Decision No. 03/2002/QD-BTS On Issuing the Regulation on Management of Aquatic Veterinary Medicines.

 

Pursuant to …;

Regarding the issuance of the Regulations on Management of Aquatic Veterinary Drugs.

MINISTER OF AQUATIC RESOURCES

Pursuant to Decree No. 50/CP dated June 21, 1994 of the Government stipulating the tasks, powers, and organizational structure of the Ministry of Fisheries;

Pursuant to Decree No. 93/CP dated November 27, 1993 of the Government guiding the implementation of the Ordinance on Veterinary Medicine;

Pursuant to Decree No. 30/2000/NĐ-CP dated August 11, 2000 of the Government regarding the abolition of some licenses and the conversion of some licenses into business conditions;

Pursuant to Decree No. 86/2001/NĐ-CP dated November 16, 2001 of the Government on business conditions for fisheries occupations;

Pursuant to Circular No. 02/TS/TT dated June 25, 1994 of the Ministry of Fisheries guiding the implementation of Decree No. 93/CP dated November 27, 1993 of the Government on veterinary work for animals and aquatic animal products;

In accordance with the proposal of the Director of the Fisheries Resource Protection Department;

DECISION:

Article 1. Issued together with this Decision is the Regulation on Management of Aquatic Veterinary Drugs;

Article 2. THIS DECISION SHALL TAKE EFFECT 15 DAYS FROM THE DATE OF SIGNATURE.

The Regulation issued together with this Decision replaces the provisions at Section IV of Circular No. 02TS/TT dated June 25, 1994 of the Ministry of Fisheries.

Article 3. The Heads of the Office, Heads of Departments, Chief Inspectors of the Ministry, Directors of the Fisheries Resource Protection Department, Quality Control and Sanitation Testing Centers, Directors of Fisheries Departments, Departments of Agriculture and Rural Development (with fisheries management) shall be responsible for implementing this Decision./.

 

REGULATIONS

Management of Aquatic Veterinary Drugs
(Issued together with Decision No. 03/2002/QĐ-BTS)

Chapter 1

GENERAL PROVISIONS

Article 1: These Regulations prescribe uniformly the procedures and conditions for production, business, importation, and testing of aquatic veterinary drugs within the territory of Vietnam.

Article 2: Organizations and individuals related to activities concerning aquatic veterinary drugs (hereinafter referred to as entities) must strictly comply with the provisions of these Regulations.

Article 3: In these regulations, the following terms are understood as follows:

1. Aquatic veterinary drugs: are products (including finished products, semi-finished products, raw materials) of animal, plant, mineral, chemical, or biological origin used in aquaculture for the purpose of:

a) Disease prevention and treatment.

b) Disease diagnosis.

c) Adjustment of reproductive, growth, and development processes.

d) Environmental improvement and treatment.

2. Testing of aquatic veterinary drugs involves determining their effectiveness and safety when used in aquaculture (effectiveness in preventing and treating diseases in aquatic animals, safety for humans and livestock, non-pollution of the environment, and non-destruction of the ecological environment).

3. Activities concerning aquatic veterinary drugs include management, production, business, importation, and testing of aquatic veterinary drugs.

Article 4: State management agencies for aquatic veterinary drugs:

1. At the central level: The Fisheries Resource Protection Department assists the Minister of Fisheries in performing state management functions over aquatic veterinary drugs throughout the country.

2. At the local level: The Fisheries Resource Protection Sub-department assists the Director of the Fisheries Department or the Department of Agriculture and Rural Development with fisheries management in performing state management functions over aquatic veterinary drugs.

In areas where there is no Fisheries Resource Protection Sub-department, the agency carrying out this task will be designated by the Department of Agriculture and Rural Development.

Chapter 2

PROVISIONS ON ACTIVITIES CONCERNING AQUATIC VETERINARY DRUGS

Article 5: Conditions for producing veterinary drugs for aquatic animals

The production facilities for veterinary drugs for aquatic animals must meet the following conditions:

1. The location, factory buildings, storage areas, and waste treatment systems must comply with environmental protection and veterinary hygiene standards as prescribed by the Ministry of Fisheries.

2. Equipment must meet the requirements for production and preservation of raw materials and products.

3. There must be technical staff and specialized technical workers. The person responsible for technical production of veterinary drugs for aquatic animals must be a Veterinary Doctor, Aquaculture Engineer, Biology Bachelor, Biochemistry Bachelor, or Pharmacist.

4. There must be means to check the quality of drugs before they leave the factory.

5. Products leaving the factory must ensure the declared quality and must have product labels. The content on the label shall be in accordance with Circular No. 03/2000/TT-BTS dated September 22, 2000, issued by the Ministry of Fisheries guiding the implementation of Decision No. 178/1999/QĐ-TTg dated August 30, 1999, of the Prime Minister promulgating the Labeling Regulations for goods circulating domestically and exported/imported goods.

6. There must be a certificate of registration for the production of veterinary drugs for aquatic animals issued by the General Department of Fisheries Resources Protection.

7. Only types of veterinary drugs for aquatic animals listed in the Certificate of Registration for Production of Veterinary Drugs for Aquatic Animals may be produced.

Article 6: Conditions for trading veterinary drugs for aquatic animals

Trading facilities for veterinary drugs for aquatic animals must meet the following conditions:

1. The trading location must comply with veterinary hygiene standards as prescribed by the Ministry of Fisheries.

2. There must be equipment for preserving veterinary drugs for aquatic animals.

3. The store manager for trading veterinary drugs for aquatic animals must have at least a high school diploma in veterinary science or a junior college degree in aquaculture.

4. Only types of veterinary drugs for aquatic animals included in the list of permitted uses published by the Ministry of Fisheries may be traded.

Article 7: Testing of veterinary drugs for aquatic animals

1. Types of veterinary drugs for aquatic animals not included in the list of permitted uses published by the Ministry of Fisheries must undergo testing upon their first import into Vietnam or first production within the country.

2. The testing of veterinary drugs for aquatic animals shall be carried out in accordance with the regulations of the Ministry of Fisheries.

Article 8:Importation of veterinary drugs for aquatic animals

The importation of veterinary drugs for aquatic animals shall be carried out in accordance with the regulations of the Ministry of Fisheries regarding the management of import and export of specialized aquatic products.

Chapter 3

CONTENTS AND PROCEDURES FOR REGISTRATION OF PRODUCTION OF VETERINARY DRUGS FOR AQUATIC ANIMALS

Article 9: Documents for registering the production of veterinary drugs for aquatic animals:

1. Application for registration of production of veterinary drugs for aquatic animals accompanied by a list of drug types requested for permission to produce.

2. Report on the production conditions of veterinary drugs for aquatic animals.

3. Copy of the professional qualification certificates of the technical supervisor.

4. Technical documents must include:

a) Production process and product quality standards for each type of registered drug, registered drug labels.

b) Test result certificates confirming compliance with registered quality standards issued by state inspection agencies.

5. Copies of relevant documents related to the establishment of the production facility such as: decision on establishment, Business Registration Certificate, Investment License.

Article 10: Procedures for examination and issuance of the registration certificate for production of veterinary drugs for aquatic animals.

1. Upon receipt of the application, the issuing authority shall examine it based on Article 9 and guide the applicant to supplement missing contents.

2. Within ten working days from the date of receiving a complete application, the General Department of Fisheries Resources Protection must review the production conditions. If the conditions are met, the General Department of Fisheries Resources Protection will issue a Registration Certificate for Production of Veterinary Drugs for Aquatic Animals to the production facility. If the review concludes that the production conditions are not met, the production facility may request a re-review after addressing the deficiencies identified in the previous review.

Article 11: Inspection of production conditions for veterinary drugs for aquatic animals

Inspections of production conditions for veterinary drugs for aquatic animals shall be conducted in the following cases:

1. Initial inspection for new production facilities and those already registered but have changed their production locations.

2. Re-inspection for facilities previously inspected but not meeting production conditions and for those expanding their production sites or production lines.

3. Periodic inspections shall be conducted annually to monitor the maintenance of production conditions.

4. Spot inspections shall be conducted when deemed necessary by the supervisory authorities.

Article 12: Authorities inspecting production conditions for veterinary drugs for aquatic animals

1. The General Department of Fisheries Resources Protection is the authority inspecting production conditions for veterinary drug production facilities nationwide.

2. Provincial Fisheries Resources Protection Departments are the authorities inspecting production conditions for veterinary drug production facilities authorized by the General Department of Fisheries Resources Protection.

Article 13: The validity period of the registration certificate for production of veterinary drugs for aquatic animals is one year (from the date of issuance). When the validity period expires, the facility must apply for an extension if it continues to produce these veterinary drugs. The validity period of the extended registration certificate is one year.

Article 14: Extension of the Registration Certificate for Production

1. Documents for requesting an extension:

a. Request for extension.

b. Report on the production activities of the facility during the validity period of the issued Registration Certificate for Production.

c. Issued Registration Certificate for Production.

2. Procedures for reviewing the extension:

Within seven working days from the date of receiving a complete application, the General Department of Fisheries Resources Protection must review and notify the results.

Chapter 4

RESPONSIBILITIES AND LIMITATIONS OF THE STATE MANAGEMENT AUTHORITIES AND RELATED ENTITIES IN ACTIVITIES REGARDING VETERINARY DRUGS FOR AQUATIC ANIMALS

Article 15: Responsibilities and powers of the General Department of Fisheries Resources Protection:

1. Responsibilities:

a) Drafting and submitting to the Ministry for promulgation legal documents to manage veterinary drugs for aquatic animals.

b) Annually or periodically, drafting lists of permitted, restricted, and prohibited veterinary drugs for aquatic animals in Vietnam for the Ministry's leadership to issue decisions for publication.

c) Resolving disputes, complaints, and reports related to the management of veterinary drugs for aquatic animals within its jurisdiction.

2. Powers:

a) Issuing and revoking registration certificates for the production of veterinary drugs for aquatic animals for organizations and individuals nationwide.

b) Conducting inspections and supervision of activities related to veterinary drugs for aquatic animals.

c) Request organizations and individuals producing and trading aquatic animal drugs to provide relevant materials and documents upon request.

d) Collect fees as prescribed.

Article 16: Responsibilities and authorities of the Aquatic Resources Protection Agency or agencies designated by the Department of Agriculture and Rural Development to assist the Department Director in managing state affairs related to aquatic animal drugs.

1. Responsibilities:

a) Organize the management of activities related to aquatic animal drugs within the local area.

b) Receive and resolve complaints, petitions, and accusations regarding the management of aquatic animal drugs within the scope of authority granted or transfer them to other competent agencies for resolution.

2. Powers:

a) Inspect production conditions for authorized facilities, conduct inspections, and handle violations of laws on aquatic animal drugs in the locality.

b) Request organizations and individuals producing and trading aquatic animal drugs in the locality to provide relevant materials and documents upon request.

c) Collect and use fees as prescribed.

Article 17: Responsibilities of the facility:

Fully comply with all provisions of this Regulation and be subject to supervision and inspection by the state management agency for aquatic animal drugs.

Chapter 5

FEES AND USE OF FEES

Article 18: Inspection agencies are entitled to collect inspection fees for the production conditions of aquatic animal drugs in the following cases: Initial inspection, re-inspection, periodic inspection.

Article 19: The level of fees, management, and use of fees shall be implemented in accordance with the regulations and guidelines of the Ministry of Finance.

Chapter 6

PETITIONING, REPORTING AND HANDLING VIOLATIONS

Article 20: Organizations and individuals engaged in activities related to aquatic animal drugs have the right to appeal and report against the conclusions and measures of handling by inspection and audit agencies regarding aquatic animal drugs at their own facilities according to the Law on Appeals and Reports.

Article 21: Organizations and individuals engaged in activities related to aquatic animal drugs who fail to comply with or violate the provisions of this Regulation will be subject to administrative penalties as prescribed by law.

Article 22: State managers responsible for managing aquatic animal drugs who violate the provisions of this Regulation may, depending on the severity of the violation, be subject to disciplinary action, administrative penalties, or criminal liability as prescribed by law.

Chapter 7

IMPLEMENTING PROVISIONS

Article 23: Any amendments or supplements to the contents of this Regulation shall be examined and decided in writing by the Minister of Fisheries.

Article 24: The Aquatic Resources Protection Bureau is responsible for guiding, inspecting, and organizing the implementation of this Regulation.