04 February 2012

EMA Proposes Solution to Address Some EVMPD Concerns – By Adam Sherlock Director, CSC's Life Sciences group and Andrew Marr

The EMA has given the industry breathing space in the lead up to the 2nd July EVMPD mandate, however the date for EVMPD implementation remains unchanged. In response to concerns raised by the industry around the short timeline to comply with the regulation, particularly with regard to the structured substance information (SSI), the agency has proposed a substantial reduction of the mandatory data set for July 2012. Specifically, the agency has proposed the following solutions to address concerns:

1. The submission of the SmPC only and this to be used solely for validation purpose

2. Clarification of the language requirements depending on the authorisation procedure, which amounts to:
  • English language agreed SmPC text is all that would be required for DCP/MRP
  • National language(s) SmPC for national products would be required
3. Reduction of the mandatory data set for medicinal products compared with July 2011

4. Not to request any mandatory data set for structured substances.

To find more information please use the below mentioned weblink

No comments:

Post a Comment