Spring Intro 2023

03/03/2023

Evaluation Phase: Day 121-180

Rapporteur and co-rapporteur evaluate the information sent by the Applicant and produce an assessment report. As before, CHMP comment on the updated assessment report, so do PRAC. Comments from CHMP and PRAC are consolidated into a single report called the ‘List of Outstanding Issues’

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Day 121: Submission of the responses, including revised SmPC, labelling and package leaflet texts in English and worst case (usually trilingual). Restart of the clock. Day 157: Receipt of the joint Response Assessment Report from CHMP, Rapporteurs and PRAC Rapporteur. Contains the draft recommendation for opinion Day 157: Where applicable GCP inspection to be carried out. All major GCP issues need to be resolved by Day 210 or there will be negative opinion Day 165: QRD group meet to review the English product information Day 180: Inspection team submit their final inspection report. Day 180: List of outstanding issues and/or invitation to an oral explanation

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Procedure stops while Applicant responds.

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Submission of Orphan Maintenance Report (if applicable) at D121 (unless following Accelerated Assessment)

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Clock Stop (90 days)

Clock Stop (30 days)

Phase 1: 120 Days

Phase 2: 60 Days

Phase 3: 30 Days

EMA link: Marketing authorisation guidance documents

The Organisation for Professionals in Regulatory Affairs

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Evaluation Phase: Day 181-210

• A Scientific Advisory Group (SAG) may be convened in cases where for example there’s major public health interest, public controversy expected, disagreement between rapporteurs on clinical aspects, complex technical aspects etc • An oral explanation might be held if major objections are remaining. This would be a face to face meeting with CHMP and experts at EMA in Amsterdam • Once the responses are received (and/or discussed at an oral explanation) the clock restarts. The rapporteurs again assess the information and produce an assessment report, as do PRAC. • By Day 210 CHMP adopt an opinion which is reached by a vote. Ideally it’s a consensus opinion, but if this is not possible the committee’s opinion is the majority view.

Day 181: Restart of the clock with submission of responses or oral explanation Day 210: Adoption of CHMP Opinion + CHMP Assessment Report. Adoption of a timetable for the provision of product information translations

Clock Stop (90 days)

Clock Stop (30 days)

Phase 1: 120 Days

Phase 2: 60 Days

Phase 3: 30 Days

EMA link: Marketing authorisation guidance documents

The Organisation for Professionals in Regulatory Affairs

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