Variations for Medicinal Products authorised by purely national procedure
Friday, September 03, 2010
From 1 October, the MPA will accept variation applications for nationally authorised products only if they are submitted according to the new variation regulation (EC) No 1234/2008.
The variation regulation (EC) No 1234/2008 applies from 1 January 2010 for medicinal products approved via the mutual recognition procedure (MRP), decentralised procedure (DCP) and the Centralised procedure.
During a transition period, companies have been able to submit variations for nationally approved medicinal products under both the old and the new regulation. The MPA has now decided that the variation regulation (EC) No 1234/2008 shall apply even for nationally approved medicinal products from 1 October, 2010, i.e. from 1 October, 2010, the MPA will accept variation applications for nationally authorised products only if they are submitted according to the variation regulation (EC) No 1234/2008.
Further information/documents can be found on the webpage on variations.