Guidance applicable from 1 January 2025 Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition ProcedureChapter 1: CMDh BPG for the Allocation of the Mutual Recognition Variation Number for Type I Notifications, Type II Variations, Grouping and Worksharing (October 2024) [Track version]Chapter 2: Procedure for Automatic Validation of Mutual [...]
Added In November 2024 4 November NEW - PSUFU SmAR Fluoroquinolones (for systemic and inhalation use)
Fluoroquinolones (for systemic and inhalation use)Date of publication: 04/11/2024
Template request for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No 1234/2008 (October 2024) [Track version]
Template Letter of Intent for the submission of a type IA super-grouped procedure to the reference authority according to Article 7a of Commission Regulation (EC) No 1234/2008 (October 2024) [Track version]
Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus.
Best Practice Guide for the exchange of regulatory and administrative information regarding orphan medicinal products between EMA and National Competent Authorities (October 2016, correction March 2024) [Track version]
Overview of timetables 2024 (September 2023)Overview of timetables 2025 (September 2024)
Following the adoption of the E11A Guideline, a Step 4 Introductory Training Presentation has been developed by the E11A Expert Working Group.
Loperamide, loperamide/simethiconeEnd of procedure: 25/05/2024Date of publication: 25/09/2024