Regulations on the administration of veterinary drugs

Introduction: Chapter I General Provisions Article 1 These Regulations are formulated for the purpose of strengthening the administration of veterinary drugs, ensuring the quality of veterinary drugs, preventing and treating animal diseases, promoting the development of breeding industry and safeguarding human health Article 2 These Regulations shall be observed in the development, production, operation, import and export, use, supervision and administration of veterinary drugs within the territory of the people's Republic of China Article 3 the administrative department for veterinary medicine under the State Council shall be responsible for the supervision and administration of veterinary drugs throughout the country The administrative department for veterinary medicine of the local people's government at or above the county level shall be responsible for the supervision and administration of veterinary drugs within its own administrative area Article 4 the State shall implement a system for the classified management of veterinary prescription drugs and over-the-counter drugs The measures for the classified administration of veterinary prescription drugs and over-the-counter drugs and the specific steps for their implementation shall be formulated by the administrative department for veterinary medicine under the State Council Article 5 the State practices a reserve system for veterinary drugs In the event of a major animal epidemic, disaster or other emergency, the administrative department for veterinary medicine under the State Council may urgently transfer veterinary drugs stored by the state; when necessary, they may also transfer veterinary drugs other than those stored by the state Article 6 the State encourages the development of new veterinary drugs and protects the legitimate rights and interests of developers in accordance with law Article 7 in the development of new veterinary drugs, there shall be suitable places, instruments and equipment, professional and technical personnel, safety management norms and measures In the development of new veterinary drugs, safety evaluation should be carried out Units engaged in the safety evaluation of veterinary drugs shall be recognized by the administrative department for veterinary medicine under the State Council, and shall abide by the quality management standards for non clinical research and clinical trials of veterinary drugs Article 8 For the development of a new veterinary drug, an application shall be submitted to the veterinary administrative department of the people's Government of the province, autonomous region or municipality directly under the central government prior to the clinical trial, with the phase safety evaluation report of the new veterinary drug laboratory and other preclinical research materials attached; the veterinary administrative department of the people's Government of the province, autonomous region or municipality directly under the central government shall, within 60 working days from the date of receiving the application, make a written examination result Notify the applicant Where a new veterinary drug developed belongs to a biological product, an application shall be submitted to the administrative department for veterinary medicine under the State Council before the clinical trial, and the administrative department for veterinary medicine under the State Council shall, within 60 working days from the date of receiving the application, notify the applicant in writing of the results of the examination In the development of new veterinary drugs, the use of a class of pathogenic microorganisms shall also meet the requirements prescribed by the administrative department for veterinary medicine under the State Council, and shall be submitted to the administrative department for veterinary medicine under the State Council for approval before the laboratory stage Article 9 after the completion of clinical trials, when applying for registration of new veterinary drugs to the administrative department for veterinary medicine under the State Council, the developer of new veterinary drugs shall submit samples of the new veterinary drugs and the following information: (1) name, main ingredients, physical and chemical properties; (2) development method, production process, quality standard and testing method; (3) pharmacological and toxicological test results, clinical test reports and stability test reports; (4) environmental impact reports and pollution prevention and control measures If the new veterinary medicine developed belongs to biological products, it shall also provide the relevant materials and materials such as bacteria (toxin, insect) species, cells, etc Bacteria (poisons, worms) and cells shall be preserved by institutions designated by the administrative department for veterinary medicine under the State Council For the development of new veterinary drugs for edible animals, the veterinary drug residue test shall be carried out in accordance with the provisions of the veterinary administrative department under the State Council, and the rest period, the maximum residue limit standard, the residue detection method and the basis for formulation shall be provided The administrative department for veterinary medicine under the State Council shall, within 10 working days from the date of receiving the application, send the new veterinary drug materials to the veterinary drug review institution established by it for review, send the new veterinary drug samples to the inspection institution designated by it for review and inspection, and complete the review within 60 working days from the date of receiving the review and review and inspection conclusion If it passes the examination, it shall issue a new veterinary drug registration certificate and issue the quality standard of the veterinary drug; if it fails to pass the examination, it shall notify the applicant in writing Article 10 the State shall protect the test data and other data obtained and not disclosed by the applicant for the veterinary drugs registered according to law and containing new compounds Within 6 years from the date of registration, if other applicants apply for registration of veterinary drugs by using the data specified in the preceding paragraph without the consent of the applicant who has already obtained the registration of veterinary drugs, the veterinary drug registration authority shall not register, except that other applicants submit their own data Except for the following circumstances, the veterinary drug registration authority shall not disclose the data specified in the first paragraph of this article: (1) the public interest needs; (2) measures have been taken to ensure that such information will not be improperly used for commercial purposes Chapter III production of veterinary drugs Article 11 the establishment of an enterprise producing veterinary drugs shall conform to the development plan and industrial policy of the state for the veterinary medicine industry, and shall meet the following conditions: (1) the technical personnel of veterinary medicine, pharmacy or other relevant specialties suitable for the veterinary drugs produced; (2) the factory buildings and facilities suitable for the veterinary drugs produced; (3) the institutions, personnel, instruments and equipment for quality management and quality inspection of veterinary drugs that are suitable for the veterinary drugs produced; (4) the production environment that meets the requirements of safety and health; and (5) other production conditions specified in the production quality management specifications for veterinary drugs The applicant may apply to the veterinary administrative department of the people's Government of the province, autonomous region or municipality directly under the central government only if it meets the conditions prescribed in the preceding paragraph, and attach the certification materials that meet the conditions prescribed in the preceding paragraph; the veterinary administrative department of the people's Government of the province, autonomous region or municipality directly under the central government shall, within 20 working days from the date of receiving the application, submit the examination opinions and relevant materials to the State Council Medical administration department The administrative department for veterinary medicine under the State Council shall complete the examination within 40 working days from the date of receiving the examination opinions and relevant materials If it passes the examination, it shall issue a veterinary drug production license; if it fails to pass the examination, it shall notify the applicant in writing The applicant shall go through the industrial and commercial registration formalities with the veterinary drug production license Article 12 the production license of veterinary drugs shall specify the scope of production, place of production, period of validity, name and address of the legal representative, etc The period of validity of veterinary drug production license is 5 years If it is necessary to continue the production of veterinary drugs at the expiration of the period of validity, it shall apply to the original license issuing authority for the renewal of the veterinary drug production license six months before the expiration of the period of validity of the license Article 13 Where an animal medicine production enterprise changes its scope of production or place of production, it shall apply for the renewal of the animal medicine production license in accordance with the provisions of Article 11 of these regulations, and the applicant shall go through the formalities of industrial and commercial change registration with the renewed animal medicine production license; where the enterprise name or legal representative is changed, it shall apply to the original license issuing authority for renewal within 15 working days after going through the formalities of industrial and commercial change registration Veterinary drug production license Article 14 the production enterprises of veterinary drugs shall organize production in accordance with the quality control standards for veterinary drug production formulated by the administrative department for veterinary medicine under the State Council The administrative department for veterinary medicine under the State Council shall supervise and inspect whether the production enterprises of veterinary drugs meet the requirements of the standards for the quality control of veterinary drug production, and publish the inspection results Article 15 for the production of veterinary drugs, an enterprise producing veterinary drugs shall obtain the product approval number issued by the administrative department for veterinary medicine under the State Council, which shall be valid for five years Measures for the issuance of approval numbers of veterinary drug products shall be formulated by the administrative department for veterinary medicine under the State Council Article 16 An enterprise producing veterinary drugs shall carry out production in accordance with the national standards for veterinary drugs and the production process approved by the administrative department for veterinary medicine under the State Council Where an enterprise engaged in the production of veterinary drugs changes the production process affecting the quality of veterinary drugs, it shall report to the original approving department for examination and approval The veterinary drug production enterprise shall establish production records, which shall be complete and accurate Article 17 the raw materials and auxiliary materials needed for the production of veterinary drugs shall meet the national standards or the quality requirements of the veterinary drugs produced Packaging materials and containers in direct contact with veterinary drugs shall meet the pharmaceutical requirements Article 18 veterinary drugs shall pass the quality inspection before leaving the factory, and those that do not meet the quality standards shall not leave the factory Veterinary drugs shall be accompanied by a product quality certificate before they leave the factory It is forbidden to produce fake or inferior veterinary drugs Article 19 before leaving the factory, each batch of veterinary biological products produced by veterinary drug manufacturing enterprises shall be examined and verified by the inspection institution designated by the veterinary administrative department under the State Council, and spot checked and inspected when necessary Those products that have not been examined and verified or fail to pass the spot check and inspection shall not be sold Biological products for animal use for compulsory immunization shall be produced by enterprises designated by the administrative department for veterinary medicine under the State Council Article 20 the packaging of veterinary drugs shall be printed or pasted with labels and instructions in accordance with the regulations, and the words "for veterinary use" shall be indicated in a prominent position The labels and instructions of veterinary drugs shall not be used until they are approved and published by the administrative department for veterinary medicine under the State Council The labels or instructions of veterinary drugs shall indicate in Chinese the general name, composition, content, specification, manufacturer, product approval number (registration number of imported veterinary drugs), product batch number, production date, validity period, indications or function indications, usage, dosage, off drug period, taboo, adverse reactions, precautions, transportation, storage and storage conditions of veterinary drugs and Other contents to be explained Where there is a commodity name, the commodity name shall also be indicated In addition to the contents specified in the preceding paragraph, the labels or instructions of veterinary prescription drugs shall also be printed with the warning contents specified by the administrative department for veterinary medicine under the State Council, among which the veterinary narcotic drugs, psychotropic drugs, toxic drugs and radioactive drugs shall also be printed with the special marks specified by the administrative department for veterinary medicine under the State Council; the labels or instructions of veterinary non prescription drugs shall also be printed with the warning contents specified by the administrative department for veterinary medicine under the State Council Signs of over-the-counter drugs prescribed by the administrative department for veterinary medicine under the State Council Article 21 the administrative department for veterinary medicine under the State Council may, in accordance with the need to ensure the quality and safety of animal products and human health, establish a monitoring period of not more than five years for new veterinary drugs; during the monitoring period, no other enterprise may be approved to produce or import the new veterinary drugs The production enterprise shall, within the monitoring period, collect the efficacy, adverse reactions and other data of the new veterinary drug, and submit them to the administrative department for veterinary medicine under the State Council in a timely manner Article 22 An enterprise engaged in the management of veterinary drugs shall meet the following requirements: (1) technical personnel of veterinary drugs suitable for the veterinary drugs it operates; (2) business premises, equipment and warehouse facilities suitable for the veterinary drugs it operates; (3) quality management organizations or personnel suitable for the veterinary drugs it operates; (4) other business conditions specified in the quality management standards for veterinary drug business The applicant may apply to the veterinary administrative department of the people's government at the city or county level only if it meets the conditions prescribed in the preceding paragraph, and attach the certification materials that meet the conditions prescribed in the preceding paragraph; the applicant who deals in biological products for animal use shall apply to the veterinary administrative department of the people's government at the province, autonomous region or municipality directly under the central government, and attach the certification materials that meet the conditions prescribed in the preceding paragraph Animals of local people's governments at or above the county level