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

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]

Added In November 2024 4 November  NEW - PSUFU SmAR Fluoroquinolones (for systemic and inhalation use)

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 [...]

Fluoroquinolones (for systemic and inhalation use)Date of publication: 04/11/2024 

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]

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) [...]

Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus.