Administrative Measures for Imported Veterinary Drugs

Contents

Chapter 1 General Provisions

Chapter 2 Registration of Imported Veterinary Drugs

Chapter 3 Operation and Packaging of Imported Veterinary Drugs

Chapter 4 Acceptance of Imported Veterinary Drugs

Chapter 5 Supervision of Imported Veterinary Drugs

Chapter 6 Supplementary Provisions

Chapter 1 General Provisions

Article 1 In order to strengthen the supervision and management of imported veterinary drugs and ensure the quality, safety and effectiveness of imported veterinary drugs, this document is formulated in accordance with the provisions of the "Veterinary Drug Administration Regulations" way.

Article 2: The Ministry of Agriculture is responsible for the supervision and management of imported veterinary drugs nationwide, and the animal husbandry and veterinary administrative departments of local people's governments at or above the county level are responsible for the supervision and management of imported veterinary drugs within their respective jurisdictions.

Article 3: Imported veterinary drugs must pass inspection by the port veterinary drug supervision office (hereinafter referred to as the port office) before they can be sold, repackaged and used domestically.

Article 4: All foreign enterprises selling veterinary drugs to the People’s Republic of China and enterprises engaged in the import, repackaging and operation of imported veterinary drugs within the country must comply with the provisions of these Measures.

Chapter 2 Registration of Imported Veterinary Drugs

Article 5 The state implements a registration management system for imported veterinary drugs. Any veterinary drug produced by a foreign enterprise that is sold to the People's Republic of China for the first time must apply for registration and obtain an "Import Veterinary Drug Registration License." Unregistered veterinary drugs are not allowed to be sold, repackaged, used or commercially promoted within the territory of the People's Republic of China.

Article 6: The "Registration License for Imported Veterinary Drugs" is only valid for the specified varieties of veterinary drugs and production enterprises.

Article 7: Applications for registration of veterinary drugs must be submitted by the foreign enterprise’s office in China or its agent in China. When applying, relevant information must be submitted to the Ministry of Agriculture in triplicate.

Article 8 Veterinary drugs applied for registration are divided into the following three categories:

The first category has been included in the Chinese People's Liberation Army and the National Veterinary Pharmacopoeia, Veterinary Drug Specifications and the Professional Standards of the Ministry of Agriculture.

The second category is not included in the People's Republic of China and the National Veterinary Pharmacopoeia, veterinary drug specifications and professional standards of the Ministry of Agriculture, but it is included in foreign pharmacopoeias, veterinary pharmacopoeias, parapharmacopoeias or feed regulations;

The third category of foreign pharmacopoeia, veterinary pharmacopoeia, parapharmacopoeia or feed regulations is not included, but the veterinary drug administration authority of the government of the producing country (region) has approved the production and sale in the country (region), and complies with the Chinese The People's Republic of China and the State's regulations on the use of veterinary drugs. Veterinary drug products other than the above three categories will not be accepted for registration.

Article 9 To register a veterinary drug, you should fill in the "Application Form for Imported Veterinary Drugs" and submit the following information and items:

1. Enterprise registration certificate issued by the government of the country (region) where the production enterprise is located and Production and sales certificates approved by the veterinary drug administration agency and documents proving that the company complies with the Good Manufacturing Practices (GMP) for veterinary drugs. The above certificates must first be notarized by the notary office in the country where the company is located or authenticated by the Ministry of Foreign Affairs (or an institution authorized by the Ministry of Foreign Affairs) of the country where the company is located, and then confirmed by the People's Government of the People's Republic of China and the Chinese embassy (consulate) in the country (region) where the company is located. .

2. Quality standards and inspection methods for veterinary drugs.

3. Product instruction manual.

4. Source, manufacturing method, and stability test data.

5. Clinical trials or regional trials.

6. Pharmacology and pharmacokinetic tests.

7. Toxicology and special toxicity (carcinogenic, teratogenic, mutagenic) tests.

8. Feeding trials and animal breeding trials of feed drug additives.

9. Residue test, drug withdrawal period, residue limit standards and residue monitoring methods.

10. Adverse drug reactions.

11. Antimicrobial resistance and antibiotic-resistant bacterial strain testing.

12. Tests that affect the environment (toxicity to plants, fish, insects, and environmental pollution).

13. Veterinary drug samples (with test report attached), standards or chemical reference materials.

The samples for quality review testing must come from three different batch numbers. The number of samples in each batch should be three to five times the testing amount; the standard or chemical reference substance should be five to ten times the testing amount.

Chinese translations of all the above information (except items 1 and 13) are required.

Article 10: For registration of Class I veterinary drugs, materials and items in items 1 to 7 and item 13 must be submitted.

For registration of Category II veterinary drugs, submit the information and items in items 1 to 9 and item 13.

To register Category III veterinary drugs, submit information and items from items 1 to 13.

Article 11 When applying for registration of veterinary biological products, in addition to submitting information and items in items 1 to 5 and item 13, the following information must also be submitted according to the product category:

(1) Standards for raw materials of products (including sources of bacterial and virus strains, generations and preparation methods).

(2) The source of cell species, generations, passage methods, identification methods and standards of cell seedlings.

(3) Components, formula, specificity and stability tests of live vaccines.

(4) Qualitative test.

(5) Types and standards of inactivating agents and adjuvants for inactivated vaccines.

(6) Specificity, sensitivity and coincidence rate of diagnostic fluid.

Chinese translations of the above information are required.

Article 12 The Ministry of Agriculture will review the information provided by the applicant enterprise and issue a "Notice of Acceptance of Application for Registration of Imported Veterinary Drugs" to those that comply with the regulations.

Article 13: After receiving the "Notice of Acceptance of Imported Veterinary Drug Registration Application" from the Ministry of Agriculture, the applicant company shall provide veterinary drug samples for quality review testing and animal clinical efficacy within the territory of the People's Republic of China. testing and necessary safety testing.

Article 14: Applications for registration of Class I veterinary drugs generally do not require clinical efficacy testing. However, if the product formulation, dosage form, route of administration, and indications are inconsistent with the People's Republic of China and the National Veterinary Pharmacopoeia, veterinary drug specifications and professional standards, clinical efficacy trials must be conducted. To apply for registration of Class II or III veterinary drugs, clinical efficacy trials must be conducted in China. The Ministry of Agriculture will decide whether to exempt veterinary biological products from some clinical efficacy tests based on the review of data.

Article 15: The applicant enterprise and the testing unit shall jointly formulate a test plan in accordance with the relevant clinical trial regulations of the Ministry of Agriculture and submit it to the Ministry of Agriculture for approval before conducting the test.

Article 16 The number of animals used in clinical drug efficacy tests shall not be less than the following:

(1) Preventive and therapeutic drugs:

40 large livestock

60 medium-sized livestock

100 small livestock or poultry (feathers)

1,000 aquatic animals (only)

10 boxes of bees

10 silkworms

(2) Antiparasitic drugs:

60 large livestock

100 medium-sized livestock

300 small livestock or poultry (feathers)

3,000 aquatic animals (feathers)

20 boxes of bees

20 sheets of silkworms

(3) Feed drug additives:

100 large livestock

200 medium livestock

500 small livestock or poultry (feathers)

5,000 aquatic animals (only)

40 pieces of silkworms

(4) Biological products:

200 large livestock

400 medium-sized domestic animals

600 small domestic animals or poultry (feathers)

600 aquatic animals (only)

[Note] Large livestock Refers to cattle, horses, mules, donkeys, camels, etc.;

Medium livestock refers to pigs, sheep, dogs, deer, musk deer, mink, fox, otter, etc.;

Small livestock Or poultry refers to rabbits, cats, chickens, ducks, geese, pigeons, etc.

Aquatic animals refer to artificial aquaculture fish, shrimp, crab, soft-shell turtle, shellfish, etc.

The number of animals mentioned above refers to the number of animals treated with the test drug.

Article 17 When registering Class III veterinary drugs, the Ministry of Agriculture shall determine whether to conduct pharmacological, pharmacokinetic, toxicological, special toxicity and breeding tests based on the information submitted by the applicant enterprise.

For antiparasitic drugs and feed drug additives belonging to the third category of veterinary drugs, the Ministry of Agriculture will determine whether to conduct residue testing based on the submitted information.

Article 18: When registering veterinary biological products, the Ministry of Agriculture may determine safety and other test items and content according to the requirements of different products.

Article 19 The tests referred to in Articles 14, 17 and 18 must be undertaken by units designated by the Ministry of Agriculture.

Article 20: The applicant enterprise shall submit the veterinary drug samples, standards or chemical reference substances to the Veterinary Drug Supervision Office designated by the Ministry of Agriculture for quality review testing with the "Notice of Acceptance of Imported Veterinary Drug Registration Application".

Article 21 During the review period of registered products, the Ministry of Agriculture shall send personnel to the production enterprise to conduct an assessment, and the enterprise must provide the conditions required for the assessment. Registration will not be approved if there is no assessment or if the assessment does not meet the requirements.

Article 22 The Ministry of Agriculture shall conduct review based on the clinical efficacy test report, quality review test report, review opinions of the Veterinary Drug Review Committee, and production plant assessment report. If the registration is approved, an "Import" will be issued. Veterinary Drug Registration License". If registration is not approved, the applicant shall be notified in writing.

Article 23: The "Import Veterinary Drug Registration License" is valid for five years from the date of approval. When it expires, enterprises that have registered veterinary drugs can apply for re-registration, but they must apply to the licensing authority with the original license six months before the expiration of the "Imported Veterinary Drug Registration License", fill in the "Imported Veterinary Drugs Re-registration Application Form", and provide the production The latest certification documents, product instructions and product quality standards for production and sales approved by the country (region), and the certificate will be renewed after review and approval.

Article 24 During the validity period of the "Imported Veterinary Drug Registration License", if the manufacturer makes changes to the raw materials, formula, inspection methods, product specifications, etc. of the veterinary drug, it must promptly report to the Ministry of Agriculture The application shall be submitted with technical information attached. If you change the name of the product or the name of the manufacturer, you need to apply for a replacement certificate. [3

Article 25 When a veterinary drug that has obtained the "Import Veterinary Drug Registration License" is sold to the People's Republic of China, its packaging shall be marked with the "Import Veterinary Drug Registration License" number, Product names in Chinese and English, and attached with approved Chinese instructions.

Article 26: The Ministry of Agriculture regularly publishes the "Registration Catalog of Imported Veterinary Drugs".

Chapter 3: Business and Packaging of Imported Veterinary Drugs

Article 27: The import of a small amount of veterinary drugs used for scientific research but not yet registered must be reported to the Ministry of Agriculture for approval and the issuance of an "Import" Veterinary Drug License". No import is allowed without approval. For unregistered veterinary drug products that are urgently needed for the breeding industry and cannot be supplied domestically, the user unit shall submit them to the Ministry of Agriculture for review and approval according to the imported veterinary drug declaration procedures, and a one-time "Import Veterinary Drug License" will be issued. The product is for personal use only and may not be transferred. ,Sale.

Article 28: Foreign enterprises that have obtained the "Registration License for Imported Veterinary Drugs" must entrust legal veterinary drug operating enterprises in China as their agents when selling their products in China. Among them, veterinary biological products can only be entrusted to a general agent for sales.

Article 29: Foreign enterprises must submit relevant information about their agents to the Ministry of Agriculture during the registration process. The information submitted should include:

1. Name and address of the agent , postal code, contact number, fax;

2. Copies of the agent's "Business License" and "Veterinary Drug Business License";

3. Copies of the agent's "Business License" and "Veterinary Drug Business License" from the foreign enterprise; Letter of authorization;

4. Overview of the agent.

Article 30 Agents should meet the following conditions:

1. Domestic legal veterinary drug operating enterprises;

2. Personnel with the qualifications to distribute imported veterinary drugs, Conditions and capabilities;

3. Have quality assurance conditions and warehousing conditions for the distribution of imported veterinary drugs.

Article 31: The Ministry of Agriculture regularly publishes the list of agents.

Article 32: For agents who repeatedly distribute unqualified imported veterinary drugs, the Ministry of Agriculture may, depending on the severity of the case, give a warning, instruct the original issuing authority to revoke their "Veterinary Drug Business License" and other administrative penalties , and impose corresponding financial penalties in conjunction with the industrial and commercial administration authorities.

Article 33 Anyone who needs to import veterinary drugs must fill out the "Application Form for Import of Veterinary Drugs" and report it to the animal husbandry and veterinary administrative department of the province, autonomous region, or municipality directly under the Central Government or the Ministry of Agriculture.

Article 34 The animal husbandry and veterinary administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for issuing "Import Veterinary Drug Licenses" for chemical drugs, antibiotics and feed drug additives that have obtained the "Import Veterinary Drug Registration License" . The Ministry of Agriculture is responsible for issuing veterinary biological products that have obtained the "Import Veterinary Drug Registration License" and the "Import Veterinary Drug License" that comply with the provisions of Article 27.

Article 35: After receiving the "Application Form for Import of Veterinary Drugs", the animal husbandry and veterinary administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government and the Ministry of Agriculture shall review and approve the importing units, varieties of veterinary drugs, import quantities, etc. Later, an "Import Veterinary Drug License" was issued.

The "Import of Veterinary Drugs License" is valid for one year. Those who have not imported after the expiration date should re-apply.

A copy of the "Import Veterinary Drug License" should be sent to the China Veterinary Drug Supervision Office and the import port veterinary drug supervision office, and a copy of the "Import Veterinary Drug License" issued by the animal husbandry and veterinary administrative department of the province, autonomous region, or municipality directly under the Central Government should also be copied Send to the Ministry of Agriculture.

Article 36: The "Import of Veterinary Drugs License" is only valid for the name, manufacturer, specification, quantity, validity period and import port of the veterinary drug stated in the certificate. If there are any changes, you need to re-apply for certificate replacement according to the original procedures.

Article 37: Those who import veterinary drugs shall sign an import contract through an agent with the "Import of Veterinary Drugs License". The contract must be signed in accordance with the name, specifications, quantity, manufacturer and quality standards of the veterinary drug stated in the "Import of Veterinary Drugs License". A copy (or photocopy) of the contract must be submitted to the Veterinary Drug Supervision Office of the import port within 7 days before purchase.

Article 38: Any special reagents, standards or chemical reference materials required for the inspection of imported veterinary drugs shall be specified in the contract to be provided by the seller.

Article 39: When imported veterinary drugs are repackaged domestically (repackaging refers to the purchase of large packages of imported veterinary drugs for direct subpackaging activities), the domestic repackaging enterprise must hold a "Veterinary Drug Production License" , and sign a contract or agreement with a foreign veterinary drug manufacturer holding an "Import Veterinary Drug Registration License", and at the same time be authorized to use its trademark. The content of the contract or agreement must comply with my country's relevant laws and veterinary drug management regulations.

Article 40: If imported veterinary drugs are repackaged and sold domestically, the repackaging veterinary drug manufacturer shall submit an application to the animal husbandry and veterinary administrative department of the province, autonomous region, or municipality directly under the Central Government where it is located. The following relevant information:

1. Contract or agreement signed by the Chinese and foreign parties and trademark authorization letter (copy);

2. Quality standards of the veterinary drug (original text and Chinese translation) ;

3. Instructions for use of the veterinary drug (original text and Chinese translation);

4. Packaging and labeling samples;

5. Three batches of samples and inspection Report sheet. After being inspected and meeting the requirements and approved by review, an approval number for the repackaged product will be issued. The approval number for the repackaged product will be valid for three years.

Article 41 The packaging, labels and instructions of the repackaged veterinary drugs must be in Chinese, and foreign languages ??may also be added at the same time, and the name of the original foreign manufacturer, import veterinary drug registration license number and branch number must be marked at the same time. The name of the packaging manufacturer and the approval number of the subpackaged product. Its packaged products comply with imported veterinary drug quality standards and must pass the inspection by the company's quality inspection department before leaving the factory.

Article 42: All imported veterinary drugs that have undergone necessary preparation processing in my country and are sold and used domestically shall go through the approval procedures in accordance with the domestic veterinary drug approval and new veterinary drug approval management regulations.

Chapter 4 Acceptance of Imported Veterinary Drugs

Article 43 After the imported veterinary drugs arrive at the port, the receiving unit shall hold the "Imported Veterinary Drug License" and the production factory inspection within three days The report and customs declaration form for imported goods must be submitted to the designated port veterinary drug supervision office to apply for inspection.

Article 44: After reviewing the relevant documents, the Port Veterinary Drug Supervision Office shall stamp the imported goods declaration form with the seal of acceptance of inspection and the seal of the institute, or issue a certificate of acceptance of inspection and designate The place where veterinary drugs are stored and sealed pending inspection. The inspection reporting unit shall go to the customs with the stamped customs declaration form or declaration certificate to go through the inspection and release procedures.

Article 45: After the port veterinary drug supervision office accepts the inspection application, it shall immediately send personnel to the veterinary drug storage point to conduct verification and sampling, and at the same time cancel the original "Import Veterinary Drug License". The Port Veterinary Drug Supervision Office shall issue an inspection report within thirty days from the date of acceptance of the inspection application. Imported veterinary drugs that have not been inspected or failed to pass the inspection are not allowed to be sold or used. When purchasing imported veterinary drugs, veterinary drug production and operating enterprises and veterinary medical units should obtain the "Imported Veterinary Drug Inspection Report" issued by the port veterinary drug supervision office from the importing veterinary drug unit.

Article 46: Imported veterinary biological products must be affixed with a special mark by the port veterinary drug supervision office before they can be sold and used. Product sampling shall be carried out in accordance with relevant regulations.

Chapter 5 Supervision of Imported Veterinary Drugs

Article 47 The "Quality Standards for Imported Veterinary Drugs" issued by the Ministry of Agriculture are the legal standards for quality supervision of imported veterinary drugs. Any imported veterinary drug products that do not meet this standard shall not be sold and used domestically.

Article 48: The port veterinary drug supervision office designated by the Ministry of Agriculture is responsible for the inspection, release and inspection of imported veterinary drugs. Veterinary drug supervision offices at all levels are responsible for the quality supervision and inspection of imported veterinary drug products within their respective jurisdictions. The China Veterinary Drug Supervision Institute is responsible for providing technical guidance to the port veterinary drugs supervision institute and conducting technical arbitration on disputed inspection results.

Article 49: For veterinary drugs that fail to pass the inspection, the port veterinary drug supervision office shall work together with the provincial animal husbandry and veterinary administrative department to seal them up, supervise and handle them. At the same time, the relevant information will be summarized and reported to the Ministry of Agriculture.

Article 50: Animal husbandry and veterinary administrative departments at all levels should strengthen supervision and management of imported veterinary drugs that have been put on the market, and order products that have deteriorated or expired to immediately stop sales and use. If toxic or side effects occur during clinical use, use should be stopped immediately and reported to the Ministry of Agriculture.

Article 51: When importing veterinary drugs and users discover quality problems with imported veterinary drugs, they should promptly contact the local animal husbandry and veterinary administrative department and the general agent of imported veterinary drugs, or they can also go up to the next level of animal husbandry and veterinary medicine. Reported by the administrative department. The general agent should solve the reported problems in a timely manner and report the results to the local animal husbandry and veterinary administrative department and the Ministry of Agriculture.

Article 52: Those who violate the provisions of these Measures shall be dealt with in accordance with the relevant provisions of the "Regulations on the Administration of Veterinary Drugs".

Article 53: Applicant enterprises shall pay testing, inspection and registration fees in accordance with relevant regulations. Fees for drug efficacy tests, feeding tests, pharmacological tests, toxicity tests, residue tests, etc. are determined based on the test animals, content and scale, and are determined through negotiation between the testing unit and the applicant.

Chapter 6 Supplementary Provisions

Article 54 Veterinary drugs as mentioned in these Measures refer to: used to prevent, treat, diagnose livestock and poultry and other animal diseases, and to purposefully regulate their physiological functions It also stipulates the functions, usage and dosage of substances (including feed drug additives). Including:

1. Biological products such as serum, bacterial (vaccination) vaccines, and diagnostic solutions;

2. Chinese medicinal materials, Chinese patent medicines, chemical raw materials and their preparations for veterinary use;

3. Antibiotics, biochemical drugs, and radioactive drugs.

Article 55 The Ministry of Agriculture is responsible for the interpretation of these Measures.

Article 56: These Measures shall come into effect on the date of promulgation. The "Measures for the Administration of Veterinary Drugs Registered by Foreign Enterprises in the People's Republic of China" issued by the former Ministry of Agriculture on July 11, 1988 and The "Administrative Measures for Imported Veterinary Drugs" issued on July 10, 1989 were abolished at the same time.