China NMPA Letter of Authorization (LOA) Request Form
中國國家藥品監督管理局: 藥包材企業授權使用書申請表


For West to provide a Letter of Authorization (LOA) for your application of drug product registration to Center for Drug Evaluation (CDE), please complete West’s on-line LOA request form. Please enter your email address below and click "Next" to proceed to the request form. Please be sure that all information is complete and accurate. Questions marked (*) are mandatory. When you have finished filling out the form, click "Submit". A confirmation email will be sent to you upon successful submission.
如閣下為其藥品制劑向藥品審評中心(CDE)提出注冊申請而需西氏提供藥包材企業授權使用書(LOA), 請填妥西氏在線 LOA 申請表。請于下方輸入您的電子郵件地址, 然后點擊 "下一步" 進入申請表。請務必確定所填信息完整及正確,帶有“*”標示的為必填項目 。當您完成填寫表格后, 請點擊 "提交"。成功提交后, 系統將向您發送確認電子郵件。

In general, your letter of authorization will be issued within 15 business days from the date of request via email.?If the item requires an update to include the correct internal control strategy and compliance statement for the China market, your request will take approximately 10-15 weeks to process. To avoid any delay, we suggest you to plan ahead and apply for LOA at least four months prior to your application of drug product registration. If you are unsure whether your item requires an update or any other questions about an item update, please contact your Account Manager or Technical Customer Support.
一般情況下, 您的授權使用書將在收到申請之日起15個工作日內通過電子郵件發出。如果該產品需要更新以包含針對中國市場的正確內部控制策略和合規聲明,您的申請辦理時間則需大約 10-15 周。為避免任何延誤,我們建議您提前計劃并至少在藥品注冊申請前四個月提出授權使用書申請。如果您不確定您的商品是否需要更新或對產品更新有任何其他疑問,請聯系您的客戶經理或技術客戶支持。

For assistance locating West item number, click?here.
如果需要協助尋找西氏產品代號,請點擊此處。

For issues or questions regarding this form, please contact: China.LOARequests@westpharma.com
如果對此表格有任何問題或疑問,請聯系China.LOARequests@westpharma.com

 

LOA CN

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