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Guideline

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2008/C 243/09 Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies (Official Journal C 243/1, 2008)
Short Title:2008/C 243/09 PIP Guideline
Internet:http://ec.europa.eu/health/files/eudralex/vol-1/com_2008_jo243/com_2008_243_en.pdf
Origin/Publisher:European Commission
Content:Communication from the Commission — Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies
Document Type:Guideline