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近年来,由于进口药品大量进入国内医药市场,一些假冒进口药品、走私药品和未经口岸药品检验所检验的药品也混杂其中。因此,确认进口药品的合法性就成为药品生产、经营、使用者及药品监督管理部门共同关心和重视的问题。 一、确认进口药品的身份是否合法 1999年5月1日起实施的《进口药品管理办法》明确规定:国家对进口药品实行注册审批制度、检验制度和对国外企业实行监督检查制度。
In recent years, as a large number of imported drugs have entered the domestic pharmaceutical market, some counterfeit imported drugs, smuggled drugs and drugs tested without the port drug inspection are also mixed. Therefore, to confirm the legality of imported drugs has become a common concern and attention to the pharmaceutical production, management, users and drug regulatory agencies. First, to confirm whether the identity of imported drugs is valid May 1, 1999 implementation of the “Import Drug Regulations” clearly states: the state of imported drugs to implement the registration examination and approval system, the inspection system and the implementation of supervision and inspection of foreign enterprises inspection system.