<
The State Drug Administration strengthens the entrustment and management of processing drugs entrusted by overseas pharmaceutical manufacturers
Release time: 2011-08-15 & nbsp & nbsp & nbsp Source:

July 26,The State Food and Drug Administration issued a notice,To strengthen the supervision and management of processed drugs entrusted by overseas pharmaceutical manufacturers,Strictly stake online sports bettingstake betting appregulates the requirements of the commissioned processing behavior to make clear requirements。


Notification to point out,The provincial food and drug supervision and management departments must effectively strengthen the registration management of pharmaceutical manufacturers in the area to accept overseas pharmaceutical manufacturers,Strict review and accepting processed drug filing information entrusted by overseas pharmaceutical manufacturers。The client must be an overseas pharmaceutical manufacturer,And holding the drug abroad,and must sign a processing contract directly with my pharmaceutical manufacturer。The authenticity and legitimacy of the document document of its drug listing permits are suspicious,It should be required to provide the commissioner to provide our country to the country、Certification documents issued by the consulate。The external label or instructions of the trustee processing drug preparation must be marked with the name and address of the trustee processing enterprise,But there must be no approval number of Chinese medicines、Stake Sports BettingStake Sports BettingImported Drug Registration Certificate Number、Entrusted processing filing number and other content。Drug manufacturers shall not accept the entrustment of processed nude packaging preparations for overseas pharmaceutical manufacturers,The finished product should be completed after processing,and labels with the name of the drug and the name of the trusted processing enterprise。If a multinational company and other companies entrust internal commission to process nude packaging preparations,Relevant certification documents issued by overseas drug management authorities should be provided。


Notification emphasis,Provincial food and drug supervision and management departments shall do a good job of filing in accordance with regulations,Application for filing that does not meet the requirements,It shall be informed that the enterprise will not be recorded and reasons for their reasons,Inform the relevant food and drug supervision and management department。Production site inspections should include whether the enterprise strictly follows the registration stake betting appstake sports betting appof the processing process、Prescription、Craft、Quality and label descriptions and other requirements,Whether to organize production in accordance with the "Regulations on the Management of Drug Production Quality Management"。For the annual processing of all year -round processing,A measures such as regular reports should be taken to strengthen supervision and management。In the supervision and inspection, if it is found that it is found without the filing, it will be entrusted without authorization、​​Change the processing location or technical requirements of the recorded processing、Do not follow the behavior of "Specifications for the Management of Drug Production Quality",It must be ordered to correct it immediately,and deal with the "Measures for the Supervision and Management of Drug Production" and relevant regulations。