- Definitions
- Inform:PharmaStatus, PharmaInfo and SAM
- Temporarily unavailable medical products
- End of commercialisation
- Reporting a change in availability
- Contact
Definitions
The FAMHP invests in an efficient and effective approach to the availability of medicines.
We make a distinction between the following situations.
- Available medicine
A medicinal product that is available on the Belgian market and for which the marketing authorisation holder or parallel distributor has notified the FAMHP that it is being marketed in Belgium. - Temporary unavailability
A medicinal product that has been unavailable for no more than one year and for which the marketing authorisation holder or parallel distributor has notified the in advance FAMHP that it is being marketed in Belgium. Partial or interrupted deliveries are automatically considered temporarily unavailable. - Beperkte beschikbaarheid
A medicinal product that has limited availability on the Belgian market and for which the authorisation holder or parallel distributor has notified the FAMHP in advance of its availability on the Belgian market. From a legal point of view, partial or interrupted deliveries are automatically considered temporarily unavailable. In some cases, such as when recommendations were published to restrict the use of a medicinal product, the FAMHP can assign the ‘limited availability’ status. The company is still receiving deliveries but these quantities are not sufficient to meet the demand. - Discontinuation of commercialisation
A medicine whose commercialisation is permanently discontinued.
Comment
Before, a medicine that was unavailable for a year or longer was reported as an 'interruption of commercialisation'. Since 11 December 2024, this status has been removed to be in line with European procedures. From now on, a medicine that is unavailable for at least two weeks, regardless of the duration, will be reported as 'temporarily unavailable'.
The FAMHP informs: PharmaStatus, SAM and PharmaInfo
PharmaStatus
Since December 2019, any commercialisation kick-off, temporary unavailability and discontinuation of commercialisation of medicinal products for human and veterinary use, are published on the platform PharmaStatus.
The lists of medicinal products are updated in real time based on reports from authorisation holders or parallel distributors.
PharmaStatus improves the exchange of information to healthcare professionals and patients on the availability of medicines. For each case of unavailability, you will find the results of the analysis of the criticality of each unavailability and the experts' recommendations. You will also find additional explanations (by hovering over a word) in patient-friendly language about the impact and reason for unavailability. Any citizen can sign up to (a group of) medications to be notified of changes in availability via automatic emails.
This online platform facilitates the reports that companies are required to send by law (start or discontinuation of commercialisation, unavailability). Since April 2021, pharmacists and wholesaler-distributors have been able to contact the marketing authorisation holder or parallel distributors through PharmaStatus in the event they suspect a shortage or supply issue to occur. The FAMHP follows up on these reports and is therefore better informed of the situation in the field.
The numbers given on PharmaStatus about reports of temporary unavailability, do not include reports of temporary unavailability of less than 14 days. A temporary unavailability is published on PharmaStatus only when it is expected to last 14 days or longer. Stocks at wholesaler-distributors and pharmacies are normally sufficient to meet the demand.
Notifications of a discontinuation of commercialisation are published on PharmaStatus up to one year after the actual discontinuation.
Authentic Source for Medicines (SAM)
The Authentic Source of Medicinal Products (SAM) contains information on the availability of medicinal products.
In the event of an unavailability, you will find additional information such as its impact, recommendations and alternative solutions.
The data is available as open data and thus can be integrated into other applications. This can help physicians and pharmacists to be informed of the availability of medicinal products and possible solutions at the moment of prescription or dispensation. As of 1 January 2020, the use of SAM as a source is mandatory for a physician's prescribing software when dealing with outpatients. Through imposed homologation criteria, the information on the availability of medicinal products is visible whenever they prescribe one.
PharmaInfo
PharmaInfo is a user-friendly website that contains comprehensible, reliable and independent information on medicinal and health products for citizens and patients. Here you will also find information on the availability of medicinal products in Belgium. Patients can sign up to receive notifications on the (un)availability of their medicinal product. In case of unavailability, they will be notified as soon as the medicinal product is available again.
Temporarily unavailable medicines
Causes of temporary unavailability of medicines
A medicine may be unavailable for a variety of reasons.
- Actual unavailability
A genuine stock shortage can be caused by, for example:
- unavailability of the active ingredient;
- unavailability of an excipient;
- delay in production;
- delay in the release of the final product;
- logistical problems (transport, customs, etc.);
- increased demand;
- FMD – serialisation;
- import and export authorisation in application (psychotropics, narcotics);
- recall;
- force majeure (strike, disaster, etc.) ;
- patent litigation;
- other reasons.
This means the marketing authorisation holder or parallel distributor cannot supply the medicines.
- Distribution issues
Due to a local distribution issue, a medicinal product may only be unavailable from some pharmacies or veterinarians. In this case, the medicine is not genuinely unavailable.
Another distributional problem is the use of quotas. This practice is used by a number of pharmaceutical companies, whereby they interrupt deliveries to dispose their stock in a controlled manner. Based on the previous year's consumption, the company estimates the quantity of medicines that needs to be produced annually to meet the needs of the Belgian market and limits periodic supply to ensure that the number of scheduled batches is sufficient to supply the Belgian market throughout the year. If quotas are applied, the company still has batches available, but the pharmacist cannot order them through the wholesaler-distributor. In practice, such cases usually occur only at the end of the month and the medicine is available again at the start of the next month. For patients, however, the problem remains the same: they cannot obtain their medicines, or the pharmacist has to take extra steps to obtain it.
Number of unavailabilities
The increase in the number of packages reported as unavailable since 2019 does not necessarily show an increase in unavailable medicinal products itself but rather an increase in the number of reports on this issue. This is partly because the FAMHP is raising awareness among marketing authorisation holders and parallel distributors of the importance of reporting unavailability, and partly because of the Law of 20 December 2019, which clarified and tightened the reporting requirement.
Since April 2021, pharmacists and wholesaler-distributors have been able to contact marketing authorisation holders and parallel distributors through PharmaStatus in the event they suspect a shortage or supply issue to occur. This system encourages companies to pass on their reports correctly.
Reports of unavailability are made for each presentation: dose, route of administration, pharmaceutical form and pack size. Unavailability does not always affect the entire product range of a medicine.
Actions and solutions
- Unavailability Working Group
The FAMHP is investing in a more comprehensive and effective approach to the problem of the unavailability of medicinal products by convening the Unavailability Working Group (° 2013) on a regular basis.
This working group includes representatives from:
- the FAMHP;
- pharmacists (APB, OPHACO);
- hospital pharmacists (ABPH/BVZA);
- the wholesale distributors (NVGV, OPHACO);
- the pharmaceutical industry (BACHI, Medaxes, pharma.be);
- the parallel importers and parallel distributors (BAPIE);
- the health insurance funds (NIC);
- patients (LUSS, VPP);
- NIHDI;
- FPS Economy;
- the policy unit.
This working group looks for ways to systematically address unavailability of medicines. Consideration is given both to possible solutions when unavailability occurs and to measures to prevent unavailability.
2. Evaluation of unavailabilities reported through PharmaStatus
The FAMHP experts use a decision tree to analyse every reported unavailability by the marketing authorisation holder or parallel distributor in order to estimate the impact on public health. This enables the FAMHP to take appropriate measures to minimise the impact of unavailability on patients. The assessment is based on specific criteria that take into account the duration of unavailability, the number of alternative medicines available, and the indication.
If the unavailability may involve risks, the FAMHP will contact the marketing authorisation holder or parallel distributor of the relevant medicine for more information. The FAMHP also contacts marketing authorisation holders or parallel distributors of alternative medicines so they may anticipate a possible increase in orders.
The figure shown below includes all reports of temporary unavailable medicinal products. In contrast, a temporary unavailability is only published on PharmaStatus when it is expected to last 14 days or longer.
(More) limited impact
For more than 66 % of unavailable packages (data from the first half of 2024), the expected duration of unavailability is less than one month or there are at least three alternatives that simultaneously meet the following criteria:
- the same active ingredient;
- the same desired dose;
- the same route of administration;
- the same pharmaceutical form for certain medicines (same pharmacological characteristics, e.g. extended or modified release).
Of all reported unavailability, 10 % (data from the first half of 2024) can be resolved by one or two alternatives that meet the above criteria.
In 5 % (data from the first half of 2024) of all cases, the medical product is considered not essential for life.
Substantial impact
The other unavailable packages (< 19 %, data from the first half of 2024) could potentially cause problems with a substantial impact on patients.
After an expert analysis of these unavailable medicinal products having a substantial impact, their unavailability can be resolved in more than 9 % (data from the first half of 2024) of all cases by:
- an alternative with a different active substance;
- a different dose and/or a different route of administration;
- or a magistral preparation.
If the unavailable medicinal product is considered to be of such importance that its absence from the Belgian market poses significant risks, the following temporary measures can be taken.
- The FAMHP may authorise the company to import the unavailable medicine (also known as a derogation). The company may then temporarily import batches of the same medicine intended for another country into Belgium. Patients have access to the medicine at the same price and with the same reimbursement conditions. This is the case for almost 1.5 % of unavailable packages (data from the first half of 2024). The package may contain a language other than our national languages.
The price and reimbursement are the same as for the unavailable medicine.
- Since 1 November 2024, the FAMHP can authorise the distribution of a medicine not authorised in Belgium imported by the wholesaler when there is a risk of or critical unavailability. These medicines may come from a country in the European Economic Area (EEA). A list of unavailable medicines for which import is considered a possible solution can be found on PharmaStatus.
This packaging may be in a language other than our national languages.
The price of this imported unauthorised medicine may differ from that of the unavailable medicine. On 1 January 2025, the Royal Decree of 26 April 2024 on compensation for the additional cost to the patient from the National Institute for Health and Disability Insurance (NIHDI) came into force, making reimbursement possible.
The FAMHP published all relevant information on this webpage.
- Based on a medical prescription and a doctor's statement (article 105 of the Royal Decree of 14 December 2006), import by the pharmacist is possible if no equivalent medicine is available in Belgium (authorised or marketed). Thanks to this temporary import, the patient has their medicine with the same active ingredient, but with a package leaflet and packaging in a language other than the Belgian national languages. This is the case for 6 % of unavailable packages (data from the first half of 2024).
The price of this imported medicine may differ from that of the unavailable medicine. On 1 January 2025, the Royal Decree of 26 April 2024 on compensation for the additional cost to the patient from the NIHDI came into force, making reimbursement possible.
- In the event of unavailability of medicines for which there are no alternatives and importation from abroad proves difficult or impossible, other measures based on expert recommendations are necessary. This is the case for 1.9 % of unavailable packages (data from the first half of 2024). In such cases, a task force comprising experts from the FAMHP, the NIHDI, the FPS Public Health and external experts is convened. The Task Force Unavailability makes recommendations to assist healthcare professionals. The recommendations are published on the FAGG website and on PharmaStatus. They are also made available via the national authentic source for medicines (SAM) for integration into the software used by doctors and pharmacists.
When measures based on expert recommendations are necessary, the following options are discussed:
- rational use of the available stock of the medicine, such as giving priority to certain indications of the unavailable medicine or restricting distribution;
- possible solutions in the event of total unavailability, such as alternatives for certain indications.
Unavailability is considered critical if the following conditions are met:
- the unavailable medicine is necessary to prevent, diagnose or treat diseases, especially serious or chronic diseases, or diseases that can rapidly worsen;
- there are no suitable alternatives available in Belgium to replace the unavailable medicinal product;
- the treatment of patients is interrupted when their medicinal product is unavailable, causing their health to deteriorate in the short or medium term.
The FAMHP is aware that a change in treatment is not without risk: confusion, errors, under- and over-dosage when switching to another medicine (different brand name, different packaging, different colour, etc.) or when a medicine is imported (different packaging, different language, etc.). Therefore, this change must be supervised by a doctor or pharmacist. They are key to ensuring proper treatment.
3. Additional measures
The Law of 20 December 2019 provides for additional measures to limit the unavailability of medicines. The law clarifies the obligation of pharmaceutical companies to supply wholesaler-distributors (within the scope of their own special obligations) and pharmacists within three working days.
Partial or interrupted deliveries are automatically regarded as unavailability and must be reported to the FAMHP. A report must clearly describe the cause and duration of the unavailability.
Most of the provisions of this law will be elaborated further through implementation decrees, more specifically:
- transparency of stock (of wholesaler-distributors) based on the Royal Decree of 26 November 2011;
- restriction on dispensing in the case of unavailability based on the Royal Decree of 19 January 2023;
- substitution by the pharmacist in the case of unavailability based on the Royal Decree of 3 July 2022;
- option to import based on article 105 of the Royal Decree of 14 December 2006;
- import and distribution of medicines that are not authorised in Belgium by the wholesaler based on the Royal Decree of 12 September 2024.
4. Stock Monitoring Tool
In May 2021, the FAMHP launched a Stock Monitoring Tool. During the COVID-19 pandemic, accurate monitoring of stocks of medicines proved particularly useful. It enabled the FAMHP to act proactively and find solutions in a timely manner. This monitoring was carried out manually until May 2021, but the processing of the data is now automated through a new Stock Monitoring Tool. Stocks of medicines that are becoming too low are therefore more readily spotted and, in the event of issues, there is also greater visibility of the availability of alternative medicines. This tool is used for medicines that play an important role in the fight against COVID-19.
This system was expanded and optimized in 2023 to allow a proactive approach to and better management of unavailable medicinal products. The pilot phase of the Stock Monitoring Tool was launched in 2023. Within the scope of this project, the stock data of a subset of medicinal products (eight active ingredients) are requested on a weekly basis from relevant stakeholders (authorisation holders, wholesaler-distributors, hospital pharmacies and pharmacies open to the public). The purpose of the pilot phase is to check how useful the tool is in proactively addressing and better managing the issue of unavailable medicinal products.
5. European consultation
The unavailability of medicines is not a purely an issue in Belgium; it is also a Europe-wide issue, and even a global issue. For this reason, systematic consultation and information exchange takes place at European level to find common solutions.
End of commercialisation
Causes of discontinuation
Commercialisation may be discontinued as a result of:
- unavailability of the active ingredient;
- unavailability of an excipient;
- long-term production issues;
- commercial reasons;
- insufficient demand;
- replacement with a different medicine/package;
- force majeure;
- other reasons;
- discontinuation of reimbursement;
- suspension of the authorisation;
- withdrawal of the authorisation.
Number of discontinuations of commercialisation
Reports of packaging of medicinal products for human use whose commercialisation was discontinued, represent on average 3 % (data from the first half of 2024) of the total number of packages marketed in Belgium.
Reports of unavailability are made for each presentation: dose, route of administration, pharmaceutical form and pack size. Unavailability does not always affect the entire product range of a medicine.
Solutions and actions
If the marketing authorisation holder or parallel distributor decides to withdraw a product from the Belgian market, the product will no longer be available in Belgium. The FAMHP does not have the authority to force a company to market a medicine. However, the FAMHP evaluates every report of discontinuation of commercialisation to assess the impact on public health. This is done on the basis of a decision tree. It enables the FAMHP to take appropriate measures to minimise the impact of discontinuation of commercialisation on patients. This assessment is based on specific criteria that take into account the number of market players, the number of alternatives available, and the indication.
If the discontinuation of commercialisation may give rise to risks, the FAMHP initially contacts the marketing authorisation holder or parallel distributor of alternative medicines so they may anticipate a possible increase in orders. If this is not possible, experts are contacted, and they check whether the discontinuation of commercialisation can be resolved by an alternative with a different active substance or by a magistral preparation. The route of administration may also differ.
In the event of discontinuation of commercialisation of medicines for which there are no or insufficient alternatives, the FAMHP will take further steps, such as entering into dialogue with the marketing authorisation holder or parallel distributor to ascertain whether they can nevertheless remain on the market or whether they are prepared to sell their MA. The FAMHP also checks the commercialisation status in other (European) countries and may contact marketing authorisation holders or parallel distributors to ask whether they wish to enter the Belgian market. The FAMHP may also approach raw material manufacturers and ask them to market the raw material in Belgium.
The FAMHP is aware that a change in treatment is not without risk, such as confusion, errors, under- and over-dosing when switching to another medicine (different brand name, different packaging, different colour, etc.). Therefore, that change must be made under the supervision of a doctor or pharmacist; they are the key to effective treatment.
Reporting a change regarding availability
Holders of a marketing authorisation (MA), registration, authorisation for parallel import or a temporary authorisation for use and parallel distributors are required by law to report any information concerning:
- placement on the market (start of commercialisation );
- the permanent discontinuation of commercialisation
- temporary discontinuation of commercialisation (temporary unavailability of commercialisation )
of medicines to the FAMHP via PharmaStatus.
Further information about the reporting procedure.
Legal basis
- Article 6, section 1e, paragraphs one and two of the Law of 25 March 1964 on medicines.
- Articles 113, section 3, and 238, section 3, of the Royal Decree of 14 December 2006, part 1 and part 2 on medicines for human and veterinary use.
- Articles 2, 4 and 5 of the Law of 20 December 2019 amending various laws concerning shortages of medicines.
Contact
For questions regarding the unavailability or commercialisation of a medicine: supply-problems@fagg-afmps.be.