Module 6

04 October 2024

Overview of Initial MAA process

D1

D120 D121

D180

D181

D210 D277

Post Authorisation

Secondary Evaluation

Final Evaluation

Clock Stop

Clock Stop

Decision making

Primary Evaluation

PSP

Validation

EC Decision

CHMP Opinion

List of Questions

List of Outstanding Issues

Responses

Submission

Responses

• Pharmacovigilance • Variations • Extensions • Renewal

(Co)Rapporteurs D150 AR of responses

(Co)Rapporteurs D195 AR of responses

Rapp/Co-Rapp Day 80 ARs

Potential additional steps:

▪ GMP, GLP, GCP Inspections (‘routine’ and ‘triggered’)

D. 180 Hearing?

▪ Consultation of Scientific Advisory Group (SAG) or ad hoc expert group, other committees or WP

▪

Oral explanation

30

An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

30

Pre-submission activities for centralised procedure

Clinical studies

Proof of concept Non-clinical studies

M-6

PIP Compliance check

M-18 to M-7

M-7

Request for accelerated assessment

Pre-submission interaction

Letter of intent to submit Appointment of Rapporteurs

Request Eligibility for Centralised Procedure Request Invented name review

Advanced Therapy Medicinal Products (ATMP) certification CHMP Opinion on compassionate use (triggered by Member States)

Scientific Advice / protocol assistance Pipeline information Priority Medicines ( PRIME) designation

Small Medium Enterprise (SME) designation

Paediatric requirements (PIP)

Mandatory steps Optional steps Not applicable to all

Innovation task force Orphan designation ATMP classification

An Agency perspective: the success and failure of a medicinal product in the EU

31

Classified as public by the European Medicines Agency

31

16