“AEMPS extends the deadlines until May 25, 2021 for the adequacy of the labeling and instructions for use of health products as a result of the changes made by Brexit.”

 

On February 1, 2020, the United Kingdom ceased to be considered a Member State of the EU to become a third country, as stated in the Withdrawal Agreement, ratified by the European Parliament.

From this date a transition period comes into force which will last until next December 31st allowing, for practical purposes, everything to remain the same for health product companies in both the European Union and the United Kingdom.

In November 2019, the informative note PS, 29/2019 was published establishing a deadline until June 30, 2020 for the adequacy of the labeling and instructions for use of health products as a result of the changes made as a result of Brexit.

Faced with the difficulty that this change is posing to companies and considering the consequences derived from the COVID-19 pandemic, which may have hindered its implementation, the AEMPS has considered extending the deadline until May 25, 2021, in order for the companies that are in this situation to finalize the adaptation of the labels and the instructions for use of the products to the changes made.

All relevant information is updated and developed in detail on the AEMPS website.

 

Article Source: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).