This document outlines different groupings for type IA variations that can be submitted together, including several type IA variations affecting one or multiple marketing authorizations from the same marketing authorization holder. It also allows for related groupings defined in Annex III of the Regulation or by national competent authorities. The document provides examples of type IA variations that can be grouped, such as deletion of a manufacturing site or tightening of specification limits. It describes worksharing where the same group of variations can affect multiple marketing authorizations from the same marketing authorization holder in a single application.

1. Groupings:
• Several Type IA or IAIN affecting one MA
• One Type IA or change affecting several MAs from the
same MAH
Tightening of specification limits (change code B.II.d,a)
Deletion of a manufacturing site (change code A.7)
Change in the name and/or address of a manufacturer
of the active substance (change code A.4)

2. Groupings:
• Several Type IA and/or IAIN affecting several MA from the same
MAH*
• Consequential/related groupings refer to Annex III of the Regulation
or National Competent Authority for approval or published examples
*Please note that it
is not acceptable to
mix national and
MR/DC procedures
and that the same
set of type IA
variations must be
submitted for all the
MAs.
Deletion of a manufacturing site (change code A.7)
Deletion of a manufacturing site (change code A.7)
Tightening of specification limits (change code B.II.d,a)
Tightening of specification limits (change code B.II.d,a)

3. Worksharing:
• Same group of variations affecting more than one marketing
authorisation from the same MAH* in one application (see Article
20 of the Variations Regulation)
*Please note that applicants belonging to the
same mother company or group of companies and
applicants having concluded agreements or
exercising concerted practices concerning the
placing on the market of the medicinal product(s)
concerned, have to be taken as “the same
marketing authorisation holder”