Medicine

Services
Changed on: 02.02.2017

AGES has competencies at its command in various business areas in dealings with medicines. The main tasks in this regard are assumed by the AGES Medicines and Medical Devices Agency (MEA), which is responsible for checking the efficacy, safety and quality of medicines. To this end, the AGES MEA collects and evaluates all the data required by the Federal Office for Safety in Health Care (BASG) for the licensing of proprietary medicinal products and for renewal or variation to  marketing authorisations.

As soon as a medicine is authorised  and available on the market, it is automatically recorded by the AGES MEA  pharmacovigilance system. Amongst other things, this system contains the statutory reporting obligation (Austrian Medicines Act, Austrian Pharmacovigilance Ordinance 2013), which serves to minimise risks such as side effects or interactions. In addition, in the course of life cycle management, proprietary medicinal products are checked at regular intervals with regard to safety and efficacy. Licenses have to be reviewed at least once  after five years.

Another pillar of drug safety is pharmaceutical analysis. In the Official Medicines Control Laboratory (OMCL) proprietary medicinal products and vaccines, as well as blood, plasma and tissue products are quality checked against specifications. Quality defects are immediately notified to the Federal Office for Safety in Health Care (BASG) where they are published in relevant cases and the affected products withdrawn from the market if required. Medicines that are delivered via internet orders or medicines of unknown origin (e.g. customs seizures) are checked with regard to composition and authenticity. Data obtained in the laboratories is exchanged in national and international networks in order to protect consumers from lesser quality medicines and illegally produced or traded products.

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