Letter of Authorization (LOA)

Submit LOA-Request

Submission Details

Country Of Submission *

Full company name incl. legal entity. Otherwise your LOA might be rejected by the authorities.

Company Name *

Company Name China (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) *

Address 1 (Please provide Postal address in English) * Address 2 City * State/Province * Zip/Postal Code * Country * First Name * Last Name * Title Phone Country Code * Phone Area Code * Phone *

ATTENTION: Please be aware that we will use this email address to communicate required change notifications regarding DMF amendments. We recommend to use a generic email address to ensure the information will reach the relevant department at your company.

E-mail *

Is the company for whom the LOA is being issued the same as the requesting company? If not, please add additional company by clicking checkbox.

Issue LOA for the following company:

Company Name *

Company Name (in Chinese, only relevant for China Submission)

Address 1 * Address 2 City * State/Province * Zip/Postal Code * Country * First Name * Last Name * Title Phone Country Code * Phone Area Code * Phone * E-mail *

Your Drug Product Name

Drug Product Name/Active Ingredient *

SCHOTT Product Details

SCHOTT Product Manufacturing Facility *

SCHOTT Product Group *

SCHOTT Product Description (e.g. pen cartridge 20ml) * SCHOTT Article No. (7-digit starting with 1... )

Specification/model* (Please kindly enter the format or size of the container(s) used, e.g. 2 mL) *

Information of Drug to be applied at the NMPA in China (China Submission), (Should be identical to the name given in the submission dossier to NMPA)

Name of the drug (in English)* (If there is no corresponding English translation or English Name of the Drug, please enter Name of the Drug in Chinese into the field) * 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

Please enter the number of originals of the requested China LoA; if no hard copy is needed, please enter ’No original/hard copy is required’ in this field.*

First Name Last Name E-mail Phone Number