Fees (CPM)
Fees/Service Charges for Licences and Certificates of Chinese Proprietary Medicines 中成药执照及证书收费
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 (3 years' validity) 申请GMP证书(三年有效期) | $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 |


