CHMP Protocol Assistance_ Scientific Advice Briefing ...



Rev. 1

CHMP

Briefing Document Template

[Standard headings in the template should be used whenever possible; if it is considered necessary to deviate from the pre-specified headings to accommodate product-specific requirements, alternative or additional headings/sections may be considered.

This annotated template should be read in conjunction with the relevant guidelines that can be found on the website of the European Medicines Agency: ‘EMA Guidance for Companies requesting Scientific Advice or Protocol Assistance’ (EMEA-H-4260-01-Rev.6).

Bracketing convention: {text}: Information that is required to be filled in; : Text to be selected or deleted as appropriate.

[Text] is for explanation and guidance.

Formatting convention: Verdana 9 pt, single space, justified.

References convention:

- For citation of literature references, footnotes are preferred, alternatively the format (first author , publication year) is recommended.]

Invented Name: {}

Active substance: {}

Pharmaco-therapeutic group: {}

Intended indication(s): {}

Applicant: {}

Version {}

Date: {DD/MM/YYYY}

Table of Contents

List of Figures 3

List of Tables 3

List of Abbreviations 3

I. Summary 4

II. Questions and Applicant’s positions 6

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