Infarmed Bars Exports of 52 Scarce Medicines and 163 Versions of the Antipsychotic Quetiapine

Quetiapine, an antipsychotic used to treat schizophrenia, bipolar disorder and some cases of major depression, dominates the latest list of medicines that may not be sent out of Portugal. Infarmed (the national medicines authority) has temporarily suspended the export, or distribution to other European Union countries, of 163 quetiapine presentations and 52 presentations of other medicines in short supply. The list took effect on Tuesday 6 October.

The measure was approved by Infarmed's board in Deliberação n.º 100/CD/2026 (Deliberation No. 100/CD/2026) on 28 September. It applies to everyone in the supply chain, manufacturers included. The aim, Infarmed says, is to give the market enough time to restock every link of the distribution chain after a shortage, once the company that holds the marketing authorisation has resupplied it.

How the export suspension works

Infarmed describes its export controls as a way to balance regular supply at home against parallel trade, in which wholesalers sell stock on to other countries. It runs two lists:

• a prior notification list, updated every three months, of medicines that may only be exported after notifying Infarmed (the current one has applied since 15 September);
• a suspension list, updated every month, of medicines that may not be exported or sent to other EU states at all, for public health reasons.

The suspension list covers medicines that were out of stock in the previous month where Infarmed judged the impact on public health to be medium or high, plus medicines supplied under an exceptional use authorisation (Autorização de Utilização Excecional, or AUE). The legal basis is the Estatuto do Medicamento (the Medicines Statute, Decreto-Lei n.º 176/2006) and the regulation on medicine transactions abroad that Infarmed's board approved in February 2025, which provides for the list to be published monthly. October's list is a routine renewal, not a one-off emergency step.

Every solid oral form of quetiapine

The annex to the deliberation covers all authorised medicines containing quetiapine in solid oral forms, whether they are currently on sale or temporarily unavailable. Infarmed's accompanying spreadsheet lists 163 presentations from 16 companies: 89 of them prolonged-release tablets and 74 standard film-coated tablets, in strengths from 25 mg to 400 mg. The brand Seroquel SR is on it, alongside generics from Bluepharma, Generis, Sandoz, Teva, Zentiva and others.

The supply problem is not new. In a circular of 8 January, Infarmed said prolonged-release quetiapine was hard to obtain because of problems at the main manufacturing plant, in Greece, which supplies most companies on the market. Demand shifted to rival products, whose makers could not keep up, and the problem affected all of Europe. According to the news agency Lusa, as published by Observador on 6 October, Infarmed now links the shortage to a halt in production at the Greek manufacturer after microbial contamination was detected, and expects the supply constraints to last until the end of the year.

In that circular, doctors were told some patients could move to immediate-release quetiapine, with the dose adjusted case by case, or that other antipsychotics could be considered; new prescriptions of the prolonged-release form were to be limited to patients already on it who have no alternative. Pharmacies were asked to dispense quetiapine for one month of treatment at a time. Patients who cannot get their medicine were told to contact their doctor for an alternative.

The 52 other medicines on the list

The other part of the list holds 52 presentations. Among those patients may recognise from a pharmacy:

• Tramadol drops (Tramal, and generics from Generis and Ciclum, 100 mg/ml), a painkiller;
• Trazodone 300 mg prolonged-release tablets (Triticum OD and Trazone OD), an antidepressant;
• Methylphenidate 10 mg modified-release capsules (Rubifen Retard and a Ciclum generic), used for attention deficit hyperactivity disorder (ADHD);
• Depakine Chronosphere 250 mg granules (valproic acid), an epilepsy medicine;
• Medrol 4 mg tablets (methylprednisolone), a corticosteroid;
• Flutiform, a fluticasone and formoterol inhaler for asthma;
• Innohep (tinzaparin) prefilled syringes, an anticoagulant injection;
• Azithromycin oral suspension (Generis and Alvyx), a liquid antibiotic;
• Imigran injection (sumatriptan), a migraine treatment.

Hospital medicines on the list include cancer drugs such as cyclophosphamide (Endoxan and a Seacross generic), ifosfamide (Holoxan), pemetrexed and vinorelbine, several injectable antibiotics, vitamin B12 injections, and eye drops including Ikervis and Monoprost Duo.

What patients can do

An export ban keeps stock in the country but does not guarantee that your pharmacy has your pack today. Under a joint circular that Infarmed, the SNS shared services body SPMS and the health system administration ACSS sent to pharmacies in June, a pharmacy that cannot get a medicine should check whether it is officially in shortage and when it is due back. It can then, where the rules allow, dispense a smaller or larger pack of the same medicine, or a substitute indicated by Infarmed. Failing that, the patient is referred back to the prescribing doctor. Do not change or stop a psychiatric or epilepsy medicine on your own; ask your doctor first.

Patients and patient associations can also report a medicine they cannot find through Infarmed's online medicine shortage reporting form. Infarmed's medicines helpline, the Linha do Medicamento, is on 800 222 444. For how prescription costs are shared with the SNS (the national health service), see our guide to paying less for prescription medicines; for the scale of psychiatric medicine use in Portugal, see our report on 80,000 psychotropic packages dispensed a day.