药品证明书(CPP).doc

CERTIFICATE OF A PHARMACEUTICAL PRODUCT 药品证明书（CPP）This certificate conforms to the format recommended by the World Health Organization 此证明书遵照世界卫生组织推荐的格式。 No. of certificate：2009-xx 证书编号：2009-xxExporting (certifying country): 出口（证明国）： Importing (requesting country):进口（请求国）： 1. Name and dosage form of the product: 1. 产品名称和剂型Name: 名称： Dosage form:剂型： 1.1. Active ingredient(s) and amount(s) per unit dose: 1.1. 有效成分和单位剂量：.1.2. Is this product licensed to be placed on the market for use in the exporting country? 1.2. 该产品是否被授权在出口国销售？1.3. Is this product actually on the market in the exporting country? 1.3. 该产品是否确实在出口国销售？If the answer to 1.2. is yes, continue with section 2A and omit section 2B. If the answer to 1.2 is No, omit section 2A and continue with section 2B: 如果1.2的答案为是，继续2A部分而忽略2B部分；如果1.2的答案为否，那么忽略2A部分继续2B部分。2.A.1. Number of product licence and date of issue: 2.A.1. 生产许可证编号和签发日期：生产许可证：； 签发日期： 2.A.2. Product license holder (name and address): 2.A.2. 生产许可证持有者（名称和地址）Name: 企业名称： Address:地址： 2.A.3. Status of product license holder:2.A.3. 生产许可证持有者状况a. manufactures the dosage form a. 制造剂型2.A.3.1. For categories b and c the name and address of the manufacturer producing the dosage form is: 2.A.3.1. 适合于b类和c类的，其制造剂型的厂家的名称和地址：2.A.4. Is a summary basis for approval appended? 2.A.4. 是否附有批准该药品的依据摘要？2.A.5. Is the attached, officially approved product information complete and consonant with the license? 2.A.5. 所附官方批准的产品信息是否完整、且和生产许可证一致？2.A.6. Applicant for certificate, if different from license holder (name and address): 2.A.6. 申请人如果不是生产许可证持有者（名称和地址）：3. Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced? 3. 认证授权单位是否定期对生产剂型的生产车间进行检查？3.1. Periodicity of routine inspections (years): 3.1. 例行检查的周期（年）：3.2. Has the manufacture of this type of dosage form been inspected? 3.2. 该类剂型的生产是否已被检查过？3.3. Do the facilities and operations conform to GMP as recommended by the World Health Organization? 3.3. 设备和操作是否符合世界卫生组织推荐的GMP要求？4. Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product: (Key in as appropriate) 4. 申请者递交的信息是否满足认证授权单位关于产品生产所有方面的要求？发证当局地址：杭州市食品药品监督管理局Address of certifying authority: Hangzhou Food and Drug Administration签发日期： Issuing Date: 浙江省杭州市朝晖路施家花园