Circular No. 51/2009/TT-BNNPTNT stipulates the inspection and certification of conditions for producing and trading veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary and aquaculture practices.

CIRCULAR

Regulations on inspection and certification of conditions for production and business of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine, and aquatic veterinary medicine.

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Pursuant to Decree No. 01/2008/NĐ-CP dated January 3, 2008, of the Government, detailing the functions, tasks, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the Veterinary Law dated April 29, 2004;

Pursuant to Decree No. 33/2005/NĐ-CP dated March 15, 2005, of the Government, detailing the implementation of certain provisions of the Veterinary Law;

Pursuant to Decree No. 59/2006/NĐ-CP dated June 12, 2008, of the Government, detailing the Law on Trade regarding prohibited goods and services, restricted goods and services, and goods and services subject to conditions;

The Ministry of Agriculture and Rural Development stipulates the procedures for inspection and certification of conditions for production and business of veterinary drugs, aquatic veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine, and aquatic veterinary medicine; raw materials for veterinary drugs, aquatic veterinary drugs (hereinafter referred to collectively as veterinary drugs) as follows:

PART I

 GENERAL PROVISIONS

Article 1. Scope of regulation and applicable subjects

1. This Circular specifies the conditions, procedures for inspection, and certification of conditions for production and business of veterinary drugs, aquatic veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine, and aquatic veterinary medicine; raw materials for veterinary drugs, aquatic veterinary drugs (hereinafter referred to collectively as veterinary drugs).

2. This Circular applies to production facilities for veterinary drugs that have not yet obtained Good Manufacturing Practice (GMP) certification, business, import-export, storage, and preservation facilities for veterinary drugs that have not yet obtained Good Storage Practice (GSP) certification; retail stores and agents selling veterinary drugs that have not yet obtained Good Pharmacy Practice (GPP) certification.

Vietnamese organizations and individuals, foreign organizations and individuals engaged in the production and business of veterinary drugs within the territory of Vietnam must comply with the provisions of this Circular.

Article 2. Legal basis

The fee for inspection and certification fees for facilities meeting the conditions for production and business of veterinary drugs shall be implemented according to the current regulations of the Ministry of Finance and other relevant legal documents.

Chapter II

CONDITIONS FOR PRODUCTION OF VETERINARY DRUGS

Article 3. General Conditions for Production Facilities of Veterinary Drugs

1. Location:

a) Not susceptible to contamination from the external environment;

b) Not causing adverse effects on the surrounding environment;

c) Separated from residential areas, schools, offices, hospitals, diagnostic, and testing facilities;

d) Convenient transportation, with assured water and electricity supply for facility activities.

2. Production Workshop:

a) Constructed solidly and stably, suitable for the nature and scale of production, resistant to adverse natural influences such as weather, flooding, moisture, and intrusion by insects or other animals;

b) Solid foundation, dry, smooth, capable of bearing the pressure of machinery during operation;

c) Walls and ceilings made of durable material;

d) Floor without cracks, not water-permeable or water-retaining, easy to clean, resistant to disinfectants;

đ) Equipped with adequate lighting system;

e) Rational layout, suitable for the nature and scale of production.

g) Each area must meet the veterinary hygiene standards as prescribed.

3. Equipment:

a) Machinery and equipment must be arranged and installed appropriately for the operations to be performed, with operating instructions, maintenance plans; hygiene procedures must ensure no cross-contamination between products.

b) Must have sufficient equipment as prescribed in Appendix 1 attached hereto.

4. Packaging:

a) Direct contact packaging must not affect the quality of the drug, protected from adverse external factors such as light, humidity, microorganisms throughout the storage period.

b) Glass packaging must be sturdy and durable, suitable for sterilization, transportation, and storage.

5. Laboratory:

a) Must be separated from the production area. Areas conducting biological and microbiological tests must be isolated from each other.

b) Must have sufficient space to avoid cross-contamination and to store samples and standards.

c) Must have complete equipment as prescribed in Appendix 2.

d) The person responsible for the laboratory must hold a Professional Practice Certificate issued by the competent veterinary authority as prescribed.

6. Personal Hygiene:

Personnel working in the production facility of veterinary drugs must meet the following requirements:

a) Must be in good health according to the regulations of the Ministry of Health, undergo regular health check-ups once a year; must not have open wounds or skin diseases;

b) Must be trained in professional skills, personal hygiene, and industrial hygiene in the production of veterinary drugs.

c) Personnel working in the production facility of veterinary drugs must strictly adhere to veterinary hygiene regulations in the production area.

7. Occupational Safety and Health Protection:

a) Must provide individual protective equipment suitable for assigned work.

b) Must have written regulations on the issuance, use of protective equipment, and work attire.

c) Must have fire-fighting, odor removal, ventilation, dust extraction equipment with appropriate capacity; safety equipment for users of thermal, electrical, mechanical, pneumatic devices.

d) Must have written regulations on occupational safety and health protection, with proactive measures and means to prevent and quickly resolve potential incidents.

8. Waste Collection and Treatment System:

a) The wastewater treatment system must be designed suitably for the workshop, production scale, ensuring the collection of wastewater from all sources, preventing pollution of the production workshop and surrounding areas.

b) Each area in the facility must have appropriate waste containers, easy to transport. Wastewater must be treated to meet standards before being discharged into the environment;

Article 4. Conditions for pharmaceutical production facilities and chemicals used in veterinary medicine

1. Warehouse system:

a) There must be warehouses or separate areas for raw materials, auxiliary materials, packaging, finished products; there must be external warehouses to store solvents and flammable, explosive raw materials, and places to isolate rejected semi-finished and finished products.

b) The warehouse capacity must be appropriate for the scale of production.

c) There must be sufficient equipment and means necessary to ensure product quality in accordance with storage requirements, specifically:

Normal storage conditions: temperature from 15-30°C, humidity not exceeding 70%; ⁰Cool storage: temperature from 8-15°C;

Cold storage: temperature from 2-8°C;⁰C.

Frozen storage: temperature ≤ -10°C;⁰C.

d) Avoid direct sunlight and contamination from the external environment;⁰C

e) Goods must be neatly and scientifically arranged on shelves, at least 20 cm above the floor and 20 cm away from walls; the minimum distance between shelves or between stacks of goods must be 30 cm to ensure ventilation, easy entry and exit of goods, and easy sanitation;

f) There must be documentation from the facility specifying the arrangement and storage of goods, regular inspection procedures, timely detection and handling of any issues during storage;

g) There must be sufficient equipment to check storage criteria, and a regular recording system for technical parameters.

2. Sterilization processing area:

a) There must be a place for mechanical and chemical cleaning of direct packaging materials: tube shells, bottle shells, jars, caps; tools and equipment for mixing, labor protection items. The floor in the mechanical cleaning area must have a slope of about 1.5 degrees towards the drainage ditch and have friction to prevent slipping.

b) Bottles, tubes, caps, tools, and labor protection items must meet sterilization requirements according to each production stage.⁰ c) There must be adequate equipment, tools, and chemicals suitable for the sterilization process;

d) There must be documentation specifying hygiene and sterilization procedures for direct packaging materials, tools used in production, and labor protection items.

3. Raw material weighing and distribution area:

a) There must be a separate raw material weighing room. In cases where there is no separate raw material weighing room, measures must be taken to ensure cross-contamination does not occur between different types of raw materials.

b) There must be sufficient scales and tools for weighing, which must be cleaned and kept clean after use.

4. Mixing, blending, and semi-finished product storage area:

a) Walls and ceilings must have high reflectivity, and the junctions between walls and floors and between walls and ceilings must form obtuse angles.

b) For injectable drug production lines: there must be a pre-sterile room for changing sterile clothing before working in the sterile area; open washing basins and drainage ditches must not be arranged in the sterile area.

Items must be sterilized before being used in the sterile area and must be stored under sterile conditions with labels indicating sterilization.

Measures must be taken to avoid recontamination by microorganisms before and during use.

c) For powder drug production lines: there must be dust extraction equipment.

d) There must be sufficient equipment, chemicals, and specialized materials suitable for the production process.

e) There must be a separate area for storing semi-finished products if they have not been divided or dosed immediately.

5. Finished product completion area:

a) It must be located adjacent to the division and dosing area to facilitate the reception of products awaiting packaging.

b) There must be sufficient equipment and tools suitable for packaging, labeling, and transporting finished products to the finished goods warehouse.

6. Area for products that do not meet quality standards: it must be separated and secured with locks or warning signs to avoid confusion with other goods.

7. Product inspection area before shipment:

a) There must be sufficient equipment, tools, chemicals, and environments suitable for final product inspection before shipment. If the facility does not have the necessary conditions for testing, it must have a contract with a qualified testing unit as prescribed.

b) There must be regulations for sample retention, storage, and inspection.

8. Personal hygiene and other areas serving production:

a) They must be reasonably arranged and must not directly connect to the production area.

b) There must be sufficient hygiene equipment; there must be sufficient chemicals and items needed for personal hygiene and area cleaning.

c) There must be ventilation and odor removal equipment.

b) Equipped with necessary sanitation facilities; sufficient chemicals and items for personal hygiene and the area.

c) Ventilation and odor removal equipment are provided.

Article 5. Conditions for vaccine production facilities, biological products, microorganisms

In addition to the provisions stipulated in Article 3 and 4 of this Circular, there must be areas for keeping and processing experimental animals; areas equipped to store microbial strains for production purposes.

Article 6. Conditions for hormone production facilities used in veterinary medicine:

In addition to the provisions stipulated in Article 3 and 4 of this Circular, they must be produced in a separate area.

Article 7. Conditions for processing, dividing, and repackaging veterinary drugs

Apply the provisions of Clause 1, 2, 4, 5, 6, 7, 8 of Article 3; Clause 1, 2, Point a, c, d of Clause 4; Clause 5, 6, 7, 8 of Article 4 of this Circular.

Chapter III

CONDITIONS FOR VETERINARY DRUGS BUSINESS

Article 8. Conditions for veterinary drug business for retail shops, wholesale agents, and retailers of veterinary drugs are as follows:

1. Have a fixed address, with a signboard displaying the shop name, establishment name, or enterprise name, and business registration number; display the business registration certificate.

2. The minimum shop area is 10 square meters.²

3. Have sufficient equipment necessary for displaying and selling goods; goods should be arranged scientifically and kept clean.

4. Maintain adequate record books for tracking purchases and sales.

5. Store drugs according to the manufacturer's instructions, specifically:

a) Under normal conditions: temperature from 15-30 degrees Celsius.⁰_C.

b) Cool storage: temperature from 8-15 degrees Celsius.^0­­C.

c) Cold storage: temperature from 2-8 degrees Celsius.⁰C.

d) Frozen storage: temperature ≤ -10 degrees Celsius.⁰C

6. Veterinary drugs shall not be displayed or sold alongside other goods. If permitted to sell animal feed together with veterinary drugs, they must be displayed in a separate area.

7. For wholesale shops selling veterinary drugs, there must be a warehouse with sufficient area; have adequate equipment and means suitable for storing various types of drugs and raw materials allowed to be traded. Goods must be arranged on shelves. Shelves must be at least 20 cm off the floor and 20 cm away from walls, with a minimum distance of 30 cm between shelves to ensure ventilation and easy sanitation; have a backup generator with sufficient capacity.

8. Shops selling vaccines must have cold storage equipment and alternative means to store vaccines and biological products when power failure occurs; have a thermometer to monitor temperature and record daily.

9. The owner of the establishment or the seller must be issued a Practice Certificate by the authorized veterinary authority.

Article 9. Conditions for veterinary drug business for establishments importing veterinary drugs are as follows:

In addition to the provisions stipulated in Clause 1, 4, 5, 7, 8 of Article 8, the following additional conditions must be met:

1. For establishments importing animal vaccines, there must be dedicated transportation means to meet the requirements for storage during transportation and distribution to consumption points.

2. The owner of the establishment or the technical manager must be issued a Practice Certificate by the authorized veterinary authority.

Chapter IV

PROCEDURES FOR INSPECTION AND CERTIFICATION OF ESTABLISHMENTS MEETING THE CONDITIONS FOR PRODUCTION AND BUSINESS OF VETERINARY DRUGS

Article 10. Forms of inspection

1. Initial inspection applies to:

a) New establishments registering;

b) Establishments that have registered for production and business but have changed location or upgraded their production lines;

c) Establishments producing and trading veterinary drugs whose certificates of compliance have been revoked, or which have been suspended from production and trading activities and wish to reapply for certification.

2. Re-inspection applies to establishments that have been inspected but do not meet the conditions for production and business.

3. Regular inspections are conducted every two years to evaluate the maintenance of production and business conditions and serve as a basis for competent state authorities to reissue certificates of compliance for establishments.

4. Surprise inspections are carried out when signs of violations in the production and trading of veterinary drugs are detected or upon request of authorized authorities.

Article 11. Inspection authority and issuance of certificates of compliance for production and business of veterinary drugs

1. The Department of Animal Health is responsible for inspecting the conditions of veterinary drug production facilities and import/export trading establishments.

2. Provincial and centrally-administered city Animal Health Services are responsible for inspecting the conditions of veterinary drug retail shops and agents within their jurisdiction.

Article 12Registration documents for inspection of compliance with conditions for veterinary drug production

1. Initial registration documents include:

a) Application for inspection of production conditions (Annex 3);

b) Report on production conditions (Annex 5);

c) List of types of veterinary drugs produced.

d) Business registration certificate (certified copy);

e) Production practice certificate (certified copy).

2. Re-registration documents include:

a) Application for re-inspection of production conditions;

b) Report on corrective actions for non-compliance.

3. Documents for extension of the certificate include:

a) Application for extension of the certificate of compliance for production;

b) Previously issued certificate of compliance for production.

Article 13. Registration documents for inspection and certification of compliance with conditions for business and import/export of veterinary drugs

1. Initial registration documents include:

a) Application for inspection of business conditions (Annex 4);

b) Report on business conditions (Annex 6);

c) Business registration certificate (certified copy);

d) Business practice certificate (certified copy);

2. Re-registration documents include:

a) Application for re-inspection of business conditions;

b) Report on corrective actions for non-compliance.

3. Documents for extension of the certificate include:

a) Application for extension of the certificate of compliance for business;

b) Previously issued certificate of compliance for business.

Article 14. Time limit, content, and method of inspection

1. Within ten working days from receipt of the application, the competent authority will review the documents and respond in writing.

Within fifteen working days from receipt of a valid application, the competent authority will conduct the inspection.

2. Content and method of inspection:

a) The head of the inspection team will notify the representative of the inspected establishment about the Decision, inspection content.

b) Inspection content: inspect production conditions for veterinary drugs as prescribed in Annex 7; inspect business conditions for veterinary drugs as prescribed in Annex 8 attached to this Circular. Take samples and specify hygiene indicators for inspection for production establishments and direct import/export establishments.

c) After completing the inspection, the inspection team unifies the evaluation results and prepares the inspection record according to the model prescribed in Appendix 7, 8 issued together with this Circular.

d) Notify the inspection results to the representative of the inspected entity. The representative of the inspected entity records their comments and signs the inspection record. In case the representative of the inspected entity does not sign the record, the record still has legal validity when it is signed by all members of the inspection team.

The inspection record is prepared in two (2) copies having equal legal value, one (1) copy sent to the inspected entity, and one (1) copy retained at the inspecting authority.

3. Within twenty (20) working days from the completion of the inspection process, the competent authority shall perform:

a) Issue a certificate for entities meeting the conditions for producing and trading veterinary drugs according to the model at Appendix 9, 10 issued together with this Circular. The certificate has a validity of two (2) years. For certificates for production conditions of veterinary drugs with a time limit according to the implementation schedule of Good Manufacturing Practices (GMP) approved by the Ministry of Agriculture and Rural Development, the validity period is determined separately.

Two (2) months before the expiration date of the certificate, the entity must submit an extension application to the competent authority. The extension application follows the provisions of Clause 3, Articles 12 and 13 of this Circular. The extended certificate has a validity of two (2) years.

b) Inform the entity about the non-compliant points if the inspection result does not meet the requirements. After rectifying the non-compliant points, the entity submits an application for re-inspection according to the provisions of Clause 2, Articles 12 and 13 of this Circular.

Article 15. Surprise inspections

1. The competent veterinary authority establishes an inspection team to conduct surprise inspections upon discovering signs of violation of laws in the production and trade of veterinary drugs by an entity or upon request of the competent state management agency.

2. The procedures and contents of the inspection are carried out according to the provisions of Clause 2, Article 14 of this Circular.

3. Based on the results recorded in the Inspection Record, the competent veterinary authority revokes the certificate according to the provisions of Article 16 of this Circular.

Article 16.Revocation of the certificate for conditions of production and trade of veterinary drugs

1. The certificate for conditions of production and trade of veterinary drugs shall be revoked in the following cases:

a) The results of a surprise inspection do not meet the conditions for production and trade of veterinary drugs stipulated in this Circular and other regulatory documents related to the production and trade of veterinary drugs.

b) The entity refuses inspection when requested by the competent state authority more than twice.

2. The decision to revoke the certificate for conditions of production and trade of veterinary drugs is made in two (2) copies: one (1) copy sent to the entity whose certificate is revoked and one (1) copy retained at the inspecting authority.

Chapter V

RESPONSIBILITIES AND LIMITATIONSOF THE RELATED PARTIES

Article 17. Responsibilities and limitations of entities producing and trading veterinary drugs

1. Responsibilities:

a) Register for inspection of production and trade conditions of veterinary drugs and raw materials for veterinary drugs and comply with the inspection according to the provisions of this Circular.

b) Provide complete information and relevant documents and create favorable conditions for the inspection authority to carry out its tasks.

c) Continuously maintain and ensure the conditions for production and trade of veterinary drugs and raw materials for veterinary drugs that have been certified.

d) Seriously correct any errors noted in the inspection authority's record.

đ) Participate fully in training courses on the production and trade of veterinary drugs organized by the state management agency for veterinary affairs.

e) Pay fees and charges as prescribed.

2. Authorities:

Have the right to appeal if they disagree with the conclusion in the inspection record, the inspection results of sanitary indicators for animals.

Article 18. Responsibilities and limitations of the inspection authority

1. Responsibilities:

a) Conduct inspections and certify the conditions for production and trade of veterinary drugs and raw materials for veterinary drugs according to the provisions of this Circular.

b) Ensure objectivity and fairness in inspection activities and issuance of certificates.

c) Conduct regular or surprise inspections of entities that have been granted certificates when required by the competent state authority.

d) Handle violations and resolve complaints and denunciations according to the provisions of the law.

2. Authorities:

a) Issue or revoke certificates for conditions of production and trade of veterinary drugs according to the regulations.

b) Supervise and require entities to rectify deficiencies in production and trade conditions of veterinary drugs.

c) Require entities to provide documents and create favorable conditions for the inspection of compliance with the provisions of this Circular and other regulatory documents related to the production and trade of veterinary drugs.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 19. Effective date

This Circular takes effect forty-five (45) days from the date of signature. This Circular replaces Decision No. 46/1999/QĐ-BNN dated March 5, 1999 of the Minister of Agriculture and Rural Development promulgating the Sanitary Conditions for Entities Producing and Trading Veterinary Drugs and replaces the provisions on inspection of production conditions of aquatic veterinary drugs stipulated in the Management Regulations for Aquatic Veterinary Drugs issued together with Decision No. 03/2002/QĐ-BTS dated January 23, 2002 of the Minister of Fisheries.

Article 20. Implementation

The Animal Health Department, Provincial Animal Health Sub-department is responsible for disseminating and guiding entities producing, distributing, packaging, and trading veterinary drugs to implement this Circular.

During the implementation, if there are difficulties, organizations and individuals should reflect them to the Ministry of Agriculture and Rural Development (Animal Health Department) for timely adjustment and supplementation./.