Chapter 1 of the CMDh Best Practice Guide for the submission and
processing of variations in the Mutual Recognition Procedure (see
http://www.hma.eu/96.html) describes how variation
numbers should be assigned.
In most cases, the applicant can assign the number himself, but
there are two exceptions:
- Grouped applications concering more than one marketing
authorisation (which by definition is limited to type IA
variations)
- Worksharing applications
With this e-form only variation numbers for these two kind of
applications can be requested. Procedure numbers for grouped
applications concering a single marketing authorisation can be
assigned by the applicant himself, according to the instructions
given in Chapter 1 of the CMD Best Practice Guide. In case of
doubt, the case manager can be contacted. Procedure numbers for new
applications (MRP or DCP) should be requested by the case
manager.
.