Request for a zero-day MRP/RUP - #00022
Applicant intends to submit a “zero day” MRP for the below mentioned product with Iceland as the only CMS. The product is authorised via a national procedure in the below mentioned country which will act as RMS
Name and address of the applicant:
Name:
Tel:
Email:
Product:
Proposed name of the medicinal product in in Iceland:
Name of the medicinal product in RMS:
Select Domain
- Choose Domain -
Human use
Veterinary use
Human and Veterinary use
Procedure number:
Dosage Form:
Strength:
Active Ingredient:
Indication(s):
Country which will act as RMS:
Other member states where the product is authorised:
Proposed legal status (Rx / OTC):
- Choose RX or OTC -
Rx
OTC
Is the full dossier available? (Yes / no)
Yes
No
Intended submission date:
Reason for requesting a zero-day procedure:
Other CMS in the Zero day procedure (if applicable) :
Contact person on behalf of the applicant:
Name:
Tel:
Email:
Email of NCA that will act as RMS:
Is the RMS approval available?
Yes - please attach the RMS approval
No – RMS is pending approval
Approval of RMS:
