Decision No. 72/2007/QD-BNN Issuing Regulations on Quality Control of Veterinary Drugs

Pursuant to …;

Decision No. 72/2007/QĐ-BNN dated August 6, 2007

Issuing Regulations on Quality Inspection of Veterinary Drugs

______________________

MINISTER MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to Decree No. 86/2003/NĐ-CP dated July 18, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the Law on Technical Standards and Regulations No. 68/2006/QH11 dated June 29, 2006;

Pursuant to the Animal Health Ordinance dated April 29, 2004 and Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing implementation of certain provisions of the Animal Health Ordinance;

Pursuant to Decision No. 50/2006/QĐ-TTg dated March 7, 2006 of the Prime Minister promulgating the List of Products and Commodities Subject to Quality Inspection;

Pursuant to Circular No. 02/2006/TT-BKHCN dated January 10, 2006 of the Ministry of Science and Technology guiding conditions and procedures for designating organizations to conduct quality inspection of products and commodities;

CONSIDERING the proposal of the Director of the Department of Animal Health,

DECISION:

Article 1. Issuing with this Decision the "Regulations on Quality Inspection of Veterinary Drugs".

Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette of the Government.

Article 3. The Director of the Office, the Director of the Department of Animal Health, the Heads of relevant units, organizations, and individuals are responsible for implementing this Decision.

DEPUTY MINISTER

VICE MINISTER

(Signed)

 

Bui Ba Bong

 

REGULATIONS

Quality Inspection of Veterinary Drugs

(Issued together with Decision No. 72/2007/QĐ-BNN,

dated August 6, 2007 of the Minister of Agriculture and Rural Development)

_______________________________

PART I

GENERAL PROVISIONS

Article 1.  Scope of Regulation

These regulations stipulate the procedures and formalities for quality inspection of raw materials for veterinary drugs and veterinary drugs (hereinafter referred to as veterinary drugs) produced, traded, exported, imported, and circulated in Vietnam.

Article 2. Applicability

Domestic and foreign organizations and individuals engaged in production, processing, repackaging (hereinafter referred to as production), trading, importing, exporting veterinary drugs, and those involved in activities related to the quality inspection of veterinary drugs must comply with these regulations and other relevant legal documents.

Article 3. Explanation of Terms

In these regulations, the following terms are understood as follows:

1. Veterinary drug is a substance or compound of animal, plant, microbial, mineral, or chemical origin used for disease prevention, diagnosis, treatment, or to restore, adjust, or improve the functions of animals' bodies, including pharmaceuticals, chemicals, vaccines, hormones, some biological preparations, and certain microorganisms used in veterinary practice.

2. Quality inspection of veterinary drugs is the process of determining the conformity of veterinary drug quality indicators, technical standards, and quality assurance conditions as prescribed.

3. Standard is a specification regarding technical characteristics and management requirements used as a benchmark for classifying, evaluating products, goods, services, processes, environments, and other objects in economic and social activities to enhance their quality and effectiveness.

Standards are published by an organization in the form of a document for voluntary application.

4. Technical standard is a regulation regarding the limit of technical characteristics and management requirements that products, goods, services, processes, environments, and other objects in economic and social activities must comply with to ensure safety, hygiene, health protection, animal and plant protection, environmental protection; national interests and consumer rights protection, and other essential requirements.

Technical standards are issued by competent state agencies in the form of documents for mandatory application.

5. Veterinary drug quality standard includes technical indicators, testing methods, packaging requirements, labeling, storage, transportation, and other requirements related to drug quality.

6. Qualified veterinary drug is a drug meeting the quality indicators announced (or registered) by the manufacturer or trader according to the National Standard, technical standard, or enterprise standard approved by the competent authority.

7. Unqualified veterinary drug is a drug failing one or more quality indicators announced (or registered) and approved by the competent authority.

8. Shelf life of a drug is the period defined for a type of drug during which, if stored under specified conditions, it must maintain its quality according to the registered or announced standard.

The shelf life of a drug is usually indicated on the label by number or letter to clearly indicate that the drug is no longer usable after this period.

9. Fake veterinary drug is a product manufactured and circulated under the guise of a veterinary drug in one of the following cases:

a) It does not contain or does not contain sufficient active ingredients as registered;

b) It contains different medicinal substances than those listed on the label;

c) It uses a trademark, registration number, or假冒的翻译内容，请提供正确的越南语原文以便我为您准确翻译。看起来在第33和34行之间有部分内容缺失或格式问题。请检查并提供完整的内容。

d) Using a trademark or geographical indication that is protected for the same goods without the permission of the trademark owner or the organization managing the geographical indication.

Article 4. Cases where veterinary drugs must be quality checked

1. Veterinary drugs listed in the Catalogue of Veterinary Drugs, the Catalogue of Vaccines, Biological Preparations, Microorganisms, and Chemicals Permitted for Circulation in Vietnam (hereinafter referred to as the Catalogue of Veterinary Drugs Permitted for Circulation).

2. Veterinary drugs not listed in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam but approved by the Department of Animal Health for import orders to serve production and disease prevention.

Article 5. Cases where veterinary drugs do not need to be quality checked

1. Sample veterinary drugs, exhibition goods without commercial value.

2. Veterinary drugs for testing, experimentation, and trial purposes for registration circulation.

3. Special veterinary drugs imported in small quantities without commercial value for diagnosis, prevention, and treatment of diseases in rare animals.

Article 6. Veterinary drug quality management and inspection system

1. The Animal Health Department shall be responsible for state management of veterinary drug quality throughout the country.

2. Provincial Animal Health Sub-departments (hereinafter referred to as Provincial Animal Health Sub-department) shall be responsible for managing the quality of veterinary drugs circulating within their respective administrative areas.

3. The organization responsible for inspecting veterinary drug quality (hereinafter referred to as the inspection organization):

a) The Central Veterinary Drug Testing Center I and II shall be responsible for inspecting veterinary drug quality.

b) The Central Veterinary Hygiene Inspection Center I and II shall be responsible for inspecting hygiene conditions at production, trading, export, import, storage, and transportation facilities of veterinary drugs.

c) Technical organizations meeting the conditions stipulated in Circular No. 02/2006/TT-BKHCN dated January 10, 2006, issued by the Ministry of Science and Technology guiding the conditions and procedures for designating organizations to conduct product quality inspections, designated by the Ministry of Agriculture and Rural Development.

Article 7. Fees and charges

Organizations and individuals producing, exporting, and importing veterinary drugs must pay fees and charges according to the State's regulations.

Chapter II

QUALITY INSPECTION OF VETERINARY DRUGS

Article 8. Technical basis for veterinary drug quality inspection

1. National Standards (TCVN).

2. Technical standards issued by the Ministry of Agriculture and Rural Development.

3. Basic standards established and published by organizations permitted under Article 11 of the Law on Standards and Technical Regulations.

4. Standards in the Vietnamese Pharmacopoeia or foreign pharmacopoeias, international standards, regional standards permitted for application in Vietnam.

Article 9. Content of veterinary drug quality inspection

1. Quality inspection of veterinary drugs based on quality criteria announced (or registered) by organizations and individuals producing and trading in accordance with Article 8 of this Regulation.

2. Inspection of compliance with quality standard regulations for veterinary drugs (technical documentation on quality, equipment in production, measurement, testing, adherence to production processes, technological processes, packaging, storage, and transportation regulations).

3. Inspection of veterinary hygiene conditions ensuring the quality of veterinary drugs.

Article 10. Mechanism for veterinary drug quality inspection

1. For veterinary drugs listed in the permitted circulation directory, quality inspection will not be conducted on a batch-by-batch basis but rather according to the following provisions:

a) Periodic inspection:

Annually, based on actual circumstances, the Animal Health Department shall organize periodic sampling of veterinary drugs from production, trading, import, storage, and transportation facilities for quality inspection.

b) Spot inspection: To be carried out when there are complaints or reports about the quality of veterinary drugs or upon request of competent authorities.

2. For imported raw materials for veterinary drugs listed in the permitted circulation directory but without registration numbers, quality inspection will be conducted through pre-registration and post-inspection:

a) Before importation, enterprises shall prepare the registration dossier in accordance with Clause 2, Article 11 of this Regulation and submit it to the Animal Health Department.

b) The Animal Health Department shall review and confirm the registration dossier for the enterprise to register for quality inspection with the inspection organization and complete customs clearance procedures.

c) Based on the confirmation by the Animal Health Department in the registration dossier, the inspection organization shall take samples for quality inspection.

d) The inspection organization shall send the results of the quality inspection to the Animal Health Department and the importing enterprise.

Based on the inspection results, the Animal Health Department shall decide whether to allow the goods to enter circulation and use or handle them according to regulations.

3. Conditions for importing raw materials for veterinary drugs listed in the permitted circulation directory but without registration numbers:

a) Having a complete registration dossier as stipulated in Clause 2, Article 11.

b) Results of quality inspection of imported raw material samples by authorized inspection organizations.

4. Time limit for inspection organizations to respond with test results:

a) For pharmaceutical products: Within ten working days from the date of sampling or receiving samples. In special cases, up to thirty days may be allowed.

b) For vaccines, biological preparations, and microorganisms used in veterinary medicine: Within two months. In special cases, up to six months may be allowed.

In cases where the response time specified in points a and b of Clause 4 of this Article needs to be extended, the inspection organization must clearly state the reasons and notify the customer.

Article 11. Documents for importing raw materials for veterinary drugs listed in the Catalogue of Permitted Circulation but without registration number.

1. Organizations and individuals importing raw materials for veterinary drugs shall establish quality inspection registration documents with the Department of Animal Health.

2. Contents of the registration documents

a) Import order: three copies, clearly stating the quantity, types of raw materials, name of manufacturer, expected time of arrival in Vietnam and location for goods consolidation after customs clearance (inspection location).

b) Certificate of Origin (CO);

c) Quality Analysis Certificate (CA) issued by the manufacturer;

d) Product characteristics summary;

e) Copy of Good Manufacturing Practice (GMP), ISO certification (for certain chemicals used in veterinary medicine) issued by the manufacturer;

f) Copy of quality inspection results of imported raw material samples (from the same origin, same manufacturer) conducted by authorized inspection agencies within six months.

Article 12. Conclusion after quality inspection

The inspection agency must issue a conclusion after inspecting the quality of veterinary drugs at one of the following two levels:

1. Level A: Meeting all standards and contents of quality inspection as prescribed.

2. Level B: Not meeting standards and must be handled according to regulations of the Department of Animal Health.

Chapter III.

RESPONSIBILITIES OF THE PARTIES INVOLVED

Article 13. Responsibilities of the Department of Animal Health

1. State management over the quality of veterinary drugs in export, import activities and production, circulation throughout the country.

2. Organizing and implementing quality inspection work of various types of veterinary drugs throughout the country.

3. Resolving cases of non-compliance with drug quality, complaints and denunciations according to the Law.

4. Issuing decisions on handling veterinary drugs that do not meet quality standards according to current regulations.

Article 14. Responsibilities of Provincial Animal Health Sub-departments

1. Organizing and implementing quality inspection work of circulating veterinary drugs within their jurisdiction.

2. Resolving cases of non-compliance with drug quality, complaints and denunciations according to the Law.

3. Organizing supervision and recovery of veterinary drugs that do not meet quality standards within their jurisdiction.

Article 15. Responsibilities of quality inspection agencies of veterinary drugs

1. Directly conducting sampling (or receiving) of veterinary drugs for quality inspection, organizing accurate testing of quality indicators according to the prescribed deadlines for each type of sample and storing inspected samples as required.

2. Providing quality inspection results of veterinary drugs to organizations and individuals according to regulations.

3. Being responsible for the results of quality inspections of veterinary drugs before the Law.

4. Establishing technical standards in the field of veterinary drug quality inspection.

Article 16. Responsibilities of domestic and foreign organizations and individuals engaged in the production, export, import, and circulation of veterinary drugs.

1. Providing technical documentation and facilitating conditions for inspection agencies while performing their duties.

2. Bearing responsibility under the Law for the quality of veterinary drugs produced, exported, imported, and circulated from their facilities.

3. Paying fees and charges as prescribed by the state.

4. Adhering to decisions on handling substandard veterinary drugs made by competent state management agencies.

Chapter IV

INSPECTION, HANDLING VIOLATIONS AND RESOLUTION

COMPLAINTS, REPORTS

Article 17. Inspection and Quality Control of Veterinary Medicines.

1. The Department of Animal Health shall be responsible for inspecting and supervising the quality of veterinary medicines; resolving disputes, complaints, and accusations; and handling violations related to the quality of veterinary medicines in accordance with the provisions of the Law.

2. The Provincial Animal Health Sub-department shall be responsible for inspecting and supervising the quality of veterinary medicines within its jurisdiction; resolving disputes, complaints, and accusations; and handling violations related to the quality of veterinary medicines within its jurisdiction in accordance with the provisions of the Law.

Article 18. Handling of Veterinary Medicines Not Meeting Quality Standards.

The handling of veterinary medicines not meeting quality standards shall be carried out in accordance with the provisions of the Ordinance on Animal Health as follows:

1. Recall of Veterinary Medicines:

a) The Department of Animal Health shall issue a decision to recall and notify the Provincial Animal Health Sub-department and entities holding the medicines to implement the suspension of circulation and recall of veterinary medicines in accordance with the regulations;

b) Upon receipt of the notification, the Provincial Animal Health Sub-department shall inspect and supervise the recall and disposal of veterinary medicines within its jurisdiction;

c) Entities holding recalled veterinary medicines shall have the responsibility to:

Notify trading and using entities; recall and submit reports on the recall and disposal of the non-compliant batch of medicines to the Department of Animal Health and relevant authorities; address consequences caused by substandard veterinary medicines.

2. Destruction of Veterinary Medicines:

a) The Department of Animal Health shall issue a decision to destroy the medicines and notify the Provincial Animal Health Sub-department, entities whose medicines are to be destroyed, and supervisory agencies to organize the implementation of the decision;

b) The Provincial Animal Health Sub-department shall request the Department of Agriculture and Rural Development to establish a Supervisory Board for the destruction of medicines;

c) Entities whose medicines are to be destroyed shall be responsible for organizing the destruction in accordance with the Law on Environmental Protection and other relevant laws, and report the results to the Department of Animal Health.

Article 19. Complaints and Accusations and Resolution of Complaints and Accusations.

Complaints and accusations and the resolution of complaints and accusations in the field of quality inspection of veterinary medicines shall be carried out in accordance with the provisions of the Law on Complaints and Accusations.

Chapter V

IMPLEMENTATION

Article 20. The Director of the Department of Animal Health shall be responsible for guiding the implementation of this Regulation.