With its withdrawal from the EU, the United Kingdom of Great Britain and Northern Ireland (UK) will become a third country. As a result, certain medicinal products and medical devices will no longer be marketable in the EEA after this date unless appropriate measures are taken in good time. This applies not only in the case of a hard Brexit, but also in many cases when the UK withdraws from the EU in a regulated manner according to a withdrawal agreement.
For medicinal products with a centralised marketing authorisation, the marketing authorisation holder must be established in the EEA (EU, Norway, Iceland or Liechtenstein). If the current marketing authorisation holder has an address in the UK, the marketing authorisation must be transferred before the UK withdraws from the EU. Otherwise, the medicinal product will no longer be marketable in the EEA.
In addition, medicinal products for which batch release takes place in the UK may no longer be placed on the market in the EEA after Brexit. Batch release must therefore take place within the EEA after the UK has left the EU. The pharmacovigilance master file and the pharmacovigilance officer may also not remain in the UK after Brexit. This may necessitate changes to internal processes, logistics and the supply chain.
Action is also necessary if approval has been granted in the mutual recognition procedure (MRP) or in the decentralised procedure (DCP). If the UK is the reference member state (RMS), the marketing authorisation holder must designate a new RMS within the EEA; it cannot make any regulatory submissions until a new RMS has been designated. On-going procedures in which the UK is the RMS that have not been completed when Brexit occurs must be carried out with another RMS after Brexit.
Medical devices from a UK manufacturer will become, after Brexit, medical devices from a third country. They therefore require an authorised representative established in the EEA to be responsible for the declaration of conformity and the legality of the medical device.
Medical devices whose conformity assessment was carried out with the assistance of a notified body from the UK are no longer marketable in the EEA after Brexit and may therefore only be placed on the market in the EEA after a new conformity assessment has been carried out. In order to avoid an interruption of market access, it may therefore be necessary to change the notified body in good time before Brexit.