Centralised authorisation procedure

10 September 2018
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The British medicines agencies in both the human and veterinary fields (MHRA and VMD) have undertaken a number of tasks on behalf of the community. These tasks must now be undertaken by the remaining EU countries.

Together with the EMA and the other medicines agencies in the EU, the Danish Medicines Agency has therefore worked determinedly to create an overview of the tasks to be distributed and the resources available. We are actively involved in this process so that we can take on our share of tasks to ensure that the supply of medicines will be disturbed as little as possible by Brexit.

Together with the other agencies in the European network, we have assessed that there are many strong forces which together can undertake the tasks that the UK will no longer be handling. In this connection, the Danish Medicines Agency is one of the European agencies having the strength to undertake this work in a number of areas. We have therefore actively offered our contribution to handle the tasks to be distributed and have up until the beginning of July 2018 accepted to take over approximately 30 rapporteurships/co-rapporteurships in the human and veterinary fields. 

For information about what applies to centrally authorised products, we refer to the guidelines of of the CMDh/v and the EMA.

Links

CMDh Brexit information including Q&A

CMDv Brexit information including Q&A

The EMA's Brexit information

EMA identifies gaps in industry preparedness for Brexit

Practical Guideline Document (PDF)

 

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