Animal Genetic Materials Production License Options

Original Language Title: 家畜遗传材料生产许可办法

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Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/201007/20100700259032.shtml

Animal genetic materials production license options

    (January 21, 2010 Ministry of agriculture promulgated as of March 1, 2010, 2010 5th) Chapter I General provisions

    First to enhance livestock frozen semen, embryos, ova and other genetic material (hereinafter referred to as animal genetic material) production management, in accordance with the People's Republic of China Law on animal husbandry, these measures are formulated.

    Second freezing semen in these measures refers to the Cryopreservation of animal semen.

    Embryo in these measures, refers to artificial methods of early embryo in livestock, including embryos in vivo and in vitro fertilization embryos.

    Eggs are mentioned in these measures refers to female oocytes of ovaries, including oocytes cultured in vitro.

    Third production of units and individuals engaged in animal genetic materials, shall, in accordance with the access to the livestock and poultry production and operation license issued by the Ministry of agriculture.

    Chapter II Declaration

    Fourth production of units and individuals engaged in animal genetic materials, subject to the following conditions:

    (A) fitting in with the production scale of animal husbandry, breeding, treatment site and animal genetic material production, quality inspection, storage, file management sites; (B) commensurate with the scale of production of livestock and genetic material for production, testing, preservation, transport and other facilities and equipment.

    Which, production frozen semen should equipped with sperm density determination instrument, and difference microscope, and analysis balance, and fine tube semen points installed, and fine tube printing Word machine, and semen frozen program instrument, and low temperature balance Cabinet, and ultra-low temperature storage equipment, instrument equipment; production embryos and egg should equipped with Super NET Taiwan or clean between, and body depending on microscope, and ultra-low temperature storage equipment,, production body outside embryos also should equipped with carbon dioxide training box, instrument equipment;

    (C) the breeding stock for verification or identification of the animal genetic resources through the National Committee or to the Ministry of Agriculture approved the introduction of foreign species, and to comply with such standards;

    (D) in vitro fertilized embryos, using eggs made from clear, clear three generation pedigree, for the livestock in line with national animal health standards and quality requirements; (E) the keeping breeding livestock reach number prescribed by the Ministry of agriculture.

    Which, production cattle frozen semen of qualified mining fine species Bull number many Yu 30 head, production sheep frozen semen of qualified mining fine species Rams number many Yu 50 only; production cattle embryos of level above based cow many Yu 200 head, production sheep embryos of level above based Ewe many Yu 300 only; production cattle egg of level above based cow many Yu 100 head, production sheep egg of level above based Ewe many Yu 200 only; other livestock varieties of breeding stock feeding number by Ministry of agriculture separately provides; (Vi) above 5 animal husbandry and veterinary technicians.

    The main technical director should have the animal husbandry and veterinary medicine senior technical titles or Bachelor degree, and more than 5 years working in our professional; product quality inspection personnel should possess more than mid-level titles and training; junior titles or a college education should account for the number of technicians and technicians total more than 80%; with licensed veterinarians to provide clinic services;

    (G) epidemic prevention prescribed by law, administrative regulations and Department of agriculture;

    (H) establish appropriate administrative rules and regulations, including responsibility, product quality control and safeguards system, production and sales records.

    Fifth applied for licensing of animal genetic material, it should be submitted to the provincial animal husbandry and veterinary Administrative Department under, and submit the following materials:

    (A) the application form;

    (Ii) explanatory material production conditions;

    (C) animal genetic materials for the original copy of pedigree livestock from imported breeding stock and genetic material should also provide a copy of the approval of the Ministry of agriculture; production of eggs, embryos should also provide proof of source of donor animals; Holstein Bull should also be submitted to the China dairy industry association and its progeny from recognized organizations;

    (D) the equipment test report;

    (E) technician certificate or copy of certificate of qualification and training;

    (Vi) copies of animal epidemic prevention certification;

    (G) the feeding, breeding, production, quality inspection, storage and management systems;

    (H) applications for renewal of animal genetic materials production license, animal genetic material should be provided in the last three years of production and sales situation;

    (IX) other technical materials stipulated by the Ministry of agriculture.

    Application materials are incomplete or do not comply with the statutory format, the provincial animal husbandry and veterinary Administrative Department under the spot or within 5 working days from the date of receipt of application materials, inform all applicants need to supplement the content at a time.

    Sixth provincial animal husbandry and veterinary administrative departments shall be completed within 30 working days from the date of receipt of the application review and audit observations, and the relevant material submitted to the Ministry of agriculture.

    Article seventh Ministry of agriculture within 10 working days from the date of receipt of the application to complete written review, through a written examination, expert on-site review.

    Chapter site assessment Eighth on-site review the group accountability system into practice.

    5 or more of the Group of experts designated by the Ministry of agriculture animal husbandry and veterinary professional personnel with senior professional titles, and singular number.

    Team leader is responsible for site assessment call, organize and summarize site assessment work.

    Nineth expert groups should be on animal genetic materials production sites and layouts, instruments and equipment, vaccination and other basic conditions for review.

    Tenth Group of experts should be based on domestic animals breeding standards on Cryopreservation of livestock semen and embryos, egg donor evaluation of each animal.

    11th specialist technicians should be sets of related laws and regulations, production procedures, product standards and other knowledge of theory examination; livestock frozen semen, embryos, ova complete production processes of assessment, and randomly choose 3 or more key technical staff related to the actual examination.

    12th group should be spot checks of more than 30% instruments and equipment, equipment performance and resolution, good condition, procedures, records, test to verify the content.

    13th the applicant shall under the supervision of the group, each donor animal production of frozen semen, 3% donor animal embryos and eggs produced by random sampling sequestration, sent breeding livestock and poultry quality inspection agencies with statutory qualification testing.

    Article 14th after the on-site review is complete, the Group of experts should be a written review comments, signed by the members of the Group of experts confirmed.

    Review submissions include the following:

    (A) verification of declared materials;

    (B) essential findings;

    (C) donor evaluation of animal genetic materials;

    (D) the technical theory and practical assessment results;

    (E) animal husbandry, breeding and genetic material production, quality control, quality inspection, implementation of the regulations.

    Review comments in duplicate, save the hand a copy to the applicant, a Department of agriculture.

    15th site assessment shall review in writing within 40 working days from the date of adoption is complete.

    The fourth chapter approval and supervision Receipt of the on-site review 16th Department of agriculture and animal genetic material within 10 working days after the quality inspection report, decides whether to grant the permit for livestock and poultry production and management.

    Not to be granted, inform the applicant in writing and state the reasons.

    17th under any of the following circumstances, not to be granted the livestock and poultry production and operation license:

    (A) failed to pass the site assessment;

    (B) for livestock frozen semen quality of qualified number lower than the provisions of this article fourth fifth;

    (C) the total of embryos or eggs failed to pass the quality test.

    18th issued by the Ministry of agriculture in the production of frozen semen of domestic animals of the species of livestock and poultry production and operation license at the same time, announced qualified number of donor animals. Livestock frozen semen production units and individuals within the validity of the license count of donor animals shall promptly declare to the Department of agriculture.

    Organization of the donor in accordance with these measures the Ministry of agriculture livestock on-site review and frozen semen quality, meet the required conditions of announced donor animal numbers.

    Without the announced number of donor animals, shall not be put into production. Production units and individuals should promptly eliminate unqualified frozen semen donor animals.

    Refused to phase out, published by the Department of agriculture are not qualified for livestock numbers, and will be punished according to law. Article 19th Ministry of agriculture animal genetic materials issued by the livestock and poultry production and operation license valid for 3 years.

    Expires to continue with animal genetic material, the applicant shall permit expires 5 months ago, reapply in accordance with these measures.

    Article 20th animal genetic materials has been made of the livestock and poultry production and operation license units and individuals, when they apply for expanding the scope of animal genetic materials, the Department of agriculture can organize the site the link appropriate simplifying related procedures.

    21st animal husbandry and veterinary administrative departments of people's Governments above the county level shall implement supervision on animal genetic material production activities checks and quality checks, for violation of these measures of animal genetic material production activities, in accordance with the People's Republic of China animal husbandry and the relevant provisions of the Act.

    The fifth chapter by-laws

    22nd article does not engage in animal genetic materials, units and individuals engaged in business activities only, shall, in accordance with the provisions of provincial-level people's Governments make the breeding livestock and poultry production and operation license. 23rd these measures shall come into force on March 1, 2010. November 5, 1998 issued by the Ministry of agriculture livestock and poultry production and management management of license (Ministry of agriculture, 4th) repealed simultaneously.