Applications for renewal of purely national marketing authorisations (MA)
(06.03.2006)
According to new EU legislation MAs are, as a general rule, renewed once only. The MA then normally becomes valid without time limit. These new provisions should have been implemented in Norwegian legislation at the latest by 31 October, 2005.
However, the implementation can only be completed when an amended EEA Agreement is in place. Presently the Norwegian Medicines Agency (NoMA) is not in a position to give information as to when this will happen. Due to this situation the NoMA has decided the following concerning the renewal of purely national MAs:
MA’s with a renewal date of 1 July 2006 or later will be renewed such that the MAs normally will have unlimited validity. The condition for this is that the applications are submitted according to the present EU legislation with the correct EU application form and the requested documentation. In this particular situation the NoMA will have to accept deviation from the EU legislation in that applications for renewals shall be submitted no later than the 6 months before the expiry of the MA.
The measure above is taken by the NoMA on the assumption that the new EU legislation is not being implemented into Norwegian legislation before 1 July, 2006.
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