Spring Intro 2023

03/03/2023

Scientific advise

CHMP • Single opinion, may not reflect national differences • May advise a cautious, low risk approach • Likely to carry more weight at time of MAA • No/reduced fee for orphans (protocol assistance) National • Can obtain a number of opinions • May reflect differences between national views • More potential for informal exploration

17 Understanding Clinical Development Program, March 2022

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Don’t and do’s

• Don’t start the same variation on a national level in various EU member states. Do start a work-sharing

• Don’t submit a variation on the SmPC without indication were the changes come from

• Do state from which SmPC the text (EU member) is coming and if relevant the GMA

• Do substantiate the changes in a SmPC/application even when asked by an authority

18 Understanding Clinical Development Programme, 27-28 June 2018

18