Decision No. 72/2007/QD-BNN, on 06 August 2007 Regulation quality control of veterinary medicines _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ the MINISTER of AGRICULTURE and RURAL DEVELOPMENT, pursuant to Decree No. 86/2003/NĐ-CP on 18/7/2003 of the Government functions, tasks, powers and organizational structure of the Ministry of agriculture and rural development;
Pursuant to the law of standards and technical regulation No. 69/2006/QH11 on 29/6/2006;
Based on animal health 29/4/2004 Ordinance and Decree No. 32/2005/ND-CP of the Government 15/03/2005 detailing the implementation of a number of articles of the Ordinance on veterinary medicine;
Pursuant to decision No. 50/2006/QĐ-TTg of the Prime 07/3/2006 day, the Government issued a list of products, the goods must be checked on the quality;
Pursuant to circular No. 02/2006/TT-BKHCN on 10/01/2006 of the Ministry of science and technology guidance on the conditions and procedures specified organizations make product quality inspection of goods;
Proposal of the Director of the Department of animal health, decision: article 1. Attached to this decision "stipulated quality control of veterinary drugs".
Article 2. This decision takes effect 15 days from the date the Government Gazette.
Article 3. Office Manager, Director of animal health, the head of the unit, the Organization, the individual concerned is responsible for the implementation of this decision.
KT.  MINISTER DEPUTY MINISTER (signed) Bui Ba Scholarships REGULATIONS quality control of veterinary medicines (attached to decision No 72/2007/QD-BNN, on August 6th, 2007 by the Minister of agriculture and rural development) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ chapter I GENERAL PROVISIONS article 1.  Scope this regulation regulates the order and procedures for quality control of the raw materials do veterinary medicine and veterinary medicine (hereafter referred to as veterinary) production, sales, export, import, circulate in Vietnam.
Article 2. The object to apply the Organization, individuals in the country, outside the country has production operations, processing, repackaging (hereafter referred to as production), sales, import, export of veterinary medicine and organization, individual activities related to the quality control of veterinary drugs must comply with this regulation and the provisions of other legal texts concerned.
Article 3. Explanation of terms In this regulation, the terms below are interpreted as follows: 1. Veterinary drugs are substances or substances derived from animals, plants, microorganisms, minerals, chemicals are used for prevention, diagnosis, cure disease or to restore, adapt, improve the function of the animal body , including pharmaceuticals, chemicals, vaccines, hormone, a number of other biological products and some micro-organisms used in veterinary medicine. 2. Quality control of veterinary medicine is determining the conformance of the quality targets veterinary medicines, the technical standards and quality assurance conditions prescribed.
3. standard is the regulation on technical characteristics and regulatory requirements as the standard for classification, reviews of products, goods, services, processes, environment and other subjects in the social-economic activities aimed at improving the quality and efficiency of these objects.
By the standards of an organization declared as text to voluntarily apply.
4. Technical Regulation is the regulation of the limit of the technical characteristics and regulatory requirements that the products, goods, services, processes, environment and other subjects in the social-economic activities must comply with to ensure safety, human health, animal protection , plant, environment; protection of national security and interests, the interests of consumers and other essential requirements.
Technical regulation by competent State agencies issued as text to force applied.
5. drug quality standards is the technical norms, testing methods, require packaging, labeling, storage, transportation and other requirements related to the quality of the drug.
6. Veterinary quality: is the drug reaches the quality criteria that the manufacturer, business has announced (or register) according to national standards, technical regulation or standard base of manufacturers, the business and were competent authority approval.
7. Veterinary Medicine quality does not meet one or a number of quality criteria which manufacturers, business has announced (or sign) and are approved by the competent bodies of the quality criteria.
8. Limit the use of drugs is the period determined for a drug which at this time is preserved in the regulatory conditions to ensure standards of quality have signed or announced.
Limit the use of drugs is often credited by number or by letter on the drug label to specify the drug after the deadline no longer worth using.
9. fake veterinary drugs are the products produced, circulated in pill form a in the following cases: a) there is no or not enough active types as signed; 
b) Have different drug substance indicated on the label;
c) use the trademarks, registration code circulating counterfeit product or the name of another base.
d) use of trademarks, geographical indications are protected uses for the item without permission of the owner of the trademark or of the governing geographical indications.
Article 4. Veterinary cases are quality control 1. Veterinary medicine already in the category list, veterinary vaccines, probiotics, microorganisms, chemicals used in veterinary medicine are allowed to circulate in Vietnam (hereafter referred to as veterinary medicine catalog is allowed to circulate).
2. Veterinary drugs not yet available in veterinary medicine are allowed to circulate in Vietnam but are animal health browse orders to production and disease prevention.
Article 5. The case of veterinary drugs are not inspected 1. Veterinary medicine is the row template, serves exhibitors, no commercial value.
2. Veterinary drugs to test, experiment, assay for the purpose of registration.
3. Veterinary miscellaneous imports with little amount, there is no commercial value to the diagnosis, treatment, disease to rare animals.
Article 6. Management systems, quality control of veterinary drugs 1. Animal health is responsible for the governance of quality veterinary medicine across the country.
2. the veterinary Bureau of the province, central cities (hereafter referred to as the provincial animal health Bureau) is responsible for managing the quality of veterinary drugs circulating in the local range management.
3. the bodies responsible for quality control of veterinary medicines (hereinafter the Agency): a) testing centre of the central veterinary medicine I and II is responsible for quality control of veterinary drugs;
b) test center of the central veterinary hygiene I and II is responsible for checking the hygiene conditions of animal health production, import-export business, storage, transport, veterinary medicine;
c) technical institutions are eligible as specified in circular No. 02/2006/TT-BKHCN on 10/01/2006 of the Ministry of science and technology guidance on the conditions and procedures specified organizations make product quality inspection of goods, is the Ministry of agriculture and rural development.
Article 7. Fees and charges for personal organization, production, export, import of veterinary fees and charges prescribed by the State.
Chapter II QUALITY CONTROL of veterinary medicine article 8. Technical base for quality control of veterinary drugs 1. The national standards (ISO).
2. The technical standards by the Ministry of agriculture and rural development.
3. standard base of organizations allowed to build and published according to the provisions of article 11 of law standards and technical regulation

4. Standards in Vietnam Pharmacopoeia or the pharmacopoeia of the country, international standards, regional standards are allowed to adopt in Vietnam.
Article 9. Content quality control of veterinary drugs 1. Quality control of veterinary medicines on the basis of quality criteria were the organizations, individuals, business and production of publication (or register) according to article 8 of this regulation.
2. check the implementation of the standard rules on the quality of veterinary (documents of quality engineering, manufacturing equipment, measuring, testing, compliance processes, process technology, regulations on packaging, preservation, shipping).
3. check condition of VSTY quality assurance elements veterinary. Article 10. The mechanism of quality control of veterinary drugs 1. For veterinary drugs already in the list are allowed to circulate, then no quality check each shipment that check as defined below: a) check periodically: every year, the actual situation based, animal health veterinary medicine sampling organizations periodically in the manufacturing facility , trading, import, storage, transportation, to check the quality.
b) irregular: check is done when there are complaints, accusations of quality veterinary medicine or at the request of the competent authority.
2. for raw materials do veterinary import was named in the list of allowed drugs in circulation but have not got the registration number, the quality control is performed according to the method of the previous registration, check the following: a) before import, corporate records as defined in paragraph 2 of article 11 of this regulation , posted on animal health;
b) animal health evaluation and validation on profile to import business registered with the quality control checks and clearance procedures;
c) base of animal health in the registration records, the Agency conducts inspections to check the quality of sampling;
d) Agency to send the results of quality control Department of animal health and import business.
The base quality test results, animal health decided to put the goods into circulation, used or processed according to the rules.
3. Conditions of imported ingredients for veterinary medicine was named in veterinary medicine are allowed to circulate but not have the registration number: a) has enough registration documents according to item 2, article 11;
b) test results of sample quality raw materials imported by the competent inspection authorities.
4. The time limit for the Agency reply check test results: a) for pharmaceuticals: within 10 working days from the date of obtaining or receiving a sample. Special circumstances may to 30 September.
b) for vaccines, probiotics, microorganisms used in veterinary medicine: within 2 months. Special circumstances may to 6 June.
These special cases are due to reply results referred to in point a, b paragraph 4 of this Article, the Agency must clearly state the cause and inform the customer.
Article 11. Profile import ingredients for veterinary drug names has been allowed to circulate but no registration number. 
1. organizations and individuals importing ingredients for veterinary establishment quality control registration with the Department of animal health.
2. Registration documents include: a) the import orders: 3 a, content to specify the number, types of material, manufacturer name, expected time of Vietnam and assembled to order after customs clearance (check location).
b) certificate of origin (CO);
c) certificate of quality analysis (CA) of the manufacturer;
d) summary of product characteristics;
e) copy of certificate of GMP, ISO (for some types of chemicals used in veterinary medicine) of the manufacturer;
f) a copy of the test results of sample quality imported raw materials (of the same origin, the same producers) of the authorized Inspection Agency made within not more than 6 (six) months.
Article 12. Conclusion after checking the quality inspection bodies must have concluded after examining the quality of veterinary medicine in one of the two following levels: 1. A Level: Reach full, standard and content quality testing as prescribed.
2. The extent b: not standard must be handled according to the regulations of the Department of animal health. Chapter III.
RESPONSIBILITY of the PARTIES CONCERNED in article 13. The responsibility of the Department of animal health 1. State administration for quality veterinary activities in export, import and manufacture, circulation within the country.
2. Organization direction, perform quality control of veterinary drugs within the country.
3. To resolve the violations of quality veterinary drugs, the case of a complaint, the report under the provisions of the law.
4. Decision process the type of veterinary quality according to current rules.
Article 14. The responsibility of the provincial veterinary Bureau 1. The Organization directs, perform quality control of veterinary drugs circulating in the local range management.
2. Solve the case violated the quality of veterinary medicines, the complaints, accusations under the provisions of the law 3. Inspect, monitor the recovery, processing of veterinary medicine quality in geographical range.
Article 15. The Agency's responsibility to check the quality of veterinary medicine 1. Directly implement the retrieved (or receiving) drug samples to check quality testing organization, the quality criteria correctly, on time as prescribed for each type of template and save the test sample according to the regulations.
2. Answer the test results of quality veterinary medicine for organizations and individuals, in accordance with the regulations.
3. Responsible for the drug quality control results the vet before PL. 4. Build the technical standards in the field of quality control of veterinary drugs. Article 16. The responsibility of individual organizations in the country, outside the country have production, export, import, circulate veterinary. 1. Provide technical documentation and creating favorable conditions for the examination bodies while on duty.
2. Be responsible before the law for quality veterinary medicine due to production, export, import and circulation.
3. Submission of fees prescribed by the State.
4. the executor decides to treat veterinary quality of State administration authorities.
Chapter IV INSPECTION, HANDLING of COMPLAINTS and VIOLATIONS, accusations the thing. Inspector, quality control of veterinary drugs. 1. Veterinary Bureau is responsible for checking, inspection of the quality of veterinary medicine; dispute resolution, finance, dealing with the breach of quality veterinary medicine under the provisions of the law;
2. the provincial veterinary Bureau is responsible for checking, inspection of the quality of veterinary medicine; dispute resolution, finance, dealing with the breach of quality veterinary drugs in geographical scope as defined by the law.
Article 18. Handle veterinary drugs did not meet quality standards in the handling of veterinary quality standard not under the provisions of the Ordinance on veterinary medicine is done as follows: 1. Recovery of veterinary medicine: a) animal health decision to withdraw, notify the veterinary Bureau, the base has a medication to make the suspension and revocation of veterinary drugs as prescribed;
b) of the notice, the Bureau of animal health inspection and monitoring of the recovery, processing of veterinary medicine in geographical scope;
c) The basis of veterinary medicine revoked, have a responsibility to: inform the business establishments, the use of drugs; recovery and send reports on the recovery, processing for drug quality batch to the Department of animal health and the relevant competent authorities; solving the consequences of smoking does not cause quality standards.
2. Destroy veterinary medicine: a) animal health drug destruction decision and inform the Bureau of animal health facility smoking be canceled and the agencies responsible for monitoring and implementation decisions;

b) veterinary Bureau recommended the Department of agriculture and Rural Development Council to supervise the destruction of drugs;
c) drug establishments destroyed is responsible for organizing the destruction under the provisions of the law on the protection of the environment and the provisions of other relevant laws, reports results on animal health. Article 19. Complaints, accusations and complaints, accusations.
Complaints, accusations and complaints, accusations in the field of quality control of veterinary drugs was made under the provisions of the law on complaints and denunciation.
Chapter V IMPLEMENTATION article 20. The Medical Director is responsible for implementation of this regulation guidelines.