Spring Intro 2023

16/02/2023

Safety Variations Overview

24 hours

Risk to Public Health

Urgent Safety Restrictions

• PV • Pre-clinical • Quality

MAH / Agency

Referral procedures (Art. 107i, 20, 31)

Reassess B/R of medicine / class of medicines

Agency

Type II – 30 day

Expedited safety variation

MAH

Increasing urgency

Type II – 60 day

“Typical” safety variation

17

Referral procedures

Article 107i / 20 / 31 Determined by:  Authorisation route  Type of data  Urgency

Safety concern identified

Initiation

Provisional measures

Actions: • Suspension of a MA (stop use) • Revocation of MA (permanent) • Non-renewal of license • Product Recall • Further evaluation • PASS

Restricted: • Indication • Dosage Additional: • Contraindication • Warning • Interaction • ADR

Update to: • PI

Questions Review

• RMP • EdTs

OE / SAG

DHPC

Final outcome

18