51/2009/TT-BNNPTNT in Vietnam, Circular 51/2009/TT-BNNPTNT inspection certification eligibility production sale veterinary drugs bio preparations in Vietnam

Vietnamese
English
Official Gazette
Content relation
Validity relation
Related Content
Description
Download

Text size large => Please "Download" to view content.

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT -------	SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ----------------
No.: 51/2009/TT-BNNPTNT	Hanoi, August 21, 2009

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

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

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

...

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;

...

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:

...

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:

...

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.

...

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.

...

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.

...

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.

...

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:

...

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;

...

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

b) Cool storage: temperature is from 8 to 15⁰C.

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:

...

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.

...

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);

...

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

...

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.

...

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.

...

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:

...

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.

...

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.

...

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

...

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./.

PP MINISTER
DEPUTY MINISTER

Diep Kinh Tan

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

...

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

...

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

...

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

...

No.

Required equipments of a producer of bio-preparations or vaccines

No.

Required equipments of a producer of pharmaceuticals or chemicals

Incubator

Analytical balance

...

Technical balance

Optical microscope

Moisture balance; pH meter

pH meter

...

Colony counter

Water still - double distillation

Sterile autoclave

Ultraviolet-visible spectrophotometer or thin-layer chromatography machine

...

Glass devices and other necessary equipment to serve the qualitative analysis made at the inspected establishment

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

...

Name of the producer of veterinary drugs:

Address:

Telephone:………..

Fax:………………….

Name of the owner:

Permanent residence:

Types of products:

o Pharmaceuticals o Vaccines, bio-preparations

o Chemicals o Other types

...

Enclosed documents (if this is the initial inspection):

a) The application form for the certification of eligibility for production and sale of veterinary drugs;

b) Report on production and business facilities;

c) List of kinds of veterinary drugs and materials.

d) Certificate of business registration (certified copy)

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

...

Representative of the inspected establishment

(Signature and seal, if any)

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⁾

...

Name of the seller of veterinary drugs:

Address:

Telephone:………..

Fax:………………….

Name of the owner:

Permanent residence:

Type of products which shall be sold:

o Pharmaceuticals o Vaccines, bio-preparations

o Chemicals o Other types

...

Enclosed documents (if this is the initial inspection):

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

b) Report on business facilities;

c) Certificate of business registration (certified copy)

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

……[place], on………………..[date]

...

(Signature and seal, if any)

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
-----------------------

...

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

...

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

...

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

...

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

…….[place], on………[date]

Owner of the inspected establishment

(Signature and seal)

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

...

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:

...

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

…….[place], on………[date]

Owner of the inspected establishment

(Signature and seal, if any)

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)

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

No.: /…………………

………….. ……..[place], on………………….[date]

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

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

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

...

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:………………………… ...........

...

- 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

...

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.

Representative of the producer of veterinary drugs

...

Representative of the inspection agency

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

No.

...

Yes

Standard mark

Mark granted

(1)

(2)

(3)

(4)

(5)

...

Production location

4.0

1.1. Be in distant from residential areas, public works, etc.

...

1.2. Do not cause adverse impacts on surrounding environment

...

5.0

2.1. The workshop is designed and built in conformity with GMP standards

...

2.2. Have areas for production

2.3. Areas are designed in an appropriate way for minimizing mistake or cross-contamination in course of production

...

2.4. The production is carried out according to one-way production line

...

2.6. Be convenient for inspection

...

2.7. Comply with regulations on environmental hygiene

2.8. Be easy for disinfection and decontamination

...

2.9. Be proof against dust and the infiltration of harmful animals

...

5.0

3.1. The quantity, types and capacity of each type of equipment are in conformity with each production line.

...

3.2. Be convenient for operation, cleaning and maintenance

3.3. Equipment and devices are made of suitable materials

...

3.4. Have regulations on operation, inspection and maintenance

...

2.0

4.1. Have suitable structure and materials

...

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

4.3. Have equipment for checking technical criteria (temperature, humidity, etc.), records.

...

4.4. Have regulations on the arrangement and inspection of stored materials and products

...

- By records

...

- With computer aid

Sterilization area

...

1.0

5.1. Have separate area for treating packing and devices

...

5.3. Have adequate and appropriate equipment, devices and chemicals

...

5.4. Have regulations on sterilization

Area for weighing and delivering materials

...

1.0

Area for preparing, dividing and storing semi-finished products

5.0

...

7.2. Have adequate and appropriate equipment and devices

...

7.3. Comply with regulations on hygiene and sterilization

Area for finishing products

...

1.0

8.1. Have suitable structure and materials

...

Hygienic area

1.0

...

9.1. Have suitable structure and materials

9.2. Have necessary equipment for practicing personal hygiene

...

10.

Waste and sewage collection and treatment system

2.0

...

10.2. Have regulations on inspection of sewage

...

10.3. Have regulations on waste collection and treatment

11.

Packing

...

1.0

11.1. Made of suitable materials

...

12.

Labeling

2.0

...

a. Be in conformity with the approved labels

b. Specify all contents as regulated.

...

13.

Disinfection and decontamination

2.0

...

13.2. Equipped with suitable devices and chemicals

...

13.3. Have measures for distinguishing sterilized devices

14.

Human resource

...

3.0

14.1. Production manager has qualified professional knowledge, and possesses certificate of practice

...

14.3. Workers have certificates of health examination as regulated

...

14.4. Workers are trained in regular and periodical basis.

15.

Personal hygiene

...

1.0

15.1. Have regulations on personal hygiene in production;

...

16.

Labor safety and hygiene

1.0

...

16.1. Have regulations on delivery and use of personal protective equipment.

16.2. Change and sterilize personal protective equipment after production shift;

...

16.3. Equipment for air ventilation, vacuum, and fire prevention and fighting is suitable.

17.

...

3.0

17.1. Have clear water for production and hygiene.

...

17.2. Analyze water samples as regulated.

No.

Yes

Standard mark

...

Prepare documents for each type of products

Have adequate documents and monitoring sheets

...

Have test report of each batch

...

No.

Yes

Standard mark

Mark granted

Establish a quality control department in regular way

...

Managers and staff of the quality control department have obtained certificates of practice

...

Equipment:

3.1

Required equipment of a producer of pharmaceuticals or chemicals

...

- Ultraviolet-visible spectrophotometer

- Analytical balance

...

- Moisture meter

...

- Technical balance

- Water still - double distillation

...

- Drying oven (50 - 250 ^oC)

- Glass devices and other necessary equipment to serve the testing

...

3.2

Required equipment of a producer of bio-preparations or vaccines

...

Incubator

Sterile laminar flow cabinet

...

Optical microscope

pH meter

...

Colony counter

...

Sterile autoclave

Glass devices and other necessary equipment to serve the testing

...

3.3

Inspection of materials

3.4

Inspection of semi-finished products

...

3.5

Inspection of finished products

...

Store samples and inspect stored samples as regulated

Total

...

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

...

(Signature and seal)

REPRESENTATIVE OF THE INSPECTION AGENCY

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)

Department………… ……..SUB-DEPARTMENT OF ANIMAL HEALTH
--------

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

No.: /…….

...

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:………………… ..

...

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

Representatives of the seller of veterinary drugs:

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

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

- 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

...

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

...

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

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.

REPRESENTATIVE OF THE SELLER OF VETERINARY DRUGS

REPRESENTATIVE OF THE INSPECTION AGENCY

LIST OF INSPECTED ITEMS

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

...

Address: ……………………………………………………………..

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

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

No.

CONTENTS

INSPECTION RESULTS

Yes

Standard mark

...

Facilities (35 marks)

Construction and design

1.1

...

1.2

Built at a safe, high and dry place, far away from sources of pollution

...

1.3

Built of firm and solid materials

1.4

Ceiling is proof against dust

...

1.5

Walls and ceiling must be smooth, and be cleaned easily

...

Have area for showing products

...

Have area for storing veterinary drugs

Have separate area for showing animal feeds for sale

...

Equipment (25 marks)

Equipment for storing veterinary drugs may prevent adverse effects of light, temperature, moisture, pollution and the infiltration of insects.

...

1.1

Have cabinets for storing veterinary drugs

1.2

Cabinets and shelves for storing veterinary drugs are easily cleaned and arranged aesthetically

...

1.3

Have thermometer and hygrometer, and take notes

1.4

...

1.5

The area for selling veterinary drugs is bright for facilitating selling activities and avoiding mistakes

...

Storage equipment can meet requirements for storage stated in labels of relevant drugs, including: refrigerators, air conditioners, dehumidifiers

The area for selling veterinary drugs has ambient temperature (temperature is below 30⁰c, humidity is equal or below 75%)

...

III

Records (10 marks)

Legal documents

...

1.1

Have certificate of business registration

1.2

Have certificate of practice in sale of veterinary drugs

...

1.3

Have adequate records of employees

...

2.1

Records of input and delivery of each type of veterinary drugs

...

2.2

Records of batch number and expiry date

Origin of veterinary drugs (20 marks)

...

Have the list of types of veterinary drugs for sale

...

Performance of professional regulations (10 marks)

Have a separate area or cabinet for storing drugs or insecticides

...

The label and instruction sheet are to indicate and matched with the type of drug contained inside.

...

All types of veterinary drugs are tidily arranged for avoiding mistake

Veterinary drugs are arranged in conformity with storage requirements specified in their labels

...

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:

...

- Excellent: from 90 to 100 marks

- Good: from 70 to below 90 marks

- Satisfactory: from 50 to below 70 marks

REPRESENTATIVE OF THE INSPECTED ESTABLISHMENT

(Signature and seal)

REPRESENTATIVE OF THE INSPECTION AGENCY

...

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)

MINSITRY OF AGRICULTURE AND RURAL DEVELOPMENT
DEPARTMENT OF ANIMAL HEALTH
----------

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

CERTIFICATE OF ELIGIBILITY FOR PRODUCTION OF VETERINARY DRUGS

No.: …….../ GCN-SXT

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

Address: ……………………………………………………………..

Telephone:….. .. Fax:……….

...

…………………………………………………………………………………………...

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

…………………………………………………………………………………………..

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

...

DIRECTOR

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

DEPARTMENT OF AGRICULTURE AND RURAL DEVELOPMENT
PROVINCE………….
SUB-DEPARTMENT OF ANIMAL HEALTH
----------

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

...

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].

... ... ...[place], on…………………………[date]

DIRECTOR

...

FORM 2

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT
DEPARTMENT OF ANIMAL HEALTH
----------

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

CERTIFICATE OF ELIGIBILITY FOR SALE OF VETERINARY DRUGS

No.: …….../GCN-KDT

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

...

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].

... ... ...[place], on…………………………[date]

DIRECTOR

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

You are not logged!

So you only see the Attributes of the document.
You do not see the Full-text content, Effect, Related documents, Documents replacement, Gazette documents, Written in English,...