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)

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)

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”