Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Dear colleagues,

I would appreciate if someone can help me with my questions.

1) Do I need to submit a SmPC with the Presubmission request form for the Central Procudure Eligibility Request? Is a Target Product Profile (instead of the SmPC0 ok to include with the submission?

2) We do not have a Market Authorization Holder (MAH) yet. Is this acceptable to be eligible for the Central Procedure?  We will have ou MAH when we file our MAA.

Thanks!

Eligibility requests are submitted about 12 - 18 months before the planned submission date so the EMA would not expect to see the final SmPC.  It is good manners to prepare a draft SmPC, and complete section 4 as far as possible.  I don't believe the absence of an EU-based representative will be an issue at this stage.
Good luck with the application!
Steve


------------------------------
Steve Binysh
Acta Pharma Services Ltd
RUISLIP
United Kingdom
------------------------------

Original Message:
Sent: 12-Oct-2017 14:59
From: Anonymous Member
Subject: Central Procedure Eligibility Request (EU)

This message was posted by a user wishing to remain anonymous

​Dear colleagues,

I would appreciate if someone can help me with my questions.

1) Do I need to submit a SmPC with the Presubmission request form for the Central Procudure Eligibility Request? Is a Target Product Profile (instead of the SmPC0 ok to include with the submission?

2) We do not have a Market Authorization Holder (MAH) yet. Is this acceptable to be eligible for the Central Procedure?  We will have ou MAH when we file our MAA.

Thanks!

This message was posted by a user wishing to remain anonymous

​Thank you, Steve for sharing this information.
Original Message:
Sent: 14-Oct-2017 06:25
From: Steve Binysh
Subject: Central Procedure Eligibility Request (EU)

Eligibility requests are submitted about 12 - 18 months before the planned submission date so the EMA would not expect to see the final SmPC.  It is good manners to prepare a draft SmPC, and complete section 4 as far as possible.  I don't believe the absence of an EU-based representative will be an issue at this stage.
Good luck with the application!
Steve


------------------------------
Steve Binysh
Acta Pharma Services Ltd
RUISLIP
United Kingdom

Original Message:
Sent: 12-Oct-2017 14:59
From: Anonymous Member
Subject: Central Procedure Eligibility Request (EU)

This message was posted by a user wishing to remain anonymous

​Dear colleagues,

I would appreciate if someone can help me with my questions.

1) Do I need to submit a SmPC with the Presubmission request form for the Central Procudure Eligibility Request? Is a Target Product Profile (instead of the SmPC0 ok to include with the submission?

2) We do not have a Market Authorization Holder (MAH) yet. Is this acceptable to be eligible for the Central Procedure?  We will have ou MAH when we file our MAA.

Thanks!