The approval Letter of Supplementary application and a drug approval number will be issued for qualified application.
符合规定的,发给《药品补充申请批件》及药品批准文号。
Methods: the quality management were strengthened through three measures: quality standard, drug approval number and GMP management.
方法:从中药饮片的质量标准、批准文号管理和GMP管理三方面来加强中药饮片的质量管理。
In case the transferor did not obtain a drug approval number, the reference drug shall be selected in accordance with the drug Registration Regulation and relevant technical guidelines.
转让方仅获得《新药证书》的,对照药品的选择应当按照《药品注册管理办法》的规定及有关技术指导原则执行。
A drug manufacturer may produce the drug only after an approval number is granted to it.
药品生产企业在取得药品批准文号后,方可生产该药品。
A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it.
药品生产企业在取得药品批准文号后,方可生产该药品。
This takes account of the number of countries in which a company wins approval for a new drug, weighted by the size of each country's market.
这考虑到了允许一家公司的新药在本国上市的国家的数量,并依照每个国家的市场规模权衡其重要性。
Article 4 the Ministry of Agriculture shall be responsible for the work of issuing and supervising the approval document number of veterinary drug products of the whole country.
第三条兽药生产企业生产兽药,应当取得农业部核发的产品批准文号。
Article 3 a veterinary drug production enterprise shall obtain the product approval document number as is issued by the Ministry of Agriculture for the production of veterinary drugs.
第三条兽药生产企业生产兽药,应当取得农业部核发的产品批准文号。
Article 2 the present Measures shall be applicable to the application for, issue of and supervision over the approval document number of veterinary drug products.
第二条兽药产品批准文号的申请、核发和监督管理适用本办法。
Article 2 the present Measures shall be applicable to the application for, issue of and supervision over the approval document number of veterinary drug products.
第二条兽药产品批准文号的申请、核发和监督管理适用本办法。
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