Fees/Service Charges for Licences and Certificates of Chinese Proprietary Medicines 中成药执照及证书收费
Effective Date: 1 February 2007 （实行日期：2007年2月1日）
Note: The licences/certificates are issued with 1-year validity unless otherwise stated.
注：除非另有规定，执照/证书的有效期为一年。
1. | IMPORT LICENCE 进口商执照 | ||
(1) | Application for a licence 申请费 | $500 | |
(2) | Licence for — 执照费 — | ||
(a) the first year 第一年 | No charge 不收费 | ||
(b) each subsequent year 随后每一年 | $500 | ||
(3) | Application to amend a licence 执照修改费 | ||
(a) with site inspection 需实地视察 | $300 | ||
(b) without site inspection 无实地视察 | $50 | ||
2. | WHOLESALE DEALER'S LICENCE 批发商执照 | ||
(1) | Application for a licence 申请费 | $500 | |
(2) | Licence for — 执照费 — | ||
(a) the first year 第一年 | No charge 不收费 | ||
(b) each subsequent year 随后每一年 | $500 | ||
(3) | Application to amend a licence 执照修改费 | ||
(a) with site inspection 需实地视察 | $300 | ||
(b) without site inspection 无实地视察 | $50 | ||
3. | MANUFACTURER'S LICENCE 制造商执照 | ||
(1) | Application for a licence for 申请费 | ||
(a) Manufacture of external preparations OR oral preparations 制造外用或者口服制剂 | $1,500 | ||
(b) Manufacture of external preparations AND oral preparations 制造外用以及口服制剂 | $2,000 | ||
(c) Primary assembly 一级分装 | $1,000 | ||
(d) Secondary assembly 二级分装 | $600 | ||
(2) | Licence for — 执照费 — | ||
(a) the first year for 第一年 | No charge 不收费 | ||
(b) each subsequent year for — 随后每一年 — | |||
(i) a manufacturer of external preparations OR oral preparations 制造外用或者口服制剂 | $1,500 | ||
(ii) a manufacturer of external preparations AND oral preparations 制造外用以及口服制剂 | $2,000 | ||
(iii) a primary assembler 一级分装 | $1,000 | ||
(iv) a secondary assembler 二级分装 | $600 | ||
(3) | Application to amend a licence 执照修改费 | ||
(a) with site inspection (for manufacturer) 需实地视察 (制造商) | $1,000 | ||
(b) with site inspection (for assembler) 需实地视察（分装商） | $500 | ||
(c) without site inspection 无实地视察 | $50 | ||
4. | CERTIFICATES AND DOCUMENTS 证书和文件 | ||
(1) | Certificate for Export of a Chinese Proprietary Medicine (Free Sale Certificate) (2 years' validity) 中成药出口证书(自由销售证书)（两年有效期） | $100 | |
5. | GMP CERTIFICATE GMP证书 | ||
(1) | Application for GMP certificate (2 years' validity) 申请GMP证书（两年有效期） | $6,000 | |
(2) | Application for issuance of additional certificate 申请额外证书 | $200 | |
6. | GDP CERTIFICATE GDP证书 | ||
(1) | Application for GDP certificate (3 years' validity) 申请GDP证书（三年有效期） | $3,500 | |
(2) | Application for issuance of additional certificate 申请额外证书 | $200 | |
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Target Processing Timelines 审评时限
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