Regulations Governing Reviewing Procedure of Drug Injury Review Committee of Ministry of Health and Welfare Article 4

When the Review Committee believes documents from the applicant are incomplete and can be fulfilled or require an applicant to submit interpretation or evidence, the competent authority, other commissioned authority (institution) or organization may inform the applicant to fulfill the requirements within 15 days after receiving the notice. The application shall be rejected if the required documents did not submit before the expiration date or the documents are still not fulfilling the requirements.If there is a legitimate reason with submitting the required documents mentioned in the preceding paragraph, the applicant may apply for an extension for document submission before the expiration date, however, the extension period shall not be over 15 days and may be applied only once.