Quality defects
For patients
If you suspect that the quality of your medicinal product may not correspond, first check the package leaflet (instructions for use) referring to point 6. for information on the appearance of the medicinal product and the contents of the package.
The currently valid version of the instructions for use can be found in the Austrian medicinal product index on the BASG website.
If you still have questions, contact your physician or pharmacist. They will submit a quality defect notification to the BASG.
Further inquiry note
Fax: +43 (0)50 555- 36408
Address for sending defect samples
If you wish to send a defective drug for examination as part of a quality defect notification, please use the following laboratory address:
Bundesamt für Sicherheit im Gesundheitswesen (BASG)
Institut Begutachtung & Analytik / Abteilung CPAA
Spargelfeldstrasse 191, 1220 Wien
24H number
Please note: The emergency number is only to be used for emergencies within the meaning of § 10 Pharmacovigilance Ordinance 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.
24-hour emergency telephone number for pharmacovigilance officers or safety officers:
Phone: +43 (0) 664 831 28 43
Defective product report template
- Available in German only
Defective product report template for healthcare professionals25/05/2022 - Available in German only
Defective product report template for pharmacies and wholesalers25/05/2022 - Available in German only
Defective product report template for marketing authorisation holders25/05/2022
Documents of interest
"Compilation of Community Procedures on Inspections and Exchange of Information"
This procedure is published by the European Medicines Agency and applies in all European member states for dealing with quality defects and recalls.
Information of the European Medicines Agency regarding quality defects and recalls.