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總局關于停止進口瑞士OM Pharma SA 細菌溶解產物膠囊的公告(2017年第30號)

發布時間:2017-03-27 13:58:24 發布人:湖南楚濟堂

2017年0320 發布 


       國家食品藥品監督管理總局組織對瑞士OM Pharma SA的細菌溶解物膠囊(商品名:泛福舒)生產現場檢查。檢查發現該品種的發酵工藝變更、發酵條件變更、裂解步驟混合工藝變更未按照《藥品注冊管理辦法》附件4的規定申報,不符合《藥品生產質量管理規范》第一百八十四條的要求;違反了《中華人民共和國藥品管理法》第九條、《藥品注冊管理辦法》第八十四條第二款的規定。國家食品藥品監督管理總局決定停止瑞士OM Pharma SA的細菌溶解物膠囊進口,要求各口岸食品藥品監督管理局停止瑞士OM Pharma SA細菌溶解物膠囊的進口通關備案。

  特此公告。


                                



                                                                                                                                                                                            食品藥品監管總局

                                                                                                                                                                                              2017年3月13

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