An adverse reaction is a reaction to the drug that is harmful and unintended. It is considered a serious adverse reaction if the reaction is fatal or life-threatening, requires hospitalization or prolongation of hospitalization, results in permanent or serious disability or incapacity, or is a congenital anomaly or birth defect.
For vaccines, the absence of an effect (e.g., no vaccine protection after vaccination has occurred) is also particularly relevant and should be reported in all cases.
Health care professionals, like physicians, dentists, veterinarians, dentists, midwives, pharmacists, druggists, and tradespeople who are authorized to manufacture medicinal products or engage in wholesale trade in medicinal products pursuant to the Gewerbeordnung 1994 (Trade, Commerce, and Industry Regulation Act) are required to report adverse drug reactions occurring in Austria to the BASG pursuant to the Arzneimittelgesetz (Medicinal Products Act) and Pharmakovigilanzverordnung (Pharmacovigilance Ordinance).
Patients and relatives also have the option of voluntarily reporting suspected adverse drug reactions directly to the BASG.
Online form for patients
Online form for healthcare professionals
BASG, 1200 Wien, Traisengasse 5
+ 43 (0) 50 555 36207
+ 43 (0) 50 555 36600
24-hour emergency telephone number for pharmacovigilance officers or safety officers:
Tel.: +43 (0) 664 831 28 43
Please note: The emergency number is only to be used for emergencies within the meaning of § 10 Regulation on Pharmacovigilance or § 70 Austrian Medical Devices Act.
An emergency only exists if there is an immediate danger to life or a serious and considerable danger to health.
Any further questions or information should be submitted via the contacts of the Austrian Federal Office for Safety in Health Care.
Your reports will be treated confidentially. There are no negative consequences for the notifier.
By reporting adverse reactions, you can help provide more information about the safety of this medicine.
Once the Federal Office for Safety in Health Care has identified medically unacceptable risks, it can support the safe handling of medicinal products by imposing restrictions on use - possibly until the withdrawal of a marketing authorisation already granted by the authorities. The Federal Office for Safety in Health Care cooperates with the relevant authorities in other European Member States and with the European Medicines Agency.
The reporting of suspicious cases is therefore indispensable in terms of consumer protection.
We would also like to draw your attention to the European database, where you will find information on adverse reactions of medical products and active substances (at EU level).
- Meldung über eine Arzneimittel-Nebenwirkung (auch Verdachtsfälle)28/11/2019
- Patientenmeldung über eine Arzneimittel-Nebenwirkung (auch Verdachtsfälle)28/11/2019
- Nebenwirkungsmeldungen bei Pandemie – Impfstoffen11/12/2020
While vaccines are safe and effective for most patients, they can have potential side effects in addition to positive effects, which can occur in individual cases. It is therefore particularly important that side effects of vaccines are reported and evaluated. This allows the respective benefit-risk ratio to be further evaluated continuously and comprehensively even after approval, thus ensuring that all available vaccines are safe.
In Austria, adverse reactions can be voluntarily reported directly to the Federal Office for Safety in Health Care (BASG) by patients as well as their relatives. Physicians, pharmacists, and other health care professionals are required by law to report adverse reactions.
An adverse reaction is any reaction to the vaccine that is harmful and unintended. In the case of vaccines, the absence of an effect (e.g., no vaccine protection after vaccination) is also particularly relevant and should be reported in all cases.
To report adverse reactions after COVID-19 vaccination or the lack of a protective effect after vaccination has taken place, please use one of the following options:
- Online form for patients
- Online form for healthcare professionals (for direct online registration)
- Paper form to print (to send via the following ways):
- By Post: BASG, 1200 Wien, Traisengasse 5
- Fax: 0043 (0) 50 555 36207
- E-mail: firstname.lastname@example.org
If possible, please provide at least the following information:
- Information about the person who experienced the side effects, including age and sex.
- Description of the side effects, including date of occurrence
- Name of the vaccine (brand name and active ingredient) suspected of causing the side effects
- Lot number of the vaccine (on the package)
- Any other medicines taken around the same time (including non-prescription medicines, herbal remedies, or contraceptives)
- Contact person for queries (name, contact details)
Marketing authorisation holder should send all suspected serious and non-serious post-marketing case reports, which occurred within Austria, directly electronically to EVPM (EudraVigilance post-authorization module). This also includes case reports from the worldwide literature and non-interventional data collection schemes which occurred in Austria.
Medical literature monitoring – MLM Service EMA
Since September 2015 the European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorised in the European Union, and for entering the relevant information into the EudraVigilance database.
The MLM service currently includes 300 active substances and 100 herbals.
The results of this research is available for MAHs and member states as Individual Case Safety Reports (ICRS) in the Eudravigilance database. However, this does not release pharmaceutical companies from their obligation to monitor the literature (local literature search) with regard to their marketing authorisations.
In the interests of effective pharmacovigilance, it is essential that reports of suspected adverse reactions are received by the competent authority.
Accordingly, § 75g Austrian Medicines Act stipulates that healthcare professionals must report suspected adverse reactions to the Federal Office for Safety in Health Care without delay.
According to § 75h Austrian Medicines Act, patients can and should also report suspected adverse reactions to the Federal Office for Safety in Health Care.
Another way of reporting suspected adverse reactions is to report them to the marketing authorisation holder. According to § 75j Austrian Medicines Act, a marketing authorisation holder may not refuse the acceptance and examination of reports from healthcare professionals and patients. Marketing authorisation holders are obliged to submit information on all suspected adverse reactions electronically to the Eudravigilance database. This ensures that the competent authorities also become aware of reports of suspected adverse reactions received by the marketing authorisation holder. Furthermore, the marketing authorisation holder is obliged to inform himself regularly about the reports in accordance with §§ 75g and 75h Austrian Medicines Act by means of the Eudravigilance database.
The Austrian Medicines Act does not provide for other types of reporting of a suspected adverse reaction.
The reporting channels for suspected adverse reactions described above ensure that these reports of suspected adverse reactions are assessed for causality, that the benefit-risk ratio of all approved drugs is continuously monitored in close cooperation with the European network of authorities, and that a continuous evaluation takes place, which is reflected in the current version of the technical information.
In the case of vaccines, the absence of an effect (e.g. no protection after a second vaccination) is also particularly relevant and should be reported in any case. In the case of COVID-19 vaccines, 1 to 2 doses are necessary for complete vaccine protection, depending on the vaccine, and then a certain period of time must be waited for the development of an appropriate immune response. In this context, it has been defined that COVID-19 should be reported as a so-called vaccine breakthrough when a period of 7 days has elapsed after the 2nd dose or a period of 28 days or more has elapsed after the single dose. This means that the affected person is SARS-CoV-2 positive and also has symptoms such as fever, shortness of breath, cough, loss of smell or taste. Infection with SARS-CoV-2 after COVID-19 vaccination, with no apparent illness with symptoms, is not currently considered a vaccine breakthrough, as the currently licensed COVID-19 vaccines were developed to prevent illness.
Medication errors are unintentional errors in the prescribing, dispensing, administration or monitoring of a medicine while under the control of a healthcare professional, patient or consumer. They are the most common single preventable cause of adverse events in medication practice: An estimated 19 - 56% of all adverse drug events among hospital patients result from medication errors that would be preventable1.
According to a WHO statistics, 18% of all European citizens claim to have experienced a serious medical error in a hospital and 11% to have been prescribed wrong medication.
Since July 2012, the new European pharmacovigilance legislation has required all adverse drug reactions resulting from medication errors at the European level to be reported to EudraVigilance, the European database of adverse drug reactions.
The legal requirements detailed in Title IX of Directive 2001/83/EC and chapter 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, marketing authorisation holders and the European Medicines Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union are addressed in Module VI of the "Guideline on Good Pharmacovigilance Practices“ (GVP): Module VI – Collection,management and submission of reports of suspected adverse reactions to medicinal products(Rev 2) ".
Medication errors are an important topic on the agenda of the European Medicines Agency. In February 2013 the European Medicines Agency organised a regulatory workshop on medication errors.
The Committee for Medicinal Products for Human Use published a position paper on potential medication errors in the context of risk-benefit balance and risk minimisation measures (EMA/274183/2012).
1 'Creation of a better medication safety culture in Europe: Building up safe medication practices', Council of Europe Expert Group on Safe Medication Practices (2006).
No. Testing should be performed only with the European Medicines Agency. For further information see http://www.ema.europa.eu.
Literature cases have to be submitted electronically to the European Medicines Agency. The copy of the original literature article should be sent to evlit @ema.europa.eu
Events may occur, which do not fall within the definition of reportable valid Individual Case Study Reports (ICSR), and thus are not subject to the reporting requirements, even though they may lead to changes in the known risk-benefit balance of a medicinal product and/or impact on public health. Examples include:
• major safety findings from a newly completed non-clinical study;
• major safety concerns identified in the course of a non-interventional post-authorisation study or of a clinical trial;
• signal of a possible teratogenic effect or of significant hazard to public health;
• safety issues published in the scientific and medical literature;
• safety issues arising from the signal detection activity (see Module IX) or emerging from a new ICSR and which impact on the risk-benefit balance of the medicinal product and/or have implications for public health;
• safety issues related to the use outside the terms of the marketing authorisation;
• safety issues due to misinformation in the product information;
• marketing authorisation withdrawal, non-renewal, revocation or suspension outside the European Union for safety-related reasons;
• urgent safety restrictions outside the European Union;
• safety issues in relation to the supply of raw material;
• lack of supply of medicines.
These events/observations, which may affect the risk-benefit balance of a medicinal product, are not to be submitted as ICSRs. They should be notified as emerging safety issues in writing to the competent authorities in Member States where the medicinal product is authorized via email and to European Medicines Agency via email; this should be done immediately within 3 working days when becoming aware of them. The document should indicate the points of concern and the actions proposed in relation to the marketing application/authorisation for the concerned medicinal product. Those safety issues should also be analysed in the relevant sections of the periodic safety update report of the authorised medicinal product.
- Only available in German24/07/2018
- Only available in German24/07/2018