Thông tư 51/2009/TT-BNNPTNT

CIRCULAR

REGULATIONS ON INSPECTION AND CERTIFICATION OF ELIGIBILITY FOR PRODUCTION AND SALE OF VETERINARY DRUGS, BIO-PREPARATIONS, MICROORGANISMS AND CHEMICALS USED IN VETERINARY MEDICINE AND AQUATIC VETERINARY MEDICINE

Pursuant to the Government’s Decree No. 01/2008/ND-CP dated January 03, 2008 defining functions, tasks, powers and organizational structure of Ministry of Agriculture and Rural Development;

Pursuant to the Ordinance on Veterinary Medicine dated April 29, 2004;

Pursuant to the Government’s Decree No. 33/2005/ND-CP dated March 15, 2005 detailing the implementation of certain articles of the Ordinance on Veterinary Medicine;

Pursuant to the Government’s Decree No. 59/2006/ND-CP dated June 12, 2008 detailing the implementation of the Law on Commerce on goods and services banned and restricted from business, and subject to conditional business;

Ministry of Agriculture and Rural Development promulgates the following regulations on procedures for the inspection and the certification of eligibility for production and sale of veterinary drugs, bio-preparations, microorganisms and chemicals used in veterinary medicine and aquatic veterinary medicine.  

Chapter I

GENERAL PROVISIONS

Article 1. Scope and regulated entities

1. This Circular provides for requirements and procedures for the inspection and the certification of eligibility for production and sale of veterinary drugs, bio-preparations, microorganisms and chemicals used in veterinary medicine and aquatic veterinary medicine; ingredients used for producing  veterinary drugs and aquatic veterinary drugs (hereinafter referred to as veterinary drugs).   

2. This Circular apply to producers of veterinary drugs that have not possess GMP Certificates, sellers, importers, exporters and storage facilities of veterinary drugs that have not possess GSP Certificates; veterinary drug stores and vendors that have not possess GPP Certificates.

Domestic and foreign organizations and individuals whose production and sale activities of veterinary drugs are carried out in the territory of Vietnam must comply with this Circular.

Article 2. Fees and charges

The collection of the inspection fees and charges for certifying the eligibility for production and sale of veterinary drugs shall comply with Ministry of Finance’s current regulations and other relevant legal documents.     

Chapter II

REQUIREMENTS FOR MANUFACTURING OF VETERINARY DRUGS

Article 3. General requirements for producers of veterinary drugs

1. Location:

a) Be not contaminated from the outside environment;

b) Do not cause adverse impacts on surrounding environment;

c) Be in distant from residential areas, schools, office buildings, hospitals, medical testing and diagnosis facilities;  

d) Be convenient for transport, ensure water and power sources for manufacturing activities.  

2. Workshop:

a) The workshop must be built in a strong and firm manner in conformity with the nature and the scale of production, avoiding adverse natural impacts such as weather, flood, moisture and the infiltration of insects or other animals;

b) The workshop must have firm, dry, flat and non-slip foundation which has to bear the compression of machinery during the manufacturing of veterinary drugs;   

c) Walls and ceiling must be made of strong and solid materials;

d) The floor must not be cracked, be designed to prevent the water absorbance or stagnation, easy for cleaning and suitable for disinfectants;

dd) Have a strong lighting system;  

e) The planning for construction must be suitable and conformable to the nature and the scale of production.

g) Each place in the workshop must meet with the criteria of veterinary hygiene as regulated.

3. Equipment:

a) Machinery and equipment must be arranged and installed in conformity with intended operations; operational manual and maintenance plans should be available. There should be the proper industrial cleaning process to prevent the contamination or cross-contamination between products.     

b) Equipment must be available as regulated in the Annex No. 1 enclosed with this Circular.

4. Packages:

a) Primary packages must not harm the quality of veterinary drugs contained inside, and may prevent adverse impacts from the outside such as light, moisture, and microorganisms during the preservation of veterinary drugs.

b) Glass packages must be firm and durable kinds in conformity with the sterilization, transport and preservation.

5. Testing laboratory:

a) Must be isolated from the production area.  Places for conducting bio-tests and microbiological tests must be separate from each other.

b) Area of the testing laboratory must be enough for avoiding the cross-contamination and maintaining samples and titrants.

c) Equipment must be available as regulated in the Annex No. 2 herein.

d) The testing laboratory manager must possess an appropriate practice certificate which has been granted by the competent veterinary agency as regulated.

6. Personal hygiene:

Workers in producers of veterinary drugs must meet the following requirements:

a) They must be fit for work as regulated by Ministry of Health; go for periodic check-up once for every year; do not have any open wounds and dermatological diseases;

b) They must be trained in professional skills, personal hygiene and industrial cleaning knowledge during the production of veterinary drugs.

c) Workers in producers of veterinary drugs must comply with regulations on veterinary hygiene in the production area.

7. Labor safety and hygiene:

a) Each worker must be provided with labor safety equipment in conformity with his/her assigned tasks.

b) Written regulations on the issuance and use of working equipment and clothing must be promulgated.

c) Fire equipment, and equipment for deodorization, air ventilation and vacuum must be equipped with suitable capacity. Workers who use heating, electrical, mechanical, or compressed air equipment must be provided with safety equipment.

d) Written regulations on labor protection must be formulated; measures and facilities for preventing and solving problems which may occur must be available.

8. Waste collection and treatment system:

a) The wastewater treatment system must be designed in conformity with the workshop and the scale of production, ensuring that the wastewater from all sources must be treated in the appropriate manner and avoiding the pollution in the workshop and surrounding area.

b) Garbage bins must be placed in all areas in the producer in the appropriate manner which must be easy for transport. The wastewater must be treated in conformity with technical regulations before it can be discharged.

Article 4. Requirements for producers of medicinal products and chemicals used in veterinary medicine

1. Warehouse system:

a) Build warehouses and special areas for storing materials, auxiliary materials, packages and finished products; the producer must build a warehouse in the outside for storing explosive and inflammable solvents and materials, and have special areas for storing discarded materials, semi-finished and finished products.

b) The warehouse’s capacity must be in conformity with the scale of production.

c) Necessary equipment and facilities for ensuring the quality of products must be available and in conformity with preservation requirements. To be specific:

Storage at normal conditions: temperature is from 15 to 30 ⁰C, and the humidity shall not exceed 70%;

Cool storage: temperature is from 8 to 15 ⁰C.

Cold storage: temperature is from 2 to 8 ⁰C.

Freezing storage: temperature is ≤-10⁰C.

d) Prevent the direct light and the contamination from the outside environment;  

dd) Products must be arranged on brackets/shelves in a tidy and scientific way. Brackets/shelves must be at least 20 cm far away from the foundation surface, and at least 20 cm far away from the walls; the distance between brackets/shelves or that between items of products must be at least 30 cm for ensuring the ventilation and facilitating the warehousing input or delivery of goods, cleaning and sterilization;      

e) The producer must promulgate written regulations on the arrangement and preservation of goods, periodical inspection, discovery and handling of problems which occur during the preservation;

g) Equipment for checking preservation standards and policies on regular recording of technical parameters must be available.

2. Sterilization area:

a) It must have a place for practicing mechanical hygiene and chemical hygiene for primary packages, including ampoule covers, vial covers, bottles, and caps, devices and equipment for preparation, and personal protective equipment.  The floor surface where the mechanical hygiene is performed must slope about 1.5⁰ towards the drainage ditch and has the rubbing for preventing slip.

b) Ampoules, vials, bottles, caps, devices and personal protective equipment must be sterilized to meet requirements on each manufacturing step.

c) Equipment, devices and chemicals must be suitable for the sterilization;  

d) Written regulations on hygiene and sterilization of primary packages, manufacturing devices and personal protective equipment must be promulgated.

3. Area for weighing and delivering materials:

a) Have a separate room for weighing materials. If a separate room for weighing materials is not available, measures against the cross-contamination between kinds of materials must be prepared.

b) Scales and devices for weighing materials must be available and cleaned after they are used.

4. Area for preparation, mixture and storage of semi-finished products:

a) The walls and ceiling must be shiny; the intersection between the foot of the wall and the floor surface, and that between the wall and the ceiling must be obtuse angles.

b) The production line for injectable veterinary drugs: it must have a pre-sterilization room for dressing sterile lab clothing before entering the sterilization area; the sink and the open drainage ditch are not built in the sterilization area.

All equipment must be sterilized before they are moved to the sterile area. They must be stored in sterile conditions with “sterilized” labels.

Measures against re-contamination before and during using must be available.

c) The production line for veterinary drugs in the form of powder: vacuum devices must be equipped.

d) Equipment, devices and chemicals must be available and suitable for the production process.

dd) It must have special area for storing semi-finished products whose division is not yet carried.  

5. Area for finishing products;

a) This area must be arranged next to the area for division of drugs for facilitating the receipt of products for packing.

b) Equipment and devices must be available and suitable for the packing, labeling and transport of products to the warehouse of finished products.

6. The area for storing products which fail to meet quality standards must be arranged separately, are lockable or have a warning sign put up to avoid the confusion with other products.

7. The area for inspection of products before they are released:

a) Equipment, devices, chemical and the environment must be in conformity with the procedures for the final inspection of products before they are released.    If the producer fails to meet requirements for carrying out the inspection, it must contract a qualified inspection unit to carry out the inspection of products as regulated.

b) Regulations on storage, preservation and inspection of stored samples must be promulgated.

8. Personal hygiene area and other areas serving the production.

a) Must be arranged in an appropriated way and out of contact with the production area.

b) Have necessary equipment, chemicals and devices for practicing personal hygiene and cleaning such areas.

c) Have air ventilation and deodorization equipment.

Article 5. Requirements for producers of vaccines, bio-preparations and microorganisms

Apart from regulations stated in Article 3 and Article 4 of this Circular, producers of vaccines, bio-preparations and microorganisms must have separate areas for raising animals for experimental purpose and treating tested animals; areas and equipment for keeping breeds of microorganisms to serve the production.  

Article 6. Requirements for producers of hormones used in the veterinary medicine:

Apart from regulations stated in Article 3 and Article 4 of this Circular, hormones must be produced in a separate place.

Article 7. Requirements for processing, dividing and packing veterinary drugs

Regulations in Clauses 1, 2, 4, 5, 6, 7, and 8 Article 3; Clauses 1 and 2, Points a, c, d Clause 4; Clauses 5, 6, 7, 8 Article 4 of this Circular shall apply.

Chapter III  

REQUIREMENTS FOR SALE OF VETERINARY DRUGS

Article 8. Wholesalers and retailers of veterinary drugs must satisfy the following requirements:

1. Have a registered address, signboard indicating the name of store, establishment or enterprise, and the issued business code; the board posting the business registration certificate.   

2. Minimum area of a veterinary drug store is 10m²

3. Have been equipped with adequate equipment for showing and selling products; veterinary drugs must be arranged in a scientific and clean way.

4. Have records for monitoring the input or delivery of products;

5. Preserve veterinary drugs in conformity with producers’ instructions. To be specific:

a) Storage at normal conditions: temperature is from 15 to 30⁰C_.

b) Cool storage: temperature is from 8 to 15^0­­C.

c) Cold storage: temperature is from 2 to 8⁰C.

d) Freezing storage: temperature is ≤-10⁰C.

6. Do not sell veterinary drugs together with other commodities. If animal breeds and veterinary drugs are allowed to sell in the same store, they must be arranged separately.

7. A wholesaler of veterinary drugs must have a warehouse for storing veterinary drugs with suitable area; have equipment and devices in compliance with requirements for storage of veterinary drugs and materials which such wholesaler are licensed to sell. Products must be arranged on brackets/shelves. Brackets/shelves must be at least 20 cm far away from the foundation surface, and at least 20cm cm far away from the walls; the distance between brackets/shelves must be at least 30 cm for ensuring the ventilation, cleaning and sterilization; electric generators must be available.       

8. Veterinary vaccine store must be equipped with cold storage equipment and standbys for storing vaccines and bio-preparations in case of the power cut; thermometers for monitoring storage temperature and taking daily notes.

9. Owners or storekeepers must possess certificates of practice granted by competent veterinary agencies as regulated.

Article 9. Importers of veterinary drugs must satisfy the following requirements:

Apart from regulations stated in Clauses 1, 4, 5, 7, and 8 Article 8 herein, importers of veterinary drugs must satisfy the following requirements:

1. Importers of veterinary vaccines must have specialized means of transport of vaccines in order that vaccines are stored in appropriate method during the transport.

2. Owners or technicians must possess certificates of practice granted by competent veterinary agencies as regulated.

Chapter IV

PROCEDURES FOR INSPECTION AND CERTFIICATION OF ELIGIBILITY FOR PRODUCTION AND SALE OF VETERINARY DRUGS  

Article 10. Methods of inspection

1. The initial inspection shall apply to:

a) Establishments that carry out the first registration;

b) Establishments that have registered their production and trading but change location or improve production line;

c) Establishments that have certificates of eligibility for production and sale of veterinary drugs revoked, production and trading been suspended, and apply for re-certification.

2. The re-inspection shall apply to establishments that have been inspected but ineligible for production and trading.

3. The periodical inspection shall be carried out once for every two years for evaluating the maintenance of production and trading conditions and using as the basis for re-issuance of certificate of eligibility for production and sale of veterinary drugs.

4. The unscheduled inspection shall be conducted if the establishment is suspended of committing violations against the law on veterinary drug production and business or at the request of competent agencies.

Article 11. Competence to conduct the inspection and issue certificate of eligibility for production and sale of veterinary drugs

1. Department of Animal Health shall inspect the compliance with requirements by producers, sellers, importers and exporters of veterinary drugs.

2. Sub-departments of animal health of central-affiliated cities and provinces shall inspect the compliance with requirements by veterinary drug stores and vendors in their provinces.

Article 12. Application for certification of eligibility for production of veterinary drugs

1. The application for initial inspection consists of:

a) The application form for the certification of eligibility for production of veterinary drugs (Annex 3);

b) Report on production facilities (Annex 5);

c) List of kinds of veterinary drugs which shall be produced.

d) Certificate of business registration (certified copy) 

dd) Certificate of practice in production of veterinary drugs (certified copy).    

2. The application for re-inspection consists of:

a) The application form for re-certification of eligibility for production of veterinary drugs;

b) Report on the rectification of deficiencies exposed by the previous inspection.

3. The application for renewal of certificate of eligibility consists of:

a) The application form for certificate of eligibility for production of veterinary drugs.  

b) The issued Certificate of eligibility for production of veterinary drugs 

Article 13. Application for inspection and certification of eligibility for sale, importation and exportation of veterinary drugs

1. The application for initial inspection consists of:

a) The application form for the certification of eligibility for sale of veterinary drugs (Annex 4);

b) Report on business conditions (Annex 6);

c) Certificate of business registration (certified copy) 

d) Certificate of practice in sale of veterinary drugs (certified copy).   

2. The application for re-inspection consists of:

a) The application form for the re-certification of eligibility for sale of veterinary drugs;

b) Report on the rectification of deficiencies exposed by the previous inspection.

3. The application for renewal of certificate of eligibility consists of:

a) The application form for the renewal of certificate of eligibility for sale of veterinary drugs. 

b) The issued Certificate of eligibility for sale of veterinary drugs.

Article 14. Period, contents and method of inspection

1. Within 10 (ten) working days from the receipt of the application, the competent agency shall check the application and respond in writing to the relevant establishment.  

Within 15 (fifteen) working days from the receipt of the valid application, the competent agency shall conduct the inspection.

2. Contents and method of inspection:

a) The head of the inspectorate shall inform the representative of the inspected establishment of the decision and contents of the inspection.

b) Contents of the inspection: The inspection of the compliance with requirements for production of veterinary drugs shall comply with Annex 7; the inspection of the compliance with requirements for sale of veterinary drugs shall comply with Annex 8 herein.  As for direct producers and importers of veterinary drugs, samples shall be taken and criteria of veterinary hygiene shall be specified.  

c) Upon the completion of the inspection, the inspectorate shall reach an unanimous agreement on inspection results and prepare the written record on inspection by using the form stated in Annex No. 7 and Annex No. 8, enclosed to this Circular.

d) Inform the representative of the inspected establishment of the inspection results.  The representative of the inspected establishment shall state opinions and sign on the written record on the inspection.  If the representative of the inspected establishment refuses to sign on the written record on inspection, it still remains its legal effect provided that it is signed by all members of the inspectorate.

dd) The written record on inspection is made into 02 (two) copies of the same legal effect, 01 (one) copy of which shall be sent to the inspected establishment and 01 (one) other shall be retained at the inspection agency. 

3. Within 20 (twenty) working days from the end of the inspection, the competent agency shall:

a) Issue certificate of eligibility for production and sale of veterinary drugs by using the form stated in Annex No. 9 and Annex No. 10 of this Circular.  Certificate of eligibility shall take effect within 02 (two) years.  Particularly, certificate of eligibility for production of veterinary drugs shall be valid in conformity with the implementation progress of GMP which has been approved by Ministry of Agriculture and Rural Development. 

Within 02 months before the certificate of eligibility expires, the certificate holder must submit the application for renewal to the competent agency.  The application for renewal shall comply with regulations stated in Clause 2 Article 12 and Article 13 of this Circular. Renewed certificate of eligibility takes effect within 02 (two) years.  

b) If the inspected establishment fails to meet requirements for certification of eligibility, deficiencies must be announced. The application for re-certification may be submitted as regulated in Clause 2 Article 12 and Article 13 of this Circular after deficiencies exposed by the previous inspection are rectified.

Article 15. Unscheduled inspection

1. The competent veterinary agency shall establish the inspectorate for conducting the unscheduled inspection if the establishment is suspended of committing violations against the law on veterinary drug production and business or at the request of competent agencies.

2. Procedures and contents of the inspection shall comply with Clause 2, Article 14 of this Circular.

3. The competent veterinary agency shall, on the basis of the written record on inspection, revoke certificate of eligibility as per Article 16 of this Circular.

Article 16. Revocation of certificate of eligibility for production and sale of veterinary drugs

1. Certificate of eligibility for production and sale of veterinary drugs shall be revoked in the following cases:

a) The result of the unscheduled inspection shows that the inspected establishment fails to meet requirements for production and sale of veterinary drugs as regulated in this Circular and other legislative documents relating to the production and sale of veterinary drugs.

b) The establishment refuses to bear the inspection at the request of the competent state agency for 02 (two) times or more.

2. Decision on the revocation of certificate of eligibility for production and sale of veterinary drugs shall be made into 02 (two) copies, 01 (one) copy of which shall be sent to the establishment whose certificate of eligibility is revoked and 01 (one) other shall be retained at the inspection agency.

Chapter V

RESPONSIBILITIES AND RIGHTS OF INVOLVED PARTIES

Article 17. Responsibilities and rights of producers and sellers of veterinary drugs

1. Responsibilities:

a) Apply for the inspection and certification of eligibility for production and sale of veterinary drugs and materials, and bear the inspection as regulated in this Circular.

b) Provide information and relevant documents in sufficient manner, and facilitate the inspection agencies in performing their duties.

c) Maintain the compliance with requirements for production and sale of veterinary drugs as per the issued certificate.

d) Rectify any deficiencies stated in the written record on inspection made by the inspection agency.

dd) Attend training courses in production and sale of veterinary drugs which are organized by state veterinary agencies.

e) Pay fees and charges as regulated.

2. Rights:

Have the right to make complaint against the conclusion stated in the written record on inspection or inspection results of criteria of veterinary hygiene.

Article 18. Responsibilities and rights of inspection agencies

1. Responsibilities:

a) Conduct the inspection and certification of eligibility for production and sale of veterinary drugs and materials in compliance with this Circular.  

b) Ensure the objectiveness and the impartialness in the course of inspection and issuance of certificates of eligibility.

c) Conduct the periodical inspection and the unscheduled inspection of a given establishment that possesses a certificate of eligibility at the request of the competent state agencies.   

d) Take action against violations and handle complaints and denunciation as regulated by laws.

2. Rights:

a) Issue or revoke certificates of eligibility for production and sale of veterinary drugs as regulated.

b) Supervise and request producers and sellers of veterinary drugs to rectify their deficiencies in the production and sale of veterinary drugs. 

c) Request relevant establishments to provide documents and facilitate the inspection of the compliance with regulations stated in this Circular and other legislative documents relating to the production and sale of veterinary drugs.

Chapter VI

IMPLEMENTATION

Article 19. Effect

This circular takes effect 45 days from the date on which it is signed.   This Circular shall replace for the Decision No. 46/1999/QD-BNN dated March 05, 1999 of the Ministry of Agriculture and Rural Development promulgating Regulations on veterinary hygiene applicable to producers and sellers of veterinary drugs, and regulations on the inspection of the compliance with requirements for production of aquatic veterinary drugs which are stated in the Statute of the management of aquatic veterinary drugs, enclosed with Decision No. 03/2002/QD-BTS dated January 23, 2002 of Minister of Aquatic Resources.     

Article 20. Implementation organization

Department of Animal Health and Sub-departments of animal health in provinces shall disseminate and instruct producers and sellers of veterinary drugs to implement this Circular.  

Any difficulties arisen during the course of implementation should be promptly submitted to the Ministry of Agriculture and Rural Development (via the Department of Animal Health) for amendment./.

ANNEX 1

EQUIPMENT USED IN THE PRODUCTION OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

I. VETERINARY DRUGS IN SOLUTION FORM FOR ORAL ADMINISTRATION, INJECTION AND MIXING WITH ANIMAL BREEDS

1. Technical balance

2. Graduated cylinders

3. Dissolution flasks.   

4. Filtration equipment: purification filter, bacteria filter

5. Homogenization devices (colloid mill or homogenizer) used for producing injectable suspensions and emulsions.

6. Equipment for testing semi-finished products: turbidimeter, pH-meter, graduated cylinders or technical balance.

7. Sterilization equipment: steam sterilizer or steam sterilization chamber (used in the production of injectable solutions)

8. Packing equipment: vial filling machine, ampoule sealer  

9. Batch coding machine

10. Other equipment: machines for washing vials, ampoules, plastic and aluminum caps, vial and cap drying oven or tunnel, autoclave for plastic caps.    

II. INJECTABLE DRUGS IN THE FORM OF POWDER

1. Technical balance

2. Moisture balance

3. Sterilization equipment

4. Equipment for dividing drug dosage: powder filling machine

5. Batch coding machine

6. Other equipment: machines for washing vials, ampoules, plastic and aluminum caps, vial and cap drying oven or tunnel, autoclave for plastic caps.   

III. VETERINARY DRUGS IN THE FORM OF POWDER OR GRANULE FOR ORAL ADMINISTRATION OR MIXING WITH ANIMAL FEEDS

1. Technical balance

2. Moisture balance

3. Mill or grinding machine

4. Sieve machine (vibrating or shaking)

5. Mixing equipment (batch mixer)

6. Granulation equipment

7. Drying equipment: stationary dryer or fluidized-bed dryer.

8. Tablet press machine (applicable to the production of veterinary tablets)

9. Machine for dividing drug dosage or packing machine (bag packing machine)

10. Batch coding machine

Note: In case of production of effervescent tablets, other than the tablet press machine, a separate drying system must be available for maintaining the humanity of below 25% in the preparation, pressing and packing area.  

ANNEX 2

VETERINARY DRUG TESTING EQUIPMENT
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

ANNEX 3

APPLICATION FOR CERTIFICATION OF ELIGIBILITY FOR PRODUCTION OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-----------------------

APPLICATION FOR CERTIFICATION OF ELIGIBILITY FOR PRODUCTION OF VETERINARY DRUGS

To: Department of Animal Health

ANNEX 4

APPLICATION FOR CERTIFICATION OF ELIGIBILITY FOR SALE OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-----------------------

APPLICATION FOR CERTIFICATION OF ELIGIBILITY FOR SALE OF VETERINARY DRUGS

To:   ⁽¹⁾

Notes:

(1) Submit the application to the sub-department of animal health if the applicant is the seller of veterinary drugs.

    Submit the application to Department of Animal Health if the applicant is the importer of veterinary drugs.

ANNEX 5

REPORT ON THE COMPLIANCE WITH REQUIREMENTS FOR PRODUCTION OF VETERINARY DRUGS
(Promulgated under the Circular No. 51/2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-----------------------

REPORT ON THE COMPLIANCE WITH REQUIREMENTS FOR VETERINARY DRUGS

To: Department of Animal Health

Name of the inspected establishment: …………………………………………………………….

Address: ……………………………………………………………..

Telephone:………………….. Fax………………………………… Email:……………..

Type of products:    

         o Pharmaceuticals                      o Vaccines, bio-preparations      

         o Chemicals                   o Other types                 

We hereby explain about our facilities for producing veterinary drugs. To be specific:

1. Production location

2. Workshop

3. Equipment and devices used in the production

4. Warehouse system

5. Sterilization area

6. Area for weighing and delivering materials

7. Area for preparing, dividing and storing semi-finished products

8. Area for finishing products

9. Hygienic area

10. Waste and sewage collection and treatment system

11. Packing

12. Labeling

13. Disinfection and decontamination

14. Human resource

15. Personal hygiene

16. Labor safety and hygiene

17. Industrial water

18. The implementation of regulations on batch-related documents

19. The implementation of regulations on quality management:

- Testing laboratory

- The staff of the testing laboratory

-  Equipment

- Regulations on inspection of materials, finished products, sample storage and inspection of stored sample

Note: The applicant must explain about contents stated from item 1 to item 19 according to the contents of inspection stated in the List of inspected items, enclosed with the written record on inspection of the compliance with requirements for production of veterinary drugs in Annex 7 herein.

ANNEX 6

REPORT ON THE COMPLIANCE WITH REQUIREMENTS FOR SALE OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-----------------------

REPORT ON THE COMPLIANCE WITH REQUIREMENTS FOR SALE OF VETERINARY DRUGS

To: ^(*)  ………………………………………..

Name of the inspected establishment: …………………………………………………………….

Address: ……………………………………………………………..

Telephone:………………….. Fax………………………………… Email:……………..

Type of business:………………………………………………….

We hereby explain about our conditions for sale of veterinary drugs. To be specific:

1. Facilities: (description of structure, area and scale of store/establishment, areas for showing products)

2. Equipment: (specify name, quantity of equipment serving the storage of veterinary drugs such as cabinets, shelves, hygrometers, thermometers, refrigerators, etc.)

3. Records: (certificate of business registration, certificate of practice, records for following selling activities, etc.)

4. The list of types of veterinary drugs which shall be sold

Note: (*) Submit the report to Department of Animal Health if the applicant is the importer or exporter of veterinary drugs; or the sub-department of animal health if the applicant is the veterinary drug store or vendor.  

ANNEX 7

WRITTEN RECORD ON INSPECTION OF THE COMPLIANCE WITH REQUIREMENTS FOR PRODUCTION OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

WRITTEN RECORD ON INSPECTION OF THE COMPLIANCE WITH REQUIREMENTS FOR PRODUCTION OF VETERINARY DRUGS

Today, on………………..[date], at……………………………………………

- Address:……………………………………………………………........................................

- Telephone: .............................. Fax:...................... E-mail:………...............................

We, consisting of:                                

Representative of the inspection agency:

1. Mr. (Mrs.):………………………………………..   Position:………………………… ...........

2. Mr. (Mrs.):………………………………………..   Position:………………………… ...........

3. Mr. (Mrs.):………………………………………..   Position:………………………… ...........

4.  Mr. (Mrs.):………………………………………..   Position:………………………… ..........

5. Mr. (Mrs.):………………………………………..   Position:………………………… ...........

Representatives of the producer of veterinary drugs:

1. Mr. (Mrs.):………………………………………..   Position:………………………… ...........

2. Mr. (Mrs.):………………………………………..   Position:………………………… ...........

- Pursuant to the Ordinance on veterinary medicine in 2004 and the Government’s Decree No. 33/2005/ND-CP dated March 15, 2005 detailing the implementation of certain articles of the  Ordinance on veterinary medicine;

- Pursuant to the Circular No.                 /2009/TT-BNNPTNT dated…………………….. of Ministry of Agriculture and Rural Development promulgates regulations on the inspection and the certification of the eligibility for production and sale of veterinary drugs, bio-preparations, microorganisms and chemicals used in veterinary medicine and aquatic veterinary medicine;

- Pursuant to Decision No…………….dated…………….of Director of Department of Animal Health on the establishment of the Inspectorate in charge of conducting the inspection of the compliance with requirements for production of veterinary drugs

1. Name of inspected producer of veterinary drugs:……………………………

...............................................................................................................................

2. Production location:…………………………………………………………………….

3. Date of establishment: ................/............/……………………………...............

4. Operating production lines

         o Pharmaceuticals            o Vaccines, bio-preparations      

         o Chemicals                          o Other types              

5. The quantity of products which are permitted for free sale:                     product(s)

In which:

- The quantity of products which are produced and sold:                     product(s)

- The quantity of products which are not produced:              product(s)

6. Inspection results: As per enclosed list

7. Conclusion of the Inspectorate:

………………………………………………………………………………………………….

……...…………………………………………………………………………………………..

……...…………………………………………………………………………………………..

………………………………………………………………………………………………….

………………………………………………………………………………………………….

8. Opinions of the producer of veterinary drugs:

…………………………………………………………………………………………………

……...………………………………………………………………………………………….

……...…………………………………………………………………………………………..

………………………………………………………………………………………………….

This record has been re-read to the inspectorate and representative of the producer of veterinary drugs who have unanimously agreed and signed this record. This record is made into 02 copies of the same effect.. The inspectorate shall keep 01 copy and the other is kept at the producer of veterinary drugs for implementation.

LIST OF INSPECTED ITEMS
(Enclosed to the Written record on inspection of the compliance with requirements for production of veterinary drugs)

1. Name of the inspected establishment: …………………………………………………………….

2. Address: …………………………………………….                                                             

Telephone:………………….. Fax………………………………………………

3. Inspection results  

Part 1. General evaluation of the producer of veterinary drugs: 40 marks

Part 2. Implementation of regulations on batch-related documents: 20 marks

Part 3. Implementation of regulations on quality control: 40 marks

Note: With regard to the producer of both pharmaceuticals, chemicals and bio-preparations, vaccines, the mark of equipment stated in Part 3 is calculated by arithmetic mean of Item 3.1 and Item 3.2 of Part 3.

Ranking of inspected establishment:  

1. Failed: below 50 marks

2. If the criteria of veterinary hygiene are satisfactory as assessed by the National Center for Veterinary Hygiene Inspection I or the National Center for Veterinary Hygiene Inspection II, the inspected establishment shall be ranked as follows:

- Excellent: from 90 to 100 marks

- Good: from 70 to below 90 marks

- Satisfactory: from 50 to below 70 marks

ANNEX 8

WRITTEN RECORD ON INSPECTION OF THE COMPLIANCE WITH REQUIREMENTS FOR SALE OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

WRITTEN RECORD ON INSPECTION OF THE COMPLIANCE WITH REQUIREMENTS FOR SALE OF VETERINARY DRUGS 

Today, on………………..[date], at……………………………………………

- Address:……………………………………………………………........................................

- Telephone:…………… Fax:…………………….. E-mail: ……………...............................

We, consisting of:                                

Representatives of the inspection agency:

1. Mr. (Mrs.):.................................................................... Position:……………………….         

2. Mr. (Mrs.):.......................................................................... Position:…………………         

3. Mr. (Mrs.):.........................Position:………………… ..

4. Mr. (Mrs.):................................... Position:…………… .............................................

5. Mr. (Mrs.):.................................................................................. Position:……………         

Representatives of the seller of veterinary drugs:

1. Mr. (Mrs.):.......................................................................... Position:………………….         

2. Mr. (Mrs.):..........................................Position:……………………………………… ......

- Pursuant to the Ordinance on veterinary medicine in 2004 and the Government’s Decree No. 33/2005/ND-CP dated March 15, 2005 detailing the implementation of certain articles of the  Ordinance on veterinary medicine;

- Pursuant to the Circular No.                 /2009/TT-BNNPTNT dated…………………….. of Ministry of Agriculture and Rural Development promulgates regulations on the inspection and the certification of the eligibility for production and sale of veterinary drugs, bio-preparations, microorganisms and chemicals used in veterinary medicine and aquatic veterinary medicine;

- Pursuant to Decision No……………dated……………..on the establishment of the Inspectorate 

to conduct the inspection of the compliance with requirements for sale of veterinary drugs

I. Inspection results: As per enclosed list

II. Conclusion of the Inspectorate:..............................................................................

..................................................................................................................................

..................................................................................................................................

..................................................................................................................................

..................................................................................................................................

..................................................................................................................................

..................................................................................................................................

..................................................................................................................................

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..................................................................................................................................

III. Opinions of the seller of veterinary drugs:............................................................

..................................................................................................................................

..................................................................................................................................

This record is finished at ................ hour(s), on................[date], and has been re-read to the Inspectorate and representative(s) of the inspected establishment who have simultaneously signed on this record.   This record is made into 02 copies of the same effect, and each party shall keep 01 copy.

LIST OF INSPECTED ITEMS

(Enclosed to the written record on inspection of the compliance with requirements for sale of veterinary drugs)

Name of the inspected establishment: …………………………………………………………….

Address: ……………………………………………………………..

Telephone:………………….. Fax………………………………… Email:……………..

Type of business registration:………………………………………………….

Ranking of inspected establishment:

I. The seller of veterinary drugs:

- Excellent: from 90 to 100 marks

- Good: from 70 to below 90 marks

- Satisfactory: from 50 to below 70 marks

- Failed: below 50 marks

II. The import or export of veterinary drugs:

1. Failed: below 50 marks

2. If the criteria of veterinary hygiene are satisfactory as assessed by the National Center for Veterinary Hygiene Inspection I or the National Center for Veterinary Hygiene Inspection II, the inspected establishment shall be ranked as follows:

- Excellent: from 90 to 100 marks

- Good: from 70 to below 90 marks

- Satisfactory: from 50 to below 70 marks

ANNEX 9

CERTIFICATE OF ELIGIBILITY FOR PRODUCTION OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

CERTIFICATE OF ELIGIBILITY FOR PRODUCTION OF VETERINARY DRUGS

No.:  …….../ GCN-SXT

Name of producer of veterinary drugs: ……………………………………………………………..

Address: ……………………………………………………………..

Telephone:….. ..                                            Fax:……….

Is eligible for production of veterinary drugs, including the following products: ^(*)

…………………………………………………………………………………………...

…………………………………………………………………………………………...

………………………………………………………………………………...................

…………………………………………………………………………………………..

…………………………………………………………………………………………..

 This Certificate of eligibility shall remain validity until………………………………..[date].

Note: (*) specify production lines such as the production line for drugs in the form of powder, the production line for injectable solutions, etc.

ANNEX 10

CERTIFICATE OF ELIGIBILITY FOR SALE OF VETERINARY DRUGS
(Promulgated under the Circular No. 51 /2009/TT-BNNPTNT dated August 21, 2009 of Ministry of Agriculture and Rural Development)

FORM 1

CERTIFICATE

 OF ELIGIBILITY FOR SALE OF VETERINARY DRUGS

No.:  …….../GCN-KDT

Name of the seller of veterinary drugs: …………………………………………………………….

Address: ……………………………………………………………..

Telephone:….. ..                                            Fax:……….

Name of the owner: …………………………………………………………….

Permanent residence: ……………………………………………………………..

Is eligible for sale of veterinary drugs, including the following products: ^(*)

…………………………………………………………………………………………...

…………………………………………………………………………………………...

………………………………………………………………………………...................

…………………………………………………………………………………………..

…………………………………………………………………………………………..

This Certificate of eligibility shall remain validity until………………………………..[date].

Note: (*) specify types of products such as vaccines, pharmaceuticals, chemicals, etc.

FORM 2

CERTIFICATE OF ELIGIBILITY FOR SALE OF VETERINARY DRUGS

No.:  …….../GCN-KDT

Name of the seller of veterinary drugs: …………………………………………………………….

Address: ……………………………………………………………..

Telephone:….. ..                                            Fax:……….

Name of the owner: …………………………………………………………….

Permanent residence: ……………………………………………………………..

Is eligible for sale of veterinary drugs, including the following products: ^(*)

…………………………………………………………………………………………...

…………………………………………………………………………………………...

………………………………………………………………………………...................

…………………………………………………………………………………………..

…………………………………………………………………………………………..

 This Certificate of eligibility shall remain validity until………………………………..[date].

Note: (*) specify types of products such as vaccines, pharmaceuticals, chemicals, etc.