Spring Intro 2023

30/03/2023

What, Why and When?

• The tradename is the name for your commercial brand and will be how the medicinal product is recognised.

• Tradenames for medicinal products need to be approved by the EMA (via the Name Review Group) prior to use.

• Start Applications as early as possible - at least 12 -18 months prior to MAA filing

Top Tip: Start early as you may require multiple rounds

Top tip: You do not need a tradename for initial MAA filing (Required 1 month prior to CHMP opinion in order to use at launch)

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How ?

Formal Application is submitted to NRG • NRG Application form • Product Profile or Draft EU SmPC • Tradename justification documentation

Assessed at scheduled NRG meetings (with defined submission deadlines) • https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre authorisation-guidance#3.1-product-name,-product-information-and-prescription status-section • From submission to CHMP endorsement (approximately 3 months) • Outcome will be either to approve or to reject on the grounds that similar Tradenames exist (and could cause medication error) NRG recommendation taken to CHMP for endorsement at the next CHMP meeting Negative outcomes can be appealed through a formal process • Justification to retain rejected name • Justify why the identified similar names do not pose a risk for medication error

The Organisation for Professionals in Regulatory Affairs

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