Medicines

Authorisation of medicines

Authorisation of medicines on the basis of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) is one of the main duties of the Austrian Federal Office for Safety in Health Care/Austrian Medicines and Medical Devices Agency.

During the authorisation procedure, experts assess the medicine's efficacy, safety and quality. A medicine will only be authorised with an adequate benefit-risk-profile, i.e. if the benefits exceed the risks.

An authorisation is initially granted for five years. Before the end of this period, a subsequent application needs to be made to the Austrian Federal Office for Safety in Health Care/Austrian Medicines and Medical Devices Agency, on the basis of which the medicine is re-assessed. Positive assessment leads to renewal of the authorisation.

Furthermore, any variations of medicines must be submitted to the Austrian Federal Office for Safety in Health Care/Austrian Medicines and Medical Devices Agency for approval.

Authorisation types

In Europe there exist three types of procedures for the authorisation of medicines:

  1. national procedure
  2. mutual recognition/decentralised procedure
  3. centralised procedure

Created: 01.03.2009 | Page last modified: 19.04.2013

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