CIRCULAR additional amendments, repeal some regulations on administrative procedures in the field of veterinary medicine under resolution 57/NQ-CP on 15/10/2010 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to Decree No. 01/2008/ND-CP dated 9 January 2008 of the Government functions, tasks, powers and organizational structure of the Ministry of agriculture and rural development; Decree No. 75/2009/ND-CP on February 10, 2009 by the Government on the amendment of article 3, Decree No. 01/2008/ND-CP dated 9 January 2008 of the Government functions, tasks, powers and organizational structure of the Ministry of agriculture and rural development;
Pursuant resolution No. 57/NQ-CP on December 15, 2010 by the Government on the simplification of administrative procedures in the scope of the management function of the Ministry of agriculture and rural development;
The Ministry of agriculture and rural development issued circular additional amendments, repeal some regulations on administrative procedures in the field of veterinary medicine under resolution 57/NQ-CP on 15/10/2010 are as follows: article 1. Amendments and supplements to some articles of decision No. 10/2006/QD-BNN on February 10, 2006 of Ministry of agriculture and rural development 1. Article 1 be amended and supplemented as follows: "article 1. Scope this circular regulates the registration of circulation, import veterinary drugs, veterinary materials, vaccines, biological preparations, microorganisms, chemicals used in veterinary medicine, aquatic animal health (hereinafter referred to as veterinary) in Vietnam ".
2. Supplement Article 4b as follows: "article 4b. Conditions for registering circulating veterinary 1. Manufacturing establishments veterinary drugs a) production base veterinary in the country must have the certificate of the qualified drug production or standard certificates of "good manufacturing practice" (GMP), in accordance with the regulations and the applicable GMP pathway of the Ministry of agriculture and rural development;
b) production base outside Vietnam veterinary drugs must reach the GMP standard;
c) chemical production facilities and In vitro diagnostic products are GMP standard or ISO or other equivalent standards.
2. business establishments to import veterinary business establishments to import veterinary drugs must have the certificate of eligible veterinary medicine business as specified in circular No. 51/2009/TT-BNNPTNT on 21/08/2009 the test regulations, certification of eligible production, veterinary medicine business , probiotics, microorganisms, chemicals used in veterinary medicine, aquatic animal health (hereinafter referred to as the circular No. 51/2009/TT-BNNPTNT) ".
3. Article 5 be amended and supplemented as follows: "article 5. Veterinary labels 1. Veterinary drugs circulating on the Vietnam market are labeled. The labeling of veterinary compliance with Decree No. 89/2006/ND-CP on 30/9/2006 by the Government on goods labels and circular No. 03/2009/TT-BKHCN on 14/01/2009 of the Ministry of agriculture and rural development veterinary labeling regulations.
2. Label veterinary drugs circulating on the market are true to label smoking patterns in the registration records in the governing body and at the base register ".
4. Article 6 is modified and supplemented as follows: "article 6. Register floated veterinary 1. The new facility, registering circulation veterinary records must first include: a) the certificate of eligible production, imported veterinary business according to regulations;
b) a copy of the relevant papers to the establishment: establishment, business registration certificate, certificate of practice consistent with the type of production;
c) registration record circulation of each drug product under the provisions of this circular.
2. The facility has eligible production, veterinary import business when registering circulation follow the point c paragraph 1 of this article ".
5. Paragraph 1 article 7 be amended and supplemented as follows: "article 7. The registration procedure for imported veterinary drugs 1. Import veterinary drugs veterinary drugs in the category have been allowed to circulate in Vietnam or have been circulating The certification basis of eligible veterinary import business under regulations made the import of the following: a) for drugs, veterinary materials : The base-procedure in the Customs gate;
b) for vaccines, microorganisms: base made of import order according to the template in the form 2, Appendix 3 (01 a bundled file software) posted about animal health. 2. Import veterinary drugs not yet available in veterinary medicine are allowed to circulate in Vietnam a) imported cases:-veterinary drugs are samples, the exhibition served, no commercial value;
-Veterinary drugs to test, experiment, assay for circulating registration purposes;
-Veterinary pharmaceuticals import difference with the number at least, there is no commercial value to the diagnosis, prevention, treatment for the rare animals, pets;
-Raw materials (chemicals, Pharmaceutical Excipients, solvents, chemicals, and other materials) to produce the product had the name in veterinary medicine are allowed to circulate in Vietnam.
b) profile to import veterinary drugs include: 1-importing orders form in form 1, Appendix 3 attached to this circular (01 a bundled file software);
-The type of certificate or ISO (for some kinds of common chemicals); Certificate of circulation for the imported drugs;
-Quality analysis of Votes of producers and the competent authorities of the country of origin (for vaccines, biological preparations);
-The summary of product characteristics (for new drugs).
c) approvals to import veterinary drugs are sent to the Department of animal health;
d) time limit for answers: in time of 7 working days from the date of receiving the registration record, veterinary Bureau is responsible for the appraisal of records and answer results ".
6. Article 8 is replaced by the following articles 8a, 8b, 8 c, 8 d as follows: "Article 8a. Registration documents circulating veterinary pharmaceutical-chemical forms: 1. for new veterinary medicines, including the registration documents: 1 the a) application released under the template in form 1, annex 1 attached herewith;
b) summarizes the characteristics of the product, including information on the composition, quantitative composition, dosage, packaging, use, assign, contraindications, instructions for use, maintenance instructions, the note for specified animals, with users and other technical characteristics of the product , according to the model in annex 6 attached to this circular;
c) Sample product labels (3 sets), the instructions for use;
d) GMP certificate types or ISO (for some kinds of common chemicals); The certificate issued by the competent authority of the country of origin (for imports);
DD) production process;
e) quality standards and testing methods (full details), the vote of quality analysis of production facilities;
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). The study on the residual subsistence in all animal species indicated the use of drugs;
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 stopped using the drug) period (if any);
k) research on stability and duration of use of the drug;
m) study materials about dosage and treatment data for each animal species is specified;
n) product quality analysis of Votes by the competent authority of the country of origin (for imported products) and the votes of product quality analysis of testing authority veterinary assigned in Vietnam;
p) test results or assay;
q) A commitment not to violate the regulations of intellectual property law according to the model in annex 5 attached herewith;
r) other technical information (if available).
2. for generic drug registration documents, including: a) The content of the provisions in points a, b, c, d, e, f, i, k, q, r paragraph 1 of this Article;
b) Vote of product quality analysis of testing authority veterinary assigned in Vietnam;
c) information about the drug discovery (product name, manufacturer name, formula, dosage, use, treatment, contraindications, dosage, use the time to stop the use of drugs (if any), the note for specified animals, with users and other technical characteristics of the product).
3. Registration of changes and supplements include: 1 the a) registration form change, additional form in form 1, in Appendix 2 attached to this circular;
b) documents related to the change, Supplement;
c) copies of certificates in circulation veterinary validity;
d old label) model (1), a new label template (3 sets);
DD) sheets of old manuals, new.
4. Profile registration contains the content prescribed in paragraph 1 of this article.
5. certificate renewal records floated veterinary, including: 1 the a) renewal certificate released under the form in the form 2, Appendix 2 attached to this circular;
b) copies of certificates in circulation veterinary validity;
c) The type of certificate or ISO or the certificate of eligible production of veterinary drugs; Certificate of circulation for the imported drugs;
d) Vote of product quality analysis of manufacturing or testing of veterinary drugs is indicated in Vietnam issued within 12 months;
DD) reports to track the stability of products in common conditions;
e) report the process of circulation of medicines according to the model in Appendix 3 attached to this circular.
Article 8b. Profile registration materials circulation veterinary drugs from pharmaceutical chemicals 1. Registration documents circulating drug materials include: 1 a set) the contents defined in points a, b, c, d, e, f, i, k, n, r paragraph 1 Article 8a of this circular;
b) with information on ingredients for medicines invented has exclusive expiry (raw material name, manufacturer name, formula, dosage and other technical characteristics of the product).
2. Registration documents circulated new materials, in addition to the provisions in clause 1 of this article, must be added: a) reporting on the metrics to prove safety including material research on toxicity (acute toxicity, toxicity to sell the school, school, cell toxicity). The study on the residual subsistence in all animal species indicated the use of drugs;

b) report on the figures prove the validity of the product including the documentary research on pharmacological experiments; about pharmacodynamics, pharmacokinetics and availability of products;
c) reported the results of testing or assay;
d) study materials on stability of raw materials;
DD) other technical information (documentation on the product has been released in other countries in the world).
3. the registration records of circulation of medicines from medicinal herbs contains the content prescribed in clause 1 Article 8a of this circular.
4. Registration of changes and supplements include the content of the provisions in paragraph 3 Article 8a of this circular.
5. certificate renewal records in circulation include the content prescribed in clause 5 Article 8a of this circular.
Article 8 c. Registration records released vaccines, biological preparations 1. Registration records released vaccines, biological preparations includes: 1 set of a) visa application released under the registration form in the form 2, annex 1 attached herewith;
b) summarizes the characteristics of the product, including information on the composition, quantitative composition, dosage, packing, specify, contraindications, instructions for use, instructions for preserving vaccines, biological preparations, the note for specified animals, with users and other technical characteristics of the product;
c) Sample product labels (3 sets), the instructions for use;
d) certificate of GMP; The license product circulation of competent authority country of origin (for imported products);
DD) production process;
e) quality standards, methods of testing vaccines, biological preparations, Polling analyst the quality of production facilities;
g) reporting on the metrics to prove safety including material research on toxicity (acute toxicity, toxicity to sell the school, school, cell toxicity). The study on the residual subsistence in all species of animals are specified (if any);
h) report on the figures prove the validity of the product including the documentary research on antibody concentration and the length of immunity (for vaccines);
I) stop using the time (if available);
k) study materials on stability, the summary records of each batch produced 3 consecutive batches and proposed shelf life;
m) method determines the dosage and whether the process used for each species of animals are specified;
n) product quality analysis of Votes of the competent authority of the country of origin (for imported products) and testing of veterinary drugs is indicated in Vietnam;
p) reported test results (assay results for imported products) which includes all the content about the effect, the safety of the product for the target animals, the use of the product and the environment);
q) related documents include:-origin, history and the stability of the original micro-organism strain used for vaccines, biological preparations;
-The documentation relating to copyright and to apply the certificate of production of vaccines, biological preparations (if available);
r) other technical information such as test results, assay laboratory in scope, data on the product has been released in other countries in the world (if available);
s) The epidemiological data demonstrate the presence of pathogens in Vietnam (applicable to vaccines, biological preparations).
2. Registration documents circulating probiotics for diagnosis: 1 set a) visa application released under the registration form in the form 3, annex 1 attached herewith;
b) summarizes the characteristics of the product, including information on the composition, quantitative composition, dosage, packing, specify, manuals, guides preservation, the note to the user and other technical characteristics of the product;
c) Sample product labels (3 samples); Manual sheet;
d) certificate of GMP, ISO or equivalent certificate or; The license product circulation (FSC) by the competent authority of the country of origin (for imported products);
DD) the vote analysis by the competent testing authorities of the country of origin (for imported products), analyze the quality of biological products testing agency veterinary assigned in Vietnam;
e) report on the figures prove safety;
g) report on the figures prove the validity of the product;
h) production process;
I) quality standards, methods of testing probiotics (full details), the vote of quality analysis of biological preparations of production facilities;
k) study materials on stability, the summary records of each batch produced 3 consecutive batches and expiry;
m) to report test results, assay (including content validity testing, safety of products);
n) The relevant documents include:-Wrath of the historic original material, used to produce biological products;
-The documentation relating to copyright and to apply the certificate of production of vaccines, biological preparations (if available);
p) other technical information.
3. Registration of changes and supplements include the content of the provisions in paragraph 3 Article 8a of this circular.
4. Profile registration contains the content prescribed in paragraph 1 of this article.
5. certificate renewal records in circulation include: 1 the a) renewal certificate released under the form in the form 2, Appendix 2 attached to this circular;
b) copies of certificates in circulation has been granted;
c) certificate or certificate of eligible production of veterinary drugs, a certificate issued by the competent authority of the country of origin (for imported products);
d) product quality analysis of Votes by the competent authority of the country of origin (for imported products) and testing of veterinary drugs is indicated in Vietnam issued within 12 months;
DD) reports to track the stability of products in conservation conditions indicated on the label;
e) report the process of circulation of products according to the model in Appendix 3 attached to this circular ".
7. Article 9 paragraph 1 be amended and supplemented as follows: "article 9. Registration of changes and supplements the content circulation certificate veterinary medicine: 1. organizations and individuals have veterinary certificates were circulating and were named in veterinary medicine are allowed to circulate in Vietnam, during valid certificates, as requested by change In addition, the following must be agreed by the Bureau of veterinary medicine: a) change the name of the product;
b) change of name registration facility;
c) change the name of the production facility;
d) change or supplement packing;
DD form drug label changes);
e) change the expiry date and time to stop using drugs;
g) change the dosage;
h) changes or additions to this treatment;
I) changes or additions to data treatment;
k) other changes but does not affect the quality, efficiency, safety of the drug.
2. Particularly for imported drugs: a) change of name must be certified by the drug manufacturer;
b) change location production facilities are certified production facility in new locations reaching drug good manufacturing practices (GMP);
c) change the name of the production facilities are certified production base with the new name of standard drug good manufacturing practices (GMP) and other relevant information ".
8. Article 10 is amended and supplemented as follows: "article 10. Veterinary registration 1. The base contains veterinary certification have been circulated and were named in veterinary medicine are allowed to circulate in Vietnam, during valid certification, when required, additional changes to one of the following to perform the registration procedure again : a) changing ingredients, formulas;
b) change the dosage form;
c) changes the way users of the drug;
d) change the method, production process that alters the quality of products;
DD) reassess the quality, efficiency, safety of veterinary drugs as required by the Department of animal health;
e) change or addition of animal species are indicated.
2. Registration not applicable to generic drug ".
9. Article 11 is amended and supplemented as follows: "article 11. Receiving registration documents circulation, registration changes, supplements, registration records, the record renewed circulation of veterinary drugs and the time limit for replies 1. Profile register registration, circulation changes, supplements, registration records, the record renewed circulation of veterinary medicine was sent to the Department of animal health.
2. The time limit for replies: a) case registration circulation, registration veterinary drugs:-during 15 days from the date of 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;
-During 30 days from the date of receiving documents, veterinary Bureau is responsible for the evaluation and establishment of specialized scientific Council to review records and answer results.
b) modification, additional certificates of veterinary medicine: circulation within 10 working for veterinary medicinal chemistry, chemical form; 20 working days for vaccines, probiotics, microorganisms from the day of receiving satisfactory records, veterinary Bureau is responsible for the appraisal of records and responding to results;
c) where registration of renewal floated veterinary-during 10 working days from the date of receipt, the Department of animal health has a responsibility to notify the Organization, individuals register know to perfection for the cases of unsatisfactory records;
-During the period of 20 working days from the date of receiving documents, veterinary Bureau is responsible for the evaluation of records, certificate of circulation ".
10. Article 12 is amended and supplemented as follows: "article 12. Term of circulation certificate veterinary certificate veterinary drug circulation and registration number in circulation has a time limit is 5 years from the date of issue ".
11. Article 13 is amended and supplemented as follows: "article 13. To renew a certificate issued before the date of expiry of the veterinary medicines indicated on the certificate of veterinary drug circulation 3, registered facility, records of Bureau of animal health sending renewal. Too on the certificate recording duration 1 months that registered establishments do not do the procedure to renew the certificate issued is considered expired ".
12. Supplement Article 13b as follows: "article 13b. Rules of language, drug name, form of records 1. The language used in the application:

a) registered veterinary records produced 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. 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 and confirmation of registered establishments or drug manufacturing facility in the first page of each section in the full profile.
3. Each veterinary medicine must have a separate registration.
4. for veterinary medicines produced in the country, the latest drug name should adhere to the following principles: a) registered establishments may use the name of the drug under the name international public (INN);
b) where not named veterinary by name INN, registration facility can name the trade but must ensure compliance with the following principles:-do not advertise too therapeutic effect of smoking;
-Does not reflect the wrong therapeutic effects of drugs, do not confuse about the pharmacological effects of the drug group; smoking has a different active ingredient to put different names;
-No offense, pure America, the tradition of Vietnam;
-Does not cause conflict with the objects of the intellectual individuals, other organizations are protected;
-Do not coincide with the name of the medication has been granted registration number of other establishments.
5. The type of certificate, certificate of eligible production, ISO certificate, certificate of circulation of products (FSC, CPP, MA) is included in the registration documents, may be filed in one of the following categories:-the originals;
-Legitimate copies (certified copy or certified);
-Copy at the same time must present themselves to the test in the case of direct filing;
-Private Slips of product quality analysis (CA) is a main ".
13. Item 2 article 14 be amended and supplemented as follows: "article 14. Review of certification, floated veterinary medicine 2. Review, certification of veterinary medicines in circulation are as follows: a) animal health receiving registration documents circulation, appraisal records, organize specialized scientific Council meeting veterinary certification, circulation of veterinary drugs; the Minister of agriculture and rural development, in addition to veterinary medicine catalog is allowed to circulate in Vietnam. With respect to veterinary drugs production, production, animal health evaluation of registration documents, certificate of circulation circulation of veterinary drugs; the Minister of agriculture and rural development, in addition to veterinary medicine catalog is allowed to circulate in Vietnam;
b) specialized scientific Council of veterinary medicine by the Minister of agriculture and rural development mandate for the Director of animal health decided to establish. The specialized scientific Council of veterinary meetings at least once per three months to evaluate the results of the evaluation, testing, test results, assay and recommend to the Minister of agriculture and rural development, complementary veterinary register to veterinary drugs are allowed to circulate in Vietnam;
c) Ministry of agriculture and rural development issued directory of aquatic veterinary medicine, veterinary medicine, vaccines, biological preparations, microorganisms, chemicals used in veterinary medicine in Vietnam ".
Article 2. To annul some articles of decision No 3/2007/QD-BTS on 03/4/2007 of the Ministry of fisheries on issuing the registration regulations circulated aquatic veterinary medicine; processed products, improving the environment aquaculture 1. Annuls Article 1, article 6.
2. Abolition of clause 1, 2, 3.4, 5 article 7.
3. Repeal of article 8 paragraph 1.
4. the abolition of clause 1, 2, 3 article 9.
5. Removal of Articles 11, 12, 13, 14.
Article 3. Amendments and supplements to some articles of the decision No 66/2008/QD-BNN on 26/5/2008 of the Ministry of agriculture and rural development department procedures, secure base animal disease 1. Article 11 be amended and supplemented as follows: "article 11. Subscribe to build the safe, secure base disease disease 1. The people's committees, districts, towns and cities in the registration of building safe zone disease; The people's Committee of the communes, wards and towns (hereinafter the township-level people's committees), the owner of registered breeding establishments to build secure foundations diseases posted 01 record according to the provisions of article 10 of the regulations, the safe base animal disease are attached to decision No 66/2008/QD-BNN on 26/5/2008 of the Minister of agriculture and development rural veterinary Bureau of the province, central cities (hereafter referred to as the provincial animal health Bureau).
2. After receiving the registration profile to build safe zone disease, provincial animal health Bureau check record if full then moved immediately to the Department of animal health. During 10 working days from the receipt of the record, animal health review and have the text answer to accept or not accept the construction of the disease safely.
3. After receiving the registration profile to build secure foundations diseases of livestock facility by the central management, the breeding base of foreign investment, the provincial animal health Bureau check record if full then moved immediately to the veterinary authorities (animal health) in charge of the area. Within 10 days of receipt of the record, the Veterinary Authority reviewed and there is official answer to accept or not accept the construction of safety basis of disease.
4. within 10 working days from the date of receiving the registration profile to build secure foundations diseases of local-breeding facility management, the registration records of the social people's Committee, the provincial animal health Bureau reviewed and there is official answer accepted or not accepted for breeding building construction, social and safe animal disease ".
2. Article 12 is amended and supplemented as follows: "article 12. Registration Department, recognized safety basis of disease 1. The Organization, individuals register to build the secure basis of disease, as defined in article 11 of this circular, the Department recognized registration, secure foundations diseases posted 1 the records of the competent authorities accept the construction Department, the safe base disease according to the provisions in clause 2 7 article 11 of this circular.
2. the registration records recognized include: a) Department recognition application, the secure basis of disease;
b) Sheets on conditions of the region, secure base disease was built;
c) other related documents: vaccination, surveillance results after vaccination; test results of veterinary hygiene conditions; the diagnostic results, animal quarantine certificate, veterinary diagnostic Center Central, veterinary testing center I and II, the central laboratory of the veterinary agency, animal health level depending on the disease, diagnostic tests, divisions of the Department of animal health. 3. Within 15 working days from receipt of valid records, the agency receiving records to conduct evaluation and answer results for local and base.
4. the competent authority receiving the registration dossier assessment, recognizing the safety basis of disease, are responsible for keeping records ".
3. Article 13 is amended and supplemented as follows: "article 13. Establishment of the evaluation group, safe base disease 1. The decision to establish the mission.
a) Director of animal health decision established mission with regard to the safety of animal disease; The Director of the veterinary agency decision established the Mission of safe facility for animal disease breeding facility by the central management and breeding of foreign investment;
b) Bureau Chief of the veterinary Bureau of the province, the city decided to establish the Mission of safe facility for animal disease with local-breeding facility management and safety of animal disease Township.
2. Mission composition consisting of representatives of departments such as epidemiology or quarantine, technical, and Legal Affairs. In case of need can complement representative of specialized centres such as the veterinary diagnosis Center TW, hygiene inspection center of veterinary medicine or diagnostic tests ".
4. Article 16 is amended and supplemented as follows: "article 16. The safety management, the safe base disease disease 1. The safety certificate, secure base disease epidemics are worth 2 years from date of issue for diseases cholera Epidemic, FMD; 1 year for diseases of respiratory and reproductive disorders (PRRS) cholera, Newcastle, Gumboro, duck, CRD, the white seat; 6 months for bird flu. Animal health is responsible for announcing the list of the accredited facility, safe room; revoke the certificate, secure base if the disease does not guarantee the conditions prescribed.
2. registration procedure for renewal of the certificate of safety, facility safety epidemic disease was defined as follows: a) before the certificate expires 2 months (particularly for the safety certificate for bird flu is 15 days), the unit must submit the renewal registration records to the Department of animal health;
b) renewal registration records including: renewal application; The certificate, safety basis of disease; other documents as specified in point c of paragraph 2 of article 12 of this circular.
3. Within 15 working days from the date of the renewal registration certificates of the safety base, disease, animal health review and renewal of the certificate for the, the base ensures the conditions prescribed. In case of need, the established mission to check reviews before renewal.
4. Model safety certificate specified animal disease in annex No. 10 included herewith ".
Article 4. Terms of implementation 1. This circular has the effect after 45 days from the date of signing.
2. Director of the Department of animal health, Chief of the Ministry, Director of Legal Affairs, heads of units of the Department and the organizations and individuals concerned is responsible for the implementation of this circular.