Acessibilidade

Availability of Medicines

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One of the most important aspects of the fundamental right of access to healthcare is the continuous and appropriate supply of medicinal products to patients. All stakeholders involved in the pharmaceutical supply chain – marketing authorisation holders, wholesalers and pharmacies – have legal responsibilities in the supply and availability of medicines as part of their public service obligations.

The availability of medicines has been a central subject to European and national authorities.  Regulation 2022/123 of the European Parliament and of the Council reinforced the role of the European Medicines Agency in crisis preparedness and management of medicinal products and medical devices, and established the SPOC working Party and the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), where all Member States, the Agency and the European Commission share information and collaborate on the management of the availability of medicines. Infarmed actively participates in the European network.

At Infarmed, the management of the availability of medicinal products is guaranteed by a dedicated unit - Unit for Interinstitutional and Health System Projects (USS) -, which develops an extensive collaboration with all stakeholders, analysing and discussing each shortage situation and its correspondent mitigation measure.
It also collaborates with the National Commission of Pharmacy and Therapeutics, which provides clinical guidance in the identification of therapeutic alternatives.

Infarmed also chairs a national commission on the management of the availability of medicines, which gathers all stakeholders (marketing authorisation holders, wholesalers, pharmacies, professional societies, patient organisations, and the National Commission of Pharmacy and Therapeutics). This commission is established in accordance with the national regulation on the management of the availability of medicines, approved by the Executive Board of Infarmed.

Infarmed collaborates in European and national projects aiming at strengthening the harmonisation of the management of medicines shortages and the robustness of supply chains.

For further details, read our brochure.

Contact: uss@infarmed.pt

GLP-1 receptor agonists

Recommendations for managing the availability of GLP-1 receptor agonist

Shortages of medicines Ozempic (semaglutide, in its 3 strengths), Trulicity (dulaglutide) and Victoza (liraglutide) are expected to continue in 2025. This limitation is due to the high prescription of these medicines combined with restrictions in the production capacity.
The use of these medications for indications that are not approved, namely weight loss, has contributed significantly to the worsening of the situation.
These medicines are only reimbursed by the National Health Service (SNS) for the treatment of adults with insufficiently controlled type 2 diabetes mellitus with a BMI (Body Mass Index) equal to or higher than 35 kg/m2, as an adjunct to diet and exercise, in addition to other medicines for the treatment of diabetes, to be used in 2nd and 3rd lines of therapy, as already published in the guidelines of the National Pharmacy and Therapeutics Commission.
If you have difficulty obtaining this medication, consult your doctor for an alternative therapy can be indicated.

On this topic you can consult:
Methylphenidate

Difficulties with medicines containing methylphenidate

Unavailability problems with medicines containing methylphenidate have been prolonged in Portugal and other European countries, due to the inability of companies to respond to increased demand. Although there are several authorized holders in Portugal, these problems have affected the majority of companies present in the market.
In the last 12 months, Infarmed met with companies, authorized the marketing of medicines labelled with a foreign language, but due to the shortage of active substances at European level, there are still constraints.
The European Medicines Agency indicated atomoxetine and lisdexamfetamine dimesylate as therapeutic alternatives.
Methylphenidate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and over and adults when the measures taken to resolve this problem prove to be insufficient.

On this topic you can consult:
Pancreatin

Difficulties in the supply of Kreon

Pancreatin-containing medications are essential for the treatment of exocrine pancreatic insufficiency. The marketing authorisation holder has informed Infarmed and the European Medicines Agency of manufacturing difficulties until 2026. Infarmed together with the marketing authorisation holder established a set of rules for controlled distribution, as well as guidelines aimed at healthcare professionals.
At the moment, the market is supplied.
Kreon medicines is indicated for the treatment of exocrine pancreatic insufficiency.

On this topic you can consult:
Potassium bismuth subcitrate + Metronidazole + Tetracycline

Difficulty in the supply of Pylera

Medicine Pylera is experiencing a period of shortage due to high demand and the marketing authorisation holder's inability to increase available quantities. This drug is also currently in high demand in other European countries.
Infarmed has been monitoring the market supply situation together with the marketing authorisation holder. At the moment, the quantities of Pylera placed on the market are slightly lower than patients needs.
In combination with Omeprazole, Pylera is indicated for the eradication of Helicobacter pylori and for the prevention of relapses of peptic ulcers in patients with active pathology or a history of ulcers associated with H. pylori.

Sucralfate

Difficulties in the supply with medications containing sucralfate

Only two companies have a marketing authorisation to sell medicines with Sucralfate, and one of them is in shortage until June 2025.
There is a high demand for the available quantities.
The available presentation (Ulcermin) is being supplied in quantities that are still not enough to meet demand, although more recently the available quantities have increased.
The therapeutic indications for Sucralfate are in the treatment of peptic, gastric or duodenal ulcers, reflux esophagitis, erosive gastritis, duodenitis, prevention of stress ulcers and nosocomial pneumonia in ventilated patients, stomatitis, mucositis and prevention of hemorrhage after sclerotherapy of esophageal varices.

On this topic you can consult:

Shortages
A shortage of a marketed presentation must be submitted by the marketing authorisation holder two months in advance through the SiATS platform.

Unavailabilities
Whenever a prescribed medicine is not available at the pharmacy for dispensing for a period up to 12 hours, the pharmacy should submit a notification to Infarmed through a dedicated web service.
Likewise, wholesalers notify unavailabilities (difference of quantities ordered to marketing authorisation holders and quantities received) through a dedicated web service.
This data is of utmost importance to monitor market supply.
Access to the web service can be requested by email to uss@infarmed.pt.

Healthcare professionals, citizens and patient organisations can also notify these unavailabilities through a dedicated web form available at Infarmed’s webpage.

Marketing cessation
The cessation of a marketed presentation must be notified by market authorisation holders two months in advance, through the SiATS platform.

Medicines included in the ex-ante notification list (parallel trade and exports)
The notification of transactions of medicines included in the ex-ante notification list should be done through SiExp platform.
Please consult Availability control.

Infarmed may authorize the exceptional use of some medicines considered essential for the prevention, diagnosis or treatment of certain pathologies, for which there are no therapeutic alternatives.
This exceptional use is subject to an authorization granted by Infarmed under the terms and conditions set out in article 92º of the Medicines Act (according with art. 5 of Directive 2001/83/EC) and in Deliberation nº 840/2023, of August 31st.

Exceptional use authorisations fall into two groups:

  • Medicines aimed at patient groups;
  • Medicines intended for a specific patient.
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Exceptional authorisations for patient groups

These exceptional authorisations may be granted to marketing authorisation holders, wholesalers, hospitals and other entities with medicines purchasing authorisation.

Marketing authorisation holders
Guideline for exceptional use authorisation
Request Form
List of exceptional use authorisations issued by Infarmed

Notice on how wholesalers, manufacturers, hospitals and other entities with medicines purchase authorisation may request exceptional use authorisations is available in the Portuguese version.   

Exceptional authorisations for patient groups
Pharmacies are also entitled to acquire patient specific medicines through an exceptional use authorisation, without prior authorisation from Infarmed. Please refer to the Portuguese version.  

Hospitals and other entities with direct acquisition authorization
Requests for a patient specific exceptional authorisation should be submitted through the "Authorization for specific patient" module of the SIATS platform:

  • Medicines with marketing authorisation (including new therapeutic indications) without previous hospital evaluation process completed (see link);
  • Medicines without marketing authorisation and with preliminary evidence of clinical benefit (see link).
     

Exceptional use authorisation requests for controlled substances should be submitted to dil-lic@infarmed.pt.

Shortages, unavailabilities and cessations of commercialization are monitored on a daily basis, in order to identify and avoid critical situations that may affect the availability of medicines.
Within the scope of availability control, one of the measures adopted to ensure a balance between the regular supply of the market and the export of medicines is the compliance with the Regulation on ex-ante notification system on transactions of medicinal products.

Ex-ante notification list (LNP)

The list of medicines which export or distribution to other EU Member States requires ex-ante notification to Infarmed is updated quarterly. This list is based on a set of criteria, namely:

Mandatory criteria:

  • Percentage of consumption satisfied;
  • Percentage of prescription satisfied;
  • Number of reported unavailabilities;
  • Relationship between exports / reported unavailabilities.
     

Additional criteria:

  • Number of available medicines with the same CNPEM;
  • Critical INN (based on the list of substances whose accessibility is considered essential);
  • Narrow therapeutic margin (based on the list of active substances with a narrow therapeutic index or margin).

 
Notification
The notification is made on the SiExp platform by:

  • MAH holders the quantities of medicinal products included in the ex-ante notification list supplied monthly until the 15th of every month;
  • Distributors and Intermediaries:
    • the quantities of medicinal products included in the ex-ante notification list supplied monthly until the 15th of every month;
    • the intention of exporting or distributing to other Member States medicines listed in the ex-ante notification list, 5 to 20 days before the transaction.
  • Pharmacies - the quantities of medicinal products included in the ex-ante notification list supplied monthly until the 15th of each month.

 

List of medicinal products which exports are temporarily suspended

The list of medicinal products which exports are temporarily suspended includes effective shortages of high and medium impact in public health registered in the previous month and medicinal products supplied under exceptional authorisations.
This list is updated monthly and is intended to ensure the adequate market supply.