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 [...]
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 Recognition Procedures for Variations (October 2024) [...]
Guidance is available on the implementation of the amended Variations Regulation (EU) 2024/1701 for variation applications implemented and submitted from 1 January 2025. This guidance provides instructions on the implementation of the amended Variations Regulation applicable as of 1 January 2025 that includes amendments to the Article 5 procedure, on the annual update for minor [...]
Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 (October 2024) [Track version]
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]