Regulations for Registration of Medicinal Products Article 83
After an applicant receives a drug testing notice as set forth in the first paragraph of the preceding article, the applicant shall pay the fees and submit three portions of raw materials and a drug sample test form before the deadline. The deadline for drug testing shall be within 30 days for domestic Chinese medicines and within three months for imported Chinese medicines.When necessary, the central competent health authority may order the applicant to provide three portions of drug samples or an appropriate quantity of reference standards.The three portions mentioned in the preceding two paragraphs shall refer to a quantity sufficient for carrying out three tests.If the central competent health authority deems it necessary to re-test a tested Chinese medicine product, the applicant shall pay the fees again.Article 29 shall apply mutatis mutandis to the matters that the applicant shall comply with when proceeding with drug testing.
中文原文 藥品查驗登記審查準則第83條
申請人接獲前條第一項送驗通知後，應於期限內繳納費用，並檢附原料藥材三份及藥物樣品檢驗遞送表送驗。
送驗期限，國產中藥為三十日，輸入中藥為三個月。
中央衛生主管機關於必要時，得令其提供藥物樣品三份或適量對照標準品。
前二項所稱三份，指足夠三次檢驗之數量。
中藥檢驗案件經中央衛生主管機關認定應重新檢驗者，申請人應再繳納費用。
申請人送驗時，應遵守之相關事項，準用第二十九條規定。
送驗期限，國產中藥為三十日，輸入中藥為三個月。
中央衛生主管機關於必要時，得令其提供藥物樣品三份或適量對照標準品。
前二項所稱三份，指足夠三次檢驗之數量。
中藥檢驗案件經中央衛生主管機關認定應重新檢驗者，申請人應再繳納費用。
申請人送驗時，應遵守之相關事項，準用第二十九條規定。