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Brexit

Fimea encourages MAHs to follow the updates of the CMDh and CMDv pages as well.

What has to be taken into consideration if the Marketing Authorisation holder (MAH) or registration holder of the medicinal product is located in the UK at the moment?

MAH or registration holder has to be located in the EU/EEA member state. Therefore the MAH or registration holder of the medicinal product located in the UK has to be relocated into EU/EEA member state before Brexit. Fimea encourages MAHs or registration holders to submit MAH or registration holder transfer applications to Fimea as soon as possible in order to avoid the database being congested at the end of March 2019.  MAH or registration holder transfer application can be submitted even if there are ongoing variations. The MAH or registration holder transfer applications will be assessed in 120 days.

What has to be taken into consideration if the only batch release site is located in the UK at the moment?

Batch release site can’t be located in the UK after Brexit. If the only batch release site of the medicinal product is located in the UK, the MAH or registration holder has to apply for a new batch release site that is located in EU/EEA member state with an appropriate variation.

Batches released before Brexit:

Batches released in the UK before Brexit and still stored in the UK after Brexit can’t be brought to EU/EEA  area without a new release

Batches released in the UK before Brexit and brought to EU/EEA area before Brexit can be sold and the batch doesn’t need a new release

If Fimea has approved that the packages of two marketing authorisation holders or registration holders may be simultaneously on the market as part of the MAH or registration holder transfer application, how this is possible after Brexit for medicinal products whose MAH or registration holder has been located in the UK?

Packages of two marketing authorisation holders or registration holders may be simultaneously on the market also after Brexit. If there will be no contract between UK and EU similar to the contract between current EEA member states, the Qualified Person (QP) located in UK isn’t allowed to release medicinal products into the EU/EEA market. The QP releasing medicinal products into the EU/EEA market must be located in EU/EEA member state.

What will happen to those medicinal products whose MAH or registration holder is located in the UK and for which no MAH or registration holder transfer has been applied for before Brexit?

If there will be no contract between UK and EU similar to the current contract between EEA member states, the legal grounds for maintaining the Marketing Authorisation or registration aren’t valid anymore. Fimea has to take appropriate legal action regarding these medicinal products.

What will happen to those medicinal products whose only batch release site is located in UK and for which no change of batch release site has been applied before Brexit?

Fimea will take appropriate legal action regarding these medicinal products too.

If the batch control testing is not possible to transfer into EU/EEA area in time before Brexit, how should the exemption be applied for?

The exemption request should follow the instructions published on CMDh website

The exemption request should be submitted before Brexit to Fimea to the following address: 

FI-Brexit-QC@fimea.fi 

Where can more information concerning Brexit be asked?

  • HUM: MRP(a)fimea.fi
  • VET: heidi.mustalammi(a)fimea.fi

What will happen to those medicinal products whose QPPV or PSMF is located in the UK after Brexit?

The QPPV or PSMF can’t be located in the UK after Brexit and therefore the MAH or registration holder should move these into EU/EEA area and submit an appropriate notification.

11 Apr 2019