Danish MA fully booked as RMS

The Danish Medicines Agency has said that, while it wants to participate actively in the decentralized procedures for drugs approvals in the European Union as reference member state, it has received many more application requests than it is able to accommodate. To ensure that it can act in this capacity, in as many procedures as possible, the Agency is advising pharmaceutical companies wanting to use Denmark as the RMS to make a time slot request well in advance of the expected date of submission of the application.

It points out that 2008 and the first half of 2009 are fully booked. The Agency will therefore not allocate time slots for DCP applications with Denmark as RMS for any further requests submitted for this time period. From May 1, it will resume the allocation of time slots for decentralized procedures with Denmark as RMS for the second half of 2009. It expects to reply to these requests at the beginning of July 2008. Also with effect in May, a detailed procedure and request form will be available on the Agency's web site.