Spring Intro 2023

Changes to Marketing Authorisations (MAs)

Marketing Authorisation Application

Approved MA 1.Authorisations are legally binding 2.All aspects of

Module 1

Health Authority Approval

Module 2

medicine on market must comply with the MA

Module 3, 4, 5

The Organisation for Professionals in Regulatory Affairs

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The Importance of Compliance The lack of compliance is a risk to the entire company, and can lead to: • Increase of product complaints and recalls • Risk to patient safety and potential for product withdrawal • Trigger for unexpected inspections • Failure of GMP • Potential manufacturing site closure • Lost reputation with regulators and physicians/patients • Application Rejections

COMPLIANCE IS KEY FOR YOUR SUCCESS

The Organisation for Professionals in Regulatory Affairs

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