中华民国
PEOPLE’S REPUBLIC OF CHINA
药品出口销售证明
CERTIFICATE OF A PHARMACEUTICAL PRODUCT
（未中国注册药品）
(Product Unregistered in China)
This certificate conforms to the format recommended by the World Health Organization
该证书符合世界卫生组织（WHO）推荐格式
证书编号
Certificate No
中文：
英文：
进口国区(提出求国家区)[外公开]
Importing Country Region (Requesting Country Region)[Not disclosed to the public]
中文：
英文：
产品名称剂型
Name and Dosages Form of the Product
中文：
英文：
商品名
Trade Name
中文：
英文：
活性成分规格[外公开]
Active Ingredient(s) and Strength[Not disclosed to the public]
中文：
英文：
包括辅料完整处方组成（附表）[外公开]
For complete composition including excipients see attached[Not disclosed to the public]
中文：
英文：
该药品否获许中国市场
Is this product licensed to be placed on the market for use in China
否（No）
药品生产企业（名称址）
Manufacturer（name and address）
名称
Name
中文：
英文：
址
Address
中文：
英文：
未中国注册理
Why is the product not registered in China
产品专门治疗中国外域疾病（）
The product has been developed exclusively for the treatment of diseases outside of China
产品处方组成调整改进中国外域特定条件稳定性（）
The product has been reformulated with a view to improving its stability under specific conditions outside of China
产品处方组成调整进口国未批准辅料（）
The product has been reformulated to exclude excipients not approved for use in pharmaceutical products in the importing country
受专利权限制（）
Restricted by patents
原（中英文）（）
Any other reason (Chinese and English)
证明局否该药品实际生产企业进行定期检查
Does the certifying authority arrange for periodic inspections of the manufacturing plant in which the dosage form is produced
（Yes）
定期检查周期（年）
Periodicity of routine inspections (years)
类剂型生产否检查
Has the manufacture of this type of dosage form been inspected
（Yes）
生产设备操作否符合WHO推荐药品生产质量理规范
Do the facilities and operations conform to GMP as recommended by the World Health Organization
（Yes）
申请提供信息否满足证明局求
Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product
（Yes）
兹证明述产品未中国注册尚未进入中国市场该产品出口受限制
This is to certify that the above product(s) is not registered in China and not authorized to be placed in China The exportation of the product(s) is not restricted
证明效期
This certificate remain valid until
证明局
certifying authority
名 称
Name
中文：
英文：
址
Address
中文：
英文：
电 话
Telephone number
传 真
Fax
签 字
Signature
签章日期
Stamp and date
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《香当网》用户分享的内容，不代表《香当网》观点或立场，请自行判断内容的真实性和可靠性！
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PEOPLE’S REPUBLIC OF CHINA
药品出口销售证明
CERTIFICATE OF A PHARMACEUTICAL PRODUCT
（未中国注册药品）
(Product Unregistered in China)
This certificate conforms to the format recommended by the World Health Organization
该证书符合世界卫生组织（WHO）推荐格式
证书编号
Certificate No
中文：
英文：
进口国区(提出求国家区)[外公开]
Importing Country Region (Requesting Country Region)[Not disclosed to the public]
中文：
英文：
产品名称剂型
Name and Dosages Form of the Product
中文：
英文：
商品名
Trade Name
中文：
英文：
活性成分规格[外公开]
Active Ingredient(s) and Strength[Not disclosed to the public]
中文：
英文：
包括辅料完整处方组成（附表）[外公开]
For complete composition including excipients see attached[Not disclosed to the public]
中文：
英文：
该药品否获许中国市场
Is this product licensed to be placed on the market for use in China
否（No）
药品生产企业（名称址）
Manufacturer（name and address）
名称
Name
中文：
英文：
址
Address
中文：
英文：
未中国注册理
Why is the product not registered in China
产品专门治疗中国外域疾病（）
The product has been developed exclusively for the treatment of diseases outside of China
产品处方组成调整改进中国外域特定条件稳定性（）
The product has been reformulated with a view to improving its stability under specific conditions outside of China
产品处方组成调整进口国未批准辅料（）
The product has been reformulated to exclude excipients not approved for use in pharmaceutical products in the importing country
受专利权限制（）
Restricted by patents
原（中英文）（）
Any other reason (Chinese and English)
证明局否该药品实际生产企业进行定期检查
Does the certifying authority arrange for periodic inspections of the manufacturing plant in which the dosage form is produced
（Yes）
定期检查周期（年）
Periodicity of routine inspections (years)
类剂型生产否检查
Has the manufacture of this type of dosage form been inspected
（Yes）
生产设备操作否符合WHO推荐药品生产质量理规范
Do the facilities and operations conform to GMP as recommended by the World Health Organization
（Yes）
申请提供信息否满足证明局求
Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product
（Yes）
兹证明述产品未中国注册尚未进入中国市场该产品出口受限制
This is to certify that the above product(s) is not registered in China and not authorized to be placed in China The exportation of the product(s) is not restricted
证明效期
This certificate remain valid until
证明局
certifying authority
名 称
Name
中文：
英文：
址
Address
中文：
英文：
电 话
Telephone number
传 真
Fax
签 字
Signature
签章日期
Stamp and date
文档香网(httpswwwxiangdangnet)户传
《香当网》用户分享的内容，不代表《香当网》观点或立场，请自行判断内容的真实性和可靠性！
该内容是文档的文本内容，更好的格式请下载文档
