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 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.
符合规定的,发给《药品补充申请批件》及药品批准文号。
The approval Letter of Supplementary application and a drug approval number will be issued for qualified application.
转让前已取得药品批准文号的,应同时注销转让方原药品批准文号。
For drugs having obtained drug approval Numbers before the technical transfer, the original drug approval Numbers issued to the transferor shall be written off simultaneously.
对于仅持有《新药证书》,但未取得药品批准文号的新药技术转让,转让方应当为《新药证书》所有署名单位。
For drugs with new drug certificates but without drug approval numbers, the transferor shall be all the holders of the new drug certificates.
对于持有药品批准文号的,应当同时提交持有药品批准文号的药品生产企业提出注销所转让品种药品批准文号的申请。
For drugs with drug approval Numbers, the application of writing off the original drug approval Numbers by the holders shall be submitted simultaneously.
对于持有药品批准文号的,应当同时提交持有药品批准文号的药品生产企业提出注销所转让品种药品批准文号的申请。
For drugs with drug approval Numbers, the application of writing off the original drug approval Numbers by the holders shall be submitted simultaneously.
应用推荐