The CIRCULAR stipulated check, certified eligible production business, veterinary medicines, probiotics, microorganisms, chemicals used in veterinary medicine, animal health fisheries _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to Decree 1/2008/ND-CP dated 03/01/2008 of the Government functions, mandate and organizational structure of the Ministry of agriculture and rural development;
French veterinary command base on April 29, 2004;
Pursuant to Decree No. 32/2005/ND-CP dated 15/3/2005 of the Government detailing the implementation of a number of articles of the Ordinance on veterinary medicine;
Pursuant to Decree 59/2006/ND-CP dated 12/6/2008 detailing the Government's commercial law on goods, services and business, prohibition of business restrictions and conditional business;
The Ministry of agriculture and rural development regulations testing procedures, certification of eligible production business, veterinary, veterinary fisheries, probiotics, microorganisms, chemicals used in veterinary medicine, animal health fisheries as follows: chapter I GENERAL PROVISIONS article 1. Scope and objects 1. This circular stipulates the conditions, test procedures, certification of eligible production business, veterinary, veterinary fisheries, probiotics, microorganisms, chemicals used in veterinary medicine, aquatic animal health; ingredients for the veterinary, veterinary fisheries (hereinafter referred to as veterinary drugs).
2. This circular is applicable to the veterinary medicine production base has not yet certified the drug good manufacturing practices (GMP), business establishments, export and import, storage, preserving the veterinary certificate yet have good storage practice (GSP); the shop, agents sell veterinary drugs not yet certified good practice pharmacy (GPP).
Organizations and individuals in Vietnam, foreign organizations have active production, veterinary medicine business on the territory of Vietnam must comply with the provisions of this circular.
Article 2. Fees The fee checking, certification fee basis of eligible production, veterinary medicine business is done according to the current rules of the Ministry of finance and the other legal texts concerned.
Chapter II CONDITIONS for the PRODUCTION of veterinary medicine article 3. General conditions for the production of veterinary drugs 1. Location: a) Matthew not infected from the outside environment;
b) Not bad influence to the surrounding environment;
c) difference with neighborhoods, schools, offices, hospitals, diagnostic facility, tests;
d) convenient traffic, power and water resources are assures the operation of the facility.
2. Workshop: a) solidly built, solid, consistent with the nature and scale of production, to avoid the bad effects of nature as forecast, moisture infiltration, inundation and the entry of insects or other animals;
b) solid floors, high-drain, smooth, not smooth; have the ability to withstand the pressure of the machine when operating;
c) wall and ceiling are made of durable material, sure;
d) the floor not cracking, not stagnant water, or ease of sanitation, reducing chemical resistant disinfectant;
DD) Have adequate lighting;
e) rational construction planning, consistent with the nature and scale of production.
g) each area must ensure veterinary hygiene norms according to the regulations.
3. Equipment: a) the equipment must be arranged in accordance with the installation, the operation will perform, operating instructions, maintenance plans; hygienic process guarantees do not cause infection or opportunistic crossover between the products.
b) have adequate equipment, as defined in annex 1 attached to this circular.
4. Packaging, packing: a) The type of packaging is not directly affecting the quality of medicines, to avoid the bad effects from outside such as light, humidity, microorganisms during storage.
b) glass packaging ensures sure, durable fit with sterilization processing, transportation, storage.
5. Laboratory: a) Must be separate from the manufacturing areas. Those areas to conduct biological, microbiological tests must be separated from each other.
b) Should have enough area to avoid cross-contamination and to preserve the form of the c standard, quality) are full of equipment as defined in annex 2 d) Who is in charge of laboratory animal health agencies have the authority to grant a certificate of practice under the regulation.
6. personal hygiene: people working in manufacturing establishments veterinary drugs to ensure the following requirements: a) has enough health as defined by the Ministry of health, the periodic health exam once a year; no open wound, skin diseases;
b) trained on professional expertise, personal hygiene, industrial hygiene in the production of veterinary drugs. c) of people working in manufacturing establishments veterinary drugs must comply the hygiene rules on animal health in the manufacturing sector.
7. labor room hygiene: a) must be equipped with protective labor for each individual match work.
b) Must have the specified text about the play mode, use of equipment, work attire.
c) must have fire fighting equipment, deodorizing, ventilation, dust extraction with suitable capacity; Safety equipment available for the use of the thermal equipment, electrical, mechanical, pneumatic.
d) Must have the specified text about the labor room, take measures and means to prevent and resolve quickly problems are likely to occur.
8. Wastewater and waste disposal: a) wastewater treatment system must be designed to fit the factory, production scale, ensuring collectors from every source of escape targets, causing no pollution to the region well production factory and around.
b) each area in the base must have proper waste containers, easy to transport. Waste water must be processed before standard emissions;
Article 4. Conditions for the production of pharmaceuticals, chemicals used in animal health 1. Storage system: a) Have separate areas or warehouses for raw materials, packaging, and product; have a private repository outside of the solvents and raw materials easily cause fire, explosion, where the difference of raw materials, semi-finished and finished products were removed.
b) capacity suitable to the scale of production.
c) have adequate equipment and facilities required to ensure a quality fit, specific preservation requirements: preserved in normal conditions: temperature from 15-30 0 c, humidity not exceeding 70%;
Cool preservation: in temperature from 8-150C.
Preservation: in temperature from 2-80 c.
Frozen: a temperature ≤-100 c d) Avoid direct light, Matthew infected from the outside environment;
DD) goods are arranged neatly, science, to on the shelves. Prescribed shelves the way the background of at least 20 cm away at least 20 cm long; the distance between the shelves or between blocks every 30 cm minimum to ensure ventilation, easy to import, export, easy hygiene and detoxification;
e) Has the text of the regulatory basis of the arrangement, preserving order, periodic examination modes, detection and timely handling of problems in the process of preservation;
g) have sufficient equipment to check the norms of maintenance, there is regular record mode the specifications.
2. sterile processing area: a) where sanitary mechanical processing, the chemical for packaging: tube shell, shell vases, bottles, buttons; Tools, equipment, processing workers. Floor surface where the toilet handle the mechanics must have a slope of around 1.50 to the trench and the friction to avoid slippery.
b) drying, cleaning, sterilization of bottles, tubes, buttons, tools, labor protection meets at the request of each stage of production.
c) have adequate equipment, tools, chemicals consistent with the pasteurization process;
d) have written regulations of hygiene, processed pasteurized for direct packaging types, tools used in manufacturing, labor protection.
3. Regional balance, allocate raw materials: a) has separate material balance. The absence of separate material balance room must take measures to ensure no cross-contamination between raw material type b) have sufficient weight, the weight and serving utensils are sanitary, kept clean after using.
4. The area of blending, mixing, storage products: a) wall and ceiling must have high gloss, where borders between wall and floor with legs between the wall with the ceiling must be the corner of prison.
b) for injection production lines: there are sterile room to replace the sterile outfit before working in sterile areas; not deployed sink and drainage trench openings in the sterile area widgets must be sterilized before use in the sterile area and must be preserved in sterile conditions tagged sterilized.
Take measures to avoid microbial infections before and during use.
c) for the production line of powder drugs: have dust d) Must have sufficient equipment, chemicals and specialized materials match product manufacturing process.
special storage area) products if not san Administration Division, right.
5. complete product areas;
a) Are positioned adjacent to the area san Administration Division, to the reception waiting product packaging was convenient.
b) have sufficient equipment and instruments consistent with the packing, labelling, shipping the product to the warehouse of finished products.
6. Area to the substandard product quality: must be arranged separately, have a lock or signage to avoid confusion with other goods.
7. product test area before: a) have adequate equipment, tools, chemicals, the environment consistent with the process of checking the final product before. In case of insufficient basis the conditions made the testing must have contracts with eligible unit tested as required.
b) Has specified the retention, preservation of samples and test patterns.
8. personal hygiene areas and other areas of production.
a reasonable layout, not) be passed directly to the manufacturing sector.
b) have sufficient sanitary equipment needed; There are enough chemicals, items needed for personal hygiene and the area.
c) Have ventilation equipment, deodorizing.
Article 5. Conditions for vaccine production facility, probiotics, microorganisms in addition to the provisions referred to in article 3, 4 this circular, must have custody and processing sector animal experiments; the area of the equipment to keep the same micro-organisms serving for production.
Article 6. Conditions for hormone production facility used in veterinary medicine: in addition to the provisions referred to in article 3, 4 this circular, must be manufactured in a separate area.

Article 7. Processing conditions, san chia, repackage veterinary applies the provisions in clause 1, 2, 4, 5, 6, 7, 8 of article 3; clause 1, 2, points a, c, d paragraph 4; clause 5, 6, 7, 8 article 4 this circular.
Chapter III veterinary BUSINESS CONDITIONS article 8. Business conditions for veterinary drug stores, wholesale dealers, retail veterinary as follows 1. Have a fixed address, you write the name of store, base or business name, business number was issued; business registration listing table.
2. Shop area a minimum of 10m2 3. There are sufficient facilities required to display, sales; goods are sort of science, keeping clean.
4. Have enough books to track goods import export;
5. Storage in accordance with the manufacturer's instructions, in particular: a) preserved in normal conditions: temperature from 15-300C.
b) preserving cool: temperatures from 8-150C. c) cold preservation: in temperature from 2-80 c.
d) frozen: temperature ≤-100 c 6. Not allowed to showcase veterinary medicine along with other goods. If allowed to feed business with veterinary medicine, are sold in the private sector.
7. for the store, wholesale dealer veterinary drugs must have enough cargo area; There is enough equipment, means of matching stored drugs, raw materials for drug-making business is allowed. The goods must be arranged on shelves. Shelf, cargo racks are the way the floor of at least 20 cm, 20 cm away, the distance between the minimum 30 cm shelves to ensure ventilation, ease detoxification hygiene; There is enough backup generator power. 
8. Store vaccines must be cold preservation equipment and means for preserving vaccines, biological preparations when occurs blackout; There are thermometers, temperature monitoring and recording.
9. Home Base, sales people are competent veterinary authority certificate of practice as required.
Article 9. Business conditions veterinary for veterinary import establishments as follows: in addition to the provisions in clause 1, 4, 5, 7, 8 article 8, to add the following condition: 1. import establishments veterinary vaccines must have specialized vehicles ensure preservation requirements when shipping distribution, to the place of consumption.
2. The owner or person in charge of technical be competent veterinary authority certificate of practice as required.
Chapter IV PROCEDURE for checking, CERTIFICATION of QUALIFIED PRODUCTION FACILITY, veterinary BUSINESS article 10. Form check 1. First check for: a new registration facility);
b) registered establishments, manufacturing business but changed location or renovate, upgrade production lines;
c) production facilities, veterinary business revoked the certificate of eligible production, veterinary medicine business, suspended production, business activities veterinary certification needs.
2. Check the apply to facilities have been examined but not yet eligible production, business.
3. Periodically check to be done 2 years/times to assess the maintenance conditions of production, business and as a base to the competent State authorities re-eligibility certification of production, trading for the base.
4. sudden checks are performed when the base showing signs of breaking the law in the produce business, veterinary medicine, or when required by the competent authority.
Article 11. The authority checking, certification of eligible production, veterinary medicine business 1. Animal health is responsible for checking the condition of production establishments veterinary drugs, base business export import veterinary drugs. 2. Veterinary Bureau of the province, central cities are responsible for checking with the store, business agents in veterinary management.
Article 12. Check registration records to qualify the production of veterinary drugs 1. Profile register first test includes: a) check application conditions of production, (Appendix 3);
b) Sheets on production conditions (Appendix 5);
c) directory of the form veterinary drugs production.
d) business registration certificate (certified copy)) manufacturing practice certificate in veterinary medicine (certified copy).
2. the registration records check including: a) check application conditions of the production of veterinary drugs;
b) fix the report does not reach.
3. Application for certificate renewal include: a) an application for renewal of the certificate of eligible veterinary production. b) certificate of eligibility has been issued the production article 13. Registration records check, certified eligible business, import-export business veterinary 1. Profile register first test includes: a) check application business conditions veterinary drugs (Appendix 4);
b) the Sheet about business conditions. (Appendix 6) c) business registration certificate (certified copy) d) practice veterinary medicine business (certified copies) 2. Registration records check including: a) check application conditions of veterinary business;
b) fix the report does not reach.
3. Application for certificate renewal include: a) an application for renewal of the certificate of eligible veterinary business b) certificate of eligibility has been issued the business article 14. The duration, content and methods of test 1. Within 10 (ten) working days from the receipt of the record, the Agency has jurisdiction to examine records and reply in writing.
Within 15 (fifteen) working days from the date of receipt is valid, the competent authorities conduct the check.
2. The content and methods of inspection: a) check Group Chief informed the representative base of the decision to be tested, test content.
b) content check: check the condition of the production of veterinary drugs as defined in annex 7; check the condition of the business required veterinary drugs in annex 8 attached to this circular. Sampling and specify target veterinary hygiene inspection for manufacturing, import-export businesses directly.
c) after the end of the test, the test crew uniform results reviews and created a test according to the model defined in annex 7, 8 attached to this circular.
d) announced the test results with the tested base representation. Represents the basis is check comments and sign the minutes of the test. The case represented the basis was not sign checks, report still has legal value when the full signature of the members of the test group.
DD) test was established thereon 02 (two) copies have the same legal value, 1 (a) a post for the facility to be checked, 1 (a) a save at the Agency.
3. within 20 (twenty) working days, since the end of the screening process, the Agency has the authority to: a) certification for qualified production facility, veterinary business according to the model in annex 9, 10 attached to this circular. The certificate has a value of 2 (two) years. Particularly for the certificate of eligible production of veterinary drugs has the time limit according to the GMP implementation Roadmap has been the Ministry of agriculture and rural development approved.
Before the certificate expires 12 months basis must submit the application for renewal of the authorized agency. Application for renewal in accordance with paragraph 3 article 12, 13 this circular. Renewal of certificate of value 2 (two) years.
b) notice the points do not reach for the base if the test results do not meet the requirements. After overcoming the points not reached base, send subscribe check back as prescribed in clause 2 article 12, 13 this circular.
Article 15. Unscheduled inspections 1. The competent veterinary authorities established Corps of irregular test when detecting the base showing signs of breaking the law in the production business, veterinary medicine, or when required by State administration authority.
2. sequence, content inspection as defined in clause 2 article 14 of this circular.
3. The base results in a check, the competent veterinary authority to revoke certificates as defined in article 16 of this circular.
Article 16. Revoking the certificate of eligible production, veterinary medicine business 1. Revoke the certificate of eligible production, veterinary medicine business in the following cases: a) the irregular test results do not meet the conditions for the production and trading of veterinary regulations this circular and the text of other laws-laws that are related to the production, veterinary medicine business. b.) basis refused to examine when the competent State Agency request from 02 (twice).
2. The decision to revoke the certificate of eligible production, veterinary medicine business is made up of 2 (two) copies: 1 (a) a sending base is recovered and 01 (a) stored at the Agency.
Chapter V the RESPONSIBILITY and AUTHORITY of the PARTY CONCERNED article 17. The responsibility and authority of the production base, the veterinary business 1. Responsibilities: a) check registration conditions of production, business, veterinary materials and observance of the test according to the provisions of this circular.
b) provide full information, relevant records and create conditions favorable to examining authority performing the task.
c) regular maintenance, ensure the conditions in the production, business, veterinary materials have been certified.
d) seriously fix the errors noted in the minutes of the examination.
DD) fully involved the training of production business, veterinary medicine due to the management bodies of the State veterinary organization e) Filed the prescribed fees.
2. Powers: the right to complain when it doesn't agree with the conclusions in the report on the test, the test results of the sanitary veterinary norm. Article 18. The responsibilities and powers of the Agency 1. Responsibilities: a) make check, certified eligible production, business, veterinary materials in accordance with the provisions of this circular.
b) ensure objectivity and fairness in performance testing, certification.
c) periodically check or irregularly for the facility was issued a certificate upon request by the competent State bodies.
d) handle infringement, resolved the complaint to report as required by the law 2. Powers: a) the grant or revoke the certificate of eligible production, veterinary medicine business according to regulations.

b) monitoring and request basis to overcome the shortcomings of the production conditions, the veterinary business. c) requires the facility to provide the records, document and create favorable conditions for the work to examine the observance of the provisions of this circular and the writing by-laws other relevant laws on production business, veterinary. Chapter VI TERMS and ENFORCEMENT of article 19. Effective enforcement of this circular effect after 45 days from the date of signing. This circular replaces decision 46/1999/QD-BNN on 5/3/1999 of the Minister of agriculture and rural development regulation of veterinary hygiene conditions for production facilities, business and replace the regulations about checking the conditions of production of the aquatic animal health drugs defined in regulations to manage aquatic animal health drugs attached to Decision No 3/2002/QD-BTS on 23/1/2002 of the Minister of fisheries.
Article 20. Implementation of veterinary Bureau, the provincial veterinary Bureau is responsible for popular, guide the production base, san chia, packaging, business veterinary made this circular.
In the process, if there are problems the Organization, personal reflections on the Ministry of agriculture and rural development (animal health) to timely adjust, Supplement.