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日前,北京市药品监督管理局向市各药品生产企业、各区县药监分局转发了国家药品监督管理局《关于药品包装标签和说明书使用期限的公告》(国药监注[2002]156号)的通知。通知中指出: 一、药品的包装、标签和说明书须符合第23号国家局局令的规定,药品生产企业应在批准文号换发通知后6个月内完成新旧包装、标签和说明书的更换工作。在批准文号换发6个月后生产药品不得再使用原包装、标签和说明书,此前已进入流通领域的药品,可在其有效期内继续流通、使用。 二、进口药品的包装、标签、说明书及注册证号格式,在换发《进口药品注册证》时一并更换,已进入流通领域的药品,可在其有
Recently, Beijing Municipal Bureau of Drug Administration to the city’s pharmaceutical manufacturers, the district Drug Administration Branch forwarded the State Drug Administration “on the label of pharmaceutical packaging and the use of the term notice” (State Drug Regulatory Notice [2002] 156) announcement of. The notice states: 1. The packaging, labeling and instructions of the drug shall comply with the requirements of the State Bureau Decree No.23. The pharmaceutical manufacturer shall complete the replacement of old and new packaging, labels and instruction manuals within 6 months after the notification of the approval number is renewed jobs. After the approval number is renewed for 6 months, the original medicines, labels and manuals for the production of drugs can not be used any more. Drugs that have entered the circulation field before may be continuously circulated and used within the validity period. Second, the packaging of imported drugs, labeling, manuals and registration number format, in the renewal of the “Import Drug Registration Certificate,” be replaced, have entered the circulation of drugs, in its