CRED ERP 25

01/07/2025

What to expect pre-submission

T minus 18 months

T minus 7 months

T minus 6 months

T minus 3 months

T minus 2 months

Submission

Invented Name (Tradename) Request (deadlines per EMA website)

Request for Accelerated Assessment (deadlines per EMA website – discuss in advance with Rapporteurs/EMA)

PIP Compliance Check

Preparation of Application for “Maintenance of Orphan Designation”

Submission Preparation

The Organisation for Professionals in Regulatory Affairs

9

…and remember

• Multiple rounds of Invented Name Requests may be needed

• Worst case, you can launch with a “Generic” tradename

• You may also need to apply (to WHO) for an ATC code…allow time for this!

• Accelerated Assessment requires a commitment on both sides

• If you plan for this, make sure you can fulfil your obligations – you may not be able to withdraw!

• Robustly review whether you are in compliance with the PIP

• If in any doubt allow for at least two rounds of compliance check

• Orphan Maintenance runs in parallel to the MAA assessment

• This can even lead to a separate Oral Explanation!

The Organisation for Professionals in Regulatory Affairs

10