X.C.2. Criteria for defining the initial time period of maintenance in the additional monitoring list

X.C.2.1. Mandatory scope

For medicinal products containing new active substances as well as for all biological medicinal products approved after 1 January 2011 the initial period of time for inclusion is five years after the Union Reference Date (URD) referred to in Article 107c(5) of Directive 2001/83/EC.

X.C.2.2. Optional scope

The period of time for inclusion in the list of medicinal products authorised subject to conditions is decided by the European Commission or the national competent authority, as appropriate, is linked to the fulfilment of the conditions and obligations placed on the marketing authorisation.

If new conditions are imposed to the marketing authorisation during a product’s lifecycle, it is envisaged that a medicinal product previously removed from the list can be added to the list again if for example the criteria stipulated in Article 23(2) of Regulation (EC) No 726/2004 are met again.