Regulations for Registration of Medicinal Products｜第 3 條｜Food and Drug Administration｜Regulation｜In Force
第 一 章｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
For the registration items mentioned in the preceding article, the applicant should pay the application fees and submit completed application forms and all required dossiers to the central health competent authority for assessment. The above-mentioned application forms and documents include those for drug review and registration, post-approval changes, extension of validity of drug license, assurance statement, sticking label and package insert, sticking licenses and certificates, and other forms and documents in relation to the application procedure. “Chinese language” in the Regulations denotes traditional Chinese. For forms and documents requiring Chinese language, please provide information in traditional Chinese characters or documents with translations in traditional Chinese characters. The license holder may retain the original certificates for future inspection when submitting an application via the electronic submission platform an electronic system, but needs to submit the original drug license to the central health competent authority to have the approval status marked on the license.