Reporting

Reporting includes monitoring of medicinal products used for the prophylaxis, diagnosis or treatment of diseases in the period following their authorisation.

It covers all reports concerning adverse reactions, quality defects or illegality of medicinal products. Side effects from clinical studies are also reported.

If you have problems with a medical device, you can also make notifications.

Who should report when?

Medicinal products

Members of the health professions, doctors, dentists, veterinarians, dentists, midwives, pharmacists, druggists and companies who are authorised to manufacture or wholesale medicinal products in accordance with the Industrial Code 1994 are obliged under the Medicines Act and the Pharmacovigilance Ordinance to report any adverse reactions occurring in Austria to the BASG. Patients and their relatives can also report suspected adverse drug reactions directly to the BASG.

Medical devices

Malfunctions, quality defects or side effects of a medical device are reported by health care professionals or by manufacturers and distributors.

Haemovigilance

The medical director of a hospital blood bank, where such a bank does not exist, the medical director of a hospital, established doctors including group practices and the medical director of a blood bank are obliged to report serious undesirable reactions.

The responsible person of an establishment that processes, stores or distributes human blood or blood components intended for transfusion, the medical director of a blood establishment, the medical director of a hospital blood bank where there is no blood bank, the medical director of a hospital, and established doctors including group practices are obliged to report serious incidents.

Tissue Vigilance

Each institution shall report all suspected serious adverse reactions and incidents.

What should be reported?

Side effects

A side effect is a reaction to the medicinal product that is harmful and unintended. It shall be considered a serious adverse reaction if the reaction is fatal or life-threatening, requires hospitalisation or prolongation of hospitalisation, results in permanent or serious disability or invalidity, or is a congenital anomaly or birth defect.

Quality defects

If you suspect that the quality of your medicinal product may not correspond, first check the package leaflet (instructions for use) under point 6. for information on the appearance of the medicinal product and the contents of the package.

If you still have questions, contact your doctor or pharmacist. They have the possibility to submit a quality defect notification to the BASG.

Illegal medicines

If you have a well-founded suspicion that a drug that you have purchased from a legal source could be a counterfeit or an illegal drug, the BASG is the competent authority to report to.

Problems with a medical device

If you suspect malfunction, lack of quality, or side effect of a medical device, or a counterfeit of a medical device, first contact the person treating you, or the retailer from whom you purchased the medical device, or the manufacturer of the medical device, who, as members of a legally regulated health profession or as distributors of a medical device, have the opportunity to submit a corresponding notification to the AGES Medical Market Authority.

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