CRED 8 Presentations

01/07/2024

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

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…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

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