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Spain to allow more time for post-Brexit labelling changes.

  • Posted by: inetika
  • Category: GLOBAL NEWS

The Spanish Agency of Medicines and Medical Devices medical device authorities (AEMPS) have published a notice indicating that companies will have until the end of June 2021 to change labels and instructions for use should the UK leave the EU without a deal at the end of the transition period on 31 December 2020. This is a change from the Agency’s position in 2019 that all medicinal products and medical devices, originating from the UK would be treated as if they were imported to the EU from a third country.

The Agency acknowledges the difficulties faced by medical device manufacturers in respect of Brexit uncertainty, in particularly those associated with labelling and instructions for use.

Industry has asked for an EU-wide approach to this issue but so far responsibility remains with each member state as to how they plan to act.