Module 6

04/10/2024

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REGULATORY INCENTIVES… Directive 2001/83/EC Article 74a • If in your Switch application • - you provide support on the basis of “significant pre -clinical tests or clinical trials”

● ONE YEARS DATA EXCLUSIVITY

The Organisation for Professionals in Regulatory Affairs

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The PRIME OBJECTIVE of the regulatory agencies…

• To assure… ● SAFETY, SAFETY, SAFETY

● and also… as we have seen… REDUCE HEALTH SERVICE COSTS

The Organisation for Professionals in Regulatory Affairs

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