CMDh
- New - Template for Applicants to Prepare Similarity Report
- Update - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications (Clean / Tracked Version)
- Update - RMS validation checklist for human medicinal products in DCP
- Update - Request for MRP/RUP / Update assessment report
- Update - CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (Clean / Tracked Version)
- Update - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
- New - Overview of timetables 2023 - CMDh 60-day procedures for MRP/DCP applications
FDA
Health Canada
