Guidance for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines.

Published EMA Slideshow presentation containing 28 slides about general principals, advice and examples for presenting information in the SmPC of fixed combination medicinal products

SmPC Training for EMA - June 2019_Page_01.jpg

SmPC Training for EMA - June 2019_Page_02.jpg

SmPC Training for EMA - June 2019_Page_03.jpg

SmPC Training for EMA - June 2019_Page_04.jpg

SmPC Training for EMA - June 2019_Page_05.jpg

SmPC Training for EMA - June 2019_Page_06.jpg

SmPC Training for EMA - June 2019_Page_07.jpg

SmPC Training for EMA - June 2019_Page_08.jpg

SmPC Training for EMA - June 2019_Page_09.jpg

SmPC Training for EMA - June 2019_Page_10.jpg

SmPC Training for EMA - June 2019_Page_11.jpg

SmPC Training for EMA - June 2019_Page_12.jpg

SmPC Training for EMA - June 2019_Page_13.jpg

SmPC Training for EMA - June 2019_Page_14.jpg

SmPC Training for EMA - June 2019_Page_15.jpg

SmPC Training for EMA - June 2019_Page_16.jpg

SmPC Training for EMA - June 2019_Page_17.jpg

SmPC Training for EMA - June 2019_Page_18.jpg

SmPC Training for EMA - June 2019_Page_19.jpg

SmPC Training for EMA - June 2019_Page_20.jpg

SmPC Training for EMA - June 2019_Page_21.jpg

SmPC Training for EMA - June 2019_Page_22.jpg

SmPC Training for EMA - June 2019_Page_23.jpg

SmPC Training for EMA - June 2019_Page_24.jpg

SmPC Training for EMA - June 2019_Page_25.jpg

SmPC Training for EMA - June 2019_Page_26.jpg

SmPC Training for EMA - June 2019_Page_27.jpg

SmPC Training for EMA - June 2019_Page_28.jpg

Go back >