CRED 8 Presentations

01/07/2024

Reconfirm Communicated Submission Date At least 2-3 months before Submission • Re-confirm the submission date initially communicated to EMA • …or inform EMA of any delays or cancellations

The Organisation for Professionals in Regulatory Affairs

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Other Requirements: Naming of Product

Between 18 and 6 months before submission

• Invented name (brand name) applications should be made to Name Review Group (NRG). o Submit per “Guideline on the acceptability of names for human medicinal products processed through the centralised procedure” o Send “Proposed name request form” + draft SmPC to NRG@ema.Europa.eu • NRG meet 5-6 times a year (composed of representatives of EU Member States and chaired by an EMA representative) • EMA will reconfirm name choice still valid during MA procedure; final name choice should be confirmed to EMA at least one month in advance of opinion • Worst case scenario, your product will be known by “Common Name, MAH” • Don’t forget: Separate applications to the WHO for International Non-Proprietary Name (INN) and Anatomical Therapeutic Classification (ATC) code.

Further information on tradenames in Regulatory strategy session

The Organisation for Professionals in Regulatory Affairs

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