Variations - Worksharing for purely nationally authorised products not accepted
Monday, January 17, 2011
Worksharing does not apply to variations for purely nationally authorised products until the variation regulation (EC) 1234/2008 has been updated with information regarding nationally authorised products.
On the 20th of January 2011 all member states are obliged to have transferred to variation regulation (EC) 1234/2008 even for purely nationally authorised products. Note however, worksharing does not apply to variations for purely nationally authorised products until the variation regulation (EC) 1234/2008 has been updated with information regarding nationally authorised products.
For further information, see the report from CMDh in the right margin.