Pharmacovigilance in Austria
How is it with the drug safety system in this European country? Read our guide to get a clear picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Austrian pharmacovigilance services:
LCPPV / EU QPPV in Austria
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Austria?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Austria is the Federal Office for Safety in Health Care (BASG), headquartered in Vienna, Austria. BASG operates under the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK).
BASG is responsible for several key tasks related to pharmacovigilance, including: monitoring adverse reactions, implementation of safety measures and much more.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has an English version, and nearly all pages containing the most important information appear to be translated. However, some forms are only available in German.
In case you can’t find what you’re looking for, we suggest trying the German version of the website with the help of online tools like Google Translate. It is sometimes the reality of local authority pages that certain content is only available in the native language version.
Interesting website sections related to pharmacovigilance
FREQUENTLY ASKED QUESTIONS
Do you want to know for which kinds of medicinal products should PSURs be submitted? Or which medicinal products require RMPs? Answers to these questions and to many others about PV system in Austria can be found in this very comprehensive section.
PHARMACOVIGILANCE INSPECTIONS
Find out more about pharmacovigilance inspections that are conducted by The Institute for Surveillance (AGES Medizinmarktaufsicht).
It regularly checks pharmacovigilance systems across Austria to ensure that they comply with both Austrian and European regulations.
MEDICINAL PRODUCTS DATABASE
The BASG keeps a detailed database called “Arzneispezialitätenregister” that includes information on all products approved for use in Austria. A special section of the website is dedicated to this medicine register.
FACTS WORTH KNOWING ABOUT MEDICINES
Whether you want to know more about different types of medicines, their use or storage for example, all essential information can be found in this section.
WHAT’S NEW & NEWSLETTERS
Something new in medicine and health is happening every day. If you want to stay on track for Austria, be sure to follow this news section or subscribe to the “UptoDate” newsletter. It regularly features the most recent articles from the past month – however, only in German.
Other important institutions & industry groups
FEDERAL MINISTRY OF SOCIAL AFFAIRS, HEALTH, CARE AND CONSUMER PROTECTION (BMSGPK)
This ministry oversees public health policies in Austria and works closely with BASG and AGES to implement health regulations and ensure the safety of healthcare practices.
Although there’s no section entirely focused on pharmacovigilance, you can take a look at the Annual reports on patient safety or the department’s efforts to improve health system, represented by their Health Care Reform or project eHealth.
BMSGPK website: https://www.sozialministerium.at/en.html
PHARMIG
A voluntary, politically independent organisation representing the interests of the Austrian pharmaceutical industry at national and international level. PHARMIG covers around 120 companies.
We recommend to visit their Publication section and look for the latest “PHARMIG Facts Figure” – there is a chapter which also includes information related to pharmacovigilance (in the 2024 issue, it starts with page 71).
PHARMIG website: https://www.pharmig.at/
AUSTRIAN GENERIC MEDICINES ASSOCIATION
Officialy called “Österreichischen Generikaverband”, this association unites 10 manufacturers and suppliers of generic medicines in Austria. The main goal of this group is to promote use of generics to public and it also tries to shape current health policy debate in general.
In its “Wissenshub” section (knowledge hub), it publishes materials mostly related to regulations and drug supply.
Generikaverband website: https://www.generikaverband.at/
Some of the most important laws
Basic legislation
Austrian Medicines Act (Arzneimittelgesetz – AMG)
Updated in 2012 to follow the EU pharmacovigilance rules, the Austrian Medicines Act is the main law that covers medicinal products, including the requirements for pharmacovigilance.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
Developed by the Pharmig providing guidelines for its member companies on various aspects, including pharmacovigilance and adverse event reporting – not a legal requirement.
Essential EU Legislation and EMA Guidlines
Since Austria is a member of the EU, every Marketing Authorization Holder with a product on the Austrian market needs to follow the European pharmacovigilance legislation and guidelines by EMA (European Medicine Organization).
To navigate through the European regulations, its is useful to know following:
EMA Pharmacovigilance System Manual
Directive 2001/83/EC and Regulation (EC) 726/2004
Commission Implementing Regulation (EU) 520/2012
Local pharmacovigilance specifics
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Austria, following terms will be helpful for you to get familiar with:
EMA (European Medicine Organization)
→ Key part of the EU, dedicated to ensuring the safety and effectiveness of medicines.
EVPM (EudraVigilance post-authorization module)
→ Dedicated to the collection of ICSRs related to all medicinal products authorised in the EEA.
PRAC (Pharmacovigilance Risk Assessment Committee)
→ Committee responsible for assessing and monitoring the safety of human medicines
BASG (Bundesamt für Sicherheit im Gesundheitswesen)
→ Federal Office for Safety in Health Care
AGES Medizinmarktaufsicht
→ AGES MEA / Austrian Medicines and Medical Devices Agency
BMSGPK (Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz)
→ Federal Ministry of Social Affairs, Health, Care and Consumer Protection
Is LCPPV needed or is EU QPPV enough?
LCPPV is not legally required in Austria. However, according to Austrian law, the BASG has the option to request the nomination of an LCPPV from the Marketing Authorization Holder (MAH) if deemed necessary.
If an LCPPV is requested by the BASG, there are no specific legal requirements for the qualifications of this person.
If you need a translation of those instructions or more information about LCPPV requirements in Europe in general, just check our free comprehensive guide available here.
How can be adverse events reported in Austria?
Adverse reaction reports can be submitted using online forms that are available on this BASG subpage.
The forms differ for healthcare professionals, patients and pharmaceutical companies. Reporting by email or a phone is also possible (well described on the linked page).
Local medical journals to screen
Here are few examples of Austrian local literature sources that medical authorization holders should monitor:
WIENER KLINISCHE WOCHENSCHRIFT
Founded in 1888, this is considered one of the most prestigious medical journals in Austria.
It is published by Springer and covers a wide range of medical topics.
ISSN: 1613-7671
JOURNAL FÜR ENDOKRINOLOGIE, DIABETOLOGIE, UND STOFFWECHSEL
Publishes original research, reviews, case reports, and commentaries focused on all aspects of endocrinology and metabolic diseases. It aims to provide practical insights and updates.
ISSN: 1998-7781
MEDUNI VIENNA LIBRARY CATALOGUE
The library catalogue of Medical University in Vienna offers the largest collection of medical literature and media in Austria, including both current and historical materials. It provides efficient access to scientific literature and information in the field of medicine and related areas.
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
Country Public Health / Health System Assessments
SoHEU Austria: Country Health Profile 2023
The 2023 edition of “State of Health in the EU: Austria” provides a comprehensive look at the health landscape in the country, exploring key topics such as overall health status, important health determinants and risk factors, and how the health system is organized and funded.
Large publication (292 pages) with detailed examination of Austrian health system – its history, changes and recent state.
An analysis of the present status quo of Public Health in Austria and recommendations for further improvement.
Publications and useful links by basg and AGES
Browse this subsection to explore BASG annual reports or scroll through scientific publications on Pharmaceuticals & Medical Devices by AGES.
All important links regarding health system and pharmacovigilance in one place (selection by BASG).
AGES Medical Market Surveillance
AGES – Institutes, services and links
If you want to better understand different roles of AGES, the section linked above is the right place. Also definitely visit this page to access a list of distribution restrictions in Austria, information on clinical testing of medicinal products or related links.
Studies related to pharmacovigilance in Austria
Patient safety culture in Austria
A study focused on factors that contribute to higher degree of patient safety in Austria. Based on the findings, it suggests specific improvements for patient safety in hospitals.
Potentially inappropriate medication in older persons in Austria
A nationwide prevalence study that aimed to assess potentially inappropriate medication (PIM) among aged Austrians. The result: According to the study, Austria urgently needs a nationwide strategy to reduce the high overall prevalence of PIMs.
This study tries to estimate the amount of severe drug-drug interaction warnings before and after the introduction of a nationwide eMedication system in Austria.
Do you need some help with putting the Austrian PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
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