Spring Intro 2023

30/03/2023

Tradename (NRG)

What ? • Assign a commercial Tradename to product Why ? • Facilitate commercialisation and marketing When ?

• 12-18 months prior to filing (can require multiple rounds) • Top tip: Multiple rounds may be required – Start early • Top tip: You do not need a tradename for initial MAA filing (Required 1 month prior to CHMP opinion) How + Where ? • Submission via Tradename request form and assessment via NRG • Top tip: If someone holds a similar name, it is a race to MAA • Top tip: Remember only 2 names can be held Who ? • Internal – Commercial, Global Regulatory, Intellectual Property + Trademarks • External – Name Review Group

The Organisation for Professionals in Regulatory Affairs

87

David

Intellectual Property and Data Exclusivity

MAA

Phase 1 Phase 2 Phase 3

Post Approval

Phase 3

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

88