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Application documents for Pharmaceutical packaging China NMPA register

Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |



For  Pharmaceutical packaging materials and containers CFDA register, the follow application documents must be collected and submitted to CFDA. Documents must be in both Chinese and original language or English:

1.the producer legal production qualification documents, notarized document and its Chinese translation.
2.Notarized letter of authorization to Chinese SFDA registration agent and copy of its business license or Registration of Rep. Office of Foreign Company
3.Situation of the products production, sale and use in foreign country, reason of desire get SFDA registration.
4.Test reports issued by the SFDA accredited organizations within three batches.
5.clean room (area) cleanliness inspection reports and self-test reports within three batches.
6.the product formula.
7.the production process, the instructions of main production and testing equipment.
8.product quality standards.
9.the stability test data of the packaging with the drug common (drug compatibility test)
10.The floor plan of production factory and clean room (area).




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