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

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.