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]

Template Cover letter for the submission of variation applications in the MRP (October 2024) [Track version]

EMA/CMDh Explanatory notes on variation application form (Human medicinal products only) (November 2024) [Track version]

Added in July 2025 01 July UPDATE - SOP on the processing of PSUR single assessment for nationally authorised productsUPDATE - Data requested for New Applications in the MRP/DCPUPDATE - Data requested for Variations and/or Renewal Applications in the MRP/DCPUPDATE - Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National ProceduresUPDATE [...]

LEGAL FRAMEWORK Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use (Variation Regulation) has entered into force on 7 July 2024. It became applicable on 1 January 2025. This regulation revised the rules setting [...]

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)