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Certification Documents need for chemical drugs SFDA Registration

 

A. CPP(Certificate of a Pharmaceutical Product)

If a CPP (Certificate of a Pharmaceutical Product) is available, you should provide it.

This document should be issued by competent authorities/agency of the country or region where the manufacturer located in, and this document should comply with the recommended format by World Health Organization.

The so-called recommended format regulated by World Health Organization, see the following webpage: (www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/modelbatch/en)

If the CPP is unavailable, but your product is filed in FDA and obtained a DMF (Drug Master File) number, DMF can be provided as a substituted document for CPP.

If the CPP is unavailable, or the issued CPP failure to meet the WHO?ˉs format, or the DMF is unavailable, the substituted documents in other format must be provided include the contents as follows:

a)       Documents which certify that the imported product is licensed to be on the market of the exporting country or region, which is issued by competent authorities/agency of the country or region where the manufacturer located in, for example, FSC(Free Sale Certificate).

b)       Documents which certify that the facilities and operations conform to GMP(Good Manufacturing Practices) , which is issued by competent authorities/agency of the country or region where the manufacturer located in, for example, GMP Certificate.

c)       Documents which certify that the manufacturer is legally registered in the exporting country or region, which is issued by competent authorities/agency of the country or region where the manufacturer located in;

d)       The Chinese translations and the notarization/legalization documents of above documents, the notarized/legalized documents should be issued by competent local notarizing agency (e.g. court or law office);

e)       The authentication/consularization documents of above notarized/legalized documents which should be issued by the Chinese embassy in the exporting country.

Note: Notarization/Legalization means local notarizing agency certify that the documents have legal-validation.

Authentication/Consularization means Chinese embassy identify the local notarizing agency is competent.

B. Letter of Authorization

Chinese translations of the letter, notarized/legalized documents of the letter, and authenticated/consularized documents of above notarized/legalized documents.

C. Statement of Patent Status and Ownership

Certification Documents stating patent status and ownership of this entity and formulation, manufacturing process of the product, and letter of guarantee stating that no infringement upon the patent rights of others.

This document is not limited in format and content, but the following contents should be included:

a)       Description of the patent status (domestic and international) on product, production and usage£?

b)       Declare that non patent & intellectual property infringement involved in this application;

c)       If the patent & intellectual property infringement involved, the applicant assume the responsibility.

 

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