2. Variations
2.6. Extension
Certain changes to a Marketing Authorisation, have to be considered to fundamentally alter the terms of this authorisation and therefore cannot be granted following a variation procedure. These changes are to be submitted as ‘Extensions of marketing authorisations’. They are listed in Annex I of the Variations Regulation and comprise two main categories:
1. Changes to the active substance(s) where efficacy and safety characteristics are not significantly different.
2. Changes to strength, pharmaceutical form and route of administration.
Such applications will be evaluated in accordance with the same procedure as for the granting of the initial MA.
The extension can either be granted as a new MA or will be included in the initial MA to which it relates. It is important to remember that a completely new indication for a product already on the market requires a new MA.