No export of 160 antipsychotic presentations

O Infarmed banned the export of more than 160 presentations of quetiapine, an antipsychotic, and about 50 other medicines, including antibiotics and drugs to treat cancer, according to circular that enters into force Friday.

The list of temporarily suspended export medicinal products includes drugs that were broken in October and whose impact was considered “medium to high”, as well as others that are being supplied under the Exceptional Use Authorisation (EUA).

In the list of 49 different medicines that cannot be exported are still antibiotics, vaccines and drugs to treat cardiac arrhythmias, dementia and migraines, among other diseases.

To the monthly list, Infarmed added 163 presentations of quetiapine, antipsychotic used to treat schizophrenia, bipolar disorder, and depression due to supply problems.

These supply problems, which are expected to continue by the end of the year, had already been reported by the regulator and are due to the suspension of manufacturing imposed by microbial contamination detected in a manufacturer in Greece.

The manufacturer concerned supplies most of the Marketing Authorisation Holders in Portugal and the problem also affects other countries of the European Union.

In November, the decision to suspend export also covers 15 presentations of estradiol, the main and most potent type of oestrogen (female sexual hormone).

The Infarmed daily monitors information on the absences, ruptures and cessations of marketing, to identify and avoid critical situations that may affect the availability of medicines.

The national authority of the medicinal product is part of the European network of contact points of the competent national authorities, the European Medicines Agency (EMA) and the European Commission which has been used since April 2019 to share information on supply disruptions and availability issues of medicinal products authorised in the European Union.