Mutual Recognition Process

All EU agencies are equal and should recognise each other’s approvals. One agency can review for the whole EU.

Selection of MRP

• Flexibility
• Can choose RMS for an existing MA
• Possibility to withdraw before day 90
• Early dialogue with the RMS
• Speed of first launch
• Business flexibility
  • 1st approval may allow registration process to begin in some export markets

Criteria for Selecting a RMS

• Importance/size of market within EU
• Credibility of RMS, resolving issues with CMS
• Long-term partnership
• Open to dialogue
• Consideration of future variations
• Expertise in respective medial field
• Respecing time tables

Role of RMS in MRP

• Acts as scientific assessor – write AR objectively
• Acts as regulatory advisor to applicant
• Planning MR phase
• Setting timelines
• Acts as moderator in between applicant and CMS
• Supports and represents applcants to CMS
• Input to common “European” – SmPC
• Update of Assessment Report

Role of Applicant in MRP

• Set start date for MRP
• Submission
• Dossier and SmPC must be identical to the MA in the RMS
• Responding to questions
• Negotiating SmPC
• Updating the dossier

Role of CMS in MRP

• CMS should recognise approval in RMS
  • Unless “public health” concerns are raised
  • Give final opinions at latest day 85
• CMS concerns
  • Notification to RMS, other CMSs and applicant within first 50 days
• Discussion of SmPC
  • Concentrate on Indications, Administration, Contra-Indications, Warnings, and Shelf-life storage