The United Kingdom has formally left the European Union on 31 January 2020 and has become a third country to the EU. On 1 February 2020 a transition period has started which will end on 31 December 2020. During the transition period, EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ has continued to be applicable to the UK.
In preparation of the end of the transition period, the CMDh has updated its “Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP” to further address the changes applicable after 31 December 2020.
As of 1 January 2021, the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) will apply. The IE/NI Protocol provides that the EU pharmaceutical acquis applies to and in the United Kingdom in respect of Northern Ireland. For that purpose, the CMDh has drafted a new guidance document (“CMDh Practical Guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP”), which addresses the implications of the IE/NI Protocol in relation to MRP/DCP.
Both, updated and new guidance documents will be published on the CMDh website under “Brexit”.
The CMDh is also in the process of updating other guidance documents/contact point lists etc., where references to UK will be replaced by UK(NI), as appropriate.