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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