator section must be numbered for ease of reference; each veterinary medicine must have a separate registration;
 
b) The type certificate of GMP, ISO certificate, certificate of eligible production of veterinary medicines, the certificate of eligibility to import veterinary drugs, the votes of product quality analysis (CoA), certificate of circulation of products (CFS, CPP, MA), contract machining, san chia veterinary medicines included in the registration documents , may submit the originals or copies are stamped confirmation of registered enterprises.
 
Article 7. Named veterinary 1. The Ministry of agriculture and rural development recommended the base register using the name of the drug under the name international public (INN).
 
2. in case of not naming the drug under the name INN, registered establishments veterinary drugs can name for the drug. Commercial name of veterinary medicine must ensure the following principles: a) not exceeding the therapeutic effect of drugs;
 
b) not write wrong therapeutic effect and pharmacological effects of the drug;
 
c) not violate American style, pure, traditions of Vietnam;
 
d) does not conflict with the objects of the intellectual individuals, other organizations are protected;
 
DD) are not identical or similar to the name of the drug have been given the registration number of the facility;
 
e) are not named the same drug if the drug has a different active ingredient;
 
g) Not be named different medications in the case of the drug with the same formula, the same patent production process of the same manufacturer.
 
Article 8. Appraisal of records, certificate of circulation and the time limit for replies to profile 1. Appraisal of records, certificate of circulation of veterinary medicine a) animal health receiving registration documents circulation, appraisal records, organize specialized scientific Council meeting veterinary certification, veterinary medicine circulation according to the form prescribed in annex IX attached to this circular the Ministry of agriculture and rural development, recognizing the added Category veterinary drugs are allowed to circulate in Vietnam.
 
The specialized scientific Council of veterinary medicine by the Chief vet decided to establish. The specialized scientific Council of veterinary meeting at least once in three months to evaluate the results of the appraisal records, test results, assay and recommend Director veterinary certificate veterinary circulation;
 
b) for veterinary certificates had circulated in Vietnam registered production, san chia, animal health evaluation of registration documents, certificate of circulation veterinary drugs production, san divided by form prescribed in Appendix XIII attach herewith; the Minister of agriculture and rural development, in addition to veterinary medicine Catalog is allowed to circulate in Vietnam. For veterinary medicines do not have certificates in circulation in Vietnam to export production, animal health evaluation of registration documents, certificate of circulation veterinary only to exports according to the form prescribed in annex XIV attached this circular or at the request of the importing country.
 
2. The validity of the certificate of circulation of veterinary medicine a) circulation certificate veterinary worth within a period of 5 years from the date of issue;
 
b) certificate floated veterinary drugs production, san chia in effect by the time the validity of the contract production, san chia veterinary plus the duration of use of the product and the maximum is 5 years from the date of issue.
 
3. The time limit for a reply) within 10 days from receipt of registration, the Department of animal health has a responsibility to notify the Organization, individuals register know to perfection for the cases of unsatisfactory records;
 

b) animal health is responsible for the appraisal of records and responding to results within the time limit as follows: 20 days from the date of receiving documents for the registration profile to export production, production machining, san chia; 40 days from the date of receiving documents for the registration of drugs exemption assay, biological preparations for diagnosis; 6 months from the date of receiving documents, for new drug registration documents, vaccines, antibodies, drugs from medicinal herbs.
 
Article 9. Registration records reissued certificate floated veterinary 1. Changing ingredients, formulations, dosage, use, dosage, treatment of veterinary drugs; change the method, production process that alters the quality of products; Re-evaluate the quality, efficiency, safety of veterinary medicines as prescribed. Registration records reissued certificate floated veterinary drugs are made in accordance with article 3 of this circular.
 
2. Lost, errors, damaged; change, additional product name; the name, location, registration facility; the name, location, production facilities; packing of the product; This form of drug labels; expiry date and time to stop using drugs; contraindications to treatment; whether the treatment; the change but does not affect the quality, efficiency, safety of veterinary records, including: application for certificate re-issuance proposal floated veterinary medicines according to the form prescribed in annex IV attached to this circular; documentation content changes; the old label templates, new; certificate of circulation of veterinary medicine has been granted (original or a copy of stamped confirmation, of business registration) except in case of loss.
 
Article 10. Registration renewal certificate floated veterinary 1. Renewal certificate issued according to form prescribed in Appendix V attached to this circular.
 
2. Copy of certificate of circulation of veterinary drugs.
 
3. The certificate of GMP or ISO certificate or certificate of eligible production of veterinary or qualified certificates to import veterinary drugs; the certificate issued by the competent State authorities of the country of origin for imported drugs.
 
4. Slip the product quality analysis of manufacturing or testing of veterinary drugs is indicated in Vietnam granted within the time limit of 12 months for pharmaceuticals, chemicals, biological products; the votes of product quality analysis of production facilities and testing of veterinary drugs is indicated in Vietnam granted within the time limit of 12 months for vaccines, antibodies.
 
5. production contracts, san chia veterinary between parties set machining, machining and the receiving party san, san chia for drug production, san chia.
 
6. The report tracking the product stability in the condition of preservation.
 
7. report the process of circulation of medicines according to the form prescribed in Appendix VI attached to this circular.
 
Section 2. Veterinary ASSAY article 11. The case of Veterinary Assay exemption 1. Veterinary medicines produced according to original drug, Generic Drug for pharmaceutical drugs, chemicals, biological products; imported veterinary medicines except vaccines, antibodies have been allowed to circulate in the United States, Japan, Australia, Canada and Europe.
 
2. ability to produce base veterinary of the countries other than the object specified in paragraph 1 of this article, the Department of animal health to review the Minister of agriculture and rural development, the country had additional Veterinary Assay exemption.
 
Article 12. Required for the assay animals 1. There are species, sex, age, weight matching specified using the drug.
 
2. clinical healthy for vaccines, antibodies.
 
3. No antibodies correlate with vaccines, the antibody assay.
 
Article 13. The assay target veterinary pharmaceutical forms, chemicals, biological products (except vaccines, antibodies) 1. A safety norms) for the species of animals are specified using drugs: animals do not die and normal development;
 
b) for aquaculture environment: DO, pH, in;
 
c) norm residues for animal products: time to stop using the drug before the harvest, slaughter.
 
2. Indicators for the animals is specified using a) freshness of animals after the assay: animals no longer clinical symptoms of the disease;
 
b) proportion of animals from the disease after the assay.
 
3. other technical norms (outlined in the registration records in circulation).
 
Article 14. The scale and duration of assay veterinary pharmaceutical forms, chemicals, biological products (except vaccines, antibodies) 1. A assay scale) for terrestrial animals: poultry to a minimum 300 children; minimum 40 pigs; cattle, goats, sheep, horses, dogs, cats are a minimum of 20 children; the number of other pets due to animal health decisions and record in assay license;
 
b) for aquatic animals: assay conducted in laboratory conditions and in the feed from 3 ponds, cages and over.
 
2. assay time is determined based on whether a drug treatment program.
 
Article 15. The assay target vaccines, antibodies 1. Safety norms for the animals is indicated using the following technical profile of the drug.
 
2. Only valid for specified animals use.
 

a) rate of animals with antibodies that reach the threshold of protection after vaccination;
 
b) protection rate.
 
3. other technical norms (outlined in the registration records in circulation).
 
Article 16. The scale and duration of vaccine, assay antibodies 1. A assay scale) minimum 300 bird children; minimum 40 pigs; cattle, goats, sheep, horses, dogs, cats are a minimum of 20 children; minimum 1000 fish;
 
b) In special cases, the determination of the number of animals the assay are specific provisions in the licence the assay;
 
c) identifying number serum sample take the test antibodies to ensure statistically reliable results.
 
2. assay time is determined for each type of vaccine, antibodies.
 
Article 17. Indicators, scale bio product assay to diagnose (test KIT) 1. Standard norms the manufacturer's facility announced, include: a) sensitivity analysis;
 
b) Computer.
 
2. assay: scale made in the laboratory, at least 30 responses for each type of product.
 
Article 18. Register level, level again Veterinary Assay license 1. Grant application form, the license again Veterinary Assay according to the form prescribed in annex XV, XVII, attached to this circular.
 
2. the report reviews the basis of eligible assay prescribed in clause 2, article 45 of this circular.
 
3. Technical documentation of each assay drugs include: a) the summary of product characteristics according to the form prescribed in annex VIII, attached to this circular;
 
b) technical information about the quality of the product;
 
c) technical information about the safety and effectiveness of the product;
 
d) product quality analysis of Votes of the manufacturer (original or a copy of stamped confirmation of registered establishments);
 
DD) the votes of product quality analysis of testing authority veterinary assigned in Vietnam (originals or copies are stamped confirmation of registered establishments);
 
e) outline of assay;
 
g) assay contract between registered establishments and facilities of the assay (original or a copy of stamped confirmation of registered establishments).
 
Article 19. The license of the assay and assay results reports veterinary drugs 1. Sample Veterinary Assay license according to the form prescribed in Appendix XVI attached to this circular.
 
2. the registration base animal health reports assay results of most slow assay after 15 days from the end of the assay process. The report based on the outline of assay, including the content specified in annex XVIII attached to this circular and confirmed by the monitoring unit assay.
 
Category 3. The PRODUCTION, TRAFFICKING, import veterinary medicine article 20. Register, renew, refresh the certificate of eligible veterinary medicine manufacturing 1. Grant application form, renew, refresh the certificate of eligible production of veterinary medicines according to the form prescribed in annex XIX, XXXI attached to this circular.
 
2. A detailed presentation about the facility, veterinary medicine production techniques according to the form prescribed in annex XXI attached to this circular, 3. Sample documents examine production conditions and model veterinary certificate of the eligible production of veterinary medicines according to the form prescribed in annex XXIII, XXV attached to this circular.
 
4. Registration, renewal, reissuance of certificates of good manufacturing practice veterinary medicine according to the form prescribed in annex XXVIII, XXXI attached herewith; sample documents examine good manufacturing practice veterinary medicine and samples of certificate of good manufacturing practice of drugs according to the form prescribed in annex XXIX, XXX attached to this circular.
 
Article 21. Register, renew, refresh the certificate of eligible traders, import veterinary medicine 1. Grant application form, renewal, reissuance of certificates of eligibility to trade, import veterinary medicine according to the form prescribed in annex XX, XXXI attached to this circular.
 
2. A detailed presentation about the facilities, technical traders, import veterinary medicine according to the form prescribed in Annex XXII attached to this circular.
 
3. Form a check condition of trade, import veterinary medicine according to the form prescribed in Annex XXIV attached to this circular and the form of certificates of eligibility to trade, import veterinary medicine according to the form prescribed in annex XXVI, XXVII attached to this circular.
 
Item 4. IMPORT of medicines, RAW MATERIALS for veterinary medicine Article 22. Subscribe to import veterinary drugs, veterinary materials 1. Profile import veterinary medicine has not yet certified circulation to animal epidemic prevention, remedial emergency disaster, including: a) the application to import veterinary drugs according to the form prescribed in annex XXXII attached to this circular. At the same time send through e-mail (word, excel);
 
b) copy of business registration certificate or registration certificate or business license of enterprise investment with consistent professions of the Organization, the individual proposed license to import veterinary drugs;
 
c) certificate of good manufacturing practices (GMP) or the certificate of quality management system (ISO) or other equivalent certificates for some common chemicals;
 
d) certificate of circulation of products (CFS, CPP, MA) by the competent State agencies of the exporting country;
 
DD) the votes of product quality analysis (CoA) of the manufacturer;
 
e) product label.
 

2. import profile sample veterinary to testing, assay, registering circulation, including: a) the application to import veterinary drugs according to the form prescribed in annex XXXII attached to this circular. At the same time send through e-mail (word, excel);
 
b) copy of business registration certificate or certificate of registration of business or organization's investment license, licensing proposal personally imported veterinary medicines for the first time;
 
c) certificate of good manufacturing practices (GMP) or the certificate of quality management system (ISO) or other equivalent certificates for some common chemicals;
 
d) certificate of circulation of products (CFS, CPP, MA) by the competent State agencies of the exporting country;
 
DD) the votes of product quality analysis (CoA) of the manufacturer;
 
e) summary of product characteristics.
 
3. The profile import veterinary medicine to join the gallery exhibitions, fairs, scientific research, including: a) the application to import veterinary drugs according to the form prescribed in annex XXXII attached to this circular. At the same time send through e-mail (word, excel);
 
b) copy of business registration certificate or certificate of registration of business or organization's investment license, licensing proposal personally imported veterinary medicines for the first time;
 
c) A copy of the document proving the intent to import veterinary drugs;
 
d) Vote of product quality analysis (CoA) of the manufacturer;
 
DD) summary of product characteristics;
 
e) product label.
 
4. import profile veterinary medicine for healing for animals to temporarily enter the re-export, transit the territory of Vietnam; temporary re-export import, export processing under a contract signed with the Organization, individuals, including: a) the application to import veterinary drugs according to the form prescribed in annex XXXII attached to this circular. At the same time send through e-mail (word, excel);
 
b) Vote of product quality analysis (CoA) of the manufacturer;
 
c) A copy of the document proving the intent to import veterinary drugs;
 
d) product label.
 
5. import records of raw materials, veterinary drugs, microorganisms, to study the production of veterinary drugs, diagnosis, tests, testing of veterinary medicine a) application form to import veterinary drugs according to the form prescribed in annex XXXII attached to this circular. At the same time send through e-mail (word, excel);
 
b) copy of business registration certificate or certificate of registration of business or organization's investment license, licensing proposal personally imported veterinary medicines for the first time;
 
c) the vote of product quality analysis (CoA) of the manufacturer;
 
d) summary of product characteristics;
 
DD) product label.
 
6. import profile veterinary aid by international organizations and the non-trade imports form the other.
 
a) registration form to import veterinary drugs according to the form prescribed in annex XXXII attached to this circular. At the same time send through e-mail (word, excel);
 
b) copy of business registration certificate or registration certificate or business license of enterprise investment with consistent professions of the Organization, the individual proposed license to import veterinary drugs;
 
c) certificate of good manufacturing practices (GMP) or the certificate of quality management system (ISO) or other equivalent certificates for some common chemicals;
 
d) certificate of circulation of products (CFS, CPP, MA) by the competent State agencies of the exporting country;
 
DD) the votes of product quality analysis (CoA) of the manufacturer;
 
e. the product label.
 
7. import profile veterinary materials include: a) the application to import veterinary drugs according to the form prescribed in annex XXXII attached to this circular. At the same time send through e-mail (word, excel);
 
b) certificate of good manufacturing practices (GMP) or the certificate of quality management system (ISO) or other equivalent certificates for some common chemicals;
 
c) certificate of circulation of products (CFS, CPP, MA) by the competent State agencies of the exporting country;
 
d) Vote of product quality analysis (CoA) of the manufacturer;
 
DD) copy of certificate of eligibility to import veterinary drugs of the basis of the import licensing proposal due to animal health import establishments supply ingredients for veterinary first;
 
e) report the number, purpose of using antibiotic raw material, raw material purchasing base address of antibiotic material batch import times before, when applicants register to import raw materials for antibiotics the next shipment of veterinary Bureau according to the form prescribed in annex XXXIV attached to this circular.
 
8. import profile vaccines, microorganisms in the directory of veterinary medicine are allowed to circulate in Vietnam or have certified circulation in Vietnam are: a) the application to import vaccines, microorganisms according to the form prescribed in annex XXXIII attached to this circular Sends an e-mail message (word, excel);
 
b) copies of certificates of eligibility to import veterinary drugs of the basis suggested by the import licensing of veterinary Bureau level for the first time to import.
 
9. The types of certificate of GMP, ISO, CFS, CPP, MA, the CoA is included in the registration dossier may submit the originals or copies are stamped confirmation of registered enterprises.
 

10. license to import medicines, veterinary materials worth a maximum of 1 year from the date of issue.
 
Chapter III REGISTERED veterinary medicine Article 23. The veterinary medicines are labeled 1. The drug circulation in the country; export and import drugs are labeled according to the provisions of this circular, except in the case specified in paragraph 2 of this Article.
 
2. in case the Organization, foreign individuals importing Vietnam's drug labeling requirements under the contract for the sale and responsible for the requirements of the individual organizations to export drugs made under contract with the conditions of this request does not falsify the nature of smoking , does not violate the law of Vietnam and the country's import laws.
 
Article 24. The responsibility for labeling veterinary 1. For veterinary medicines produced in Vietnam to the circulation in the country, organization or individual drug production is responsible for the label.
 
2. for veterinary medicines produced in Vietnam to export, export, individual organizations are responsible for drug labeling.
 
3. In the case of veterinary drugs has had a certificate of circulation in Vietnam does not export that was sent back to domestic organizations, individuals take drugs out of circulation are labeled according to the provisions of article 26 of this circular.
 
4. In the case of organizations, individuals responsible for labeling the drug as prescribed in article 10 of Decree No. 89/2006/ND-CP dated 30/8/2006 of government regulations about the labels of the goods (hereinafter the Decree 89/2006/ND-CP) requested organizations and individuals implement the labelling organizations personally, it still has to take responsibility for its drug label.
 
5. The drug imported into Vietnam has original label is not consistent with the provisions of this circular, the Organization, the individual must import extra label prescribed in paragraph 3 Article 26 of this circular before making circulation and must keep the original label.
 
6. The institutions, individual manufacturing, drug business must comply with the provisions of the law on intellectual property and responsible before the law about intellectual property issues for the content recorded on the drug label.
 
Article 25. The position, size, color of text, symbols and pictures on the labels of drugs 1. Position the label veterinary veterinary drug Labels must be made (print, paste, attach, attached) on the packaging of medicinal products in the position when observing can recognize easily, full of the content specified by a label that is not removable in the details, the composition of the drug, according to the provisions in clause 1 article 6 of Decree 89/2006/ND-CP.
 
2. The size label veterinary organizations, individuals are responsible for drug labeling yourself determine the size of the label but must ensure the full record content required according to the provisions of article 27 of this circular and identify easily with the naked eye.
 
3. The color of letters, symbols and pictures on the drug label color of letters, numerals, drawings, pictures, signs, symbols, indicated on the labels of drugs must be clear. With regard to the contents required by the regulations, the letters, the digits must have contrast color than the background color of the label according to the provisions of article 8 of the Decree 89/2006/ND-CP.
 
Article 26. The language of presentation on the drug label 1. The required content expressed on the label veterinary must be recorded by the Vietnamese, except for cases stipulated in clause 4 of this Article.
 
2. Veterinary drugs production and circulation in the country, in addition to the implementation of the provisions of Paragraph 1 of this article, the content shown on the label can be recorded simultaneously in another language. Write content in another language to Vietnamese content respectively. The font size is recorded in another language are not larger than the font size of the content written in Vietnamese.
 
3. Veterinary drugs imported into Vietnam on the original labels have not expressed or expresses not enough the contents required by Vietnamese must have extra labels the contents required by Vietnamese and retains the original label of the drug.
 
4. The following text may be written in other languages have Latin letters root: a root name, miscellaneous) name or common name of drug international;
 
b) international or common name scientific name of the component, the component of the weight in the case of not translate out Vietnamese or Vietnamese but that doesn't mean being out;
 
c) names and addresses of foreign production, business franchise.
 
5. The content recorded on the label veterinary including extra labels and manuals to ensure honest, clear, accurate, properly reflect the nature of the drug.
 
Article 27. The content recorded on the label veterinary 1. The content required to be shown on the label veterinary veterinary records Label ... complete the following: a) name of the veterinary medicine;
 
b) active ingredient, the quantitative component of the active ingredient (or concentration);
 
c) packing;
 
d) specify, how to use, contraindications; time to stop using the drug to milk, meat, egg extraction for each species of animals are specified;
 
DD) dosage form, the registration number in circulation, the production batch number, production date, expiry date, the phrase "only used in veterinary medicine";
 
e) the marks need attention: for veterinary poison in A table added phrases (black letters): "Don't overdose prescribed"; for veterinary poison in table B added phrases (red letters): "Don't overdose prescribed";
 
g) name and address of the organization or individual responsible for veterinary medicine;
 

h) origin of veterinary medicine: for manufacturing drugs in Vietnam to the circulation in the country, has recorded the address of where the produce drugs that are not required to record the origin;
 
I) manuals, guidelines for preservation in case of non show the total content stated on the label on the drug must write the content stated in the points a, b, c, e, f, g, h of this paragraph. The other required content must be written in the label or in the instructions for use and on the drug label must indicate where to write the content.
 
2. Other content shown on the label in addition to the veterinary medicines required content specified in article 27 paragraph 1 of this circular, may be recording more content onto the label, for example the number of quality standards. This content must ensure honest, accurate, not misleading nature, uses of the drug, not misunderstand the content of labels.
 
3. The content recorded on the label the ingredients for veterinary drugs. The label ingredients for veterinary drugs must have the following: a) the name of the material;
 
b) concentration or concentration (if applicable);
 
c) standards of raw materials;
 
d) net weight or volume;
 
the production batch Number), the date of manufacture;
 
e) expires, the conditions of preservation;
 
g) registration number (if available);
 
h) name, address, facility production;
 
I) origin of the raw materials (for raw materials produced in Vietnam to the circulation in the country, has recorded the address of the place of production are not required to record the origin);
 
k) the name, address import facility for imported raw materials;
 
l) signs that need attention.
 
4. The content recorded on the labels in blister veterinary. Labels on veterinary adapter must have at least the following: a) name of the veterinary medicine;
 
b) active substances: veterinary medicine, in the form of coordination that is less than or equal to 3 active substances must then write enough content, of each active substance;
 
c) the batch number of manufacture, expires, the registration number in circulation;
 
d) production facility Name. The name production base could write off but must ensure the recognized name of the production base.
 
Blister medication must be contained in the outer packaging with full content expression specified in article 27 paragraph 1 of this circular.
 
5. content labeling on packaging has a small size direct) Label veterinary directly on packaging has small size, has a special shape design can not present the content required in accordance with paragraph 1 article 27 of this circular, then at a minimum must have the following content : name of veterinary drugs; active substances: veterinary medicine, in the form of coordination that is less than or equal to 3 active substances must then write enough content, of each active substance; the volume or volume; the production batch number, expiration, the registration number in circulation; the name production base could write off but must be guaranteed;
 
b) The packaging directly contain the medications the vet on must be contained in the outer packaging with full content expression specified in article 27 paragraph 1 of this circular.
 
Article 28. How to label veterinary 1. Name of the veterinary medicine a) Name veterinary organization, individual manufacturing, veterinary business set. Drug name not misrepresent the nature and uses of the drug. Drug name written on the label is bold, striking.
 
Miscellaneous case is the substance must record the original name or the common name immediately following the special name international pharmacy;
 
b) drug Name can be put under: the original name; international common name (INN); Miscellaneous names.
 
2. Active ingredient, amount or concentration of a constituent Record) all the active substances and excipients used to produce and survive in the drug product, including the case form the material on has been changed in the production process as defined in clause 1 Article 18 Decree 89/2006/ND-CP;
 
b) Scored all of the active ingredient, amount or concentration of each active ingredient for a unit divided into small doses or for a small packing units for optional component records, and the amount of excipient. The active ingredient in the original name or the common name;
 
c) unit of measurement quantifying measurement unit Records on label veterinary by full name or symbol of the unit. Can use power units of international regulations for a number of active substances.
 
3. Packing a) notes the packing of medicines is recorded the number, net weight, the actual volume of the drug contained in commercial packaging of drugs;
 
b) packing of the drug must follow the natural count;
 
c) specific notes for some types, the form of veterinary drugs as follows: Veterinary pellets: record number of members, active content of members; Veterinary powder form: record the net weight; veterinary medicines in liquid form: record real volume; aphrodisiac for animals and a number of other active substances: score international units IU (or UI);
 
d) case in a commercial packaging of drugs have a variety of units packaged is the quantitative recording of each packing unit and packing unit quantity.
 
4. Specify, how to use, contraindications and time stopped using a drug) is indicated for each animal species recorded on the label must match the use of the drug;
 
b) use to specify path used, dosage, time use of drugs;
 
c) contraindications you must specify non-drug cases. The absence of contraindications, the note is not there;
 

d) specify, how to use, contraindications can burn in one of two ways as follows: burn directly on commercial packaging of drugs or in the case of the label on the outside packaging is not enough area to record the contents of the specified use, contra-indications on the label to have the words "specify , uses, contraindications: Please read in the manual "and must have manual sheet attached to the packaging of medicinal products;
 
DD) time to stop the use of drugs: a detailed record of the time stop using drugs for each species of animals are specified using the drug. The case does not have the time to stop using the drugs clearly is not there.
 
Time to stop using the medication should correspond to the time stated in the registration documents.
 
5. Dosage, the number in circulation, the production batch number, production date, expiration, preservation conditions a) dosage of veterinary record: pills, powders, pills, injection of fluids mixed drug injection, powder for injection drug epidemic, drinking fluids and medication dosage;
 
b) the registration number issued is the symbol are animal health level for a veterinary product to drug certification that registered in Vietnam;
 
c manufacturing batch Number), record the following: batch number batch number of MANUFACTURE or production. The structure of the production batch number due to self regulated production facilities;
 
d) recording days, months, years for production date, expiry date, storage specifically as follows: date of manufacture, the expiry date on the label is full or burn off with capital letters is: NSX, HSD, in order of year, month, day of the calendar year. Each number only, only, only five days, recorded by two-digit numbers are allowed, only four-digit year. The number of days, months, years of just a timeline should recorded along a line; the provisions on recording, month and year to date production, the term used in article 16 of Decree 89/2006/ND-CP; the case failed to write the word "NSX", "HSD" together with digits only days, months, years, to instructions on the label; the case on the record label on produce, term used in foreign languages on the extra label must record: date of manufacture, expiration or written off by capital NSX, HSD view "Mfg Date" Exp "Date" on the packaging;
 
preservation conditions) is the climate factor so as not to transform the quality of drugs. Must specify the conditions necessary to preserve the drugs on drug labels. For example, preserved in a dry airy place, temperature not exceeding 30° c.
 
6. The sign to note a) injection, powder medicine for injection drug use clearly. Use of the drug can be written off: intramuscular (tb), injected under the skin (tdd), intravenous (tm);
 
b) eye drops, eye burn the words "Smoking eye test";
 
c) Drugs used outside the skin burn the words "Drug user";
 
d) Smoking pipe close to drinking the inscription "Not be injected";
 
DD) for some types of chemicals in animal health notes to write the typical quality criteria and if the chemical is flammable, explosive, toxic, corrosive are added to the corresponding warning, if the chemicals contained in the average of the pressure to keep adding the average number, load capacity warning, hazardous;
 
e) on label veterinary must keep the warnings (if any) in order to ensure security for people when used for the treatment of animal diseases;
 
g) taking note of the letters of the signs, the signs note must be in clear, bold strokes to be easily identifiable; the case of a veterinary drug has many signs to note, need to fully record the signs note that.
 
7. Name, address, organization, individual producer responsibility for smoking a) name and address of organization, production, personal responsibility for the drug not to be written off;
 
b) recording the name and address of the Organization, the individual responsible for the drug prescribed in annex XXXV attached herewith;
 
c) case on label names, address distribution facility, the name, address of the distribution facility must keep in the same place with the name, the address of the manufacturing facility and the size is not greater than the name of the production facility;
 
d) name of individual responsible for the drugs must write the full name of the facility was included in the legal text concerning the establishment of the base. Can be added to the name of the transaction but the size is not greater than the full name;
 
DD) address production base, the base package, the base received the franchise, the receiving facility, san chia: House number, street (Hamlet, Hamlet), communes (commune, Ward), districts (districts, towns and cities in the province), the province (central city).
 
8. Origin of veterinary medicine a) for imported drugs: "made in" or "origin" with the name of the country or territory to produce drugs that;
 
b) for drugs produced in Vietnam to circulate in the country have recorded the address of where the produce drugs that did not require recording made of the drug;
 
c) origin of the drug must be recorded on the outer packaging and the immediate packaging of medicines.
 
9. Manual veterinary medicine a) labeling Medications as prescribed in this circular are there manual sheet by Vietnamese, can print the contents of manual medicine packaging or labels instead of mediated instruction sheet included.
 
The size, the color of the letters written on the manual sheet is large enough, apparently, to easily identify the contents with the naked eye;
 
b) manual sheet content of drugs prescribed in annex XXXVI attached to this circular.

 
10. How the extra extra Label label must be mounted on the outer packaging of veterinary medicine and not obscure the contents of the original label. The content recorded on the label not misrepresent the content of the original label and organization, individual labeling must be responsible before the law for the accuracy, honesty with regard to the content added. How to burn extra labels as follows: a) extra label case has an area of wide enough, then write the entire content required under the provisions in article 27 paragraph 1 of this circular;
 
b) extra label case is unable to write the full required at least to write the following: drug name; the active ingredient, amount or concentration; name of organization or individual responsible for smoking; the registration number in circulation; packing; date of manufacture, batch number, expiration of production; the origin of the drugs.
 
The other missing mandatory contents are recorded in the manual. Then on the right side label inscription: "other information suggested the view in the accompanying manual" and considered recording section of manual on the sheet was just out on extra label is part of the extra label;
 
c) original label instances using the language native to Latin letters that the content here is already on the original label shall be permitted not translated into Vietnamese and no needing extra labels on: Miscellaneous name, original name or common name of drug international; the common name or the scientific name of the international components of the medication in case of not translate out Vietnamese or Vietnamese but was not translated means; the names and addresses of foreign production, business franchise.
 
Chapter IV TESTED veterinary medicine Article 29. Veterinary testing system 1. The base tested in animal health: testing centre of the central veterinary medicine and veterinary testing Center No.2.
 
2. The basis of do drug testing services.
 
Article 30. Activities of veterinary test facility 1. The base tested in animal health: a) testing, evaluate the quality of drugs on a national scope;
 
b) tested the quality of registered medicines circulate;
 
c) evaluation standard of quality of drugs and other products at the request of the Ministry of agriculture and rural development;
 
d) perform testing services;
 
DD) other activities under the provisions of the relevant laws.
 
2. The basis of do drug testing service to perform services, materials testing products in the production process, the drug product for the manufacturing, trading, catering for the management, check the State of the quality of the drug.
 
3. The veterinary testing facility when performing testing activities veterinary service of the management of the State competent bodies must be appointed according to the provisions of the law.
 
Article 31. The applicable rules on veterinary testing methods 1. The drug testing is conducted according to the specified test methods, in accordance with the method of testing the quality of drug production base, base of registered importers.
 
Cases of application of other methods not according to the method in the registered standards must then be approved by the Department of animal health.
 
2. where there is doubt regarding the composition or quality of the drug, tested in animal health apply other methods with the methods in the standard have registered to test and give the test results for the quality of medicines.
 
Chapter V QUALITY CONTROL of veterinary medicine Article 32. The base construction of quality standards in veterinary medicine and veterinary medicine quality control 1. The base construction of veterinary medicine quality standard a) national technical regulation of veterinary medicines;
 
b) national standards of veterinary drugs;
 
c) Vietnam Pharmacopeia standards or applicable international standards: Europe (EU), the UK, USA, Japan. The application must include the entire regulations on quality criteria, quality level and the test method specified in pharmacopoeia.
 
2. Bases of quality control of veterinary drugs as prescribed in paragraph 1 of this article and of the basis criteria manufacturer announced, apply.
 
Article 33. Check the State of quality veterinary drugs in the production of 1. Agency: animal health 2. The base to inspect a), information alerts about veterinary export do not match the conditions specified in article 32 the product quality Law, goods;
 
b) products in circulation on the market do not conform with the standards applied, the corresponding technical standards through inspection, quality monitoring product or have recommendations of authorities on the quality of the product.
 
3. Form check: make check group form.
 
4. content check) to check the implementation of the requirements prescribed in the drug good manufacturing practices (GMP) and other legal provisions involved;
 
b) examined the implementation of drug registration, product stability studies, labeling veterinary prescribed;
 

c) sample cases: in the process of checking in at the factory, when discovered with signs products does not guarantee the quality or signs do not ensure quality when the circulation on the market, the product samples tested product quality. Product samples must be sent to the testing facility was recognized or appointed to analyze the quality of the product. Test results of test facility is the legal base for further processing inspection agency during checking.
 
5. The order and procedure of inspection prescribed in paragraph 3 Article 29 product quality Law, the goods.
 
6. Processing test results: follow prescribed in article 30, the product quality Law.
 
Article 34. Check the State of quality veterinary drugs imported 1. Agency: Department of animal health.
 
2. Test subjects a) veterinary drugs when imported into Vietnam to check the quality except not tested according to the provisions of point b of this Paragraph;
 
b) cases of veterinary import not quality control: model testing, assay, sign up, join the gallery exhibitions, fairs, scientific research; healing for pets import temporary re-export, transit the territory of Vietnam; temporary re-export import, export processing under a contract signed with foreign countries; the raw materials used in the diagnosis, tests, testing of veterinary medicine; in aid of international organizations and the non-trade imports form the other.
 
3. quality control criteria a) quantitative, qualitative raw material for veterinary drugs, pharmaceuticals, chemicals, biological products;
 
b) sterility or purity, potency and safety for vaccines, antibodies.
 
4. content check) check of records;
 
b) check the suitability of the content of quality analysis votes imports compared with the normative requirements in technical standards applied and the current rules;
 
c) check the sample label veterinary: check the mandatory content recorded on the label (and extra label) as defined in chapter III of this circular label veterinary for veterinary products; the fit of the model label with the catalog import profile.
 
5. quality analysis sampling the sampling of drugs to quality control as specified in technical regulation QCVN 01-3:2009/BNNPTNT attached to circular No. 66/2009/TT-BNNPTNT on 13/10/2009 of the Ministry of agriculture and rural development.
 
6. a sampling frequency) for raw material medicine and veterinary products (except vaccines, antibodies are used in veterinary medicine).
 
Sampling of 8 imports continued to check the quality.
 
The case with quality results, reduced sampling frequency 5 import the next one will take the form of import shipments 1 to check the quality.
 
When discovered the shipment does not reach the quality inspection agency, will take the form of import shipments 3rd row to check, if the result of this shipment quality 3, apply the frequency 5 imports will take the form of shipment for 1st quality control;
 
b) for vaccines, antibodies are used in veterinary medicine.
 
Sample all shipments of imported vaccines to check the quality of sterile or target purity and safety; valid targets will be tested with a frequency of 5 consecutive import shipment by the same manufacturer and of the same import unit will take the form of 12 imported shipments for inspection.
 
When a shipment contains only valid quality criteria, the Agency will examine sample 8 imports continued to test, if the results of the 2nd shipment quality, apply frequency 10 consecutive imports due to the same basis and the same production unit will take the form of import 1 imports to check overall the force.
 
Particularly for bird flu vaccines for foot and mouth, ears, green 100% sampling frequency the imports to check the quality of sterile norms or safety, purity and potency;
 
c) results of monitoring or quality control of veterinary import traffic on market quality will apply sample form analysis of quality control of all imports, until 2 consecutive shipments had satisfactory results, the sampling frequency was reduced to 5 imports next sampling 1 shipment to analyze quality control;
 
d) upon request of the Department of animal health shall conduct sampling to check the quality.
 
Article 35. Profile, sequence checking state of quality veterinary drugs imported 1. A record) application quality control of veterinary import according to the form prescribed in Appendix XXXVII attached to this circular (2 copies);
 
b) purchase contract (Contract), product category, quantity enclosed (Packing list), the purchase invoice (Invoice), cargo tracking (bill of lading);
 
c) text agreed to import veterinary drugs, vaccines, veterinary drugs, microorganisms due to animal health or certificate of circulation of veterinary vaccines, except microorganisms;
 
d) product quality analysis of Votes of the manufacturer;
 
DD) form label veterinary import and extra label when major labels not yet enough content according to the rules.
 
The papers included in the registration dossier may submit the originals or copies are stamped confirmation of import facility.
 
2. Order execution
 

a) base import veterinary medicine established 01 record registration test the quality delivered by post or directly to the Agency;
 
b) within 7 working days, the Agency examined the test application validation to customs procedures or have written answer if the registration records are incomplete, invalid. The case did not require quality control sampling base, imported veterinary clearance procedures at the Customs gate.
 
The case is quality control sampling base, imported veterinary drugs are permitted to move about the location recorded in the test application, keep the current state of the goods, not the production, trading, use, pending the results of quality inspection as prescribed;
 
c) for shipment of veterinary medicine must take the form of quality analysis in the object as specified in paragraph 6 to article 34 of this circular, within 2 working days, upon receipt of the documents, the Agency is responsible for sensory testing, bonded according to the form prescribed in annex XXXVIII attached to this circular , check the records prescribed in paragraph 4 to article 34 of this circular and sample quality testing.
 
Within 5 working days for the raw materials of veterinary, pharmaceuticals, chemicals, biological products and 14 days for vaccines, the antibody test only sterile or pure, safe; 60 days for vaccines, the antibody test target effect after sampling, quality control agency announced the results of quality inspection of imported products according to the form prescribed in annex XXXIX attached to this circular to the import facility, pursuant to the customs clearance procedures for the shipment.
 
In case the test results do not meet the requirements, the Agency announced the test results for the import facility. Within 5 working days from the date of notice, if the import facility has no complaints about the test results, the Agency examined recommendations the Agency handled according to regulations.
 
3. Handle the violation during check out: follow the provisions of article 36, the product quality Law.
 
Article 36. Check the State of quality veterinary drugs circulating on the market 1. The Agency examined a) animal health performs quality control of veterinary medicine across the country;
 
b) specialized agency provincial animal health quality control done in shops, sales agent of local veterinary management.
 
2. The content, the sequence of procedures to conduct quality control of veterinary drugs circulating on the market perform as specified in circular No. 26/2012/TT-BKHCN on December 12, 2012 of the Ministry of science and technology of the regulations checking on the quality of the goods circulation market.
 
Article 37. Checking veterinary medicine production base in the country to export 1. Pursuant to international treaties or agreements, on cooperation in veterinary medicine with veterinary Management Agency of water, animal health decisions establishing the Union, the plan and the actual test content production base veterinary medicine in the country of export to Vietnam.
 
2. Funds perform checking: due to State budget arranged every year according to the current rules and other funding sources as prescribed by law.
 
Article 38. Check the State of quality veterinary drugs exported 1. Agency: Department of animal health.
 
2. Test subjects and the contents checked a) veterinary drugs before export by exporting facility registration: at the request of the registered establishments;
 
b) veterinary export does not ensure quality bounce on: according to the provisions of paragraph 4, 5, 6 to article 33 of this circular.
 
3. test: base standards apply; the country's import regulations, contracts or international treaties, international agreements of mutual acknowledgment of conformity assessment results with water, territory.
 
4. the registration records check export product quality according to the requirements of the facility include: a) check the quality certificate veterinary export according to the form prescribed in Annex XL attached herewith;
 
b) standards applied, the norms require test;
 
c) the vote of product quality analysis of testing authority veterinary assigned in Vietnam for the test requirements criteria (original or certified copy of business validation stamp).
 
5. in order to check the quality of export products a) base submission directly or sent by post 1 the registration profile to check the quality of export products of animal health;
 
b) during 5 working days from receipt of valid record, veterinary Bureau is responsible for appraising records, announced the result according to the form prescribed in annex XLI attached to this circular.
 
Chapter VI sequence, REVOKE PROCEDURE, DESTRUCTION of veterinary medicine Article 39. The recovery sequence veterinary 1. Competent State agencies when veterinary medicine subject to recovery in accordance with paragraph 1 Article 105 Article 106 paragraph 1 of law and veterinary medicine must then proceed to seal immediately and recommended the competent veterinary authorities decide to revoke.
 
2. Revocation for veterinary checks do not guarantee the quality according to the respective technical regulation, standards applied were registered, published is done as follows: a) for sample case veterinary was retrieved at the facility manufacture or export, import (hereinafter referred to as the base)
 

Within a period of 10 days for the pharmaceutical, chemical, biological preparations and 60 days for vaccines, antibodies from the date of sampling, the Department of animal health reported to know the test results of samples required and the basis of self-withdrawal right plot of veterinary quality. Within 5 working days from the date of the notice of the Department of animal health, the facility has the right to complain to the Department of animal health on the sample test result veterinary. Expiry of this if the base has no complaints, animal health decision batch recovery veterinary quality across the country.
 
In the event of a complaint, the Bureau of veterinary medicine veterinary medicine sampling check back and check if the result is still not reaching the quality, animal health decision batch recovery veterinary quality across the nation; If the test results conclude veterinary quality then the batch of veterinary medicine are traffic continued on the market;
 
b) for sample case veterinary is taken in trade on the province, a city centrally: within 10 days for the pharmaceutical, chemical, biological preparations and 60 days for vaccines, antibodies since sampling, sampling Agency to notify establishments batch import, production, veterinary medicine that knew and proceeded to seal the right plot of veterinary quality. Within 5 working days from the date of the notice, the facility has the right to damage claims with the Agency about the sampling test results of samples of drugs. This time limit runs out if the base has no complaints or check results quality, sampling agency decision to withdraw across the province, the city, and to notify the Department of animal health and production facility or the importation of that drug batch said.
 
Animal health upon receipt of notification batches of veterinary quality of sampling, sampling conducted right at the base of production, imported to check back. If the test results do not conduct quality seal in batch production base, imported. Within 5 working days from the date of the notice, the facility has the right to complain to the Bureau of veterinary drugs sample test results. This time limit runs out if the base has no complaints, animal health decisions revoked nationwide.
 
3. Production, import, sales have recovered drugs are responsible for manually revoke the decision of the competent authority. After done the recovery, the facility must report the decision bodies recovered on the recovery results.
 
4. for veterinary medicine must recover nationally, the Department of animal health and recovery decision within 24 hours to notify on the unit's website. The specialized administration responsible provincial animal health supervision work on recovery management.
 
5. for veterinary medicine must recover the province, city, specialized agency provincial veterinary decision revoked and within 24 hours must be reported on the website of the unit has the responsibility of monitoring the recovery of local management.
 
Article 40. Handle veterinary drugs recovered 1. Veterinary certificates are circulating in Vietnam but not labeled properly prescribed by law or who do not meet the quality standards, the facility responsible veterinary proceed immediately recovered, disposed as follows: a) the revocation, destruction for veterinary quality violations in level 1 , including: active ingredient not properly registered; smoking mutated form (clumping, opaque, color change, worried residue, subclass, distortion); the drug has no active ingredient or the lack of the main active substances listed on the label; the vaccine does not guarantee one of three standards: sterile or purity, safety, potency; smoking emergency revoked by decision of the governing body for the imported drugs;
 
b) recovered, recycled, recovered for veterinary medicines level 2 quality violations include: Smoking aren't reached one of the norms about quality standards registered (about sensory; LY; bacterial levels, infinite speed; external drug concentrations limits allow ± 10% from the amount stated on the label for veterinary products containing probiotics, probiotics, low content of more than 90% from the amount stated on the label; net weight or volume of food beyond the limit permitted under applicable Vietnam Pharmacopeia);
 
c) recovery, fix the error label for veterinary labeled not correct provisions of the law regarding label goods;
 
d) case of veterinary drugs as defined in point b of this Clause which cannot be recycled, recovered, then are destroyed.
 
3. The basis of veterinary forced destruction must perform the destruction under the provisions of the hazardous waste management laws on environmental protection and bear all costs.
 
4. the competent State authorities decided to destroy and ban decision established the Council destroys veterinary medicine. The Council comprises the Agency chaired destruction, representative of specialized veterinary management, agency representatives and environmental resources.
 
Chapter VII Article 41 veterinary DRUG ADVERTISING. Content advertising veterinary drugs 1. Advertising veterinary drugs are required to have the following content except as prescribed in clause 2 of this: a) the commercial Name, manufacturer of veterinary medicines;
 
b) uses and things to note when using, preservation of veterinary drugs;
 

c) Organization's name, address, personal registration, distribution.
 
2. Advertising content on the veterinary medicines, the sea, panels, shelves, manifest other widgets, objects in the air, under water, mobile objects, electronic equipment, terminal equipment and other telecommunications equipment, means of transport, the transfer of advertising products is not necessarily contain adequate content required.
 
3. Advertising Content veterinary drugs must be competent authority defined in article 42 of this circular.
 
Article 42. Authority to confirm the content of advertising veterinary drugs 1. Animal health certificates certify the content of advertising veterinary drugs for press, electronic information, electronic equipment, terminal equipment and other telecommunications equipment, the product prints, sound recordings, video recordings and other technological equipment of Central, nationwide release.
 
2. specialized agency level provincial veterinary certificate veterinary ad content for the advertising case on means: a) press, electronic information, electronic equipment, terminal equipment and other telecommunications equipment, print products, recordings , recording equipment and other local technologies;
 
b) banner, banners, signboards, light box, screen advertising professional;
 
c) means of transport;
 
d) fairs, seminars, conferences, events, exhibitions, cultural and sports programs;
 
DD) The conveyed product advertising, advertising material;
 
e) other advertising media in accordance with the law, article 43. Profile, sequence, procedure for granting ad content confirmation veterinary 1. Filing a) Organization, individuals filing directly or sent by post to the competent State agencies as prescribed in article 42 of this circular;
 
b) number of records: 1.
 
2. Record a) petition to confirm the content of advertising veterinary drugs according to the form prescribed in annex XLII attached herewith;
 
b) copies of certificates of registration of veterinary drugs;
 
c) product advertisement (content, forms of advertising are represented by pictures, sounds, voices, text, icons, colors, lighting and similar forms);
 
d) rapporteurs list full record information about qualifications or scientific title of Rapporteur for the fair, seminars, conferences, events, exhibitions, cultural and sports programs (seal of the enterprise).
 
3. The appraisal of records and certificate level advertising content veterinary medicine a) within 5 working days from the date of receiving the registration records to confirm the content of advertising veterinary drugs, the competent State organs prescribed in article 42 of this circular are responsible for notifying the Organization individuals register know to perfection for the cases of unsatisfactory records;
 
b) within 10 days of receipt of a valid application, the competent State organs prescribed in article 42 of this certificate level circular advertising content veterinary form prescribed in Appendix XLIII attached to this circular. The case of not granting the confirmation of advertising content the competent State bodies must respond in writing and stating the reason is not granted.
 
Chapter VIII RESPONSIBILITIES of the PARTIES IN RELATION to article 44. Animal health 1. Direction, guidance, professional expertise related to the management of veterinary drugs; quality control of veterinary drugs in the production, import and export, business, circulation on the market.
 
2. The appraisal records, reviews and recognition of eligible production base, imported veterinary medicines.
 
3. Appraise records, licensed veterinary assay.
 
4. Evaluation of records, certificate of circulation of veterinary drugs.
 
5. inspection organization, quality control of veterinary medicines, the responsibility and authority of the Agency in the Department of animal health, the specialized agency provincial animal health in the management of veterinary drugs. In planning the annual quality control of veterinary drugs circulating on the market.
 
6. The annual management plan, monitoring antibiotic materials imported for the production of veterinary drug submission to the Ministry of agriculture and rural development approved.
 
7. Receiving and evaluating medicine advertising content jurisdiction prescribed in clause 1 Article 42 of this circular; certificate level advertising content.
 
Article 45. The organs in animal health 1. Perform quality control of veterinary import, circulation.
 
2. the facility condition assessment Veterinary Assay according to the provisions of article 88 and article 20 of law No. 35/2016/ND-CP on May 15, 2016 at the request of the Department of animal health.
 
3. assay process monitoring Veterinary Assay licensed veterinary drugs; confirmation assay results reports veterinary drugs.
 
Article 46. The specialized administration provincial animal health 1. Perform quality control of veterinary medicines on the management regulations.
 
2. Organization of training, dissemination of the provisions of the law on production, trade, use of veterinary drugs for organizations and individuals involved.
 
3. assay process monitoring veterinary drugs (except vaccines, antibody) assay licensed veterinary drugs; confirmation assay results reports veterinary drugs.
 
4. the registration records appraisal, evaluation and recognition of establishments eligible trade in veterinary medicine.
 

5. Receiving and evaluating medicine advertising content jurisdiction prescribed in clause 2 Article 42 of this circular; certificate level advertising content.
 
6. General report on the situation of trade, quality inspection, use, inspection results, checked and processed in violation of local veterinary administration of animal health six months and report annually or extraordinarily upon request of the Department of animal health.
 
Article 47. Registered establishments Veterinary Assay 1. Construction outline of assay;
 
2. Signed veterinary assay to assay basal and fulfill the terms of the signed contract.
 
Article 48. Base register floated veterinary 1. Responsible before the law and consumers on the quality of veterinary medicine due to production, circulation and distribution.
 
2. Subject to the inspection, the Inspector of the competent State bodies.
 
3. The report on the situation of production and trading of veterinary drugs for Administration when required.
 
4. Notify the veterinary authority in the event of dissolution or not registered product.
 
5. transfer of research results; assay results, transfer the copyright to the product according to the provisions of intellectual property law and other legal texts concerned.
 
Article 49. The basis of the production, trafficking, import veterinary medicine 1. The manufacturing facility must ensure the conditions specified in article 90, paragraph 2 to article 91 of the Act and article 12, article 13 of Decree 35/2016/ND-CP on May 15, 2016.
 
2. Establishments must ensure the conditions specified in article 92, paragraph 2 to article 93 of the veterinary Act and article 17 of Decree 35/2016/ND-CP on May 15, 2016.
 
3. the import facility a) guarantee the conditions specified in article 94, paragraph 2 Article 95 of the Act and Article 18 of Decree 35/2016/ND-CP on May 15, 2016;
 
b) Only are veterinary material for the base raw material business conditions enough veterinary qualified facility, the production of veterinary drugs, not veterinary material for agents, shop the veterinary drug dealers, people or livestock, aquaculture products to used.
 
Chapter IX IMPLEMENTATION article 50. Terms of implementation 1. This circular has effective from July 19, 2016.
 
2. This circular repealed the provisions of the following: a) The content of the test, the assay veterinary provisions in decision No. 18/2002/QD-BTS on 03/6/2002, issued the regulations aquatic varieties assay, food, medicines, chemicals and biological products for use in aquaculture;
 
b) Thing 1, Thing 2 circular No. 47/2009/TT-BNNPTNT on 11/8/2010 of the Ministry of agriculture and rural development on the addition of some of the rules of procedure by decision No. 71/2007/QD-BNN on 06/8/2007; Decision 98/2007/QD-BNN on 03/12/2007; Decision No 118/2008/QD-BNN on 11/12/2008 and the circular No. 06/2010/TT-BNNPTNT on 2/2/2010;
 
c) article 1 the circular No. 04/2011/TT-BNNPTNT on 6/4/2011 the Ministry of agriculture and rural development modification, Supplement, abolish some regulations on administrative procedures in the field of veterinary medicine under resolution 57/NQ-CP on 15/10/2010;
 
d) article 19, article 20 and article 21 circular No. 04/2015/TT-BNNPTNT on 12/02/2015 of the Ministry of agriculture and rural development guide and implementation of some of the content of the Decree No. 187/2013/ND-CP dated 20/11/2013 of government regulation in detail Trade Law enforcement on the international sale of goods and agency activities , buying, selling, processing and transiting goods with foreign countries in the field of agriculture, forestry and fisheries;
 
Article 2) Circular No. 10/2016/TT-BNNPTNT on 12/6/2016 of the Ministry of agriculture and rural development about issuing veterinary Category are allowed to circulate, all used in Vietnam, the HS code for veterinary import is allowed to circulate in Vietnam.
 
3. This circular replaces the following text: a) Circular No. 03/2009/TT-BKHCN on 14/01/2009 of the Ministry of agriculture and rural development and recovery procedures guide handle veterinary drugs;
 
b) Circular No. 03/2009/TT-BKHCN on 14/01/2009 of the Ministry of agriculture and rural development regulation on labeling of veterinary drugs;
 
c) decision No. 71/2007/QD-BNN on 06/8/2007 of the Ministry of agriculture and rural development regulation sequence, testing procedures, veterinary assay;
 
d) decision 98/2007/QD-BNN on 03/12/2007 of the Ministry of agriculture and rural development of additional, modifying decision No 71/2007/QD-BNN on 06/8/2007;
 
DD) decision No. 72/2007/QD-BNN on 06/8/2007 of the Ministry of agriculture and rural development, issued regulations on quality control of veterinary drugs;
 
e) decision No 100/2007/QD-BNN on 03/12/2007 of the Ministry of agriculture and rural development of additional, modifying decision No 72/2007/QD-BNN on 06/8/2007.
 
g) decision No. 10/2006/QD-BNN on February 10, 2006 of Ministry of agriculture and rural development regulation the procedure sign the manufacture, import, circulation of veterinary drugs, veterinary materials, probiotics, microorganisms, chemicals used in veterinary medicine;
 
h) decision No 99/2007/QD-BNN on 03/12/2007 of the Ministry of agriculture and rural development, additional amendments to decision No. 10/2006/QD-BNN on February 10, 2006;
 
I) Circular No. 51/2009/TT-BNNPTNT on 21/8/2009 of the Ministry of agriculture and rural development regulation check, certified eligible production business, veterinary medicines, probiotics, microorganisms, chemicals used in veterinary medicine, aquatic animal health;
 

k) Circular No. 07/2012/TT-BNNPTNT 13/02/2012 of the Ministry of agriculture and rural development regulation registration, testing, certification of veterinary medicine production base of standard drug good manufacturing practices (GMP);
 
l) Circular No. 08/2012/TT-BNNPTNT 13/02/2012 of the Ministry of agriculture and rural development regulations registration of production offshoring veterinary;
 
m) Circular No. 33/2010/TT-BNNPTNT on 6/5/2010 of the Ministry of agriculture and rural development issued the national technical regulation of veterinary sanitation business establishments veterinary and veterinary hygiene conditions for the experimental facility, veterinary assay.
 
Article 51. Transitional provisions 1. Test registration records, assay, production, veterinary medicine, filed before the date of this circular effect resolved as specified in decision No. 10/2006/QD-BNN on February 10, 2006 of Ministry of agriculture and rural development regulation the procedure sign the manufacture the import, circulation, veterinary, veterinary materials, probiotics, microorganisms, chemicals used in veterinary medicine; Decision No. 71/2007/QD-BNN on 06/8/2007 of the Ministry of agriculture and rural development regulation sequence, testing procedures, veterinary assay; Circular No. 08/2012/TT-BNNPTNT 13/02/2012 of the Ministry of agriculture and rural development regulation procedure for registration of veterinary drugs production and the decision to modify, complement.
 
2. Management of probiotics, microorganisms, chemicals, minerals used in aquaculture as defined in circular No. 23/2015/TT-BNNPTNT on 22/6/2015 of the Ministry of agriculture and rural development on product management process, improving the environment in livestock, aquaculture are as follows : a) for the record filed before 1/7/2016 made in accordance with circular No. 23/2015/TT-BNNPTNT on 22/6/2015 of the Ministry of agriculture and rural development on product management process, improving the environment in livestock, aquaculture;
 
b) The products have allowed circulation continues to be circulated to the expiry of the time limit of 5 years or granted from the date of license (for text permissions do not record the duration of circulation). The registration or renewal made in accordance with Point c or d item 2 of this Article.
 
c) products used antiseptic, disinfecting, detoxification and have the active ingredient in Appendix XLIV attached herewith made as prescribed in this circular since the day this circular effect;
 
d) products are not in Point c this Account used biodegradable organic matter, creating natural food rearing environments, steady, mineral supplements made under the regulation on feed management since the day this circular effect.
 
3. for products specified in part C of Annex IB circular No. 10/2016/TT-BNNPTNT on 12/6/2016 of the Ministry of agriculture and rural development about issuing veterinary Category are allowed to circulate, all used in Vietnam, the HS code for veterinary import is allowed to circulate in Vietnam : a) products used antiseptic, disinfecting, detoxification and have the active ingredient in Appendix XLIV attached to this circular continues to follow the rule of Law and this circular.
 
b) products not in point a of this Paragraph are allowed to circulate to the expiry stated in the certificate are allowed to circulate, then follow specified in point d of Paragraph 2 of this Article.
 
4. Production facilities, business products with active ingredient as defined in Appendix XLIV attached to this circular if not yet qualified certification of production, veterinary medicine or business certificate of GMP, within a period of 12 months from the date of this circular effect , the base implementation of the registration certificate of the eligible production, veterinary medicine business in accordance with the Law and this circular.
 
Article 52. The organization performs in the implementation process, if there are problems or need to modify, Supplement, recommended the agencies, organizations, personal reflections in time of Ministry of agriculture and rural development to consider, resolve./.