The dearth of communication from the EMA on how to proceed with the EVMPD has left companies uncertain. Questions remain unanswered, or answers are given to just the company asking and that information isn’t being shared across the industry.
As I gather information from the agency and elsewhere, I’m keen to find ways to share this with industry. My hope is this will also prompt others to share what they know, so our collective knowledge serves us all. Over the next two blogs, I’ll address some of the issues that have been uppermost in the minds of regulatory leaders across the industry.
There have been many questions as to what language should be used for the authorised product and approved substance. There’s been much back and forth on this, but it seems certain that for National, MRP and DCP procedures the following must be provided in local language: Presentation name (and its various parts), package description and the Printed Product Information (PPI). Complexities arise for countries with more than one language since the current design of the XEVMPD allows only one presentation name, one package description and one PPI attachment. The required approach is therefore to submit an authorised product record in each language, so for Belgium there would be three records submitted, one each in French, Dutch and German.
A decision on the Centralized procedure is still to be made. Although it had been stated that only English needed to be submitted, there has been debate about requiring all languages. If this eventuates it won’t be easy as it will require submitting a record for each language.
To find more information please use the below mentioned weblink
No comments:
Post a Comment