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Brexit

Brexit for marketing authorisation holders

Fimea advises marketing authorisation holders to also follow the updates made to the CMDh and CMDv websites.

Brexit-related guidance for companies (EMA)

Common guidelines from the Commission to prevent problems in the supply of medicines (25 February 2019)

What must be taken into account if the marketing authorisation holder (MAH) or registration holder is located in the United Kingdom after 31 January 2020? And what must be done if the sole manufacturer responsible batch release is located in the United Kingdom? Can the QPPV or PSMF of a medicinal product be located in the United Kingdom after Brexit?

The marketing authorisation or registration holder or the manufacturer responsible for batch release may be located in the United Kingdom until the end of the transition period (31 December 2020).  The QPPV or PSMF of a medicinal product may also be located in the United Kingdom until 31 December 2020. As the negotiations between the EU and the UK proceed, more detailed information will be provided on what will happen from 1 January 2021 onward when the transition period comes to an end.

If, in connection with the application for transfer of a marketing authorisation or registration to a new holder, Fimea has granted permission for simultaneous marketing for the packages of the old holder and those of the new one, will simultaneous marketing be possible after Brexit for medicinal products whose MAH or registration holder was located in the United Kingdom?

Simultaneous marketing will also be possible after Brexit. A Qualified Person (QP) who is located in the UK may release the medicinal product to the EU/EEA market until the end of the transition period (31 December 2020).

Is it necessary to apply for an exemption if batch control/testing is currently located in the United Kingdom?

Batch control may be normally located in the UK during the transition period, and there is no need to request for an exemption during this time.

Can the United Kingdom act as a Reference Member State (RMS) or Concerned Member State (CMS) after 31 January 2020?

The United Kingdom cannot act as a Reference Member State after 31 January 2020. The marketing authorisation holder cannot take any regulatory actions in respect of its marketing authorisations until a new Reference Member State has been assigned to replace the United Kingdom. However, the United Kingdom may continue its actions normally as a Concerned Member State.

   

Who can I contact for further information concerning Brexit?

Human medicines: mrp(a)fimea.fi

Veterinary medicines: heidi.mustalammi(a)fimea.fi

4 Feb 2020