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EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have and provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to Applicants in preparing their request.

This guidance explains the scope and nature of scientific advice and protocol assistance which will enable applicants to submit requests which are in line with Scientific Advice Working Party (SAWP) requirements and which can be validated and evaluated quickly and efficiently.

Furthermore, Applicants will be guided through the different steps of the procedure and receive useful information on the preparation of a possible discussion meeting with the SAWP.

The CHMP has established the Scientific Advice Working Party (SAWP) as a standing working party with the sole remit of providing scientific advice and protocol assistance (the name given to the scientific advice procedure for products with an Orphan Designation) to Applicant.

Scientific advice received from the Agency is applicable throughout the EU. A SAWP/CHMP consultation does not preclude the possibility of consultations with national competent authorities.

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