CRED 8 Presentations

01/07/2024

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The Organisation for Professionals in Regulatory Affairs 69

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Types of marketing authorisations

“normal” MA

Conditional MA

MA under exceptional circumstances

Comprehensive data impossible

Comprehensive data at the time of authorisation

Comprehensive data after authorisation

‘full’ MA

To later switch to ‘full’ MA

To remain such indefinitely

Valid for 5 years (renewable)

Valid for 1 year only (renewable)

Valid for 5 years (renewable), but annual re-assessment procedure

Standard situation in all registration procedures

Possible in centralised procedure only

Possible in all registration procedures

May have conditions (e.g. PASS, PAES)

Specific Obligations + may have conditions

Specific obligations + may have conditions

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The Organisation for Professionals in Regulatory Affairs

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