Hubei Food and Drug Administration
药 品 证 明 书
Certificate of a Pharmaceutical Product
证书号：
No. of Certificate:
该证书符合世界卫生组织（WHO ）推荐的格式。
This certificate conforms to the format recommended by the World Health Organization.
出口国：
Exporting (certifying country)：进口国家（需求国家）：
Importing (requesting country):
1． 产品名称和剂型：
Name and Dosage form of product :
1.1有效成分与剂量：
包括非活性成分在内的配方： For complete composition including excipients: 1.2 该药品在出口国是否允许投放市场：1.3 该药品在出口国是否已经实际投放市场：
若1.2的答案为是，请忽略2B 继续回答2A 。
If the answer to 1.2 is yes, continue with section 2A and omit section 2B.
若1.2的答案为否，请忽略2A 继续回答2B 。
If the answer to 1.2 is no, omit section 2A and continue with section 2B.
2.A.1 该药品的批准文号和签发日期：
2.A.2 药品批准文号的持有人（名称和地址）：
2.A.3 药品批准文号的持有人的性质：
Status of product-licence holder:
a: 药品制剂生产企业
a: manufactures the dosage form
b: 为其他公司生产的药品进行外包装和/或贴标签的企业：或
b:packages and/or labels a dosage form manufactured by an independent company
c. 以上均不是
c: is involved in none of the above
2.A.3.1 如果属于情况b 和c, 药品实际生产者是：For categories b and c the name and address of the manufacturer producing the dosage from are:
2.A.4 是否附有审批的文件摘要：
Is summary Basis of Approval appended?
2.A.5 所附的官方审批信息与许可证是否一致：
Hubei Food and Drug Administration
Is the attached, officially approved product information complete and consonant with the licence? 2.A.6 证明书申请人（名称和地址）如与生产许可证的持有人不一致：
2.B.1 证明书申请人（名称和地址）：
Applicant for certificate (name and address):
2.B.2 申请人性质：Status of applicant: a/b/c (key in appropriate category as defined in note 8): 2.B.2.1 如情况属于b 或c ，药品实际生产者是：
2.B.3 为何缺少官方证明？Why is the marketing authorization lacking? 2.B.4 备注：
3. 证明当局是否对该药品的实际生产企业进行定期检查：Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced?
如果答案为不是或不适合，请继续4。
If no or not applicable proceed to question 4.
3.1 定期检查的周期：
Periodicity of routine inspections(years): 3.2 对这种类型的制剂产品的生产进行过检查吗？
Has the manufacture of this type of dosage form been inspected?
3.3 生产设备和操作符合世界卫生组织推荐的GMP 规范吗？ Do the facilities and operations conform to GMP as recommended by the World Health Organization?
4. 在药品生产的所有方面，申请者所提供的信息符合批准机构的要求吗？ Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product16? 如果不符合，请解释原因：
证书的有效期至：
证明当局的地址：
Address of certifying authority: 湖北省食品药品监督管理局 武汉市武昌区公正路19号
签字： 签章与日期：
Signature: Stamp and date:
Hubei Food and Drug Administration
药 品 证 明 书
Certificate of a Pharmaceutical Product
证书号：
No. of Certificate:
该证书符合世界卫生组织（WHO ）推荐的格式。
This certificate conforms to the format recommended by the World Health Organization.
出口国：
Exporting (certifying country)：进口国家（需求国家）：
Importing (requesting country):
1． 产品名称和剂型：
Name and Dosage form of product :
1.1有效成分与剂量：
包括非活性成分在内的配方： For complete composition including excipients: 1.2 该药品在出口国是否允许投放市场：1.3 该药品在出口国是否已经实际投放市场：
若1.2的答案为是，请忽略2B 继续回答2A 。
If the answer to 1.2 is yes, continue with section 2A and omit section 2B.
若1.2的答案为否，请忽略2A 继续回答2B 。
If the answer to 1.2 is no, omit section 2A and continue with section 2B.
2.A.1 该药品的批准文号和签发日期：
2.A.2 药品批准文号的持有人（名称和地址）：
2.A.3 药品批准文号的持有人的性质：
Status of product-licence holder:
a: 药品制剂生产企业
a: manufactures the dosage form
b: 为其他公司生产的药品进行外包装和/或贴标签的企业：或
b:packages and/or labels a dosage form manufactured by an independent company
c. 以上均不是
c: is involved in none of the above
2.A.3.1 如果属于情况b 和c, 药品实际生产者是：For categories b and c the name and address of the manufacturer producing the dosage from are:
2.A.4 是否附有审批的文件摘要：
Is summary Basis of Approval appended?
2.A.5 所附的官方审批信息与许可证是否一致：
Hubei Food and Drug Administration
Is the attached, officially approved product information complete and consonant with the licence? 2.A.6 证明书申请人（名称和地址）如与生产许可证的持有人不一致：
2.B.1 证明书申请人（名称和地址）：
Applicant for certificate (name and address):
2.B.2 申请人性质：Status of applicant: a/b/c (key in appropriate category as defined in note 8): 2.B.2.1 如情况属于b 或c ，药品实际生产者是：
2.B.3 为何缺少官方证明？Why is the marketing authorization lacking? 2.B.4 备注：
3. 证明当局是否对该药品的实际生产企业进行定期检查：Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced?
如果答案为不是或不适合，请继续4。
If no or not applicable proceed to question 4.
3.1 定期检查的周期：
Periodicity of routine inspections(years): 3.2 对这种类型的制剂产品的生产进行过检查吗？
Has the manufacture of this type of dosage form been inspected?
3.3 生产设备和操作符合世界卫生组织推荐的GMP 规范吗？ Do the facilities and operations conform to GMP as recommended by the World Health Organization?
4. 在药品生产的所有方面，申请者所提供的信息符合批准机构的要求吗？ Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product16? 如果不符合，请解释原因：
证书的有效期至：
证明当局的地址：
Address of certifying authority: 湖北省食品药品监督管理局 武汉市武昌区公正路19号
签字： 签章与日期：
Signature: Stamp and date: