Denotes mandatory fields

EU-Single assessment

Active substance:
Rapporteur name:
Rapporteur country:
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  • {{rData.errors.noPsurSubmitted}}

Non-EU single assessment

Submission format is required
  • No products have been selected.
  • EMA number should be 6 digit.
  • Sequence number must be 4 digit number.
  • An eCTD submission cannot contain more than one sequence.
  • Product is already selected for submission.
  • Sequence number required.
  • Mix of CAP and NAP products are not allowed.
  • There are no products currently associated to this procedure number.
  • Contact email not in correct format.
  • Cannot modify the submission format, please delete the sequence and try again.
  • Period Covered From should always be before Period Covered To.
  • Please select a valid selection for Submission unit (initial, response, closing).