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.

 

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.

Infarmed monitors information on shortages, unavailabilities and marketing cessations on a daily basis, in order to identify and avoid, in a timely manner, critical situations that could affect the availability of medicines.
Within the scope of the control of the availability of medicines, one of the measures adopted to ensure a balance between the regular supply of the market and parallel trade and export of medicines follows the regulation on ex-ante notification of medicines transactions outside the country (Deliberation n.º 387/2021, 21st May).
According with the mentioned regulation, two lists are published periodically by Infarmed:

  • The ex-ante notification list of medicines under scarcity, updated quarterly, based on the criteria of article 2 of deliberation n.º 387/2021, 21st May.
  • The list that temporarily suspends parallel distribution/exports of medicines for other Member States/third countries, updated monthly, based on the criteria of article 3 of deliberation n.º 387/2021, 21st May.
     

Ex-ante notification list of medicines under scarcity (LNP)

The list of medicines which export or distribution to other EU Member States requires ex-ante notification to Infarmed is updated quarterly. The list is drawn up based on a set of criteria, with the main factor for inclusion of medicines in the ex-ante notification list the occurrence of unavailabilities by pharmacies, among other factors. For the full set of criteria and the list, please consult the Portuguese version.

 
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

This list includes medicines that were in shortage the previous month, and the impact of which was considered to be medium or high in public health following the regulation on ex-ante notification of medicines transactions outside the country (Deliberation n.º 387/2021, 21st May), it also includes medicines supplied under Exceptional Use Authorization (AUE).
This prohibition is intended to ensure the necessary time to restore the supply into the whole distribution channel after a shortage occurs followed by the resupply by the marketing authorisation holder and applies to all stakeholders, including manufacturers. It is worth noting that this prohibition applies to medicines included in the list and not for medicines manufactured for export.
The updated version of the list is available in the Portuguese version.

Further information please consult:
Paper on the obligation of continuous supply to tackle the problem of shortages of medicines - Agreed by the Ad-hoc technical meeting under the Pharmaceutical Committee on shortages of medicines on 25 May 2018

 

Marketing authorization for medicines without valid authorization or registration in Portugal (SAR)

Based on public health reasons, Infarmed may authorize the marketing of medicines without valid authorization or registration in Portugal (SAR), granted under the terms and conditions set out in article 93 of the Medicines Act and in Deliberation nº 840/2023, of August 31st.
The request must be sent to the email aut_sar@infarmed.pt, using the SAR Request Form and in accordance with the Instructions for Applicants.
Parallel Import Authorization (AIP)

Parallel import consists of the marketing of a medicine from another Member State, similar to a medicine that is authorized in Portugal, by an entity different from the marketing authorisation holder of the national medicine.
This marketing is subject to an authorization granted by Infarmed - Parallel Import Authorization (AIP) - under the terms and conditions set out in articles 80 and following ones of the Medicines Act.
The request must be sent by the email to importacoes.paralelas@infarmed.pt, using the parallel import authorisation request form and in accordance with the instructions for applicants.
Please note that parallel import requests intended to cover shortage situations will be subject to a priority assessment.

Parallel Distribution (DP)

It consists of the distribution of a medicinal product, authorized by a centralized European procedure, from one Member State to another, by a distributor independent of the marketing authorization holder.
The intention to carry out parallel distribution is communicated to the European Medicines Agency (EMA), in accordance with the rules available on the EMA website.
Entities wishing to market a medicinal product subject to parallel distribution in Portugal must request the issuance of a national registration number to Infarmed, via email to uss@infarmed.pt, attaching the initial notice of parallel distribution issued by the EMA.
These medicines are available at Infomed database with the indication of parallel distribution and the designation of the parallel distributor.
The current pricing and costing regime apply to the medicine subject to parallel distribution. See Pricing.

Related issues

Essential medicines of critical nature

The Ministry of Health approved Order No. 235/2023, of July 27, determining the possibility of applying specific benefits that aim to improve marketing conditions and their maintenance in the market of essential medicines, based on the compliance with certain obligations by marketing authorisation holders.
The universe of essential medicines of a critical nature potentially covered by this order is published in Deliberation no. 1132/2024, 27th August.

Instructions on the operationalization of Order No. 235/2023, of July 27th.

Obligations of the marketing authorisation holder
After the granting one of these benefits, the marketing authorisation holder will have to:
  • Guarantee the supply of the quantities necessary to satisfy consumption in the health system throughout the national territory;
  • Maintain a permanent stock level that ensures supply for a minimum period of four months of consumption;
  • Communicate stock levels weekly through SIEXP platform.