Veterinary medicine

2 Regulations on the Administration of Biosafety of Pathogenic Microorganism Laboratories (promulgated by Decree No. 424 of the State Council in 2004).

3 Administrative Measures for the Development of New Veterinary Drugs (Decree No. 55 of the Ministry of Agriculture in 2005).

4 Measures for the Registration of Veterinary Drugs (promulgated by Decree No. 44 of the Ministry of Agriculture in 2002).

Ministry of Agriculture Announcement No. 442, 449, 2223, 2326, 2335, 2336, 2337, 2368, 2464 and Ministry of Agriculture and Rural Affairs Announcement No. 75.

2 For new veterinary drugs jointly developed, one of the units may apply for registration or jointly apply for registration, but no repeated application for registration is allowed; Where a joint application for registration is made, the applicant shall jointly sign his name as the applicant for the new veterinary drug.

3 The materials submitted for applying for new veterinary drug registration shall be complete and standardized, and the data must be true and reliable.

4 When applying for the registration of new veterinary drugs, the applicant shall submit a letter of guarantee, promise that the intellectual property rights of others will not constitute infringement, and be responsible for the possible consequences of infringement, and ensure the authenticity of the test data obtained by itself.

5 If the application materials contain overseas veterinary drug test and research materials, the information items, page descriptions and notarized legal registration documents of the overseas research institution shall be attached.

2 Veterinary drugs other than inactivated vaccines and diagnostic products obtained through genetic engineering technology and failed to pass the biosafety evaluation will not be accepted.

2 Legal registration documents of the applicant, including business license, legal person certificate, etc. (copies).

3 If the product belongs to genetically modified biotechnology (except for inactivated vaccine and diagnostic products), the safety certificate of agricultural genetically modified organisms (copy) shall be provided.

4 Three consecutive batches of samples and their batch production inspection records and inspection reports.

5 If it is a biological product, it shall also provide bacteria (toxin, insect) species, cells and other relevant materials.

6 According to different categories of new veterinary drugs, other registration materials shall be submitted in accordance with the “Requirements for Registration Materials of Veterinary Drugs” and other relevant provisions.

2 The registration materials shall be in duplicate, A4 paper double-sided copy and bound into a volume, affixed with the official seal of all the registration application units (consistent with the application units of the registration application form). The application materials shall be complete in content, with contents and consecutive pages. For all entrusted tests, the original test report shall be provided, and the original atlas and photos of the test results shall be attached.

The following supporting materials in the above application materials can be replaced by a written commitment letter (see the annex).

2. Copies of business license and legal person certificate.

2 After the application for registration is accepted, the applicant shall upload the electronic version of the registration information to the veterinary drug evaluation system of the Ministry of Agriculture and Rural Affairs in accordance with the relevant requirements of the Ministry of Agriculture and Rural Affairs Announcement No. 75.

3 The Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs organized experts to conduct technical evaluation on the accepted registration materials.

4 The applicant shall submit the samples for review and inspection to the designated veterinary drug inspection agency for review and inspection according to the review comments.

5 When necessary, the Ministry of Agriculture and Rural Affairs shall organize experts to conduct on-site inspection.

6 The Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall put forward an approval plan based on the review and inspection conclusions, submit it for signature according to the procedure, approve it, print and distribute the announcement, and prepare the New Veterinary Drug Registration Certificate.

2 Measures for the Registration of Veterinary Drugs (promulgated by Decree No. 44 of the Ministry of Agriculture in 2002).

3 Ministry of Agriculture Announcement No. 442, 2223, 2326, 2335, 2336, 2337, 2464, 2599 and Ministry of Agriculture and Rural Affairs Announcement No. 75.

When applying for the export of veterinary biological products to China, the applicant shall also provide relevant materials and data such as bacteria (viruses, worms), cells, etc.

To apply for the import registration of veterinary drug preparations, it is necessary to provide the documents proving the legal source of the raw materials and excipients used to produce the preparations, the packaging materials and containers that directly contact the veterinary drugs.

4 If an API has not been approved by the Ministry of Agriculture and Rural Affairs, it shall apply for the registration of the API at the same time, and shall submit relevant research materials such as production technology, quality indicators and inspection methods.

5 The materials submitted for the registration of imported veterinary drugs shall be complete and standardized, and the data must be true and reliable. The name of the work, the name of the publication, and the volume, issue, page, etc. shall be indicated in the cited documents and materials; Chinese translations of foreign language materials shall be provided as required.

2 Veterinary drugs other than inactivated vaccines and diagnostic products obtained through genetic engineering technology and failed to pass the biosafety evaluation will not be accepted.

3. Class I epidemic disease stipulated by China and live vaccine without epidemic disease in China will not be accepted.

4 Veterinary biological products from epidemic areas that may cause the spread of epidemic diseases in China shall not be accepted.

1.1 Application Form for Registration of Imported Veterinary Drugs (Registration of Veterinary Drugs) (in duplicate, the original copy shall be prepared by the applicant).

1.2 The certification document (which must be notarized and confirmed) that the veterinary drug administration of the country (region) where the manufacturer is located approves the production and sales (one copy, which shall be provided by the applicant).

1.3 Certification document (notarized and confirmed) issued by the veterinary drug administration of the country (region) where the manufacturer is located that conforms to the veterinary drug production quality management specifications (one copy, which shall be provided by the applicant).

1.4 The power of attorney of the exporter and the identity certificate or legal registration certificate of the applicant (one copy, which shall be provided by the applicant).

1.5 Three consecutive batches of samples and their batch production inspection records, inspection reports (one original, prepared by the applicant).

1.6 Where an applicant applies to export veterinary biological products to China, it shall also provide relevant materials and materials (one original, which shall be prepared by the applicant), such as bacteria (viruses, worms), cells, etc.

1.7 According to different categories of imported veterinary drugs, submit other relevant materials (one original, which shall be prepared by the applicant) in accordance with the requirements of Announcement No. 442 of the Ministry of Agriculture.

2. Registration materials (in duplicate, the original copy shall be prepared by the applicant), A4 paper double-sided copies shall be bound into a volume, and affixed with the official seal of all registration application units (consistent with the application units of the registration application form). The application materials shall be complete in content, with contents and consecutive pages. All entrusted tests shall be provided with original test reports and attached with original atlas and photos of test results.

2 If the application is accepted, the animal husbandry and veterinary window of the Government Affairs Service Hall of the Ministry of Agriculture and Rural Affairs shall issue the Notice of Acceptance of the Comprehensive Office of Administrative Examination and Approval of the Ministry of Agriculture and Rural Affairs to the applicant.

3 After the application for registration is accepted, the applicant shall upload the electronic version of the application materials to the veterinary drug evaluation system of the Ministry of Agriculture and Rural Affairs in accordance with the relevant requirements of Announcement No. 75 of the Ministry of Agriculture and Rural Affairs.

4 The Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs organized experts to conduct technical evaluation on the accepted application materials.

5 The applicant shall submit the samples for review and inspection to the designated veterinary drug inspection agency for review and inspection according to the review comments.

6 The applicant shall carry out relevant clinical tests and relevant validation tests in the qualified institutions in the People’s Republic of China according to the review opinions.

7 If it is necessary to supplement materials, confirm technical standards, submit reference materials, bacterial (toxin, insect) species and cells during the technical review, the Evaluation Center shall notify the applicant in writing. The applicant shall supplement materials, confirm technical standards and submit reference materials on time according to the review comments.

8 When necessary, the Ministry of Agriculture and Rural Affairs shall organize experts to conduct on-site inspection.

9 The Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall put forward an approval plan according to the review results, submit it for signature according to the procedures, approve it, issue an announcement, and prepare the Imported Veterinary Drug Registration Certificate or Veterinary Drug Registration Certificate.

Measures for the Administration of the Import of Veterinary Drugs (Decree No. 2, 2007 of the Ministry of Agriculture and the General Administration of Customs).

For the import of samples, reference materials, standard products, bacterial (toxin, insect) species and cells of veterinary drugs for registration, an application shall be submitted to the Ministry of Agriculture and Rural Affairs, and an application form for the import of veterinary drugs shall be submitted.

Veterinary drugs urgently needed in China shall be imported by the unit designated by the Ministry of Agriculture and Rural Affairs, and a Customs Clearance Form for Imported Veterinary Drugs shall be issued.

The Customs Clearance Form for Imported Veterinary Drugs is subject to a single customs clearance. It can only be used once within the 30 day validity period, and its contents cannot be changed. It shall be handled again after expiration.

The import of veterinary drugs with uncertain efficacy and large adverse reactions is prohibited.

The import of veterinary biological products from epidemic areas that may cause the spread of epidemic diseases in China is prohibited.

The import of veterinary drugs whose production conditions do not meet the requirements is prohibited.

The import of veterinary drugs whose labels and instructions do not meet the requirements is prohibited.

The import of veterinary drugs without the Customs Clearance Form for Imported Veterinary Drugs is prohibited.

The Ministry of Agriculture and Rural Affairs prohibits the import of veterinary drugs that are prohibited from production, marketing and use.

2. Scientific research project initiation report, test plan and other materials (applicable to a small amount of scientific research veterinary drugs).

3. Review opinion documents of the Veterinary Drug Review Center of the Ministry of Agriculture and Rural Affairs (applicable to imported registered veterinary drug samples, reference materials, standard products, bacterial (toxin, insect) species, cells, etc.).

4. The import of veterinary drugs is urgently needed in China, and the following materials shall also be provided for the application for import of veterinary drugs (customs clearance form):

4.1 The certificate of legal registration of the import entity or the copy of the Veterinary Drug Business License.

4.2 Copies of agency contract (power of attorney) and purchase contract.

4.3 Approval certificate issued by the veterinary drug administration of the country (region) where the manufacturer is located (applicable to vaccines).

4.4 Product delivery inspection report.

4.5 Copies of packing list, bill of lading and freight invoice.

The following supporting materials in the above application materials can be replaced by a written commitment letter (see the annex).

If the application is accepted, the Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall organize risk assessment and review of the application materials.

The Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall put forward an approval plan based on the evaluation conclusion and review comments, and handle the approval documents after signing according to the procedures.

Measures for the Registration of Veterinary Drugs (promulgated by Decree No. 44 of the Ministry of Agriculture in 2002).

Ministry of Agriculture Announcement No. 442, 2223, 2335, 2599 and Ministry of Agriculture and Rural Affairs Announcement No. 75.

2. When applying for re registration, the applicant shall fill in the Application Form for Re registration of Veterinary Drugs and submit relevant materials according to the Requirements for Registration Materials of Veterinary Drugs.

2. Those who do not submit adverse drug reaction monitoring reports of veterinary drugs as required will not be re registered.

3. Those listed as prohibited varieties after safety re evaluation by the Ministry of Agriculture and Rural Affairs shall not be re registered.

4. Those whose production conditions do not meet the requirements after examination shall not be re registered.

5. Those with safety risks after risk analysis shall not be re registered.

6. Class I epidemic diseases stipulated by China and live vaccines without epidemic diseases in China shall not be re registered.

7. Veterinary biological products from epidemic areas that may cause the spread of epidemic diseases in China shall not be re registered.

8. Other cases that are not allowed to be re registered according to law.

1.1 The Application Form for Re registration of Imported Veterinary Drugs/Veterinary Drugs is in duplicate (2 originals, which shall be prepared by the applicant).

1.2 The certificate of the recent approval of the veterinary drug administration of the country (region) where the veterinary drug is produced (which must be notarized and confirmed) (1 original, prepared by the applicant).

1.3 The certification document (notarized and confirmed) recently issued by the veterinary drug administration of the country (region) where the veterinary drug is produced, which conforms to the specifications for the quality management of veterinary drug production (1 original, prepared by the applicant).

1.4 If an overseas pharmaceutical manufacturer entrusts a Chinese agency to declare on its behalf, it shall provide the authorization document, notarization document and its Chinese translation, as well as the Business License of the Chinese agency (1 copy, the applicant shall provide).

1.5 Summary report on sales, clinical use and adverse reactions in China within 5 years (1 original, prepared by the applicant).

1.6 Approved and current veterinary drug prescriptions, production processes, quality standards, inspection methods and approval documents (1 original, prepared by the applicant).

1.7 Proof documents of the source of the APIs used in the production of veterinary drug preparations, and the submission of bacteria and viruses for production inspection (1 original, prepared by the applicant).

1.8 Samples of Chinese packaging, labels and instructions for the minimum sales unit in Chinese market (1 original, prepared by the applicant).

1.9 The original and Chinese translation of the current instructions approved by the veterinary drug administration of the country (region) where the veterinary drug is produced (1 original, prepared by the applicant).

1.10 Other relevant materials required to be submitted by Announcement No. 442 and Announcement No. 2223 of the Ministry of Agriculture (1 original, prepared by the applicant).

2. The following materials shall also be provided for re registration of veterinary drugs under the following circumstances:

2.1 If the Phase IV clinical trial is required, the summary report of the Phase IV clinical trial (1 original, prepared by the applicant) shall be provided.

2.2 If it is required to continue to complete the work in the veterinary drug approval certificate or re registration approval document, the work summary report shall be provided with the corresponding data (1 original, which shall be prepared by the applicant).

3. The registration materials shall be in duplicate, A4 paper double-sided copy and bound into a volume, with the official seal of all the registration application units affixed (consistent with the application units of the registration application form). The application materials shall be complete in content, with contents and consecutive pages. All entrusted tests shall be provided with original test reports and attached with original atlas and photos of test results.

The following supporting materials in the above application materials can be replaced by a written commitment letter (see the annex).

2. After the application for registration is accepted, the applicant shall upload the electronic version of the application materials to the veterinary drug evaluation system of the Ministry of Agriculture and Rural Affairs in accordance with the relevant requirements of Announcement No. 75 of the Ministry of Agriculture and Rural Affairs.

3. The Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs will review the accepted application materials or organize experts to review them.

4. The Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall put forward an approval plan according to the review opinions or conclusions, submit it for signature according to the procedures, approve it, issue an announcement, and prepare the Certificate of Re registration of Imported Veterinary Drugs (Re registration of Veterinary Drugs).

Regulations on the Administration of Biosafety of Pathogenic Microorganism Laboratories (promulgated by Decree No. 424 of the State Council in 2004).

Administrative Measures for the Development of New Veterinary Drugs (Decree No. 55 of the Ministry of Agriculture in 2005).

Measures for the Registration of Veterinary Drugs (promulgated by Decree No. 44 of the Ministry of Agriculture in 2002).

Ministry of Agriculture Announcement No. 442, 2326, 2337, 2464.

The original of clinical trial plan and entrusted trial contract.

The preclinical research data of new veterinary biological products mainly include the systematic identification, preservation conditions, genetic stability, laboratory safety and efficacy tests, immunology studies, etc. of bacteria and virus species, cell lines, biological tissues and other starting materials.

Production process, quality standard (draft), summary report and inspection report of trial production.

The clinical trial shall be carried out in accordance with the relevant requirements of the Code for the Quality Control of Clinical Trials of Veterinary Drugs.

The number of target animals in the clinical trial shall be subject to the Announcement No. 2326 of the Ministry of Agriculture.

Application report (including the basic information of the development unit and the basic conditions for biosafety prevention, the name of new veterinary biological products, the name, source and characteristics of bacteria (toxins and pests)).

The original of clinical trial plan (including possible safety risks and other emergency response measures) and entrusted trial contract.

The preclinical research data of new veterinary biological products mainly include the systematic identification, preservation conditions, genetic stability, laboratory safety and efficacy tests, immunology studies, etc. of bacteria and virus species, cell lines, biological tissues and other starting materials.

Production process, quality standard (draft), research summary report, batch production inspection record and inspection report of intermediate trial products.

The Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs shall conduct technical examination on the application materials according to relevant national regulations.

When necessary, the Ministry of Agriculture and Rural Affairs shall organize experts to conduct on-site verification of pre clinical research and trial production.

The Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall put forward an approval plan according to the technical review opinions, and handle the approval documents after submitting for signature according to the procedures.

2 Measures for the Administration of Approval Number of Veterinary Drug Products (Decree No. 4, 2015 of the Ministry of Agriculture).

3 Measures for the Administration of Labels and Instructions of Veterinary Drugs (Decree No. 22 of the Ministry of Agriculture in 2002, revised for the first time by Decree No. 38 of the Ministry of Agriculture in 2004, and revised for the second time by Decree No. 6 of the Ministry of Agriculture in 2007).

4 Ministry of Agriculture Announcement No. 242, 1997, 2066, 2428, 2438, 2464, 2465, 2471, 2481 and Ministry of Agriculture and Rural Affairs Announcement No. 161, 205.

5 NBY [2006] No. 48, NBY [2010] No. 8, NBY [2016] No. 32, NBY [2016] No. 41, NBY [2016] No. 60, and NBY [2017] No. 29.

2 The veterinary drug product approval number is the veterinary drug approval certificate issued by the Ministry of Agriculture and Rural Affairs when approving specific veterinary drug manufacturers to produce specific veterinary drug products according to the national veterinary drug standards, production processes and production conditions.

3 The veterinary drugs applying for the approval number of veterinary drug products shall be within the production scope specified in the Veterinary Drug Production License.

4 For veterinary drugs applying for approval number of veterinary drug products, there is no record of revocation of the product approval number within three years prior to the application.

5 If the data review, on-site verification, recheck inspection or comparison test do not meet the requirements, the animal husbandry and veterinary administrative department of the provincial people’s government may return the application data to the applicant according to the applicant’s wishes.

6 The Ministry of Agriculture and Rural Affairs shall establish a monitoring period of no more than five years when issuing the approval number of new veterinary drugs. During the monitoring period, no other enterprise shall be approved to produce or import the new veterinary drug.

2. The Ministry of Agriculture and Rural Affairs shall suspend the application for the approval number of the veterinary drug product that has been proved to have potential safety hazards; If it has been accepted, the approval number of the veterinary drug product shall be suspended.

1.1 Application Form for Approval Number of Veterinary Drug Products (one original, prepared by the applicant).

1.2 Label and instruction sample (one original, prepared by the applicant).

1.3 Self inspection report of the submitted sample (one original, prepared by the applicant).

1.4 Production process, formula and other information of the product (one original, prepared by the applicant).

2 If the applicant applies for the approval number of the veterinary drug product that has obtained the New Veterinary Drug Registration Certificate developed by the enterprise itself, and the product registration review inspection sample is produced by the applicant himself, the New Veterinary Drug Registration Certificate (electronic version) shall also be submitted, but the sample self inspection report is not required. Apply for the approval number of the veterinary drug product that has obtained the New Veterinary Drug Registration Certificate developed by the enterprise itself, but if the recheck sample at the time of registration of the new veterinary drug is not produced by the applicant, the New Veterinary Drug Registration Certificate (electronic version) shall also be submitted. If it belongs to the biological product category, three consecutive batches of samples taken on site by the provincial inspection agency shall be submitted at the same time; For non biological products, samples of three consecutive batches and electronic version of original records of batch production and inspection of samples shall be submitted at the same time. (One original, prepared by the applicant)

3 If the applicant has obtained the approval number of the new veterinary drug registration certificate for biological veterinary drug products, the applicant shall also submit the new veterinary drug registration certificate (electronic version), the intellectual property transfer contract or power of attorney (the original copy shall be provided for the first application, the copy of the renewal application shall be provided and affixed with the official seal of the applicant, and the electronic version shall be provided). At the same time, the applicant shall submit three consecutive batches of samples taken by the provincial inspection agency on site. (One original, prepared by the applicant)

4 In case of applying for the approval number of biological veterinary drug products as stipulated in Article 8 of the Administrative Measures for the Approval Number of Veterinary Drug Products, the applicant shall also submit the certificate of the legal source of bacteria (toxins and pests) (stamped with the official seal of the applicant, electronic version), and shall also submit three consecutive batches of samples taken by provincial inspection institutions on the spot. (One original, prepared by the applicant)

5 If the applicant has obtained the approval number of the non biological veterinary drug product of the New Veterinary Drug Registration Certificate for transfer by others, the applicant shall also submit the New Veterinary Drug Registration Certificate (electronic version), the intellectual property transfer contract or power of attorney (the original copy shall be provided for the first application, and the copy of the renewal application shall be provided with the applicant’s official seal, and the electronic version shall be provided), and the samples of three consecutive batches shall be submitted at the same time. (One original, prepared by the applicant)

6 If the application has not been included in the veterinary drug product approval number of the comparative test variety catalog, it is not necessary to submit the self inspection report, but the Application Form for On site Verification (electronic version) should be submitted, and at the same time, three consecutive batches of samples taken on site by the provincial animal husbandry and veterinary administrative department should be submitted. (One original, prepared by the applicant)

7 If the application is included in the approval document number of veterinary drug products in the variety catalog of comparative tests, the self inspection report is not required, but the Application Form for On site Verification (electronic version) should be submitted. At the same time, the inspection report of three consecutive batches of samples (one batch of online sampling), the comparative test scheme, the comparative test protocol, the comparative test report, the relevant pharmaceutical data and other data should be submitted. (One original, prepared by the applicant)

8 If the applicant applies for the renewal of the approval document number of veterinary drug products, and if more than one batch of biological products or more than three batches of non biological products have passed the supervision and sampling inspection by the animal husbandry and veterinary administrative department of the people’s government at or above the provincial level and all of them are qualified, the applicant may no longer provide samples (one copy, photocopy, which shall be provided by the applicant).

9 Where the approval number of veterinary drug products is changed, the Ministry of Agriculture Announcement No. 2481 shall be followed (one copy, copy to be provided by the applicant).

The following supporting materials in the above application materials can be replaced by a written commitment letter (see the annex).

2 The Ministry of Agriculture and Rural Affairs shall organize the China Veterinary Drug Administration to conduct expert review of the application materials according to relevant national regulations.

3 If sample inspection is required, the provincial veterinary drug inspection institution or the China Institute of Veterinary Drug Supervision shall conduct sample inspection.

4 The Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall put forward an approval plan according to the examination opinions of the China Veterinary Drug Administration, and handle the approval document after submitting it for signature according to the procedure.

2 Other categories, 20 working days (if inspection is required, the inspection time shall not exceed 120 working days; the expert review time shall not exceed 30 working days).

Measures for the Registration of Veterinary Drugs (promulgated by Decree No. 44 of the Ministry of Agriculture in 2002).

Ministry of Agriculture Announcement No. 442, 2223, 2335, 2599 and Ministry of Agriculture and Rural Affairs Announcement No. 75.

When applying for change of registration, the applicant shall fill in the Application Form for Change of Registration of Veterinary Drugs and submit relevant materials and explanations. Where the ownership of a veterinary drug product is changed, effective supporting documents shall be provided.

For the change of registration of imported veterinary drugs, the applicant shall also submit the document approving the change issued by the veterinary drug administration of the country (region) where the manufacturer is located.

The procedures, time limits and requirements for the review and inspection of the application for the change of registration of veterinary drugs shall apply to the provisions on the registration of new veterinary drugs and the registration of imported veterinary drugs.

1. The Veterinary Drug Registration Change Application Form is in duplicate (original).

2. Veterinary drug approval documents and their attachments (copies).

3. The applicant’s legal registration certificate (copy).

4. The registration materials shall be in duplicate, A4 paper double-sided copy and bound into a volume, with the official seal of all the registration application units affixed (consistent with the application units of the registration application form). The application materials shall be complete in content, with contents and consecutive pages. All entrusted tests shall be provided with original test reports and attached with original atlas and photos of test results.

5. If necessary, submit three consecutive batches of samples, batch production inspection records and inspection reports.

6. Other relevant materials shall be submitted according to the requirements of Announcement No. 442 of the Ministry of Agriculture.

The following supporting materials in the above application materials can be replaced by a written commitment letter (see the annex).

(Announcement No. 442 of the Ministry of Agriculture, supporting documents: copies of the veterinary drug production license, business license, and veterinary drug GMP certificate provided by the applicant when the applicant is a veterinary drug manufacturer; copies of the legal registration documents provided by the applicant when the applicant is not a veterinary drug manufacturer; copies of the registration certificate of the resident representative office of foreign enterprises in China provided by the resident representative office of foreign pharmaceutical manufacturers to handle registration matters; copies of the registration certificate of the resident representative office of foreign enterprises in China provided by the overseas manufacturer) If a drug manufacturer entrusts a Chinese agency to declare on its behalf, the photocopy of the business license of the Chinese agency shall be provided.)

For veterinary drug change registration applications requiring technical review, the Animal Husbandry and Veterinary Window of the Government Affairs Service Hall of the Ministry of Agriculture and Rural Affairs shall review the Application Form for Veterinary Drug Change Registration and related materials submitted by the applicant. If the application materials are complete, they shall be accepted, and the materials shall be accepted according to the formal review opinions of the Veterinary Drug Review Center of the Ministry of Agriculture and Rural Affairs, and the Notice of Comprehensive Office Acceptance of Administrative Examination and Approval of the Ministry of Agriculture and Rural Affairs shall be issued to the applicant.

After accepting the application for change registration that requires technical review, the applicant shall upload the electronic version of the application materials to the veterinary drug review system of the Ministry of Agriculture and Rural Affairs in accordance with the relevant requirements of Announcement No. 75 of the Ministry of Agriculture and Rural Affairs.

If re inspection is required, the applicant shall submit the samples for re inspection to the designated veterinary drug inspection agency for re inspection according to the review comments.

The Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall put forward an approval plan according to the review opinions or conclusions, submit it for approval according to the procedures, issue an announcement, and make relevant certificates.

12.2 Certification materials required by the importing country (region);

12.3 Template of veterinary drug export certificate (one export certificate can be used by the same importing country (region) and the same manufacturer);

12.4 Copy of Veterinary Drug GMP Certificate;

12.5 Copy of Veterinary Drug Production License (with relevant certificate information in the application form);

12.6 Copy of approval document of veterinary drug product approval number.

13.2 The Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall review the application for veterinary drug export certificate. After signing according to the procedure, make a decision on whether to issue the veterinary drug export certificate.

2. Regulations on the Administration of Veterinary Drugs (Decree No. 404 of the State Council)

3. Measures for the Examination of Veterinary Drug Advertisements (Order No. 29 of the State Administration for Industry and Commerce and the Ministry of Agriculture)

3. Standards for Examination of Veterinary Drug Advertisements (Order No. 26 of the State Administration for Industry and Commerce)

2. Domestic enterprises that advertise their corporate image shall also provide:

① Business license (copy)

② Veterinary Drug Production License (production enterprise, copy) or Veterinary Drug Business License (operating enterprise, copy)

3. For product advertising, domestic enterprises shall also provide:

① Business License, Veterinary Drug Production License or Veterinary Drug Business License (copy)

② Approval document of veterinary drug product approval number (copy)

③ Legal veterinary drug quality standard (copy)

④ Labels and instructions of veterinary drugs approved by the Ministry of Agriculture and Rural Affairs (sample)

⑤ Other supporting documents involving the authenticity of the content of the advertising sample

⑥ Advertising draft (including text, video, audio and other forms)

4. The advertisements for imported veterinary drugs shall also provide:

① Registration Certificate of Imported Veterinary Drugs or Registration Certificate of Veterinary Drugs (copy)

② Quality standard of imported veterinary drugs (copy)

③ Labels and instructions of veterinary drugs approved by the Ministry of Agriculture and Rural Affairs (sample)

④ Letter of Authorization for Overseas Veterinary Drug Manufacturers to Handle Veterinary Drug Advertisements

⑤ Other documents proving the authenticity of advertisements

⑥ Advertising draft (including text, video, audio and other forms)

⑦ Chinese translation of non Chinese supporting documents

The following supporting materials in the above application materials can be replaced by a written commitment letter (see the annex).

2. When domestic enterprises advertise their corporate image, they provide:

2.1 Copy of business license.

2.2 A copy of the Veterinary Drug Production License or the Veterinary Drug Business License.

3. Domestic enterprises provide:

3.1 Copies of business license, veterinary drug production license or veterinary drug business license.

3.2 Copy of approval document of veterinary drug product approval number.

3.3 Copies of legal veterinary drug quality standards.

3.4 Labels and instructions of veterinary drugs approved by the Ministry of Agriculture and Rural Affairs.

4. The following shall be provided for the advertisement of imported veterinary drugs:

4.1 A copy of the Registration Certificate of Imported Veterinary Drugs or the Registration Certificate of Veterinary Drugs.

4.2 Copies of quality standards for imported veterinary drugs.

4.3 Labels and instructions of veterinary drugs approved by the Ministry of Agriculture and Rural Affairs.

2. Project review. The Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs shall conduct technical examination on the application materials according to relevant national regulations.

3. Handling of approval documents. The Veterinary Bureau of the Ministry of Agriculture and Rural Affairs shall propose an approval plan based on the review opinions, and submit it to the Minister for approval before handling the approval document.