Infarmed established a monthly list of medicines with suspended exports, which includes 163 presentations of quetiapine. This antipsychotic is used in the treatment of schizophrenia, bipolar disorder, and depression, with the suspension motivated by supply difficulties.
According to Infarmed, the supply restrictions for this medicine are expected to last until the end of the year. These difficulties are linked to production stoppage caused by microbial contamination identified in a factory located in Greece, which supplies most of the Marketing Authorisation holders in Portugal.
This supply problem does not only affect Portugal, extending also to other member countries of the European Union.
The list, issued by the National Authority of Medicines and Health Products (Infarmed) and which came into effect on Tuesday, covers drugs whose exit from the country is temporarily prohibited. The objective of this measure is to ensure that the national market maintains its supply, applying to all parties in the commercial chain, including manufacturers.
This list is prepared monthly and includes both medicines that experienced failures in the previous month and whose impact was classified as medium or high, as well as those being supplied under an Exceptional Use Authorization (EUA).
Infarmed monitors daily all information related to shortages, interruptions, and cessation of marketing, with the aim of identifying and preventing critical situations that may compromise the availability of medicines.
Additionally, the national medicine authority is part of the European network of contact points for competent entities, including the European Medicines Agency (EMA) and the European Commission. This network has been used since April 2019 to share data on supply disruptions and issues regarding the availability of medicines approved in the European Union.