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什么意思?a CEP or a ASMF or a Letter of Access ailable?

4位顾问回复201人看过

is for your product a CEP or a ASMF or a Letter of Access ailable?


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Julia
Julia服务年限:3客户评分:5.0

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CEP (Certificate of European Pharmacopoeia) ASMF (Active Substance Master File) and Letter of Access are all related to the registration and approval process for pharmaceutical products in the European Union (EU).

A CEP is a document issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of the pharmaceutical substance with the European Pharmacopoeia. It provides information about the quality, safety, and purity of the substance.

An ASMF, also known as a Drug Master File (DMF), is a confidential document that contains detailed information about the manufacturing process, quality control, and stability data of the active substance. It is submitted by the manufacturer to the regulatory authorities as part of the drug approval process.

A Letter of Access is a document issued by the owner of a CEP or ASMF, granting access to the information contained in those files. It allows a pharmaceutical company to refer to the CEP or ASMF during their own product registration process without revealing the confidential information.

If you are inquiring about the availability of a CEP, ASMF, or Letter of Access for a specific product, you may need to contact the manufacturer or supplier directly to obtain this information.

Catherine
Catherine服务年限:10客户评分:5.0

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二楼整的很明白了,最好楼主发个整句或者前后文,大家就好参谋了

Olivia
Olivia服务年限:10客户评分:5.0

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不知道呢,,,,查了些资料,好像确实是什么认证之类的

Emma
Emma服务年限:3客户评分:5.0

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ASMF=European Drug Master File

CEP没查到,客户应该是要你们产品出口欧洲的相关准入文件吧

就像电器需要CEGS一样,食品药品类的需要这几个相关认证

详细的当地的证机构,他们应该更专业一点

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