Module232025

07/05/2025

Material changes proposed in revised legislation

Article 77: Assessment timeframes

•

PIP

•

• Current: 60 days + clock-stop + 60 days • Proposed: 90 days + clock-stop + 90 days

iPIP

•

Review periods are extended Impact

Current: n/a

•

• Proposed: 70 days + clock-stop + 70 days

Waiver

•

• Current: 60 days with provision for clock-stop which isn’t used in practice • Proposed: 90 days with provision for clock-stop

Modification

•

Current: 60 days

•

• Proposed: 90 days with provision for clock-stop

The Organisation for Professionals in Regulatory Affairs

51

Material changes proposed in revised legislation

Articles 81 & 82: Deferrals

•

Concept of a time limit on deferrals is new

Specific procedure for extending deferrals

The Organisation for Professionals in Regulatory Affairs

52