Module 18 2021

07/02/2021

The Marketing Authorisation…

 The result of significant investment in money, time, resource ● For industry

● … and also for the regulatory assessors

The Organisation for Professionals in Regulatory Affairs

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What’s written in your Marketing Authorisation….

 Determines the extent to which you have flexibility to release the product

 It’s therefore crucial to understand the content of the MA and the commitments that this brings.

The Organisation for Professionals in Regulatory Affairs

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