NIS regulation in force as of 01.09.2010
In Federal Law Gazette II No. 180/2010, the Federal Minister of Health made use of the power to issue an ordinance pursuant to Section 48 (3) AMG and issued the Ordinance on the Conduct of Non-interventional Studies. This ordinance stipulates that every non-interventional study started after 01.09.2010 must be reported electronically by the responsible person to the Federal Office for Safety in Health Care (BASG) before it is carried out. The aim of this regulation is to create more transparency and clarity and, in addition, to generate valuable data for drug safety.
These studies represent an opportunity to complete the safety profile of the drug with data from everyday life. A reporting registry will be available on the AGES PharmMed website. All patient-related records are anonymized and therefore cannot be assigned to an individual patient. In addition, a "Scientific Guideline for the Conduct of Non-Interventional Studies (NIS) in Austria" will be made available on the BASG/AGES PharmMed website as an aid to planning, reporting and conducting a non-interventional study.
More information:
Regulation on the Conduct of Non-Interventional Studies
Press Conference "More Transparency and Safety for Patients
Queries:
AGES PharmMed
E-mail: nis@ages.at
