SCHOTT
肖特医药包装 (汉语)
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Submit LOA-Request
Submission Details
申请国家* 中国 (国家药品监督管理局药品)*
- Please select -
USA (FDA)
Canada (Health Canada)
China (NMPA)
你是为第三方客户提出申请吗?
我们为客户提供向第三方提交个人申请的替代方案, 请将您的要求转达给 Dr. Karen Liu (
Karen.liu@schott.com
)
原料药、药用辅料和药包材企业授权使用书申请
药品上市许可持有人(申请人) (英文)*
药品上市许可持有人(申请人)
(In China, only relevant to China submission. If there is no
corresponding Chinese translation of your Company Name
or there is no Company Name in Chinese, please use your
English Company Name)
*
地址 1
(请提供英文邮政地址)*
地址 2
城市*
州名或省名*
邮政编码*
国家/地区*
国家/地区
中国
ישראל
日本国
대한민국
الإمارات العربيّة المتّحدة
Albania
Algeria
Argentina
Australia
Bangladesh
Belarus
Belgique
BeNeLux
Bosnia And Herzegovina
Brasil
Canada
Colombia
Cyprus
Česká republika
Denmark
Deutschland
Ecuador
Egypt
España
Estonia
Finland
France
Greece
Hong Kong
Hrvatska
I.R. Iran
India
Indonesia
Ireland
Italia
Latvia
Libyan Arab Jamahiriya
Lithuania
Luxembourg
Macedonia
Magyarország
Malaysia
Montenegro
Morocco
Myanmar
México
Netherlands
New Zealand
Norway
Österreich
Pakistan
Peru
Philippines
Polska
Portugal
România
Россия
Saudi Arabia
Schweiz
Serbia
Singapore
Slovenija
Slovensko
South Africa
Sweden
Syria
Taiwan
Türkiye
Tunisia
United Kingdom
United States
Venezuela
Việt Nam
Yemen
България
Україна
名字*
姓氏*
称谓
电话*
电子邮件*
E-Mail Confirmation
Company for whom the LOA is being issued
原料药、药用辅料和药包材企业授权使用书申请人是否与药品上市许可持有人(申请人)相同?
如果不是,请单击下面的按钮添加其他申请的企业
Add Additional Company
Issue LOA for the following company:
药品上市许可持有人(申请人) (英文)*
药品上市许可持有人(申请人) (英文)
企业中文名称,仅适用于原料药、药用辅料和药包材企业授权使用书申请
地址 1*
地址 2
城市*
州名或省名*
邮政编码*
国家/地区*
国家/地区
中国
ישראל
日本国
대한민국
الإمارات العربيّة المتّحدة
Albania
Algeria
Argentina
Australia
Bangladesh
Belarus
Belgique
BeNeLux
Bosnia And Herzegovina
Brasil
Canada
Colombia
Cyprus
Česká republika
Denmark
Deutschland
Ecuador
Egypt
España
Estonia
Finland
France
Greece
Hong Kong
Hrvatska
I.R. Iran
India
Indonesia
Ireland
Italia
Latvia
Libyan Arab Jamahiriya
Lithuania
Luxembourg
Macedonia
Magyarország
Malaysia
Montenegro
Morocco
Myanmar
México
Netherlands
New Zealand
Norway
Österreich
Pakistan
Peru
Philippines
Polska
Portugal
România
Россия
Saudi Arabia
Schweiz
Serbia
Singapore
Slovenija
Slovensko
South Africa
Sweden
Syria
Taiwan
Türkiye
Tunisia
United Kingdom
United States
Venezuela
Việt Nam
Yemen
България
Україна
First Name*
姓氏*
称谓
电话*
电子邮件*
SCHOTT Product Details
肖特工厂名 (请选择)*
- Please select -
SCHOTT AG, Germany
SCHOTT Brasil Ltda., Brazil
SCHOTT Envases Argentina S.A., Argentina
SCHOTT Envases Farmacéuticos S.A., Colombia
SCHOTT de México, S.A. de C.V., Mexico
SCHOTT France Pharma Systems SAS, France
SCHOTT Glass Technologies (Suzhou) Co., Ltd., China
SCHOTT Pharmaceutical Packaging (Zhejiang) Co., Ltd., China
SCHOTT Hungary Kft., Hungary
PT. SCHOTT Igar Glass, Indonesia
SCHOTT North America, Inc., USA
LLC. SCHOTT PHARMACEUTICAL PACKAGING, Russia
SCHOTT Schweiz AG, Switzerland
肖特产品名称 (请选择)*
- Please select -
Ampoule
Ampoule Brown
Cartridge
Syringe (Glass)
Syringe (Polymer)
Vial (Glass)
Vial (adaptiQ®)
Vial (Boro 8330TM)
Vial (Glass, Brown)
Vial (Polydimethylsiloxane Film)
Vial (illax Glass, Polydimethylsiloxane Film)
Vial (illax Glass)
Coated Vial (Type I plus®)
Coated Vial (TopLyO®)
Syringe (Glass Barrel)
肖特产品描述*
肖特产品编号 (以1开头的7位数字)
specification/model*
(Please kindly enter the format or
size of the container(s) used, e.g. 2 mL)
中国国家药品监督管理局药品申请信息(中国原料药、药用辅料和药包材企业授权使用书申请 )
(应与NMPA提交文件中申请信息的名称相同)
Name of the drug (in English)*
Name of the drug (in Chinese)*
(If there is no corresponding Chinese translation or Chinese Name
of the Drug, please enter Name of the Drug in English into this
field)
Route of administration (in English)*
Route of administration (in Chinese)*
Comments
注释字段 (建议输入授权书申请的数量)
; if no hard copy is needed,
please enter ’No original/hard copy is required’
in this field.*
* 必填项