Grouped variations

Article 64 of the Veterinary Medicinal Products Regulation provides the legal basis for grouped variations. 

Timetable

Grouped VRAs are processed according to the variation that has the longest timetable in the group submitted. It is to best to avoid grouping changes that have no links to each other. 

Definition of marketing authorisation

In the context of the group approach described above, a marketing authorisation is defined as follows:

All strengths and pharmaceutical forms of a particular product. In the context of MRP/DCP products, this means that all products associated with the same root number (e.g., AT/V/1234/001-n) must be considered as falling under the same marketing authorisation.

The marketing authorisations in question may have been issued in the national procedure, the Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP).

Only variations requiring assessment are eligible

A GV procedure will always relate to variations that require assessment (VRA). GV procedures do not cover variations not requiring assessment (VNRA).

A VRNA is not eligible for a GV procedure, even if it is related to changes that are being assessed in the GV procedure. In these circumstances, you must submit both types of variations in a way that makes it possible to approve the variations simultaneously.

Characteristics of GV procedures

• If a single marketing authorisation has multiple VRAs, it is possible to combine them in a single application.
• If you have one or more identical VRAs for several different marketing authorisations and the authorisations are held by a single marketing authorisation holder and involve a single RMS, you will be able to submit a single grouped application for all those marketing authorisations.
• A grouped application for a single marketing authorisation means there is a single implementation that encompasses multiple changes. The implementation may relate to all strengths and all pharmaceutical forms of a single product. If there is only one identical change for several strengths or pharmaceutical forms within a single marketing authorisation, this does not count as a grouped implementation but as a single implementation.
• A grouped variation must be submitted as a single application with a single procedure number and only one CTS record. The number of the change procedure must be stated in the application form.

Outcomes of GV procedures

When variations are grouped, the individual variations submitted in the application can have different outcomes. Some variations may be approved while others might be rejected. Marketing authorisation holders are able to withdraw variations submitted in a grouped application when it becomes apparent that they will likely be rejected.

Grouped variations may have the following outcomes:

• Approval - all variations have been accepted;
• Partial approval: some variations have been accepted and others have been rejected or withdrawn;
• Rejection - all variations have been rejected, or some have been rejected whereas others have been withdrawn;
• Withdrawal - all variations have been withdrawn.

More information

If you have any further questions about the GV procedure, please contact the Veterinary Medicinal Products Unit.