Is there any other generic on the market? If so, contact OGD and ask with product is going to become the new RLD. If not, you may need to do a controlled correspondence and inform OGD what you plan is and they will inform you on what information they will need from you.
-------------------------------------------
John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States
-------------------------------------------
Original Message:
Sent: 04-13-2015 03:20
From: Ashish Prashar
Subject: Innovator withdrawn: Generic SmPC
Hi All,
We need to prepare SmPC/PIL of a generic product in line with reference product, however reference product is now withdrawn. Can we prepare it in line with any generic product.
-------------------------------------------
Ashish
Senior Regulatory Executive
United Kingdom
-------------------------------------------