If a situation with a large amount of applications occurs, the Norwegian Medicines Agency (NoMA) will prioritise biologicals, antibiotics and veterinary medicines for fish.
The European medicinal collaboration are in agreement that the following criteria must be fulfilled:
- Norway is currently a Concerned Member State in the relevant procedure.
- All current regulatory procedures with UK as RMS (e.g. variations applications, renewals) must be completed before a switch of RMS can take place. The MAH may however approach NoMA in advance with an informal request, thus allowing an immediate switch of RMS when ongoing procedures are completed.
Requests for switch of RMS to NoMA should be addressed to MT@noma.no using the “Template for RMS change”.
There are no fee charges for switching RMS to NoMA.
For more information on matters MAHs should be aware of in relation to Brexit, please refer to information published by CMDh and CMDv.