MRP/DCP Support
Mutual Recognition Procedure SupportOn behalf of the applicant, Arriello can provide full MRP support. In practice, this means that we can:
- Day 14 - Submit the dossier to CMS. RMS circulates the AR including SPC, PL and labelling to CMSs. Arriello will validate the application in the CMSs
- Day 60 - Send the response document to CMSs and RMS
- Close+30 - Arriello sends high quality national translations of SPC, PL and labelling to CMSs and RMS (which can be prepared by Arriello - see Translation Services)
Decentralised Procedure Support
- Pre Day -14 Arriello discussions with RMS on behalf of applicant
- Day –14 Submission of the dossier to the RMS and CMSs
- Day 105 Consultation between RMS and CMSs and Arriello on behalf of applicant. If consensus not reached RMS stops the clock to allow Arriello to supplement the dossier and respond to the questions
- Clock Stop period - Arriello may send draft responses to the RMS and agree the date with the RMS for submission of the final response. Arriello sends the final response document to the RMS and CMSs
- - 180 (Day 60) If consensus is not reached by day 150, Arriello and RMS to discuss any outstanding issues
- Day 110/125/155/215/275 - Arriello sends high quality national translations of SPC, labelling and PIL to CMS and RMS (which can be prepared by Arriello - see Translation Services)
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