With the amendment of the Federal Constitution Act and the creation of the Freedom of Information Act (IFG), official secrecy will be abolished on 1 September 2025.

The new freedom of information consists, on the one hand, of a proactive obligation to publish information of general interest and, on the other hand, the fundamental right to access government and certain corporate information upon request (information from the Federal Chancellery).

As the competent national authority, the Federal Office for Safety in Health Care (BASG) is responsible for the enforcement of the material laws listed in Section 6a (1) of the Health and Food Safety Act (GSG).

1. Enforcement of the Medicinal Products Act, Federal Law Gazette No. 185/1983, insofar as enforcement is the responsibility of the Federal Office for Safety in Health Care under this Act,
2. Enforcement of the Medicinal Products Import Act 2010, Federal Law Gazette I No. 79/2010, insofar as enforcement is the responsibility of the Federal Office for Safety in Health Care under this Act,
3. Enforcement of the Blood Safety Act, Federal Law Gazette I No. 44/1999, insofar as enforcement is the responsibility of the Federal Office for Safety in Health Care under this Act
4. Enforcement of the Medical Devices Act 2021, Federal Law Gazette I No. 122/2021, insofar as enforcement is the responsibility of the Federal Office for Safety in Health Care under this Act
5. Enforcement of the Prescription Obligations Act, Federal Law Gazette No. 413/1972, insofar as enforcement is the responsibility of the Federal Office for Safety in Health Care under this Act
6. Enforcement of the Tissue Safety Act, Federal Law Gazette I No. 49/2008, insofar as enforcement is the responsibility of the Federal Office for Safety in Health Care under this Act, 6a. Enforcement of the Federal Act on Financial Measures to Ensure the Availability of Medicinal Products, Federal Law Gazette I No. 192/2023, insofar as enforcement is the responsibility of the Federal Office for Safety in Health Care under this Act,
7. the supervision of persons authorised to possess, acquire, produce, process, convert or traffic in narcotic drugs in accordance with Section 6(1)(1) and (2) of the Narcotic Drugs Act, Federal Law Gazette I No. 112/1997, with regard to their handling of these substances,
8. monitoring the dispensing of narcotic drugs by pharmacies pursuant to Section 7 para. 1 of the Narcotic Drugs Act in accordance with an annual control plan to be drawn up by the Federal Ministry of Social Affairs, Health, Care and Consumer Protection,
9. the monitoring of the dispensing of speciality medicinal products for human use by way of distance selling by public pharmacies pursuant to Section 59a of the Medicinal Products Act,
10. Enforcement of the Veterinary Medicinal Products Act, Federal Law Gazette I No. 186/2023, insofar as enforcement is the responsibility of the Federal Office for Safety in Health Care under this Act,
11. the supervision of the dispensing of veterinary medicinal products by means of distance selling in accordance with § 50 of the Veterinary Medicinal Products Act.

Information from the BASG that is of general interest (proactive information) within the meaning of Section 2 para. 2 in conjunction with Section 4 para. 1 of the Freedom of Information Act as amended (IFG) can be accessed below or at www.data.gv.at, provided it is not subject to confidentiality pursuant to Section 6 IFG.

Furthermore, reference may be made to the Public Registers of the BASG as well as to the annual reports and fact folders.

Information on request within the meaning of § 2 para. 1 in conjunction with § 7 IFG Freedom of Information Act as amended should preferably be submitted via the application below for access to information in accordance with the Freedom of Information Act. The application must be as precise as possible and refer explicitly to the Freedom of Information Act. The information requested must already exist and be available at the BASG.

The BASG must provide the requested information to the applicant in the requested form within four weeks of the application being submitted (Section 8 (1) IFG), provided there are no confidentiality obligations pursuant to Section 6 IFG.

However, if the provision of information interferes with the rights of third parties, they must be heard by the BASG in the course of the procedure and the deadline for the provision of information is extended by a further four weeks and is therefore eight weeks. The deadline for providing information is also extended to eight weeks if there are special reasons that make it impossible to provide information within four weeks (Section 8 (2) IFG). The BASG will notify the applicant in writing in advance.

In the event that the BASG is unable to provide the information within the four or eight-week period (Section 11 IFG), the applicants will be notified accordingly in writing. If the issuance of a negative decision is desired, a corresponding written application must be submitted to the BASG at the e-mail address: IFG-Anfragen@basg.gv.at. The negative decision will be issued to the applicant within two months of the application being submitted.

However, if a contingent application for a decision in the event that the information is not issued has already been submitted to the BASG in the course of the original application, the negative decision will be issued to the applicants without further application within two months of written notification that the information will not be issued.

As part of marketing authorisation applications, extensive dossiers with administrative, pharmaceutical-chemical, non-clinical and clinical data are submitted, assessed by authorities in the form of assessment reports and, following a positive outcome, marketing authorisation is granted. These procedures can be purely national, joint with several member states (decentralised) or centralised for the EU and the EEA via the EMA (European Medicines Agency) and the European Commission. The dossiers sometimes contain trade and business secrets as well as personal data. The same applies to the very extensive internal assessment reports of the authorities, which is why these are only published in abbreviated form as "public assessment reports".

The Medicinal Products Index (BASG All-in-One Register) lists all nationally, decentrally and centrally authorised medicinal products together with further information such as authorisation numbers, authorisation holders, authorisation data, prescription status, dispensing status, active ingredients, ATC codes (Anatomical Therapeutic Chemical Classification System). This list can be searched and exported according to various criteria.

Furthermore, the daily updated Package Leaflet and Summary of Product Characteristics (SmPC) are published in the Medicinal Products Index for all nationally and decentrally authorised medicinal products; those for centrally authorised products can be accessed under Community Register. The package leaflet summarises all relevant information for patients on the safe use of the medicinal product, while the Summary of Product Characteristics contains additional important information for healthcare professionals such as doctors and pharmacists.

For national and many decentralised products authorised from 2005 onwards, public assessment reports (corresponding to the assessment reports without confidential data) have also been published in the Register of Proprietary Medicinal Products since 2005 and risk management plans for human medicinal products since 2012; in addition, these documents for decentralised authorised products are published at https://mri.cts-mrp.eu/portal/home?domain=h and https://www.medicinesinfo.eu/de and those for centrally authorised products at https://www.ema.europa.eu/en/medicines.
This and other information on veterinary medicinal products can also be viewed in the Union Product Database(Union Product Database - European Medicines Agency (EMA)).

Authorisation decisions and letters of approval for variations are not published, but all relevant key data can be viewed and searched for in the BASG announcements or, for central procedures, the information under Community Register applies.

Suspected cases of adverse reactions following the use of human medicinal products can be viewed at the following addresses: European database of suspected adverse drug reaction reports and European database of suspected adverse drug reaction reports - Search. Information on the Eudra Vigilance database is available at Access to EudraVigilance data - European Medicines Agency (EMA).

Suspected cases of adverse reactions following the use of veterinary medicinal products can be viewed at the following address: https://www.adrreports.eu/vet/.

Clinical trials conducted in Austria comply with legal requirements with a focus on subject safety and the reliability of the data.

The use of unauthorised medicinal products on a patient group outside clinical trials is carried out within the framework of the compassionate use programme in accordance with the legal requirements and with an acceptable benefit/risk ratio.

The health policy dimension of clinical trials concerns the balance between innovation and protection, the state's responsibility for quality and ethics, and the social legitimisation of clinical research.

Economic and health policy significance:

Patient safety and protection

• The central health policy mandate is to ensure that all study participants are comprehensively protected.
• This includes ethical standards as formulated in the Declaration of Helsinki.

Authorisation of safe and effective medicines

• Clinical trials serve as the basis for the authorisation of medicinal products.
• It must be ensured that only effective, tested and safe therapies come onto the market.
• This promotes public health and can reduce costs in the healthcare system, e.g. by avoiding ineffective therapies.

Regulation and control

• State control and authorisation are needed to guarantee legal standards.
• Politicians determine the legal framework (e.g. through the AMG, the EU Regulation on Clinical Trials 536/2014).
• This ensures standardised quality and transparency.

Promoting research and innovation

• The aim is to enable medical progress, e.g. for rare diseases, new cancer drugs or vaccines.
• Aspects of promoting Austria as a centre of research are an important by-product that is not part of the BASG's legal mandate, but is a given as an economic and health policy contribution, although it cannot be measured.

International co-operation

• Clinical trials often cross borders. The health policy dimension therefore also concerns the harmonisation of standards at EU, WHO or ICH level.
• Example: The EU-CTR (Clinical Trials Regulation) ensures standardised procedures within the EU.
• Austria is involved in these activities.

Equal access and participation

• All population groups have access to participation in clinical trials. Particularly vulnerable groups of the population are protected.
• Results should later benefit everyone.

Transparency and trust of the population

• Transparent communication about the benefits and risks of clinical trials is a health policy objective.
   

Legal basis:

Clinical trials

• Medicinal Products Act (AMG) as amended, specifically Section 2a and Section III, Sections 28 - 48 AMG
• Regulation (EU) 536/2014
• Guidelines of the European Commission(Eudralex Vol. 10)

Hardship programme (compassionate use)

• Medicinal Products Act (AMG) §2 para. 5a and § 8a as amended
• Regulation (EC) No 726/2004, Article 83

Published information from the monitoring programme:

The annual News Letter of the BASG with statistical data on clinical trials according to the AMG can be found here.

The European Union Clinical Trials Register allows you to search for protocol and results information on:

• interventional clinical trials authorised in the European Union (EU) / European Economic Area (EEA) according to the Clinical Trials Directive 2001/20/EC
• clinical trials conducted outside the EU/EEA and related to the development of European paediatric medicinal products.

EU/EEA interventional clinical trials authorised under or converted to the Clinical Trials Regulation (EU) No 536/2014 can be queried via the Clinical Trials Information System (CTIS).

Compassionate use programmes approved in Austria are published on the BASG website.

Clinical trials conducted in Austria or - if relevant for marketing authorisations - in third countries comply with legal requirements and good clinical practice, with a focus on subject safety and the reliability of the data.

Economic and health policy significance

The benefit of the inspection lies in the verification of compliance with the protocol and the regulatory requirements for the conduct of a clinical trial. The inspection makes it possible to assess the quality and reliability of the data generated.

If necessary, clinical trials can be stopped if hazards or gross legal violations are recognised.

The inspection helps to sensitise the market to the fact that the efficacy and safety of medicinal products can only be guaranteed if the clinical trial data collected complies with the protocol and is reliable.

Rule of law and transparency

• Inspections put the legal framework (e.g. Medicinal Products Act, GCP Regulation) into practice.
• This creates legal certainty for sponsors, investigators and patients.
• Transparent processing of violations strengthens trust in the healthcare system.

Prevention of abuse and misconduct

• The possibility of inspection prevents ethical or scientific misconduct.
• In terms of health policy, this serves the integrity of the research system.

International credibility and competitiveness

• Countries with a well-functioning inspection system are regarded as reliable partners in global research.
• Quality assurance through inspections is a decisive criterion for international drug authorisations.
• Health policy thus also secures Austria and the EU as a research location.

Efficient utilisation of healthcare resources

• Studies of poor quality lead to false conclusions and possibly unnecessary costs in the healthcare system or jeopardise patients.
• Inspection contributes to the efficiency and sustainability of medical innovation.

Sustainable promotion of innovation

• A controlled research environment creates fair competitive conditions in which reputable and quality-orientated studies can prevail.
• In this way, healthcare policy promotes sustainable and socially useful innovation.

The health policy dimension of the inspection of clinical trials lies in the state's responsibility for protection, quality and transparency. Inspections are not a purely administrative act, but a central element of democratic health control that both protects individual rights and strengthens trust in research and care.

Legal basis

The legal basis (in the currently valid form) is

• Medicinal Products Act (AMG) as amended, specifically §2a and Section III, §§ 28 - 48 AMG
• Regulation (EU) 536/2014
• Guideline on Good Clinical Practice (ICH GCP)
• Declaration of Helsinki of the World Medical Association

Published information from monitoring

The list of completed inspections is published quarterly on the website of the Federal Office.

Medicinal products only reach patients via authorised or inspected companies in compliance with national and European regulations in accordance with the intended distribution channels.

Economic and health policy significance

Inspection and monitoring in the pharmaceutical sector is a key health policy instrument to

• ensure patient safety,
• protect the quality and integrity of the pharmaceutical market
• and to ensure trust in medicinal products and healthcare systems.

It combines technical-regulatory measures with a political responsibility to protect the health of the population in the long term.

A functioning authorisation and inspection system ensures that patients are adequately protected by a uniform level of quality in the manufacture and distribution of medicinal products and that the monitored companies can participate in international business activities.

The harmonised approach to inspections within the EU ensures that all companies can adapt to a uniform inspection standard and have a level playing field.

Together with the inspection system, various national and European monitoring systems are interlinked (European intergovernmental information transfer of serious infringements in production, control or distribution; mandatory reporting of quality defects, mandatory reporting of adverse reactions), which together enable effective state risk management.

This ensures that risks to public health that may arise from medicinal products are controlled and contained in the various phases of the life cycle.

Protection of public health

• The primary objective is to protect patients from harm to their health caused by unsafe, falsified or poorly manufactured medicinal products.
• Inspections and monitoring measures ensure that medicinal products are produced in accordance with good manufacturing practices (GMP) and that they are transported, stored and placed on the market in accordance with good distribution practices (GDP).

Trust in the healthcare system

• Functioning and transparent supervision creates consumer confidence in medicinal products and healthcare institutions.

Prevention and risk minimisation

• Regular and ad hoc inspections allow undesirable developments to be recognised and corrected at an early stage.

Ensuring standardised pharmaceutical quality in the EU

• The harmonisation of monitoring standards in the EU ensures uniform safety levels and protects patients in all member states.
• The same high quality standard must also apply to medicinal products that are distributed across borders.

Economic and regulatory control

• Inspections verify compliance with legal requirements and ensure fair competition.

Global responsibility

• The EU and its member states also carry out inspections in third countries (e.g. contract manufacturers in Asia) to ensure that imported medicinal products meet European standards.

Legal basis

European Medicines Agency
AMG §§ 63, 63a, 64, 65, 66, 66a, 67, 68.
AMBO 2009, §§ 7 (8), 8 (4), 9 (4).
New blistering operating regulations

Published information from monitoring

https://www.basg.gv.at/marktbeobachtung/oeffentliche-register/arzneimittelbetriebe

https://www.basg.gv.at/marktbeobachtung/oeffentliche-register/arzneimittelvermittler

https:// eudragmdp.ema.europa.eu/inspections/logonGeneralPublic.do

GLP-compliant preclinical data form the basis for authorisations of clinical trials and marketing authorisations of medicinal products. The effectiveness of GLP monitoring lies in the identification of untrustworthy preclinical data in order to be able to exclude them from decisions on clinical trials or marketing authorisations for medicinal products.

Economic and health policy significance

Preclinical data (e.g. from animal experiments or cell cultures) are collected before a drug can be tested on humans and are therefore the first proof of safety in the development of a drug.

Protecting people from risks

• Preclinical studies are used to test the toxicity of an active substance.
• Only if these data are convincing may a clinical trial on humans take place.
• This is an ethical and health policy requirement designed to guarantee the protection of trial participants.

Basis for the official assessment

• Authorities such as the BASG evaluate preclinical data before authorising clinical trials.
• This means that preclinical data is a decisive factor both for the approval of the clinical trial and later for the authorisation of the drug itself.

Avoiding costs and bad investments

• Early data on unacceptable toxicity prevents resources from being invested in hopeless further development steps.
• This serves the efficiency of the healthcare system and protects against the economic burden of ineffective drug development.

Basis for ethical research

• Studies on humans are only ethically justifiable if robust preclinical evidence is available.

Transparency and traceability

• The publication and evaluation of preclinical data increases transparency in the drug development process.
• Health policy can thus rely on reliable information for the general public and the specialised public.

Legal basis

Directive 67/548/EEC requires chemical substances to be tested in order to assess their potential risks to humans and the environment. The principles of GLP must be applied when carrying out the tests required by Directive 67/548/EEC so that the results are of high quality and comparable.

European pharmaceutical legislation stipulates that preclinical trials on medicinal products must also be carried out in accordance with the principles of GLP.

All European regulations on GLP have been transposed into the Austrian Medicinal Products Act. The reporting obligations of the test facilities and the tasks of the supervisory authority are laid down in the GLP Regulation, Federal Law Gazette II No. 450/2006. The national legal basis consists of the mandate to monitor GLP test facilities by inspection with reference to the OECD GLP(Directive 2004/9/EC) and a procedural standard(Directive 2004/10/EC).

Preclinical tests of medicinal products may only be carried out by test facilities that are certified by the BASG. The periodicity of monitoring is carried out at least every three years.

For the effectiveness of GLP monitoring, the flow of information

• at international level between Austria and the OECD countries and
• at national level between the Inspectorate and the National Evaluation Centre for Clinical Trials or the National Medicines Agency
  is essential.

Published information from monitoring

The national GLP test facilities, their quality status, the "Areas of Expertise" and the last inspection date are listed on the respective websites of the national monitoring authorities.

The information on the Austrian GLP test facilities can be found here can be accessed here. The overview shows the annual GLP inspections, the GLP-certified facilities and their certified areas of expertise.

Clinical trials of medical devices and performance evaluation tests of in-vitro diagnostics conducted in Austria comply with legal requirements with a focus on subject safety and data reliability.

Economic and health policy significance

Patient safety and protection

• The central health policy mandate is to ensure that all study participants are comprehensively protected.
• This includes ethical standards, such as those formulated in the Declaration of Helsinki or the Medical Devices Act (MPG).

Authorisation of safe and effective medicines

• Clinical trials and performance evaluation tests serve as the basis for the marketability of medical devices and in-vitro diagnostics.
• Healthcare policy must ensure that only legally compliant medical devices and in-vitro diagnostics are placed on the market.
• This promotes public health and can reduce costs in the healthcare system, e.g. by avoiding ineffective therapies or diagnostics.

Regulation and control

• State control and authorisation are needed to guarantee ethical and legal standards.
• Politicians determine the legal framework (e.g. through the MPG, the EU regulations on medical devices 2017/745 and in-vitro diagnostics 2017/746).
• This ensures standardised quality and transparency.

Promotion of research and innovation

• The aim is to enable medical progress.
• Aspects of promoting Austria as a centre of research are an important by-product that is not part of the BASG's legal mandate, but is a given as an economic and health policy contribution, although it is not measurable.

International co-operation

• Clinical trials often cross borders. The health policy dimension therefore also concerns the harmonisation of standards at EU, WHO or ICH level.
• Example: The EU regulations on medical devices 2017/745 and in-vitro diagnostics 2017/746 ensure standardised procedures within the EU.
• Austria is involved in these activities.

Equal access and participation

• Health policy must ensure that all population groups have access to participate in clinical trials.
• The results should also benefit everyone later on - i.e. no research only for economically interesting patient groups.

Transparency and public trust

• Transparent communication about the benefits and risks of clinical trials is a health policy objective.
• Without public trust (e.g. after scandals or unethical studies), research can be hindered.

The health policy dimension of clinical trials concerns the balance between innovation and protection, the state's responsibility for quality and ethics, and the social legitimisation of clinical research. It is therefore an essential component of a responsible health policy.

Legal basis

Clinical investigations of medical devices in accordance with Regulation (EU) 2017/745
Performance evaluation studies of in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746
Guidelines of the Medical Devices Coordination Group

Published information from surveillance
Information on clinical investigations of medical devices and performance evaluation studies of in vitro diagnostic medical devices can be found here.

Clinical trials and performance evaluation trials conducted in Austria comply with legal requirements and established standards, focussing on subject safety and data reliability.

Economic and health policy significance

The benefit of the inspection lies in the verification of compliance with the protocol and regulatory requirements for the conduct of a clinical trial. The inspection makes it possible to assess the quality and reliability of the data generated.

If necessary, clinical trials can be stopped if hazards or gross legal violations are recognised.

The inspection helps to sensitise the market to the fact that the efficacy and safety of medicinal products can only be guaranteed if the clinical trial data collected complies with the protocol and is reliable.

Rule of law and transparency

• Inspections put the legal framework (e.g. Medical Devices Act, EU Regulation for medical devices and in-vitro diagnostics) into practice.
• This creates legal certainty for sponsors, investigators and patients.
• Transparent processing of violations strengthens trust in the healthcare system.

Prevention of abuse and misconduct

• The possibility of inspection prevents ethical or scientific misconduct.
• In terms of health policy, this serves the integrity of the research system.

International credibility and competitiveness

• Countries with a well-functioning inspection system are regarded as reliable partners in global research.
• Quality assurance through inspections is a decisive criterion for international drug authorisations.
• Health policy thus also secures Austria and the EU as a research location.

Efficient utilisation of healthcare resources

• Studies of poor quality lead to false conclusions and possibly unnecessary costs in the healthcare system or jeopardise patients.
• Inspection contributes to the efficiency and sustainability of medical innovation.

Sustainable promotion of innovation

• A controlled research environment creates fair competitive conditions in which reputable and quality-orientated studies can prevail.
• In this way, healthcare policy promotes sustainable and socially useful innovation.

The health policy dimension of the inspection of clinical trials lies in the state's responsibility for protection, quality and transparency. Inspections are not a purely administrative act, but a central element of democratic health control that both protects individual rights and strengthens trust in research and care.

Legal basis

Clinical investigations of medical devices in accordance with Regulation (EU) 2017/745
Performance evaluation studies of in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746
Medical Devices Act (MPG), Federal Law Gazette I No. 122/2021, specifically Section 4 and Section 3 §§ 13 - 36

Published information from monitoring
The list of completed inspections is published quarterly on the website of the Federal Office.

Only legally compliant medical devices and in-vitro diagnostics are placed on the market. The legal conformity of relevant economic actors (such as manufacturers, distributors or operators) is ensured.

Economic and health policy significance

Medical devices are subject to the free movement of goods within the EEA. This means that medical devices that fulfil the legal requirements can be placed on the market and marketed in these countries.

Proof of the marketability of medical devices is provided by means of a conformity assessment procedure followed by CE labelling. Conformity assessment and CE labelling are the sole responsibility of the manufacturer. However, the internal market regulations also require market surveillance to ensure the safety, quality and performance of medical devices, which must be carried out by the competent authority (BASG) in the respective member state.

The importance of market surveillance of medical devices in Europe lies in ensuring patient safety, protecting public health and building confidence in the healthcare system and the internal market. Market surveillance is a key instrument for ensuring that only safe and effective medical devices are used on the European market - in hospitals, by healthcare providers and in everyday life.

Market surveillance of medical devices in Europe is essential in terms of health policy because it:

• Protects patients from unsafe products,
• helps to recognise and contain risks,
• strengthens trust in medicine and the healthcare system,
• and ensures a functioning internal market with high health and safety standards.

It is therefore a central instrument of state responsibility for public health in a technologically dynamic and highly sensitive area.

What is market surveillance of medical devices?

Market surveillance refers to the activities carried out by the authorities after medical devices have been placed on the market to check whether

• they are compliant with European regulations [Regulation (EU) 2017/745 and Regulation (EU) 2017/746],
• they are safe and function effectively,
• manufacturers and other stakeholders fulfil their obligations (e.g. regarding vigilance, market surveillance, ongoing clinical evaluation and associated documentation)
• if necessary, corrective measures (e.g. product recalls, bans on use) must be taken.

The importance of market surveillance in detail:

Protection of patient safety

• Medical devices (e.g. pacemakers, implants or infusion pumps) can cause serious damage to health if they malfunction.
• Market surveillance ensures that defective or dangerous products are removed from the market.

Protection against substandard or counterfeit goods imported from third countries

• The internal market allows the free movement of goods. This includes products from third countries, provided they fulfil the legal requirements of the EEA.
• Market surveillance checks whether imported products
• are legally compliant (comply with EU regulations),
• have a valid CE marking,
• are not distributed via illegal distribution channels (e.g. under false customs declarations).

Data basis for political and regulatory decisions

Market surveillance generates important data:

• on product defects,
• reporting behaviour,
• undesirable developments on the market.

This data flows into:

• legislative reforms
• European guidelines and improved monitoring methods,
• the further development of technical standards.

Fair market conditions and promotion of innovation

Effective market surveillance protects:

• Manufacturers and other market players who comply with legal requirements,
• from unfair competition from substandard or counterfeit products.

It creates a reliable framework for:

• Innovations in the medical market,
• investment security for companies.

Legal basis

Medical Devices Act (MPG 2021) and all applicable national regulations
Regulation (EU)1020/2019 on market surveillance and the conformity of products
Regulation (EU) 745/2017 on medical devices (MDR)
Regulation (EU) 746/2017 on in vitro diagnostic medical devices (IVDR)

Published information from the surveillance
Product warnings and recalls concerning medical devices are available in the official news of the BASG.

Only legally compliant medical devices and in-vitro diagnostics are placed on the market. The legal conformity of relevant economic actors (such as manufacturers, distributors or operators) is ensured.

Economic and health policy significance

Medical devices are subject to the free movement of goods within the EEA, including Switzerland and Turkey. This means that medical devices that fulfil the legal requirements can be placed on the market and marketed in these countries.

Proof of the marketability of medical devices is provided by means of a conformity assessment procedure followed by CE labelling. Conformity assessment and CE labelling are the sole responsibility of the manufacturer. However, the internal market regulations also require market surveillance to ensure the safety, quality and performance of medical devices, which must be carried out by the competent authority (BASG) in the respective member state.

The public health significance of official inspections as part of the market surveillance of medical devices and in vitro diagnostics (IVDs) in Europe lies primarily in safeguarding public health, protecting patient safety, maintaining high quality standards and preventing risks from unsafe or illegal products.

Regulatory inspections are a key control tool to ensure that manufacturers, distributors, authorised representatives and healthcare institutions and other relevant stakeholders comply with the legal requirements of the European Medical Device Regulation [Regulation (EU) 2017/745] and the IVD Regulation [Regulation (EU) 2017/746/EU].

The importance of regulatory inspections in the medical device market is to

• to promote the safety and performance of medical devices
• help prevent crises and scandals,
• maintain a harmonised and high level of safety in the internal market
• strengthen confidence in the healthcare system and in medical innovations.

Inspections are an indispensable tool for risk prevention, patient safety and regulatory control in Europe's modern healthcare system:

Monitoring product quality and safety

During inspections, authorities can check the legal conformity of the manufacture, distribution, operation, assembly or use of medical devices, among other things. This includes, among other things

• Manufacturing processes (incl. quality management system),
• risk management systems,
• technical documentation,
• conformity assessment and CE labelling.

This involves checking whether products actually fulfil the requirements necessary for their safe use.

Monitoring the performance quality of in-vitro diagnostics

IVDs provide information for diagnoses or therapies and are relevant in medical treatment decisions.

Faulty test results can lead to incorrect diagnoses, delayed or incorrect treatment or unnecessary interventions.

Inspections can check, among other things, whether:

• Validation and proof of performance are correct,
• manufacturers are documenting and monitoring correctly.

Monitoring a safe European domestic market

• Medical devices are sold throughout Europe - inspections help to ensure a uniform safety standard.
• They help prevent substandard products, unsafe or illegal products from third countries or dubious suppliers from infiltrating the market.

Strengthening trust and transparency

Regular and transparent inspection activities strengthen

• the trust of patients in medical technology,
• the acceptance of new technologies (e.g. automated systems, digital health applications),
• the willingness of healthcare providers and manufacturers to cooperate.

Gaining data and improving regulation

Inspection results can provide important information for

• the need for legislative adjustments,
• targeted prioritisation in market surveillance,
• the need for co-operation between authorities at EU level (e.g. within the framework of coordination by the MDCG - Medical Device Coordination Group).

Monitoring the fulfilment of role responsibility

• Manufacturers and distributors are legally obliged to monitor the behaviour of their products on the market, to continuously assess identified risks and clinical performance and to react to the findings.
• During inspections, the authority checks whether these obligations are actually being implemented.

Legal basis

Medical Devices Act (MPG 2021) and all applicable national regulations
Regulation (EU) 1020/2019 on market surveillance and compliance of products
Regulation (EU) 745/2017 on medical devices (MDR)
Regulation (EU) 746/2017 on in vitro diagnostic medical devices (IVDR)

Published information from surveillance
Product warnings and recalls concerning medical devices can be found in the official news of the BASG.

The regulatory vigilance system in the surveillance of medical devices
The market surveillance of medical devices in the marketing and use phase ensures that safety and efficacy risks are recognised and communicated and that corrective measures are guaranteed.

Economic and health policy significance

The importance of an official vigilance system in the monitoring of medical devices in Europe lies primarily in the protection of patient safety, the early detection of risks and the rapid response to hazards that may arise from medical devices after their market launch.

Vigilance systems are a central component of market surveillance and serve to ensure the safety and performance of medical devices throughout their entire life cycle.

The public health significance of regulatory vigilance systems in Europe is that they:

• Continuously monitor the safety and effectiveness of medical devices,
• enable a rapid response to risks and incidents,
• contribute to transparency, quality assurance and patient education,
• and reveal regulatory and improvement potential for products and processes.

They are therefore a key instrument for active risk prevention and patient safety in the European healthcare system.

What does vigilance mean for medical devices?

Vigilance refers to the systematic recording, assessment and response to

• Serious incidents (e.g. death or permanent damage to health) in connection with the use of medical devices,
• safety corrective actions in the field (e.g. recalls, safety upgrades),
• Observations and trends that indicate potential risks.

The vigilance system is based on close cooperation between:

• Manufacturers and actors along the distribution chain (obligations to cooperate),
• users or operators in healthcare facilities (reporting obligations),
• and the competent national authority (in Austria the BASG).

Health policy significance in detail:

Protection of patient safety

• Vigilance systems help to recognise unexpected, newly occurring or rare risks that were often not visible during the development phase (e.g. also in clinical trials).
• Vigilance systems make it possible to intervene quickly in the event of defective products or faulty applications, e.g. through recalls, warnings or regulatory requirements.

Early warning system for product and system defects

By systematically analysing reports, authorities can:

• Identify risks with specific product batches or manufacturers,
• Identify product groups with increased risk (e.g. implants, software),
• recognise systematic errors in design, manufacture or use.

Support for regulatory measures

Vigilance data is the basis for

• Regulatory measures (e.g. bans on use, recalls, ordered corrective measures),
• market interventions (e.g. traffic bans),
• and, if necessary, liability or sanctioning of those responsible.

Improvement of products and manufacturing processes

Manufacturers are legally obliged to learn from vigilance data and to technically improve products:

• Improve products technically,
• revise instructions for use or training programmes,
• and adapt risk management systems.
• Continuously re-evaluate clinical evaluations

Strengthening trust in the healthcare system

If the population knows that safety-relevant incidents are systematically recorded, reviewed and communicated transparently, trust in the healthcare system grows:

• medical technologies,
• state regulation,
• and security of supply.

Exchange of information at European level

Market surveillance activities are shared at European level in official expert committees and via a centralised European data system (EUDAMED). This includes

• reported incidents,
• measures taken,

Data basis for health policy and regulation

Vigilance data provides important insights for

• the further development of laws, standards for manufacturers and guidelines for regulatory enforcement
• technology assessments,
• political decisions on the acceptability of risks or restrictions on use.

Legal basis

Medical Devices Act (MPG 2021) and all applicable national regulations
Regulation (EU) 1020/2019 on market surveillance and compliance of products
Regulation (EU) 745/2017 on medical devices (MDR)
Regulation (EU) 746/2017 on in vitro diagnostic medical devices (IVDR)

Published information from surveillance
Product alerts and recalls concerning medical devices can be found in the official news of the BASG.

Tissues and/or cells only reach patients via certified or authorised institutions and in compliance with national and European regulations.

Economic and health policy significance

Tissue facilities are specialised facilities that remove tissues and cells of human origin (e.g. skin, heart valves, corneas, bones, stem cells) for therapeutic purposes:

• extract,
• test,
• process,
• store and/or
• pass them on to medical institutions.

The ongoing official monitoring, inspection and authorisation of tissue establishments in accordance with the European Tissue Directive (Directive 2004/23/EC) is of central importance from a health policy perspective, as it serves to protect the recipients of tissue products, ensure high quality and safety standards and avoid transmission risks. During regular inspections, the quality systems of the organisations are checked to ensure that they are up to date, legally compliant and effective.

Official certification and authorisation ensure that living donors as well as Austrian and non-Austrian recipients only receive products that meet the legal quality requirements and are therefore state of the art in science and technology. The legal conformity of national collection centres and tissue banks enables them to participate in international business activities. Risks for donors and recipients are minimised through inspection and by incorporating the findings from the vigilance system.

Legal basis
Tissue Safety Act: Section 19 GSG, Section 22 GSG, Section 26 GSG 
Veterinary Medicinal Products Act: Section 30 TAMG, Section 31 TAMG, Section 36 TAMG
Medicinal Products Act: Section 67 AMG

Published information from monitoring

Austrian establishments with an authorisation in accordance with the Tissue Safety Act are published by the BASG via the European Commission's EU Coding Platform.

Blood and blood products are only supplied to patients via certified or authorised institutions and in compliance with legal requirements.

Economic and health policy significance

Blood products - both for direct transfusion (e.g. erythrocytes, thrombocytes, plasma) and for further processing into medicinal products (e.g. immunoglobulins, coagulation factors) - must be safe, traceable and effective. As they are derived from human donor blood, there is an inherent risk of:

• Transmission of infections (e.g. HIV, hepatitis B/C),
• immune reactions and transfusion incidents,
• manufacturing errors with serious health consequences.

Every year, large quantities of blood and blood products are manufactured in Austria for direct transfusion or for the production of high-quality derivatives. The safety of these products has improved considerably over the past two decades thanks to developments at a legal and industrial level. Nevertheless, the legal framework must be continuously supplemented with technical guidelines from the EDQM or the EMA and the facilities must be monitored.

During regular inspections, the quality systems of the facilities are checked to ensure that they are up to date, legally compliant and effective.

Legal basis
Blood Safety Act: Section 14 BSG, Section 18 BSG
Veterinary Medicinal Products Act: Section 30 TAMG, Section 31 TAMG, Section 36 TAMG
Medicinal Products Act: Section 67 AMG

Published information from monitoring
Authorised companies are listed in the BASG's "Register of authorised pharmaceutical companies in Austria".

The assessment of reportable incidents (serious adverse reactions and serious adverse events related to tissue and cell products) ensures that safety and efficacy risks are recognised and result in corrective action.

Economic and public health significance

The vigilance of tissue and cell products (e.g. bone, skin, stem cells, oocytes, semen) is of great importance in Europe in terms of health policy, as it directly affects the protection of donors and recipients, the safety of medical applications and confidence in biomedical procedures.

It ensures safety, quality, ethics and trust in a particularly sensitive medical field and not only protects recipients and donors, but also supports European cooperation, legal certainty and the continuous improvement of biomedical care.

Vigilance is of great importance in ensuring a high level of health protection. The more seriously vigilance obligations are taken by the healthcare professions, the more comprehensively the BASG will learn of health risks and be able to react. The more overview information on risks from tissue or cell products is made available to Austrian doctors, the better they will be able to react in a risk-avoiding manner in their role.

The main objective of vigilance is the preventive risk identification of products to eliminate causes of danger to human health and the harmonisation of national health strategies.

Collected data is used to monitor the Austrian market in order to identify potential health hazards from products in a timely manner and to be able to order risk-minimising measures. In addition, prevention strategies are developed in cooperation with the legislator and the relevant stakeholders (BMSAGPK, EEA surveillance authorities, EDQM, ECDC, GÖG/ÖBIG, IVF Fund, companies, medical profession, hospitals), particularly in the event of recognised clusters of incidents.

The BASG's reporting to the European Commission provides data on trends in the healthcare system at European level and thus enables comparisons that would not be recognisable at national level due to the lack of data density. The system of reporting to the European Commission is also an important instrument for recognising necessary adjustments to legal provisions.

Tissue and cell products can transmit infections or other complications (e.g. HIV, hepatitis, bacterial contamination). The BASG's vigilance activities are a key instrument for protecting public health:

• targeted recalls or warnings, and
• the minimisation of further risks for patients.

The systematic recording and evaluation of side effects allows data-based control for greater safety, through:

• Risk prevention measures,
• sensitisation of healthcare professionals,

EU-wide vigilance and cooperation between Member States creates the basis for the safe cross-border supply of safe tissue and cell products.

Legal basis

Tissue Safety Act § 33 (1)
Veterinary Medicinal Products Act § 41 (1)

Published information from monitoring

• Annual activity report of the tissue banks - guidance
• Activity reports are submitted to the BASG
• BASG prepares the summary: SARE report
• The BASG SARE report is submitted annually to the Transplantation Advisory Board and to the European Commission
• The summary (SARE) prepared by the European Commission of the reports on serious adverse reactions and events concerning blood and blood components received by the European Commission from the Member States
• The European Commission's summary (SARE) of reports received by the European Commission from Member States on serious adverse reactions and events involving tissues and cells
• The establishments authorised under the GSG are listed in a database of the European Commission
• Product alerts and recalls (BASG Official News - Blood and Tissues)

The evaluation of reportable incidents (serious adverse reactions and serious adverse events related to blood and blood products) ensures that safety and efficacy risks are recognised and result in corrective measures.

By publishing blood consumption data on the BASG website, users are made aware of how blood as a resource is handled. Visualisation should help to

• counteract the shortage of blood and blood products;
• recognise unnecessarily high blood consumption;
• recognise side effects that correlate with the risks of high blood consumption.

Economic and health policy significance

Haemovigilance is a reporting system for incidents and adverse reactions in blood donations and blood transfusions. It extends to:

• donors (donor haemovigilance) and
• recipients (recipient haemovigilance).

The importance of haemovigilance in terms of health policy is high, as it is a central instrument for ensuring transfusion safety, improving quality in the blood supply system and protecting patients and donors. Haemovigilance comprises the systematic monitoring, recording, evaluation and prevention of adverse effects and incidents in connection with the collection, processing and use of blood and blood components.

The more seriously vigilance obligations are taken by the healthcare professions, the more comprehensively the BASG will learn about health risks and be able to react. The more overview information on risks from blood or blood products and blood consumption quantities is made available to Austrian doctors, the better they will be able to react in a risk-avoiding manner in their role.

The main objective of vigilance is the preventive identification of risks to eliminate the causes of threats to human health and the harmonisation of national health strategies.

Through the European communication system, important information concerning blood and tissue safety is communicated via the RATC/RAB Rapid Alert for Tissue and Cells/for Blood System (formerly CIRCA System). All data collected is used to monitor the Austrian market in order to promptly identify potential health hazards and order risk-minimising measures if necessary. This data is also used to develop prevention strategies.

Haemovigilance is an indispensable health policy system that makes a decisive contribution to the safety, transparency and quality of the blood supply. It protects recipients and donors, creates trust in the transfusion system and forms the basis for risk-based, evidence-supported measures in the area of public health.

Patient safety and risk prevention

• Early detection and prevention of reactions to or infections from blood products
• Ensuring reactions to mix-ups or errors in storage or labelling

Donor protection

• Evaluation of adverse events during blood donation
• Optimisation of donor selection and donation conditions
• Contributing to ethical and safe donation practices

Quality control and system optimisation

• Collection of systematic data on transfusion processes
• Recognising structural weaknesses (e.g. in hospitals, blood banks)
• Derivation of measures to improve quality (e.g. training, new guidelines)

Transparency and trust

• Creating transparency about risks and safety standards for blood products
• Promoting public confidence in the safety of the blood supply
• Basis for the acceptance of transfusions and donations

Haemovigilance can provide reliable data for political decisions in the field of blood supply and also the basis for changes in legislation.

Legal basis

AMG: § 75n (1), § 75n (3), § 75n (5)
Blood Safety Act: § 11 (6) BSG
Regulations on the operation and quality system of blood establishments: § 17 (2)

Published information from monitoring

SARE report: Overall report of the BASG on the reports of serious adverse reactions and transfusion errors, compiled from the annual reports of the establishments subject to reporting requirements. The BASG must submit this report to the European Commission. The Commission compiles a consolidated overall European report from the national reports. The current report can be found here.

Haemovigilance report: The haemovigilance report presents the haemovigilance reports received in the course of a year with a focus on transfusion reactions and blood consumption data and compares them with previous years. Furthermore, near-miss events are described and learning potential is highlighted, which is intended to provide information, increase the safety of blood components and improve the reporting system. The current report can be found here.
Product warnings and recalls can be found here.

Illegal activities involving medicinal products, medical devices, blood and tissue products are prevented through prevention or intervention.

Economic and health policy significance

Combating illegality in the medical market is of paramount importance in terms of health policy, as it directly serves to protect public health, the integrity of the healthcare system and the safety of patients. Illegal activities such as the trade in unauthorised medicinal products or unauthorised online sales pose serious risks.

Combating illegality in the medical market protects patients, strengthens trust, ensures the quality of care and helps to avoid economic and systemic damage. It requires decisive, coordinated action by the authorities at national and international level and is an indispensable part of responsible market surveillance.

Protecting patient safety

Illegal medicines can:

• contain no, too much, too little or the wrong active ingredient,
• have misleading or false information on the packaging or about the origin
• be contaminated or not sterile,
• be incorrectly stored or expired.

Taking them can lead to serious health risks, treatment failure or even death. Combating such products is therefore a direct contribution to patient safety.

Prevention of counterfeit medicines

Counterfeit medicines are a growing global problem. Authorities play a central role in

• Monitoring legal supply chains (e.g. through end-to-end systems),
• the control of distance selling (e.g. internet pharmacies),
• international cooperation to combat cross-border counterfeiting networks.

Strengthening trust in the healthcare system

Patients must be able to rely on authorised medicines being safe and effective. Effectively combating illegality helps to maintain and strengthen trust in doctors, pharmacies and authorities.

Preventing economic damage and distortion of competition

Illegal medicines undermine the legal pharmaceutical market and cause economic damage:

• for the pharmaceutical industry,
• for the state through lost taxes,
• for the healthcare system through the consequential costs of faulty therapies.

Combating illegal activities therefore also protects the economic stability of the healthcare system.

Protection against cybercrime

The illegal trade in pharmaceuticals via online platforms is on the rise. The challenge for health policy is to

• To educate consumers about the risks,
• to differentiate between reputable and dubious online offers (e.g. through officially recognised mail-order pharmacy registers),
• and to take legal action against criminal providers.

Strengthening international cooperation

Pharmaceutical crime is often organised across borders. Effective combating requires

• cooperation with international organisations (e.g. WHO, Interpol, EMA),
• the exchange of information between national authorities (e.g. customs, police),
• joint measures such as global manhunts against drug counterfeiters (Operation Pangea).

Legal basis

The BASG is responsible for enforcing the laws listed in Section 6a para. 1 GESG and their corresponding ordinances. As part of this enforcement, the BASG is obliged to investigate violations of the provisions of these laws and to prevent further violations.

Published information from the monitoring
product warnings can be found in the Official News of the BASG under Illegalities.

Consumers obtain medicines via the Internet from safe sources and in quality-assured form. Illegal sources of supply are prevented by a uniformly labelled and easily recognisable European monitoring system.

Economic and health policy significance

Ensuring the quality and safety of medicinal products

• The aim is to prevent counterfeit, unauthorised or poor-quality medicines from coming into circulation.
• There is an increased risk of counterfeit medicines being distributed via distance selling channels (e.g. online pharmacies).
• With the Falsified Medicines Directive (2011/62/EU), the EU has introduced protective measures, including safety features on packaging and an authorisation requirement for online providers.

Patient safety and informed choice

• Consumer protection takes centre stage: when ordering online, patients should be sure that they are receiving effective and tested medicines.
• Information obligations and transparency requirements (e.g. clear labelling of reputable providers using the EU logo for online pharmacies) should contribute to this.
• Misuse and self-medication should be limited through education and monitoring.

Combating illegal trade structures

• Illegal providers often utilise cross-border structures. Standardised EU regulation is therefore crucial in order to close loopholes.
• Measures against cybercrime in the pharmaceutical sector are part of a broader public health security strategy

Controlling the distance selling of medicines in the EU is a public health necessity to guarantee patient safety, medicine quality and a trustworthy, Europe-wide supply of medicines. This is not just about market regulation, but primarily about protecting public health from the risks of counterfeiting, misuse and unsafe trade channels.

Legal basis

AMG as amended, § 59a
TAMG as amended, § 49 and § 50
Distance Selling Ordinance for Human Medicinal Specialities
Distance Selling Ordinance for Veterinary Medicinal Specialities

Published information from monitoring

The registered distance-selling pharmacies for human medicinal products and veterinary medicinal products can be found in the BASG list.

The supply of medicinal products authorised in Austria meets the needs of the population.

Economic and health policy significance

The official assessment of reported distribution restrictions or lack of availability of medicinal products is of considerable importance in terms of health policy, as it directly affects the security of supply, patient health and trust in the healthcare system.

It is an essential health policy instrument to support the continuous and safe supply of medicinal products, to recognise and influence supply risks from competitors or doctors and pharmacists, for example, and to initiate structural policy measures to strengthen security of supply.

Supporting the supply of medicines

One of the central tasks of healthcare policy is to support the endeavour to ensure that all patients have access to necessary and effective medicines. The official assessment and publication of supply bottlenecks helps to ensure that

• pharmacies, doctors and manufacturers can recognise critical gaps in supply,
• suitable countermeasures (e.g. import exemptions) can be initiated,
• the supply of equivalent alternatives, e.g. by increasing the competitor's production or importing from other countries.

Protection of patient safety

Supply bottlenecks can lead to patients having to switch to less suitable substitute preparations. The official publication of distribution restrictions helps doctors to find medically sensible interim solutions for patients by providing transparent and up-to-date information.

Early warning system and crisis management

By systematically recording and evaluating reported supply bottlenecks, the BASG acts as a data hub for reported distribution restrictions. This is particularly relevant for

• Essential medicines (e.g. cancer drugs, antibiotics, emergency medicines),
• vaccines or medicines to combat crises,
• medicines with only one or a few manufacturers.

This can enable more targeted crisis management.

Transparency and information

Actively informing the public and healthcare professionals (doctors, pharmacies) about distribution restrictions is also relevant to supply. This is ensured by the sales restriction register and the provision of data interfaces for integration into external IT systems. This creates:

• Trust in the healthcare system,
• better planning for service providers and patients,
• appropriate communication of risks.

Economic and structural control

Repeated or structural supply bottlenecks can have complex causes (e.g. production difficulties or ensuring the quality of the medicinal product) or indicate dependencies on non-European production sites. The official assessment provides

• a data basis for political interventions,
• indications of the supply relevance of certain active ingredients and medicinal products.

Legal basis

German Medicinal Products Act (AMG), 57a
Ordinance on Ensuring the Supply of Medicinal Products
Arzneimittelbetriebsordnung 2009 (AMBO 2009)
Directive 2001/83/EC 'Community code relating to medicinal products for human use', Article 1, Article 81
Regulation (EU) 2022/123 'Crisis preparedness and management' Article 11
EMA: Reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice compliance problems
EMA: Good practice guidance for communication to the public on availability issues of medicines

Published information from monitoring
The list of notifications on distribution restrictions for speciality medicinal products.
List in accordance with the Ordinance on Securing the Supply of Medicinal Products pursuant to Section 57a (2) of the Medicinal Products Act.

Market monitoring of medicinal products ensures that safety and efficacy risks are recognised and communicated and that corrective measures are guaranteed.

The monitoring of the pharmacovigilance systems to be set up and operated by the marketing authorisation holders for the market monitoring of medicinal products ensures that risk information is collected in full and passed on to the monitoring authorities.

Economic and health policy significance

Pharmacovigilance systems are legally prescribed structures that marketing authorisation holders (pharmaceutical companies) must set up and operate in order to systematically record, evaluate and report adverse drug reactions and other risks.

A pharmacovigilance system is used to monitor medicinal products in the period following their authorisation. Systematic pharmacovigilance allows benefits and harms to be weighed up and comparisons to be made between different treatments.

These systems are reviewed as part of the PV inspection to determine the suitability of the system for the intended tasks.

The health policy significance of official monitoring of pharmacovigilance systems at the marketing authorisation holders of medicinal products lies primarily in holding pharmaceutical companies accountable.

Only through functioning pharmacovigilance systems can risks be recognised, controlled or mitigated after authorisation. Official monitoring ensures that marketing authorisation holders fulfil their obligations.

The BASG monitors these systems as part of inspections to ensure that they:

• are implemented in accordance with the law,
• are actively operated,
• and contribute effectively to the protection of public health.

The monitoring follows EU-wide harmonised guidelines such as the Good Pharmacovigilance Practices (GVP). This ensures that all pharmaceutical manufacturers - regardless of where they are based - are subject to the same requirements.

Legal basis

Medicinal Products Act § 75f (1) to (6)
Veterinary Medicinal Products Act § 39 (1)

Only legally compliant or safe medicinal products (pharmaceuticals and blood products) are imported into Austria according to the current state of knowledge.

Economic and health policy significance

Quality-assured supply of the population with medicinal specialities not authorised or available in Austria, which are imported from EEA countries or third countries at the request of the treating physician or due to a distribution restriction.

Quality-assured supply of clinical trials with medicinal specialities from third countries.
Ensuring conformity with the European manufacturing standard (Article 51 of Directive 2001/83/EC) for medicinal products imported from third countries.
Monitoring the re-export of products not destined for the EEA.

Legal basis

According to Section 7 (1) of the Medicinal Products Act, medicinal products may only be dispensed or held for dispensing in Austria if they have been authorised by the BASG, unless they are (among other things) medicinal products whose introduction or import is carried out in accordance with the Medicinal Products Import Act 2010, Federal Law Gazette I No. 79/2010, as amended.

When they are placed on the market, medicinal products fulfil the legal requirements, comply with the specifications of their marketing authorisation and are free of any recognisable defects.

Economic and health policy significance

The importance of the official processing of quality defects lies in active risk prevention, the promotion of transparency and quality as well as in ensuring trust and efficiency in the healthcare system. It is an indispensable component of drug safety and healthcare.

This not only serves to directly protect patient safety, but also to ensure long-term trust in the healthcare system. The following key aspects arise in detail:

Safeguarding patient safety

Quality defects in medicinal products - e.g. impurities, incorrect information on dosages or reduced efficacy - can lead to damage to health. The official assessment enables rapid intervention (e.g. through recalls) to protect patients from harm.

Protection of public health

Individual quality defects can develop into a problem for the wider population, especially if there are systemic defects in production. Consistent action by the authorities prevents exposure to defective products.

Maintaining and promoting trust in the healthcare system

Transparent, reliable and responsive action by the authorities creates trust among patients, doctors and pharmacists. This is essential, as medicinal products are based on the principle of trust: patients must be able to be sure that the prescribed medication is safe and effective, but also free of defects.

Ensuring the quality of medicines on the market

The authority sets a standard for pharmaceutical quality by systematically assessing and monitoring all phases of the life cycle of medicinal products. Manufacturers are obliged to comply with strict production guidelines (e.g. GMP - Good Manufacturing Practice) and to react immediately to any suspected deviations. This contributes to the stability and safety of the pharmaceutical market.

Health economic relevance

Quality defects can cause follow-up costs: additional treatments, hospitalisation or the need for replacement deliveries. Efficient management of such deficiencies by the authorities has a cost-reducing effect on the healthcare system.

International co-operation

In globalised pharmaceutical production, cooperation between authorities at an international level is crucial. The national processing of quality defects can lead to information flows to other authorities if they are affected. Cooperation contributes to international drug safety and the harmonisation of regulatory standards.

Legal basis

Medicinal Products Act (AMG), Section 75q
Arzneimittelbetriebsordnung 2009 (AMBO 2009), Section 34
Tierarzneimittelgesetz (TAMG), Section 42
Tierarzneimittelbetriebsordnung 2009 (TAMBO), Section 34
Directive 2001/83/EC 'Community code relating to medicinal products for human use' Article 117
Directive EU/2017/1572 'Good manufacturing practice for medicinal products for human use' Article 13
EMA: Compilation of Union Procedures on Inspections and Exchange of Information
EMA: Management and classification of reports of suspected

Published information from surveillance

Safety information and recalls can be found in the Official Notices of the BASG for the human sector.

Safety information and recalls can be found in the Official Notices of the BASG for the veterinary sector.

If the desired information cannot be found in the above publications, you can submit a request for information.