EMA PSUR Repository

Denotes mandatory fields

EU-Single assessment

Procedure number:

Submission deadline:

Data lock point:

Active substance:

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Rapporteur name:

{{currentProcedure.rapporteurName}}

Rapporteur country:

{{currentProcedure.countryName}}

Rapporteur contact details

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Non-EU single assessment

Member state

Data lock point

Submission format:

Submission format is required

Select products:

MAH products to which the submission relates:

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.

{{shortProduct.name}} Sequence number: {{shortProduct.sequenceNumber}}

EMA number

Sequence number