Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Colleagues

Can I file two separate applications via centralised procedure for same molecule with different applicants, different composition (one as 1:1 copy of innovator and other as non infringing composition) , different finished product manufacturing site and different API vendors.


Thank You and Best Regards

Is that application ANDA ?

------------------------------
Gaurang Bhavsar, MS, RAC
Scientist-II, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
------------------------------

Original Message:
Sent: 10-Jul-2017 00:20
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

Hello Colleagues

Can I file two separate applications via centralised procedure for same molecule with different applicants, different composition (one as 1:1 copy of innovator and other as non infringing composition) , different finished product manufacturing site and different API vendors.


Thank You and Best Regards

The simple answer is Yes.

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

Original Message:
Sent: 10-Jul-2017 00:20
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

Hello Colleagues

Can I file two separate applications via centralised procedure for same molecule with different applicants, different composition (one as 1:1 copy of innovator and other as non infringing composition) , different finished product manufacturing site and different API vendors.


Thank You and Best Regards

This message was posted by a user wishing to remain anonymous

​Thank You Steve.

I have another question to add on.

In case one of my product (for which reference medicinal product is centrally authorised) is approved via De centralised procedure, then, is there any possibility to submit an application via centralised procedure (considering reference product as CP) for the same molecule with different applicant , different composition (as 1:1 copy of innovator) , different finished product manufacturing site and different API vendors.

Thank You and Regards

Original Message:
Sent: 11-Jul-2017 07:50
From: Steve Binysh
Subject: Centralised Procedure

The simple answer is Yes.

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

Original Message:
Sent: 10-Jul-2017 00:20
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

Hello Colleagues

Can I file two separate applications via centralised procedure for same molecule with different applicants, different composition (one as 1:1 copy of innovator and other as non infringing composition) , different finished product manufacturing site and different API vendors.


Thank You and Best Regards

This message was posted by a user wishing to remain anonymous

I believe "YES". Because, a generic or hybrid medicinal product of a reference medicinal product authorised via the centralised procedure has 'automatic' access to the centralised procedure under Article 3(3).

See,
Q n A on EMA site for "Pre Authorisation Guidance"
Original Message:
Sent: 13-Jul-2017 02:10
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

​Thank You Steve.

I have another question to add on.

In case one of my product (for which reference medicinal product is centrally authorised) is approved via De centralised procedure, then, is there any possibility to submit an application via centralised procedure (considering reference product as CP) for the same molecule with different applicant , different composition (as 1:1 copy of innovator) , different finished product manufacturing site and different API vendors.

Thank You and Regards

Original Message:
Sent: 11-Jul-2017 07:50
From: Steve Binysh
Subject: Centralised Procedure

The simple answer is Yes.

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

Original Message:
Sent: 10-Jul-2017 00:20
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

Hello Colleagues

Can I file two separate applications via centralised procedure for same molecule with different applicants, different composition (one as 1:1 copy of innovator and other as non infringing composition) , different finished product manufacturing site and different API vendors.


Thank You and Best Regards

This message was posted by a user wishing to remain anonymous

​Thank You Steve

Actually we had in-licensed this product and submitted via DCP in our name to get early market entry. Now, we have our own manufacturing facility and I&D where this product has been developed and scaled up. For this product we need to strategize if we can go ahead via CP or not (considering generic of Centrally authorized product). We intend to withdraw the DCP product once the application via CP gets approved.
But, initially is it possible to submit an application via CP (with different CMC) for this product for which we have a DCP in place.

Thank You and Regards
Original Message:
Sent: 14-Jul-2017 02:35
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

I believe "YES". Because, a generic or hybrid medicinal product of a reference medicinal product authorised via the centralised procedure has 'automatic' access to the centralised procedure under Article 3(3).

See,
Q n A on EMA site for "Pre Authorisation Guidance"
Original Message:
Sent: 13-Jul-2017 02:10
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

​Thank You Steve.

I have another question to add on.

In case one of my product (for which reference medicinal product is centrally authorised) is approved via De centralised procedure, then, is there any possibility to submit an application via centralised procedure (considering reference product as CP) for the same molecule with different applicant , different composition (as 1:1 copy of innovator) , different finished product manufacturing site and different API vendors.

Thank You and Regards

Original Message:
Sent: 11-Jul-2017 07:50
From: Steve Binysh
Subject: Centralised Procedure

The simple answer is Yes.

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

Original Message:
Sent: 10-Jul-2017 00:20
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

Hello Colleagues

Can I file two separate applications via centralised procedure for same molecule with different applicants, different composition (one as 1:1 copy of innovator and other as non infringing composition) , different finished product manufacturing site and different API vendors.


Thank You and Best Regards

I think your proposed strategy will be acceptable to the EMA but you should ask them to confirm it before making the submission.
Have you considered submitting a variation to the DCP product for the new formulation and API suppliers or is it excluded by the agreement with the original licensor?
Steve

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

Original Message:
Sent: 18-Jul-2017 01:39
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

​Thank You Steve

Actually we had in-licensed this product and submitted via DCP in our name to get early market entry. Now, we have our own manufacturing facility and I&D where this product has been developed and scaled up. For this product we need to strategize if we can go ahead via CP or not (considering generic of Centrally authorized product). We intend to withdraw the DCP product once the application via CP gets approved.
But, initially is it possible to submit an application via CP (with different CMC) for this product for which we have a DCP in place.

Thank You and Regards
Original Message:
Sent: 14-Jul-2017 02:35
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

I believe "YES". Because, a generic or hybrid medicinal product of a reference medicinal product authorised via the centralised procedure has 'automatic' access to the centralised procedure under Article 3(3).

See,
Q n A on EMA site for "Pre Authorisation Guidance"
Original Message:
Sent: 13-Jul-2017 02:10
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

​Thank You Steve.

I have another question to add on.

In case one of my product (for which reference medicinal product is centrally authorised) is approved via De centralised procedure, then, is there any possibility to submit an application via centralised procedure (considering reference product as CP) for the same molecule with different applicant , different composition (as 1:1 copy of innovator) , different finished product manufacturing site and different API vendors.

Thank You and Regards

Original Message:
Sent: 11-Jul-2017 07:50
From: Steve Binysh
Subject: Centralised Procedure

The simple answer is Yes.

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

Original Message:
Sent: 10-Jul-2017 00:20
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

Hello Colleagues

Can I file two separate applications via centralised procedure for same molecule with different applicants, different composition (one as 1:1 copy of innovator and other as non infringing composition) , different finished product manufacturing site and different API vendors.


Thank You and Best Regards

Your scenarios are complex and v unusual so a little more background would help.
If I understand correctly, you have two separate products referencing the same innovator product.   Can you describe why you have two different formulations and different API suppliers?  And what is the relationship between the applicant for the  CP and DCP filings?

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

Original Message:
Sent: 13-Jul-2017 02:10
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

​Thank You Steve.

I have another question to add on.

In case one of my product (for which reference medicinal product is centrally authorised) is approved via De centralised procedure, then, is there any possibility to submit an application via centralised procedure (considering reference product as CP) for the same molecule with different applicant , different composition (as 1:1 copy of innovator) , different finished product manufacturing site and different API vendors.

Thank You and Regards

Original Message:
Sent: 11-Jul-2017 07:50
From: Steve Binysh
Subject: Centralised Procedure

The simple answer is Yes.

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

Original Message:
Sent: 10-Jul-2017 00:20
From: Anonymous Member
Subject: Centralised Procedure

This message was posted by a user wishing to remain anonymous

Hello Colleagues

Can I file two separate applications via centralised procedure for same molecule with different applicants, different composition (one as 1:1 copy of innovator and other as non infringing composition) , different finished product manufacturing site and different API vendors.


Thank You and Best Regards