e-form

Scientific Advice Request (SAR) / Protocol Assistance (PA)

Please fill all the predefined fields as accurately as possible.

International Non-proprietary Name (if available):

Trade name (if available):

Company product code:

Description of the product and mechanism of action:

Type of product:

Comments:

Intended indication therapeutic field:

SA 001/05 Appendix 1 Version 2

Page 1 of 4

Applicant/ Company:

Address:

Name of contact person:

Telephone:

Fax number:

Email address:

Alternate contact person details:

Telephone:

Fax number:

Email address:

Name for Invoicing details (if different from Applicant details):

Address:

Name of financial contact person (if applicable or different from procedure contact person):

Telephone:

Fax number:

Email address:

SA 001/05 Appendix 1 Version 2

Page 2 of 4

Requirement for pre-submission meeting indicate:

Comments:

Small and Medium Sized Enterprises (SME) status:

For those with marketing approval:

Date of Marketing Authorisation granting:

Route of Marketing Authorisation:

For those with NO Marketing Approval:

Planned date for Marketing Authosiation application:

Planned Route of Marketing Authorisation application:

Additional Scientific Advice planned:

If yes, specify planned date:

SA 001/05 Appendix 1 Version 2

Page 3 of 4

At the time of submission of the SAR/PA request the following documents have to be uploaded (please use functions below):

-Questions and company’s position (Word format).

-Detailed table of contents:

a. Background information, e.g.: Product Profile Investigators’ Brochure.

b. Relevant study protocols or draft study protocols or study outlines.

c. Bibliographical data (references).

d. Content of previous scientific advice received.

e. Relevant guidelines (other than CHMP Guidance documents).

f. Contract agreement if the request is submitted by a consultant/CRO on behalf of the company.




Regulatory topics may be addressed at pre-submission meetings or in writing separately from the Scientific Advice request.

SA 001/05 Appendix 1 Version 2

Page 4 of 4