CRED 8 Presentations

01/07/2024

Post-Opinion: Linguistic Review and Decision Making

Day

Agency Activity

Company activity

N/A

Start of linguistic review. submits all final translations based on agreed English text (plus Annex IV+AnnexA) with QRD form 1

215

Member states send linguistic comments

229

235

Implement the requested changes and send back to EMA with QRD form 2 EMA sends Opinion and Product information (plus annexes) to European Commission (EC) for Decision and to EEA countries (Lichenstein, Iceland, Norway)

237

Standing Committee Consultation*

239-261

15 days before launch

Submit specimens of packaging to EMA

EC Decision on MA [and orphan designation

By 277

Approval - product can be launched!

Submit closing sequence to procedure to including final product information pdfs in all languages, final RMP, and any approved documents/responses not already submitted through eCTD

14 Days after Decision

*Standing Committee is comprised of one expert per member state (plus additional experts as needed): https://ec.europa.eu/health/sites/health/files/files/pharm_stand_comm/2011_09_13_human.pdf

The Organisation for Professionals in Regulatory Affairs

Abbreviations: eCTD= electronic common technical dossier, QRD = Quality review of documents

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What EMA publishes regarding the procedure

Document

Location published

When

Summary of Opinion

CHMP meeting highlights and pending EC Decisions

Friday after CHMP meeting

Dedicated EMA press release

EMA home page and CHMP meeting highlights (highly innovative/ significant contribution to public health) Medicines' EPAR Page (each product has a dedicated page) Medicines' EPAR Page (under 'Product Information'). Also published on EC website

EPAR

EPAR Summary

2 weeks after EC Decision

Product Information (all languages)

List of authorised presentations

Medicines' EPAR Page

Public Assessment Report

Medicines' EPAR Page

Orphan Medicine Assessment Report (OMAR) and Summary

Medicines' page and also under rare diseases designations

2 weeks after EC Decision

Dates for publishing EPAR and Orphan report are approximate, may be slightly sooner or later SOURCE: https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when

The Organisation for Professionals in Regulatory Affairs

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