Spring Intro 2023

03/03/2023

Referral to CMD(h)

Day 0: (within 30 days of Day 90/210) – RMS distributes draft list of questions (LOQ) to all MS

Day 5: CMS comment on LOQ

Day 8: RMS circulates final agreed LOQ

By Day 10: LOQ sent to applicant by EMA

Around Day 20: CMDh meeting 1 – RMS/CMS positions

The Organisation for Professionals in Regulatory Affairs

43

Referral to CMD(h)

By Day 25: applicant sends response to CMDh/MS

Around Day 35: RMS circulates updated report

7 days before CMD meeting: MS views on response

Around Day 50: CMDh meeting 2 – scientific discussion / possible Hearing / decision Day 50-60: ● If agreement – close procedure ● No agreement – EMA/applicant advised – CHMP referral RMS completes template for press release

The Organisation for Professionals in Regulatory Affairs

44