Preparations for Brexit well underway in the pharmaceutical industry

The authorities and operators in the pharmaceutical industry have for quite some time already engaged in close cooperation to prepare for the changes brought about by Brexit and initiated measures to prevent potential disruptions in the supply of pharmaceuticals.

The Finnish Medicines Agency Fimea has, in collaboration with the European Medicines Agency and operators in the pharmaceutical industry, mapped out the products whose marketing authorisation holder or manufacturer responsible for the finished product is based in the United Kingdom. “The majority of operators have already transferred their marketing authorisation or operations to an EU or EEA country, in which case they can continue their operations unchanged even after Brexit,” says Esa Heinonen, Director of the Assessment of Medicinal Products process at Fimea. “Fimea has also instructed marketing authorisation holders and other operations to take the necessary actions to prevent potential supply problems.”

The situation picture will be updated, and the measures will be continued, in collaboration with pharmaceutical industry operators on a constant basis to avoid disruptions in the availability of medicines. Heinonen points out that marketing authorisation holders are required to notify any supply problems two months prior to their onset so that it will be known at the beginning of February at the latest if any problems are to be expected in the availability of certain medicines. In potential problem situations, pharmaceutical industry operators are required to determine, in collaboration with health care professionals, replacement products to safeguard the uninterrupted treatment of patients.

fimea.fi/brexit