CRED 8 Presentations

01/07/2024

Tradename Issues (2)

• EMA Naming Review Group (NRG) invented name check process • Submission up to 18m pre-filing • Feedback in 2 months • Submit up to 4 names (NB. FDA only considers 2 names at a time) • Each Member State conducts own assessment – no standard methodology • Around 67% rejection rate!

The Organisation for Professionals in Regulatory Affairs

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Tradename Issues (3)

• Invented name of a medicinal product: • should not be liable to cause confusion in print, handwriting or speech with the invented name of existing medicinal product /INN e.g. Niagra very similar to Viagra • should not convey misleading therapeutic or pharmaceutical connotations e.g. Besteverol • should not be misleading with respect to the composition of the product e.g. Ironex for non-iron-containing product

The Organisation for Professionals in Regulatory Affairs

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