Spring Intro 2023

03/03/2023

The aim of this lecture

● What procedures exist and why you might choose them

● What problems you might experience and how to overcome them

● To provide an insight into some of the key strategic issues and practical problems

The Organisation for Professionals in Regulatory Affairs

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Key Legislation and Guidelines

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Council Directive 2001/83/EC (as amended)

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Regulation (EC) No. 726/2004

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Council Directive 2004/27/EC

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Notice to Applicants Volume 2A Procedures for marketing authorisation

The Organisation for Professionals in Regulatory Affairs

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