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|eServices Guidance notes
|Guidance notes "Medicine shortages"
Since February 1, 2018, marketing authorisation holders and their authorised representatives have to submit medicine shortages electronically by using the application eServices "Authorisation and Lifecycle of Medicinal Products".
Medicine shortages are published on the „Shortages catalouge“ on the actual date of beginning of the shortage.
Marketing authorisation holders and their authorised representatives have to submit medicine shortages because of the regulation on ensuring the provision of medicinal products, that enters into force as from April 1, 2020, and because of the "Austrian Ordinance on Good Manufacturing Practices". They are now obliged to report any restriction in supply of prescription-only human medicinal products using the eServices "Authorisation and Lifecycle of Medicinal Products".
The notification of a shortage affecting veterinary medicinal products and over-the-counter medicinal products is voluntary, if it is not subject to notification in accordance with the "Austrian Ordinance on Good Manufacturing Practices".
All reported procedures are presented in the "Shortages catalogue" - it is therefore the common register. Notifications concerning prescription-only medicines are checked by the BASG before publication.
Not included are notifications pursuant to Section 21 (2) of the Austrian Medicines Act as amended.
The notifications are automatically published in the "Shortages Catalogue" on the following day from the actual start of the shortage.
The reporters are responsible for the accuracy of the data. The BASG does not have information on existing stocks in the distribution chain (i.e. wholesalers, pharmacies).
The "Catalogue according to the regulation on ensuring the provision of medicinal products according to § 57a para. 2 Austrian Medicines Act" is based on the same data as the "Shortages catalogue", but restricted to those proprietary medicinal products which have been banned from parallel export after review by the BASG.
The BASG must be notified four months in advance of a temporary or permanent discontinuation of the marketing of medicinal products. This notification is to be made via eService and published by the BASG according to Section 21 (4) of the Austrian Medicines Act. Consequently, in the case of a withdrawal of a marketing authorisation/registration, the notification of the final discontinuation of marketing must therefore be made in due time.
Irrespective of the notification of discontinuation of marketing, in the event of unavailability of a prescription-only medicinal product for human use that is expected to last longer than two weeks or insufficient availability of a prescription-only medicinal product for human use to meet the needs of patients in Austria that is expected to last longer than four weeks, the obligation to notify in accordance with the regulation on ensuring the provision of medicinal products remains in force.
For further details, see the original notification Amendments to the AMG concerning notifications of discontinuation of placing on the market and the FAQ “Is a shortage to be notified if there is a temporary or permanent marketing cessation?”
The BASG provides information on its website in connection with distribution restrictions (supply bottlenecks) for medicinal products in Austria. With this information, the BASG creates transparency and improves the flow of information.
The primary responsibility for maintaining the ability to supply medicinal products lies with the marketing authorization holder or the wholesaler. In this respect, reference is made to the provision of § 57a. (1) AMG:
"The marketing authorization holder or the holder of a registration of a proprietary medicinal product and the wholesalers and full wholesalers of medicinal products who distribute this proprietary medicinal product actually placed on the market shall, within the scope of their respective responsibilities, ensure an adequate and continuous supply of the proprietary medicinal product for dispensing by pharmacies or for persons otherwise entitled to dispense pursuant to Section 59, so that the needs of patients in Austria are met".
In the event of a restriction of distribution capability and a resulting imminent or existing supply bottleneck, the BASG can
- Determine the circumstances that led to the distribution restriction and communicate this information to the stakeholders involved.
- Determine the extent of the distribution restriction and communicate this information to the stakeholders involved.
- Contact the marketing authorization holder and/or, if necessary, expert groups to communicate information.
- Contact other national regulatory authorities or the European Medicines Agency (EMA) to communicate information.
- Give priority to applications for the authorization of medicinal products that are useful for resolving the issue or advocate for accelerated processing in European procedures.
- Give priority to processing applications for variations of medicinal products that are useful for solving the problem or advocate accelerated processing in European procedures.
- Process and approve applications and notifications, including for medicinal products and blood products not currently authorized in Austria, for the import and shipment of medicinal products to Austria as additional supply options within the framework of the import of medicinal products.
Based on the level of knowledge of the BASG regarding a supply bottleneck, the BMSGPK can determine a crisis situation in accordance with Section 94d para. 2 AMG. This determination is a prerequisite for further (legal) measures to be taken in individual cases in order to mitigate the supply bottleneck.
In addition, reference is made to Section 94d para. 2 AMG:
"In the event of a disaster, epidemic, pandemic, terrorist threat, armed conflict or other crisis situation, the Federal Minister of Health [...] may, if the necessary supply of the population would otherwise be seriously and significantly jeopardized, issue regulations by ordinance on supply and provision obligations for marketing authorization holders, depositors, manufacturers, wholesalers of medicinal products, wholesalers of medicinal products and public pharmacies, if and as long as this is necessary due to the special situation"
- The BASG cannot oblige companies to produce medicinal products, active substances or similar, nor can it oblige companies to place medicinal products on the market.
- The BASG has no reliable information about the quantities of the medicinal products concerned that are still on the market.
- In the event of distribution restrictions, the BASG cannot provide individual medical advice or recommendations on alternative therapies. Information can only be limited to the approval status of a medicinal product and information on approved indications. Treatment recommendations in the true sense of the word, when patients have to be switched to another medicine due to a marketing restriction, always require personal contact between the doctor and the patient.
- One focus of the BASG's responsibilities is the authorization of medicinal products on the basis of the Medicinal Products Act. However, the BASG itself neither manufactures medicinal products nor can it make medicinal products available.
- Under no circumstances does the BASG act as an intermediary between different marketing authorization holders or between potential manufacturers and marketing authorization holders.
In principle, a distinction must be made between the active substance manufacturer and the marketing authorisation holder. In many cases, the marketing authorisation holder (i.e. the company that actually markets or sells the medicinal product in Austria and is also legally responsible for the product) buys the active substance/raw material required for the manufacture of tablets, for example, from another manufacturer.
Due to globalisation and the trend towards mass production, such active ingredient manufacturers have mostly relocated to low-wage countries and cover large parts of the world market or sometimes even the entire world market with their mass production at a very favourable price.
This trend has put manufacturing and active ingredient manufacturin in Europe under severe cost pressure for years, which is why production has increasingly been and will continue to be relocated to the Far East.
Europe is thus dependent on these manufacturers, who in many cases manufacture just as good quality, but due to monopolisation and in the event that isolated problems arise with production or quality in the plants in the Far East, the influence and control possibilities for Europe are less than if production were located in Europe.
Moreover, Europe is "only" one of many markets on the world market and therefore has to compete with other markets for quotas when problems arise in Asia. A negative dependence on events in Asia, some of which can no longer be influenced by Europe itself, is thus given.
The distribution chain usually follows the "classic" route: the marketing authorisation holder supplies the wholesaler that distributes the medicinal products to public pharmacies/hospital pharmacies.
In rare, but increasing cases, and especially in cases where high-priced medicinal products are distributed, a delivery model called "direct to pharmacy" (DTP) is also used, where the medicines are delivered directly from the marketing authorisation holder to public pharmacies/hospital pharmacies.
In some cases, medicines are traded between several countries via (sometimes several) parallel traders, exploiting price differentials in the free European movement of goods, until they end up in the pharmacy in the respective target country.
This route is legal and compatible with EU law, but only if sufficient goods are available for the domestic market.
The problem of supply restrictions must be described as a global problem. Due to the increasing and decades-long globalization of the production of pharmaceuticals, but also due to the merger of small and medium-sized pharmaceutical companies and manufacturers into large companies and further from large to "super"-large global corporations, there is (as a result of the formation of oligopolies, in extreme cases also monopolization) an increasing reduction of the worldwide manufacturers and suppliers. A large number of active ingredients are already being manufactured in Asia (the Far East, especially China and India).
Should problems arise in these companies (technical problems, quality problems, natural disasters, strikes, etc.), the market demand can usually no longer be covered for at least several months. As a result, insufficient quotas are now available to supply the world market and thus the individual national countries, including the EU. The replacement of other (smaller) manufacturers, if they still exist, is then not possible or only possible to an insufficient extent.
Another growing problem is the increasing cost pressure on older, but nevertheless essential drugs.
Over the years, many national and international manufacturers have discontinued the production of their expired pharmaceuticals or have postponed marketing authorisation due to falling prices and thus alleged or actual inefficiency. Globally, this trend can be observed by way of example, particularly in the area of complex sterile production of old, so-called "off-patent" i.v. (injection) preparations. This has further accelerated market concentration to only a few players.
The supply of older, but no less important and ultimately essential active substances in particular is therefore increasingly in the hands of a decreasing number of global manufacturers. The danger of shortages caused by this advancing global development has therefore increased in recent years not only in theory but also in practice.
The solutions to these questions and challenges cannot be found only nationally. Solutions must be developed jointly in the EU and ultimately coordinated globally by the EU with its global trading partners and economic areas.
The promotion of European manufacturing with incentive measures should be considered within the framework of a broad-based, overarching master plan.
For the time being, however, we in Austria urgently need a mandatory reporting system in order to be able to make any shortages that arise transparent at an earlier stage and thus initiate countermeasures on a case-by-case basis and at an even earlier stage.
A case-by-case ban on exports in the event of particularly critical shortages should also be considered or its legal provisions tightened in order to prevent quotas for unwanted exports destined for Austria and still stored in Austria from being quickly shifted to other countries in the event of impending shortages and thus effectively withdrawn from the Austrian health system.
According to the latest information, the supply of medicines is currently largely secured. However, the situation is being closely monitored on an ongoing basis. From today's perspective, there is no need for private overstocking.
The population is therefore advised: There is no need to stock up on medicines as part of much-cited so-called "hoarding purchases". Purchases and dispensing in pharmacies should only take place within a regulated framework and in the quantities necessary for the purpose and requirements. There is no reason for private overstocking.
Shortages of medicinal products are a global problem. The underlying reasons are complex and diverse. They range from difficulties in production and quality problems to increased demand from patients in one or more countries. The Austrian Federal Office for Safety in Health Care (BASG) also actively participates in key organisations, working groups and projects at European level, e.g., EMA (MSSG, SPOC) and HMA (TFAAM), which are committed to improving the availability of medicinal products in Europe.
Activities of the BASG at European level
- Active participation in the Medicine Shortages Single Point of Contact (SPOC) Working Party
- Initiate communication with other national regulatory authorities and the EMA via the Medicine Shortages Single Point of Contact (SPOC) Working Party in the event of medicine shortages that are classified as critical in at least one country.
- Active participation in the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)
- Provision of data on the availability of antibiotics during winter 2023/24 for the EU-wide assessment of the situation via EMA and HERA
- Develop and implement the national connection to the "European Shortages Monitoring Platform (ESMP)"
- Active participation in the "Solidarity Mechanism Working Group"
- Active participation in the thematic working group "Medicine availability and supply disruptions" of the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (TFAAM)
- Active participation in the Joint Action EU4Health-06 “CHESSMEN"
- Collaboration in the development of the methodology for the creation of the EU list of critical medicines as part of the EU project "CHESSMEN
Improving the availability of medicines authorised in the European Union (EU) is a key priority for the European Medicines Agency (EMA) and the European medicines regulatory network. Shortages or other problems with the availability of medicines create challenges for the medicine supply chain, with a potentially serious impact on human and animal health. Maintaining the medicines supply chain is a challenging task for everyone involved.
Regulatory authorities within and outside Europe, such as the BASG, are increasingly working together helping to minimise the frequency and limit the impact of medicines shortages. In Austria, for example, transparency is created by publishing medicine shortages (https://medicineshortage.basg.gv.at) and by providinginterfaces are available for integration into external IT systems. Additionally, there is regular dialogue with stakeholders in the supply chain ("Task Force Lieferengpässe").
To better manage and avoid shortages of medicinal products, the EMA and the Heads of Medicines Agency (HMA) have jointly set up the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (TFAAM). It provides strategic and structural solutions, with the focus on medicinal products for human and veterinary use authorised in the EU. The Task Force acts as a “supply and availability hub” relating to the supply capability and availability of medicinal products. It monitors the progress made in the framework of various EU projects and aims to streamline processes, ensure synergies, and avoid duplication of work within the network. The task force is composed of a steering committee and two thematic working groups. The BASG participates in the thematic working group "Medicine availability and supply disruptions" and is involved in the implementation of the work programme.
The EMA provides guidance for industry to help ensure the continuity of supply of human medicines, prevent shortages and reduce the impact of any shortages that occur. The EMA/HMA also provides recommendations for patient organisations and healthcare professionals on the measures they can take to help prevent and manage shortages of human medicines in the EU. For information, see the EMA website "Availability of medicines".
The "Medicine Shortages Single Point of Contact (SPOC) Working Party" is responsible for monitoring and reporting events that could affect the supply of medicines in the European Union (EU). This group meets regularly and the BASG represents Austria.
For crisis preparedness and management, Regulation 2022/123 foresees a reinforced role for EMA, which is performed by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), and which also provides for the development of the European Shortages Monitoring Platform (ESMP) by February 2025. The ESMP roadmap as of June 2023 is publicly available on the EMA website. The BASG is also working in this area to be able to provide the necessary information to the EMA or MSSG via the ESMP for future public health emergencies or major events.
According to EU Regulation 2022/123, marketing authorisation holders must register an Industry Single Point of Contact (i-SPOC)" for medicine shortages for all human medicinal products authorised in the European Union (centrally or nationally authorised medicinal products). The i-SPOC will facilitate rapid communication between the EMA and marketing authorisation holders to detect, report and prevent or manage supply and availability issues of medicines included in the list of critical medicines for a "public health emergency" or a "major event".
The generation of an i-SPOC contact is a 2-step-process. For more information see: Industry contact points for supply and availability of critical medicines and the BASG registration page for distribution restrictions at the EMA
In accordance with its role in crisis preparedness as defined in EU Regulation 2022/123, the EMA published on 8th July 2022 the list of the main therapeutics groups (MTGs) in crisis preparedness that are used for emergency care, surgeries and intensive care. This list was established by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). It will be used to help setting up the major event and public health emergencies critical medicines list, respectively.
The list of the main therapeutic groups which is based on the WHO ATC classification, consisting of five levels, indicates the therapeutic subgroups (level 2) and the relevant pharmacological subgroups (level 2).
Further Information: List of the "main therapeutic groups" (MTGs) in crisis Preparedness
The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published the first version of the Union list of critical medicines on the 12 December 2023. It contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the EU/EEA, for which continuity of supply is a priority and shortages should be avoided. The European medicines regulatory network will prioritise critical medicines for EU-wide actions to strengthen their supply chain.
The list is an important tool to support the EU’s efforts in ensuring supply security and preventing shortages of critical medicines. Inclusion in the list does not mean that the medicine is likely to experience a shortage in the near future. It means that the prevention of shortages is particularly important as a shortage could cause significant harm to patients and pose important challenges to health systems. A medicine is considered critical if it is used in serious diseases and cannot be easily replaced by other medicines, for example in case of a shortage. It is included in the Union list of critical medicines if it meets certain criteria, including being critical in more than one third of EU/EEA countries.
The list contains active substances covering a wide range of therapeutic areas, and includes vaccines and medicines for rare diseases. It reflects the outcome of the review of 600 active substances taken from six national lists of critical medicines . The Union list will be expanded in 2024 and will then be updated every year.
The review was carried out with all EU Member States, and criticality was assigned based on an agreed methodology developed in consultation with key stakeholder groups, including patients’ and healthcare professionals’ organisations and industry associations.
Medicines on the list can continue to be prescribed and used as usual by patients and healthcare professionals. Additional reporting requirements for marketing authorisation holders and national competent authorities will be established and become effective once the proposed pharmaceutical legislation becomes applicable.
The publication of the Union list will not impact existing or to-be-established national lists of critical medicines. However, it will support the network’s efforts in drawing up national lists where these do not yet exist.
The original press release and further information on the list, including its composition, criteria for compilation and how it can be used, can be found here: First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
The Solidarity Mechanism Working Group was established by the MSSG in July 2023. The BASG joined this working group by then and worked on the development of a voluntary solidarity forum for the EU/EEA member states. At the end of October, the EU Solidarity Mechanism was presented. This voluntary mechanism allows Member States to support each other in the face of a critical medicine shortage. This voluntary mechanism can only be used under very limited conditions and was developed as a last resort for Member States after they have exhausted all other possibilities.
The solidarity mechanism complements a number of actions that the MSSG can carry out to address critical shortages in the EU. These were also published in 24th October 2023 as part of the MSSG Toolkit. The toolkit includes recommendations for monitoring supply and demand, guidance on interactions with marketing authorisation holders and manufacturers to increase and redistribute existing stocks and the implementation of regulatory flexibilities, such as the exceptional supply of certain medicines that may not be authorised in a particular EU Member State, or full or partial exemptions to certain labelling and packaging requirements for medicines.
MSSG solidarity mechanism (at the bottom of the website)
EMA takes further steps to address critical shortages of medicines in the EU (EMA-News 24/10/23)
A surge in respiratory infections across the EU in winter 2022-23 led to an increased demand for antibiotics such as amoxicillin (alone and in combination with clavulanic acid), especially for use in children. Since then, EMA, the European Commission's Health Emergency Preparedness and Response Authority (HERA) and the Heads of Medicines Agencies (HMA) are taking important steps to avoid shortages of antibiotic medicines for European patients, via the Executive Steering Group on Shortages and Safety of Medicinal Products. For this purpose data were collected at national level to estimate supply and demand in the EU of the these antibiotics: amoxicillin, amoxicillin/clavulanic acid, penicillin V, azithromycin, clarithromycin, ceftriaxone, cefotaxime, piperacillin-tazobactam.
The data (as of July 2023) suggest that the supply of oral formulations of key first and second-line antibiotics for respiratory infections will match demand, assuming demand does not exceed the average over the past few years.
EMA and HERA continue to monitor supply and demand closely and interact with marketing authorisation holders to step up the production. To better assess the situation in the individual Member States across the EU the "Medicine Shortages SPOC Working Party" has been monitoring availability and reported shortages since last winter.
For information, see the EMA website "Preventing shortages of antibiotics during winter"
European Health Union: EU steps up action to prevent shortages of antibiotics for next winter (EMA-News 17/07/23)
The Austrian Medicines and Medical Devices Agency takes part in the project "CHESSMEN". The aim is a harmonised network of authorities responding to the monitoring of medicine shortages.
CHESSMEN is a Joint Action of 27 organisations from a total of 22 EU/EEA countries and means "Coordination and Harmonisation of the Existing Systems against Shortages of Medicines – European Network". The existing systems in the EU/EEA member states for monitoring medicine shortages are to be coordinated and harmonised more effectively over the next three years.
For information see
The Health Emergency Preparedness and Response Authority (HERA), created by the European commission, will anticipate threats and potential health crises for EU citizens to detect, prevent, and rapidly respond to health emergencies if necessary.
Essentially, HERA operates in two phases: In the preparatory phase, it works with the individual member states to identify, analyse, and prioritise potentially threatening scenarios. This work forms the basis for coordinating the implementation of medical countermeasures, including the necessary industrial capacities.
In the crisis phase, HERA will rely on its forward-looking overall management system and activate an emergency framework, which will be deployed by the European Council on a proposal from the Commission, depending on the economic situation and the need to protect public health.
- Process notifications from marketing authorisation without delay in accordance with the regulation on ensuring the provision of medicinal products.
- Publish reported medicine shortages in the “Medicine shortages catalogue” (general register), which is updated daily.
- Publish parallel export bans in the “Catalogue according to the regulation on ensuring the provision of medicinal products”, which is updated daily.
- Provision of daily updated data interfaces for integration into external IT systems
- Regular dialogue with stakeholders in the medicine supply chain through the "Task Force Lieferengässe"
- To identify facts that have led to the shortage and to communicate this information to the involved parties.
- Determine the extent of the shortage and communicate this information to stakeholders.
- Contact the marketing authorisation holder and/or healthcare professionals to communicate information.
- Contact other national competent authorities or the European Medicines Agency (EMA) to circulate information.
- Prioritise applications for new marketing authorisations for medicinal products if deemed necessary in order to prevent a shortage or encourage accelerated processing of European procedures.
- Prioritise variations of marketing authorisations for medicinal products if deemed necessary in order to prevent a shortage or encourage accelerated processing of European procedures.
- Process and approve applications and notifications for the import or shipment of medicinal products not currently authorised in Austria and blood products in connection with the Austrian Act on the Import of Medicinal Products as an additional supply option.