CRED 8 Presentations

01/07/2024

New proposal Pharma Legislation EC

New Regulation (Reg) • Specific rules for the most innovative medicines such as orphans, antimicrobials • Rules on shortages • EMA governance

New Directive (Dir) • Placing on the market of all medicines • Authorisation and labelling requirements • Strong incentives for access

Several operational aspects will be later drafted via so called Implementing and Delegated acts after adoption of the Regulation and Directive

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Some aspects of the new Directive/Regulation

Digitalisation

Vouchers

Timetables (from 210 days to 180 days)

Restructuring Committees

Bio-hybrid

Shortage management plan

Additional Monitoring disappears

Environmental Risk Assesment

ASMF

No standard 5y renewal, unless…

No RMP for off-patent product, unless…

Borderline products

Priority antimicrobials

Rawdata

Temporary Emergency MA

Regulatory Sandbox

Phased reviews (=Rolling review)

ePI

Scientific advice

Inspections

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