CRED ERP 25

01/07/2025

Preparing and Applying for a Centralised Procedure (Details in back-ups)

The Organisation for Professionals in Regulatory Affairs

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Before you submit

• Familiarize yourself with the EMA Pre-Submission Guidance

• Make sure you understand timelines and deadlines…and where there may be flexibility (some timelines advisory)

• Check regularly for updates; things can (and do) change without warning!

• Make sure you have an EMA Account and make sure you have back-ups (and don’t forget IRIS for Orphan products)

• This can take longer than you think – use the helpdesk if needed

• Speak to colleagues/peers who have done this before

• Be prepared for some bureaucracy…and some “Interesting” forms to fill

The Organisation for Professionals in Regulatory Affairs

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