Regulations for Registration of Medicinal Products Article 77-1
The maximum quantity for each packaging unit of Chinese medicine products is as follows:1. Tablets, pills, and capsules: No more than 1000 units2. Powders, granules, gels, ointments, and plasters: No more than 1000 grams3. Liquid for internal use, liquid for external use, plasters for internal use, wines, and distillates: No more than 1000 milliliters4. Flakes: No more than 1000 packs5. Medicated patches: No more than 1000 piecesThe minimum packaging size for multiple-dose Chinese medicine products shall be the minimum two-day dosage for adults.For the Chinese medicines concerned in applications for export only, for use by drug companies and food manufacturers as raw materials, or for use by medical institutions and academic organizations, the maximum or minimum packaging quantity shall not be subject to the limitations set forth in the preceding two paragraphs. However, for the products concerned in applications for use by medical institutions, the packaging quantity shall not exceed two times the maximum packaging quantity requirements. If the packaging quantity exceeds twice of the maximum packaging quantity, the certificate of purchase from the medical institutions shall also be attached.Provided that the packaging of Chinese medicines conforms to the requirements set forth in the preceding three paragraphs, manufacturers may, at their own discretion, make adjustments to suit the market needs without filing an application for post-approval changes. If the packaging does not conform to the requirements set forth in the preceding three paragraphs, manufacturers are required to file an application for post-approval changes.
中文原文 藥品查驗登記審查準則第77-1條
中藥之單位包裝最大限量如下：
一、錠劑、丸劑、膠囊劑：一千粒以下。
二、粉劑、散劑、顆粒劑、膠劑、油膏劑、硬膏劑：一千公克以下。
三、內服液劑、外用液劑、膏滋劑、酒劑、露劑：一千毫升以下。
四、碎片劑：一千包以下。
五、藥膠布劑：一千片以下。
中藥多劑量之最小包裝，以成人二日最小用量為準。
申請外銷專用、藥廠及食品製造廠商作為原料使用，或醫療機構及學術團體使用之中藥，其最大或最小包裝數量，不受前二項規定之限制。
但申請供醫療機構使用之藥品包裝，不得超過包裝限量規定之二倍量；超過包裝限量規定之二倍量者，仍應檢附醫療機構訂購證明。
中藥包裝於前三項規定範圍內，廠商得配合市場需要，自行調整，免申請變更登記；前三項規定範圍外之包裝，應申請變更登記。
一、錠劑、丸劑、膠囊劑：一千粒以下。
二、粉劑、散劑、顆粒劑、膠劑、油膏劑、硬膏劑：一千公克以下。
三、內服液劑、外用液劑、膏滋劑、酒劑、露劑：一千毫升以下。
四、碎片劑：一千包以下。
五、藥膠布劑：一千片以下。
中藥多劑量之最小包裝，以成人二日最小用量為準。
申請外銷專用、藥廠及食品製造廠商作為原料使用，或醫療機構及學術團體使用之中藥，其最大或最小包裝數量，不受前二項規定之限制。
但申請供醫療機構使用之藥品包裝，不得超過包裝限量規定之二倍量；超過包裝限量規定之二倍量者，仍應檢附醫療機構訂購證明。
中藥包裝於前三項規定範圍內，廠商得配合市場需要，自行調整，免申請變更登記；前三項規定範圍外之包裝，應申請變更登記。