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.

For reporters subject to § 75q Austrian Medicines Act


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

Recalls and Classification

Recalls are following the "Compilation of Union Procedures on Inspections and Exchange of Information", which is published by the European Medicines Agency (EMA) and applies in all European member states.

Recalls refer to the following classification system:

  1. A Class I recall action relates to a potentially life-threatening issue.
  2. A Class II recall action generally relates to an issue that could cause illness or mistreatment, but which does not warrant a Class I alert/recall.
  3. A Class III recall action concerns an issue that may not pose a significant hazard to health. In this case a recall may be initiated for other reasons.

Defective product report template

Documents of interest

"Compilation of Union 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.

"Quality defects and recalls"

Information of the European Medicines Agency regarding quality defects and recalls.




Further inquiry note