Areas of activity
Tasks of market surveillance
Processing reports on quality or product defects regarding medicinal products approved in Austria. Defects can be reported by physicians, pharmacists, wholesalers and marketing authorisation holders. Any report is registered, the health risk arising from the defect is assessed, the causes of the defect are determinted, and the party responsible is required not only to redress the causes but also to take appropriate measures to prevent similar occurrences in the future. In case of defects associated with significant health risks, a recall of the affected batch under official supervision may be ordered.
Review of drug advertising
Periodically reviewing drug advertising in the Austrian media. Advertising found to be in contravention of legal requirements is assessed. If necessary, the borderline review panel is called to resolve questions regarding product classification. Where appropriate, cases are reported to law enforcement agencies by BASG/AGES PharmMed.
Enforcement
Observing, researching and inspecting any illegal procedures related to medicinal products and medical devices. These activities are carried out in close cooperation with both national and international partners. Contraventions susceptible of proof are reported to law enforcement agencies. Informing people and raising public awareness, especially of the dangers of buying medicines on the Internet is part of this aspect of medical market surveillance.
Created: 10.05.2009