Market Surveillance

Market surveillance

The Federal Office for Safety in Health Care is dependent on reports from consumers, health care professionals and companies to continually re-evaluate the safety profile of medicinal products and medical devices. For this purpose, the BASG is also in constant exchange of information with other medicines authorities of the European Economic Area.

Depending on the identified risk, individual product batches can be recalled or warnings issued. Via official notifications, the BASG informs all interest groups at short notice about changes in the safety profile of medicinal products and medical devices or current risks.

In the medium term, these indications or changes will be taken into account in the marketing authorisation of a medicinal product by establishing indications of adverse reactions or restrictions on use. If the risk is particularly high, the marketing authorisation may also be suspended or withdrawn.

Representatives of the BASG participate in Austrian and European committees and working groups, in which these topics are discussed in order to make well-founded and Europe-wide agreed decisions, which are then implemented at national level.

The public registers shall provide information on the current status of this continuous process of revaluation. For example, in the Register of Medicinal Specialities, the instructions for use (package insert) and the specialist information for representatives of the health care professions can be called up on a daily basis.

Information

PSURs

For all authorised medicinal products it is required to submit Periodic Safety Update Reports (PSURs) to BASG.

PSURs read more

Haemovigilance annual reporting

Additional to immediate reporting, the Austrian Blood Safety Act requires an annual summary as basis for the Haemovigilance Report.

Haemovigilance annual reporting read more

Tissue vigilance annual reporting

Additional to immediate reporting, the Austrian Tissue Safety Act requires an annual summary as basis for the Tissue Vigilance Report.

Tissue vigilance annual reporting read more

Addictive substances

Companies holding an authorisation according to the Austrian Addictive Drug Act have to report annually import, production, use and release to BASG.

Addictive substances read more
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