Health for humans, animals & plants

Medical Market Supervision Services

The AGES Medical Market Surveillance is responsible for a wide range of tasks related to drug approval, clinical testing of drugs and medical devices, pharmacovigilance and vigilance in the field of medical devices, and inspections. The Federal Office for Safety in Health Care (BASG), a subordinate authority of the Federal Ministry of Social Affairs, Health, Long-Term Care and Consumer Protection, is entrusted with the execution of the regulatory tasks that coincide with the work of the Medical Market Inspectorate. Here you will find a summary of the services of the Medical Market Authority with links to further information on the BASG website.

Pharmaceutical Specialties Registry

Drug specialties are medicinal products that are always marketed in the same composition and under the same name in a specific form. The Register of Proprietary Medicinal Products contains information (e.g., expert information, directions for use) on all proprietary medicinal products authorized in Austria under the Austrian Medicines Act.

Distribution restrictions

If prescription-only medicinal products are likely to be insufficiently available, their marketing authorization holders are obliged to announce this in good time. These notifications are published by the Federal Office for Safety in Health Care (BASG) in the distribution restriction register.

Latest news

The Federal Office for Safety in Health Care (BASG) publishes official news on its website, such as current brief reports, safety information, reports on quality defects of medicinal products and safety warnings on medical devices.

Side effect reporting

Reporting side effects helps to ensure that more information is available about the safety of a drug. Physicians, pharmacists and other healthcare professionals are required by law to report adverse reactions to the Federal Office for Safety in Health Care (FOSH). Patients and their relatives can report side effects voluntarily.

Illegal market

There is an illegal market for any product of value, and medicines and medical devices are no exceptions. The tasks of the Federal Office for Safety in Health Care (BASG) also include combating and reporting violations of the law and preventing illegalities in the medical market.

Clinical trial

On the website of the Federal Office for Safety in Health Care (BASG) you will find relevant information on the submission as well as on fees and obligations in the context of clinical trials of medicinal products. Information on the notification procedure as well as obligations and procedures in the context of clinical trials of medical devices can also be found on the BASG website.

Laboratory

The Official Medicinal Control Laboratory (OMCL) of AGES carries out, among other things, batch releases of medicinal products, checks legal medicinal products and examines and assesses illegal or unknown medicinal products.

eSERVICES

On the page of the Federal Office for Safety in Health Care (BASG) you will find all current information about registration, updates, downtimes as well as important general announcements about the eServices of the Medical Market Authority.

Last updated: 22.01.2022

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