Hi There
1. Does anyone know the implementation time of PRAC PSUR assessment report recommendations for a DCP authorized product. I have received a PRAC PSUR assessment report, but I do not see any publication on EC register. In below Q&A, I see the implementation by NCAs is 30 days from publication. Any idea on when does it get published on the website once MAH receives the PRAC PSUR assessment report.
Periodic safety update reports (PSURs) | European Medicines Agency (europa.eu)
Q&A No 31. How should I implement the outcome of a PSUSA ?
2. I have several Type IB and Type II variations planned for submission as a part of post approval commitment to Agency. Can the variation due to PSUSA be combined with the other planned variations?
Please share link to the guidance along with any pointers on above questions.
Thank you in advance for your guidance.
------------------------------
Sharry Arora, M.Ph, RAC
Ireland
------------------------------