Regulations for Registration of Medicinal Products Article 82
The application for Chinese medicine registration shall pick up the drug license and proceed with drug testing as notified by the central health competent authority; the application for post-approval changes of Chinese medicine registration shall pick up the drug license or proceed with drug testing as notified by the central health competent authority.Upon receipt of the aforesaid notice for picking up the drug license, the applicant shall, within three months, pay the fees and proceed with the following steps:1. Two copies each of the forms for sticking outer boxes, package inserts, and labels that are printed properly shall be provided. For new drugs, three copies each shall be provided.2. The originally approved copies of the forms for sticking outer boxes, package inserts, and labels shall be returned.3. A photocopy of the drug license that was attached to the application shall be returned.If the applicant is required to correct any mistakes contained on the labels, package inserts, packaging, or other related materials submitted for the purpose of picking up the license within a specified deadline, the applicant may pick up the license only after having made corrections within the deadline specified by the central health competent authority.If the applicant applies for any other change after receipt of a notice for picking up the license, the fee for post-approval changes shall be paid again.In the review of a drug license, the competent central health competent authority shall add a supplementary clause, stating that the medicine cannot be launched in the market until it receives the notice of passed the tests; after the drug license has been picked up, the applicant does not follow the regulations to proceed with drug testing, or the sample test results are not consistent with the contents of the application or are disqualified for other reasons, then the central health competent authority shall revoke the drug license and notify the applicant to return the drug license within a specified deadline.
中文原文 藥品查驗登記審查準則第82條
申請中藥查驗登記者，應依中央衛生主管機關通知，領取藥品許可證及送驗；申請中藥查驗登記變更者，應依中央衛生主管機關通知，領取藥品許可證或送驗。
申請人接獲前項領取藥品許可證通知後，應於三個月內繳納費用，並依下列程序辦理：
一、檢附印妥之外盒、仿單及標籤黏貼表各二份，新藥為三份。
二、檢還原附外盒、仿單及標籤黏貼表之核定草本。
三、檢還原附之藥品許可證影本。
申請人於規定期限內辦理領取藥品許可證手續，所檢附之標籤、仿單、包裝或其他相關物品資料有誤而須重新更正刊印，應依中央衛生主管機關通知之期限內更正，始得領取藥品許可證。
申請人收受領取藥品許可證通知後，再次申請變更者，應重新繳納變更審查費。
中央衛生主管機關核定藥品許可證時，應附加附款，敘明應於收受送驗合格通知後，始得上市；申請人領取藥品許可證後，未依規定辦理送驗手續、送驗樣品經檢驗與申請資料不符或其他原因不合格者，中央衛生主管機關應撤銷藥品許可證，並通知限期繳回該藥品許可證。
申請人接獲前項領取藥品許可證通知後，應於三個月內繳納費用，並依下列程序辦理：
一、檢附印妥之外盒、仿單及標籤黏貼表各二份，新藥為三份。
二、檢還原附外盒、仿單及標籤黏貼表之核定草本。
三、檢還原附之藥品許可證影本。
申請人於規定期限內辦理領取藥品許可證手續，所檢附之標籤、仿單、包裝或其他相關物品資料有誤而須重新更正刊印，應依中央衛生主管機關通知之期限內更正，始得領取藥品許可證。
申請人收受領取藥品許可證通知後，再次申請變更者，應重新繳納變更審查費。
中央衛生主管機關核定藥品許可證時，應附加附款，敘明應於收受送驗合格通知後，始得上市；申請人領取藥品許可證後，未依規定辦理送驗手續、送驗樣品經檢驗與申請資料不符或其他原因不合格者，中央衛生主管機關應撤銷藥品許可證，並通知限期繳回該藥品許可證。