Date Reference Lead RMS Address Subject Letter Of Intent

date reference lead rms address subject: letter of intent for the submission of a type ia grouped procedure (“supergroup”) t

Lead RMS address
Subject: Letter of intent for the submission of a type IA grouped
procedure (“Supergroup”) to the Lead RMS authority according to
Article 7 of Commission Regulation (EC) No 1234/2008
Supergroup Applicant details:
Name
====
:
 
Address
:
 
Contact person details
(i.e. name, address, e-mail address, phone number)
:
 
Application details:
This letter of intent for the submission of a < group of
variations> following a grouping procedure according to Article 7 of
Commission Regulation (EC) No 1234/2008, concerns the following
medicinal products:
(or as an Annex I)
Medicinal product
Active substance(s)
MRP/DCP number
<(invented)Name in RMS >

The following variation(s) are intended to be part of the IA
supergroup procedure:
Number as in the classification guideline:
Title of variation as in the classification guideline
Type of variation: