Module 12 2019

Envelope information

EU Module 1, v2.0 EU Module 1, V3.0.1

Envelope country

Envelope country

Per country an envelope

it

New field, system should generate this

25635f23-a3a4-c4e0- b994-99c5f074960f 596

UUID

Submission type

Submission type

New types

maa

Submission mode

Submission mode

Only for variations

Single

Submission number

Submission number

Only for grouping / WS

EMEA/H/xxxx/WS/001

Tracking number

Tracking number

Any nr to track

NL/H/0126/001

Submission Unit

Description of the submission type initial

Applicant

Applicant

Company name

Asphalion

Agency

Agency

Agency name

EU-EMA

Procedure type

Procedure type

MRP/DCP/NAT/CP

centralised

Invented-name

Invented-name

Product name

WonderPill

INN

INN

International Non-proprietary Name Sildenafil

Sequence

Sequence

Sequence number

0000

Related sequence

Related sequence

Always mandatory

0000

Submission description Submission description Free text field

Original MAA Application for

The Organisation for Professionals in Regulatory Affairs