FAQ
Drugs

What types of administrative documents should be authenticated by R.O.C. (Taiwan) Foreign Affairs Offices for the application of an imported API registration?

刊登日期:2020-07-22  |  點閱次數 : 864 次 

The GMP-related certificates are valid for two years from the issuance date, and the original or a copy document should be authenticated by the embassies, representative offices or agencies authorized by the Ministry of Foreign Affairs of R.O.C (Taiwan). The authentication requirement is waived for documents issued by the A10 countries. If the GMP-related certificates can be checked from the official website, the authentication could be exempted. If applicants submit a copy document, an affidavit from the API manufacturer should be provided to state the photocopy is the same as the original one.

 

(中文版)


上一筆 If the submitting drug substance with two or more crystalline hydrate formulas, s
下一筆 Should GMP certificates be required for the registration of an API?