Templates for assessors
Submitted by Anonymous (not verified) on 5 November 2026 - 13:00
Templates for assessors
Assessment report for PSUSA NAPs
Submitted by Anonymous (not verified) on 5 November 2026 - 12:57
Assessment report for PSUSA NAPs
Assessment report for PSUSA CAPs
Submitted by Anonymous (not verified) on 5 November 2026 - 12:56
Assessment report for PSUSA CAPs
Nitrosamine impurities: guidance for marketing authorisation holders
Submitted by Anonymous (not verified) on 5 November 2026 - 10:50
Nitrosamine impurities: guidance for marketing authorisation holders
Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
Submitted by Anonymous (not verified) on 5 November 2026 - 10:49
Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
PSUSA/00001308/202603
Submitted by Anonymous (not verified) on 5 November 2026 - 8:00
PSUSA/00001308/202603
Suboxone : EPAR - Procedural steps taken before authorisation
Submitted by Anonymous (not verified) on 5 November 2026 - 1:00
Suboxone : EPAR - Procedural steps taken before authorisation
List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
Submitted by Anonymous (not verified) on 4 November 2026 - 16:35
List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
Ophthalmic devices ‐ other - Notified Body 0123 - 12/01/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)
Submitted by Anonymous (not verified) on 4 November 2026 - 16:16
Ophthalmic devices ‐ other - Notified Body 0123 - 12/01/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)
Resorbable filling and reconstruction devices - Notified Body 2797 - 08/05/2026 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)
Submitted by Anonymous (not verified) on 4 November 2026 - 16:13
Resorbable filling and reconstruction devices - Notified Body 2797 - 08/05/2026 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)